A Pilot Study of Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas

This phase II trial tests the safety, best dose, and effectiveness of epcoritamab when given with etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for the treatment of patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that can bind to two different antigens at the same time. Epcoritamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The EPOCH-R is administrated as the standard of care treatment. This may help the immune system kill cancer cells. Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma.

开始日期2026-01-01

申办/合作机构

University of Washington

[+1]

NCT06015750

/ Not yet recruiting临床4期

An Interventional, Prospective Open-Label Study of Immunosuppressive Therapies to Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ?) for Hypophosphatasia (RESTORE)

The primary objective of this study is to evaluate the effect of immunosuppressive therapy (IST) in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness (LoE).

开始日期2025-11-19

申办/合作机构

Alexion Pharmaceuticals, Inc.

NCT06792825

/ Not yet recruiting临床2期IIT

HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma

The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-na?ve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.

开始日期2025-10-01

申办/合作机构

University of Minnesota Masonic Cancer Center

[+1]

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项与利妥昔单抗相关的文献（医药）

2025-12-31·RENAL FAILURE

The efficacy and safety of rituximab monotherapy in the new onset pediatric idiopathic nephrotic syndrome: a randomized controlled clinical trial

Article

作者: He, Si-Yi ; Zhao, Jing-Li ; Dou, Ya-Lan ; Wang, Jing-Jing ; Liu, Fei ; Shen, Hui-Jun ; Zhang, Xiao-Jing ; Fu, Hai-Dong ; Li, Qiu-Yu ; Huang, Ling-Fei ; Lu, Zhi-Hong ; Sheng, Ai-Qin ; Yan, Wei-Li ; Mao, Jian-Hua ; Feng, Chun-Yue

BACKGROUND:

Nephrotic syndrome (NS) is a common form of glomerular disease in children, characterized by a high propensity for relapse. Prolonged use of glucocorticoids (GCs) can result in various side effects. Rituximab (RTX) may be considered as an initial treatment option for primary nephrotic syndrome in pediatric patients.

METHODS:

We conducted a prospective, single-center, randomized controlled trial (RCT) to evaluate whether the initial use of RTX monotherapy is superior to GC therapy in treating pediatric idiopathic NS and to assess its safety. The primary outcome and secondary outcomes were compared between the two groups.

RESULTS:

A total of 24 pediatric patients were included in the study, comprising 19 males and 5 females. After six weeks of treatment, the complete remission (CR) rate in the GC group was significantly higher than that in the RTX group (100% vs 33.3%). Compared with the RTX group, the GC group had a shorter time to first remission (14.25 d vs. 9.5 d). During the follow-up period, none of the patients in the RTX group who achieved CR experienced relapse, with the longest relapse-free duration being 79 weeks. In the GC group, nine patients experienced relapse with the longest relapse-free period being 94 weeks. No serious adverse events occurred in either group. The cumulative steroid dosage was not statistically different between the 2 groups (p = 0.41).

CONCLUSION:

Although the CR rate of children with idiopathic NS treated with RTX alone is significantly lower, the relapse rate among responders to RTX is also lower than that of the GC treatment.

2025-12-31·Hematology

Dose adjusted EPOCH-R is superior to RCHOP in frontline treatment of mediastinal large B cell lymphoma

Article

作者: Shahin, Omar ; Abufara, Alaa ; Al-Rwashdeh, Mohammad ; Muqbel, Ro’a ; Halahleh, Khalid ; Al-rabi, Kamal ; Al-Ibraheem, Akram ; Abed, Nebras Abu ; Farfoura, Heba ; Abdel-Razeq, Hikmat ; Ma'koseh, Mohammad ; Yaseen, Abeer ; Rahman, Zaid Abdel

INTRODUCTION:

Primary Mediastinal Large B Cell Lymphoma (PMLBCL) is a rare but aggressive B-cell lymphoma. This study compares the outcomes and toxicities of DA-EPOCH-R (Dose-adjusted etoposide, prednisolone, vincristine, cyclophosphamide, and doxorubicin in combination with rituximab) and RCHOP-21 (rituximab, cyclophosphamide, doxorubicin, and vincristine, every 21 days) in the treatment of newly diagnosed PMLBCL.

METHODS:

We retrospectively reviewed the medical records of adults (>18 years) diagnosed with PMLBCL and treated at our center from 2010 to 2023. Baseline characteristics were compared using chi-square and Mann Whitney U-tests. Survival outcomes were analysed using Kaplan Meier and log-rank tests.

RESULTS:

Eighty-seven patients were included, with a median age of 30 years (range: 18-55), 48 patients (55.2%) received RCHOP-21, and 39 patients (44.8%) received DA-EPOCH-R. Radiotherapy was more frequent in the RCHOP-21 group (66.6% vs 15%, p < 0.001). DA-EPOCH-R achieved a higher complete metabolic response (CMR) (92% vs 69%, p = 0.007). After a median follow-up of 47.4 months, patients treated with DA-EPOCH-R had superior overall survival (OS) and progression free survival (PFS); 3-year OS rates were 94.4% vs 69.8% (p = 0.01) and the 3-year PFS rates were 86.7% vs 62.2% (p = 0.016), particularly in patients with aa-IPI >1. Post-chemotherapy delta SUV max <0.75, and <0.7 correlated with relapse and mortality, respectively. Grade III-IV anemia and non-hematological toxicities were more frequent in the DA-EPOCH-R, but no therapy-related deaths occurred.

CONCLUSIONS:

DA-EPOCH-R improves CMR, PFS, and OS compared to R-CHOP-21 with radiotherapy in PMLBCL, particularly in high-risk patients. Longer follow-up is needed to assess long-term toxicities.

2025-12-01·Blood Research

Real-world data analysis of survival outcomes of patients with primary mediastinal large B-cell lymphoma treated with immunochemotherapy: the role of consolidative radiation therapy

Article

作者: Oh, Dongryul ; Lee, Yong-Pyo ; Yoon, Sang Eun ; Ko, Young Hyeh ; Kim, Seok Jin ; Kim, Won Seog ; Cho, Junhun

Abstract:

Purpose:

Primary mediastinal large B-cell lymphoma (PMBCL) is a rare subtype of diffuse large B-cell lymphoma. Radiation therapy (RT) has served as the primary treatment option for PMBCL; however, its role has been questioned with the advent of intensified immunochemotherapy. This study aimed to investigate the role of consolidative RT in the primary treatment of PMBCL.

Methods:

This single-center retrospective study analyzed the survival outcomes of 65 patients newly diagnosed with PMBCL. The patients were divided into three treatment groups: (1) EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab), (2) R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), and (3) R-CHOP with consolidative RT.

Results:

The objective response and complete remission rates were 86.2% and 63.1%, respectively, with 3-year progression-free survival (PFS) and overall survival (OS) rates of 72% and 81%, respectively. All patients in the R-CHOP + RT group achieved an objective response with better PFS) than those who did not receive consolidative RT (p = 0.028), although there was no significant difference in OS (p = 0.102). Consolidative RT benefited patients with an initially bulky disease or insufficient end-of-treatment response. The predictive value of 18F-fluorodeoxyglucose positron-emission tomography-computed tomography (PET-CT) in assessing the treatment response in PMBCL was revalidated, showing that patients who achieved negative end-of-treatment PET-CT had significantly better survival outcomes than others.

Conclusions:

R-CHOP is a useful alternative regimen when intensified chemotherapy is not feasible. Consolidative RT should be considered in cases with an initially bulky disease and insufficient end-of-treatment response.

2,057

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2025-07-31

·BioSpace

FDA Issued Myeloma, Alzheimer’s Approvals in July but Rejected Two CGTs

iStock, Grandbrothers The FDA greenlit multiple new drugs this month and issued some notable label expansions including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome. Amid an exodus of employees —not to mention the official start of Health Secretary Robert F. Kennedy Jr.’s overhaul of the agency—the FDA issued several key verdicts this month. Among the standout decisions are a Duchenne muscular dystrophy rejection, a dosing modification for an anti-amyloid Alzheimer’s therapy and an approval for the first-ever on-demand oral therapy for hereditary angioedema. Read below for more. Regeneron’s Bispecific Notches Accelerated Approval for Multiple Myeloma Drug: Lynozyfic Decision: New drug approved Date: July 2 To kick off the month, the FDA handed Regeneron a modest win in multiple myeloma with its approval of linvoseltamab, a bispecific antibody targeting both BCMA and CD3 proteins, for patients with relapsed or refractory multiple myeloma., The regulator’s greenlight for the drug, to be marketed as Lynozyfic, was supported by data from the Phase I/II LINKER-MM1 study that demonstrated a 70% objective response rate, including a 45% complete response rate or better. In a prepared statement alongside its announcement of the approval, Regeneron CEO George Yancopoulos said that with this efficacy profile, “Lynozyfic is poised to potentially become a new standard of care for multiple myeloma.” In a July 2 note, analysts at BMO Capital Markets called the approval a “small win” for Regeneron, with Lynozyfic being a “minor contributor to the company’s broader product portfolio.” BMO models around $600 million in potential revenues for Lynozyfic. The peak forecast for Lynozyfic is modest in part because it trails Johnson & Johnson’s Tecvayli , which was approved in 2022, giving it a three-year head start. Regeneron has emphasized the greater convenience of its product, however. According to the pharma, Lynozyfic is the first and so far only bispecific with this mode of action that can be dosed every two weeks, with the possibility of extending to every four weeks if a patient achieves very good partial response or better. Despite Interference, KalVista Gets Delayed Nod for Only On-Demand HAE Pill Drug: Ekterly Decision: New drug approved Date: July 7 TK weeks after the PDUFA deadline passed, the FDA signed off on KalVista’s sebetralstat, to be marketed under the brand name Ekterly, as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks. The approval comes after the regulator in June had to push back its decision date for the drug, pointing to “heavy workload and limited resources,” KalVista said at the time. There had also been some internal disagreement over the verdict, with Commissioner Marty Makary reportedly trying to get the application denied, according to Endpoints News , which cited anonymous sources at the agency. Makary relented after senior staff raised potential legal issues about his interference. The Department of Health and Human Services has denied these claims, with a spokesperson telling Endpoints that they are “totally false and untrue.” Results of the Phase III KONFIDENT study supported Ekterly’s approval. Results presented in February 2024 showed that both 300-mg and 600-mg doses of Ekterly achieved symptom relief significantly more rapidly , with a median of 1.61 hours and 1.79 hours, respectively, versus 6.72 hours for the placebo group. The open-label KONFIDENT-S trial bolstered these findings, demonstrating that in the real-world setting, Ekterly can help patients address HAE attacks within a median of 10 minutes of onset. KONFIDENT is the largest HAE program ever conducted, KalVista claims. PTC Wins Phenylketonuria Nod for Sephience Drug: Sephience Decision: New drug approved Date: July 28 On July 28, the FDA signed off on PTC Therapeutics’ sepiapterin, which will now be marketed under the brand name Sephience, for the treatment of adults and children with phenylketonuria (PKU). The approval, the biotech noted, grants Sephience a broad label and allows its use for addressing hyperphenylalaninemia in patients 1 month of age and older. This broad labeling, CEO Matthew Klein said in a prepared statement, points to “the potential of Sephience to meet the significant unmet need of PKU patients.” Data from the Phase III APHENITY trial supported Sephience’s approval. PKU is caused by a deficiency of phenylalanine hydroxylase, leading to the accumulation of phenylalanine in patients’ tissues and body fluids. Results posted in October 2024 showed Sephience could cut phenylalanine by 63% in treated patients. This effect was stronger in study participants with classic PKU, with phenylalanine reduction reaching 69%. Almost 85% of patients achieved phenylalanine levels lower than 360 µmol/L, in line with treatment guidelines. Lilly, Moderna, Bayer, GSK Win Expanded Labels for Key Assets July 9: Eli Lilly’s Kisunla The FDA signed off on a new dosing regimen for Eli Lilly’s Alzheimer’s disease therapy Kisunla. This modified schedule involves a more gradual titration of the drug, which according to the pharma lowers the risk of amyloid-related imaging abnormalities indicative of fluid accumulation (ARIA-E). Data from the TRAILBLAZER-ALZ 6 study supported this change, showing that at week 24, ARIA-E was detected in 14% of patients treated with the gradual titration of Kisunla, as opposed to 24% of those on the initially approved dosing schedule. By week 52, ARIA-E was reported in 16% and 25% of the respective groups. July 10: Moderna’s Spikevax Moderna likewise won a major label expansion this month, with the FDA granting full approval for its COVID-19 vaccine Spikevax in children 6 months through 11 years of age who are at high risk of getting infected. Spikevax was previously available for this age group only under an Emergency Use Authorization. Spikevax’s full approval comes after two key approvals for Moderna’s mRNA vaccine pipeline last month. The first was for its next-generation COVID-19 shot mNEXSPIKE , which is now cleared for older adults 65 and above, as well as people 12 through 64 years of age who have at least one underlying risk factor. The second was for its respiratory syncytial virus shot, mResvia , which secured broader coverage to include at-risk adults aged 18 through 59 years. July 14: Bayer’s Kerendia Also securing a key expansion this month is Bayer’s Kerendia, which the FDA gave a new indication : to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent visits for heart failure in adult heart failure patients with left ventricular ejection fraction of at least 40%. In the Phase III FINEARTS-HF study, Kerendia elicited a significant 16% reduction in the trial’s primary endpoint, a composite of worsening heart failure events and cardiovascular death. Kerendia likewise resulted in an 18% drop in worsening heart failure events. Kerendia was first approved in July 2021 , indicated to lower the risk of sustained kidney function decline, end-stage kidney disease, cardiovascular death, heart failure hospitalization and non-fatal myocardial infarction in patients with chronic kidney disease associated with type 2 diabetes. July 17: GSK’s Shingrix Arguably one of the biggest label expansions this month is for GSK’s shingles shot Shingrix, for which the FDA greenlit a prefilled syringe formulation . This new version, according to the pharma’s press release, simplifies the immunization process for healthcare professionals by removing the need to reconstitute separate vials of the vaccine. Approved in October 2017 , Shingrix is a recombinant herpes zoster vaccine indicated for the prevention of shingles in seniors 50 years and older. The vaccine has also since been expanded to cover at-risk adults 18 years and above. Shingrix is one of GSK’s best-performing assets and has already comfortably passed the blockbuster mark. Last year, the product brought in nearly $4.5 billion in sales. Capricor Suffers 40% Hit After FDA Thumbs Down DMD Cell Therapy Drug: Deramiocel Decision: New cell therapy rejected Date: July 11 Aside from important approvals, the FDA also issued critical rejections in July, often with harsh consequences on a company’s stock. One clear example of this is Capricor Therapeutics, which was proposing the investigational cell therapy deramiocel to treat cardiomyopathy in patients with Duchenne muscular dystrophy. The FDA handed Capricor a complete response letter (CRL) on July 11, sending the biotech’s stock freefalling 40% that day. Capricor has yet to recover. As of writing, the company has dipped some 6.3% further. The FDA’s rejection was based on Capricor’s data package for deramiocel, which the regulator said fell short of the “statutory requirement for substantial evidence of effectiveness.” The CRL also cited certain deficiencies regarding deramiocel’s chemistry, manufacturing, and controls. Capricor claimed at the time of the rejection that it had already addressed these concerns, but that the FDA was not able to review these submissions “due to the timing of the CRL issuance.” The rejection came as a surprise to Capricor, CEO Linda Marbán said in a prepared statement at the time. “We have followed their guidance throughout the process,” she said, noting that prior to the CRL the review of deramiocel “had advanced without major issues, including a pre-licensure inspection and completion of the mid-cycle review.” As in the case of KalVista’s Ekterly, deramiocel has been the subject of some internal disagreement at the FDA. Nicole Verdun, the former top regulator of cell and gene therapies at the FDA’s Center for Biologics Evaluation and Research (CBER), had previously scheduled an advisory committee meeting for the application, which new CBER leader Vinay Prasad later cancelled. Verdun was subsequently pushed out of the agency. Ultragenyx Misses Out on Rare Genetic Disease Approval Drug: UX111 Decision: New gene therapy rejected Date: July 11 Ultragenyx reported on July 11 that the FDA had declined to approve UX111, its gene therapy for Sanfilippo syndrome type A, a rare and genetic metabolic disorder that manifests as a broad range of symptoms, including developmental delays and progressive intellectual disability. According to the biotech, the rejection was not linked to its data package for UX111. “The FDA has acknowledged that the neurodevelopmental outcome data provided to date are robust and the biomarker data provide additional supportive evidence,” a statement from Ultragenyx read. Instead, the CRL cited manufacturing issues that were “not directly related to the quality of the product,” Ultragenyx said. “The company believes that these observations are readily addressable.” Ultragenyx added that the company will work to resolve these issues “in the next few months,” building up to a resubmission for UX111. The rare disease biotech expects to undergo another six-month review period after refiling for approval. The rejection capped off a difficult week for Ultragenyx, which on July 9 reported that its Phase II/III osteogenesis imperfecta study for the anti-sclerostin antibody UX143 would be moving to its final analysis. William Blair analysts at the time took this to mean that the trial failed to meet an efficacy threshold that would have otherwise warranted its early termination. As of writing, Ultragenyx’s shares have slid 33% since the osteogenesis imperfect announcement. Roche’s Earlier-Stage Push for Columvi Falls Short Drug: UX111 Decision: Label expansion rejected Date: July 21 The FDA has rejected Roche and subsidiary Genentech’s proposal to use the bispecific antibody Columvi as part of a second-line treatment regimen in patients with diffuse large B cell lymphoma. The Complete Response Letter cited insufficient evidence to support the use of Columvi in this indication in the U.S. patient population. Roche used data from the Phase III STARGLO study to support its application. Results showed that patients treated with the Columvi combo saw a 41% drop in the risk of death compared with those who received rituximab, gemcitabine and oxaliplatin. The Columvi-based regimen likewise hit secondary endpoints, including progression-free survival. Despite these results, the FDA’s Oncologic Drugs Advisory Committee (ODAC) in May voted 8–1 against Columvi’s expansion, raising concerns about the applicability of the drug’s efficacy data in the U.S. In STARGLO’s intention-to-treat population, only 25 of more than 270 participants were from North America. Columvi remains approved as a third-line treatment option for diffuse large B cell lymphoma (DLBCL) under the FDA’s accelerated pathway program. Roche and Genentech are also studying Columvi in the Phase III SKYGLO study , which combines the bispecific with Polivy, Rituxan, cyclophosphamide, doxorubicin and prednisone for the treatment of patients with large B cell lymphoma. The companies are in discussions with the FDA to use SKYGLO as the new postmarketing requirement to convert the third-line DLBCL indication to a full approval, as per their July 21 announcement.

临床3期上市批准临床结果疫苗加速审批

2025-07-30

·GlobeNewswire-Health Care

Teva's Innovative Portfolio Fuels 10th Consecutive Quarter of Growth in Q2 2025; Increases 2025 Revenue Outlook for Key Innovative Products and EPS, and Reaffirms All Other Components

On track for 30% operating profit margin by 2027 in line with our Pivot to Growth Strategy.Q2 2025 shows 10th consecutive quarter of year-over-year (YoY) revenue growth; Revenues of $4.2 billion, +1% in local currencyterms (“LC“)excluding Japan BV revenues; United States segment +2%; Europe segment +3% in LC; International Markets segment -4% inLCand excluding Japan BV revenues. Innovative portfolio continues to fuel strong growth and provide value to diverse and critical patient populations: AUSTEDO® – shows continued strong growth with global revenues of $498 million in Q2 2025, +19% in LC compared to Q2 2024; U.S. revenues +22% compared to Q2 2024. Increasing 2025 revenue outlook to $2,000 million - $2,050 million.AJOVY® – global revenues of $155 million in Q2 2025, +31% in LC compared to Q2 2024. Increasing 2025 revenue outlook to $630 million - $640 million.UZEDY® continues to accelerate in 2025 – revenues of $54 million in Q2 2025, +120% compared to Q2 2024. Increasing 2025 revenue outlook to $190 million - $200 million. Stable generics performance – global generics -2% in LC YoY excluding Japan BV; Generics product revenues -6% in the U.S., +1% in Europe and -1% in International Markets, all in LC and excluding Japan BV revenues, as compared to Q2 2024. Strong biosimilars performance with growth from existing and newly launched products. Expecting two new launches in the second half of 2025. On track to double biosimilar revenues from 2024 to 2027. Teva Transformation programs – combined with innovative product growth - drive our progress towards our 30% operating margin target by 2027. On track to deliver ~$700 million of net savings, expecting achievement of ~$70 million net savings in 2025, or ~$140 million on a full year run-rate basis, reflecting ~20% of the total savings targeted by the programs. Innovative pipeline assets accelerated with submission of U.S. NDA for olanzapine LAI, andduvakitug’s (anti-TL1A) UC and CD program initiations, both expected in Q4 2025.TAPI – Negotiations ongoing; Focused on delivering the best outcome for our shareholders. Q2 2025 Highlights: Revenues of $4.2 billionGAAP diluted EPS of $0.24Non-GAAP diluted EPS of $0.66, an increase of $0.05 or 9% year-over-yearCash flow generated from operating activities of $227 millionFree cash flow of $476 million, an increase of 47% year-over-yearIncrease of 2025 key innovative products revenues and EPS outlook and reaffirms all other outlook components (1)(2): Revenues of $16.8 ‐ $17.2 billion (reaffirmed)Non‐GAAP operating income of $4.3 ‐ $4.6 billion (reaffirmed)Adjusted EBITDA of $4.7 ‐ $5.0 billion (reaffirmed)Non‐GAAP diluted EPS of $2.50 ‐ $2.65 (+$0.05 at the low-end) Free cash flow of $1.6 ‐ $1.9 billion (reaffirmed) (1) Revised 2025 outlook excludes contribution from the Japan BV after Q1 and continues to include a full year contribution from Teva API, and excludes the expected income from development milestone payments from Sanofi in connection with the Phase 3 ulcerative colitis and Crohn’s disease initiations for duvakitug. (2) This outlook is based on the existing tariff and trade environment as of July 30, 2025, and does not reflect any policy shifts, including pharmaceutical sector tariffs, that could impact our business. TEL AVIV, Israel, July 30, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended June 30, 2025. Mr. Richard Francis, Teva's President and CEO, said, “Teva’s performance this quarter stands as a testament to the exceptional strength of our innovative portfolio, which remains the primary engine driving our revenue growth. Our key innovative products delivered a 26% increase in local currency, demonstrating their impact on our financial trajectory and value to patients. As we execute our Pivot to Growth strategy, our focus on innovation is unwavering, placing us firmly on track to achieve a 30% operating profit margin by 2027. The rapid advancement of our transformation programs is already unlocking ~$140 million in annual run-rate savings in 2025, a critical milestone toward our overall ~$700 million net savings target by 2027.” Mr. Francis added, “While our relentless commitment to advancing our innovative portfolio now truly sets Teva apart, our generics business continues to provide a stable foundation despite headwinds. The momentum behind our OTC products and biosimilars, together with our current portfolio and pipeline, reinforce our ambition to double biosimilars’ revenues by 2027.” Pivot to Growth Strategy In Q2 2025, we continued to execute on the four key pillars of our Pivot to Growth strategy, announced in May 2023, and entered into its second phase – “Accelerate Growth.” During this phase we expect to focus on growing our innovative portfolio, aligning capital allocation to invest in higher value activities, reinforcing our commitment to patients, and optimizing our organization and operations. Delivering on our Growth Engines - on the first pillar, we continued to demonstrate strong performance of our key innovative products – AUSTEDO, AJOVY, and UZEDY. Collectively, these products grew ~26% in Q2 2025 YoY in local currency. We raised the 2025 revenue outlook for these products by $95 million at the midpoint: AUSTEDO raised to $2,000 million - $2,050 million, AJOVY raised to $630 million - $640 million and UZEDY raised to $190 million -$200 million. This growth is driven by the strength of the product profiles, continued promotional activities in the U.S., and focused execution by our sales and marketing teams globally.Stepping Up Innovation - on the second pillar, we continued to accelerate the development of certain key pipeline assets. We anticipate filing olanzapine LAI’s NDA in Q4 2025 and target full enrollment for DARI’s (Dual-action Asthma Rescue Inhaler) Phase 3 trial at the end of 2025, as well the announcement of the start of the Phase 3 Crohn’s disease and ulcerative colitis programs for duvakitug in Q4 2025. Additionally, on June 16, 2025, Teva and Fosun Pharma announced collaboration in Asia for TEV-56278, Teva's internally-discovered Anti-PD1/IL-2 ATTENUKINE™ asset, which is expected to accelerate its development, while also freeing up additional resources to accelerate the development of Teva’s key pipeline assets.Sustaining Our Generics Powerhouse - on the third pillar, we remain focused on strengthening our world-class global generics business with a streamlined portfolio of high-value complex generics and biosimilars; a robust pipeline, as well as an integrated global manufacturing and commercial footprint. In the past few quarters, we achieved several successful launches of biosimilars and other high-value complex generics including octreotide (the generic version of Standostatin® LAR Depot), SELARSDITM (ustekinumab-aekn), EPYSQLI® (eculizumab-aagh). On July 15, 2025, we also launched fidaxomicin tablets (the generic version of Dificid®) in the U.S.Focusing our Business - Lastly, on the fourth pillar, to accelerate our growth, we are actively transforming our business through portfolio and global manufacturing footprint optimization. On May 7, 2025, we announced the Teva Transformation programs which are expected to generate ~$700 million of net savings through 2027. Under these programs we expect to achieve ~$70 million net savings in 2025, or ~$140 million on a full year run-rate basis, reflecting ~20% of the total programs savings. Our ongoing efforts to allocate capital in a disciplined manner include, among others: debt repayment of ~$1.4 billion at maturity in the first half of 2025 and refinancing of an additional ~$2.3 billion of debt, our recently completed divestment of our business venture in Japan, our intention to divest our API business through a sale, and ongoing programs to improve working capital efficiency.Teva continues in its effort to sell its active-pharmaceutical ingredient (API) business and is engaged with prospective purchasers. The timing and structure of the planned transaction are subject to ongoing consideration and the consummation of the sale remains contingent on reaching a definitive agreement, subject to the approval by Teva's Board of Directors. On December 31, 2024, Teva classified its API business (including its R&D, manufacturing and commercial activities) as held for sale. Second Quarter 2025 Consolidated Results Revenues in the second quarter of 2025 were $4,176 million, flat in U.S. dollars, or a decrease of 1% in local currency terms compared to the second quarter of 2024. This decrease was mainly due to a decrease from generic products in our International Markets segment associated with the divestment of our business venture in Japan, as well as in our U.S. segment, and a decrease in revenues from COPAXONE®, partially offset by an increase in revenues from our key innovative products. Exchange rate movements during the second quarter of 2025, net of hedging effects, positively impacted revenues by $49 million, compared to the second quarter of 2024. Exchange rate movements during the second quarter of 2025, net of hedging effects, had a negligible impact on our operating income and non-GAAP operating income compared to the second quarter of 2024. Gross profit in the second quarter of 2025 was $2,102 million, an increase of 4% compared to $2,024 million in the second quarter of 2024. Gross profit margin was 50.3% in the second quarter of 2025, compared to 48.6% in the second quarter of 2024. Non-GAAP gross profit was $2,278 million in the second quarter of 2025, an increase of 3% compared to $2,205 million in the second quarter of 2024. Non-GAAP gross profit margin was 54.6% in the second quarter of 2025, compared to 52.9% in the second quarter of 2024. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to a favorable mix of products, primarily driven by higher revenues from AUSTEDO, the sale of certain product rights in our Europe Segment, and the divestment of our business venture in Japan, partially offset by lower revenues from COPAXONE. Research and Development (R&D) expenses, net in the second quarter of 2025 were $244 million, a decrease of 9% compared to $269 million in the second quarter of 2024. Our lower R&D expenses, net in the second quarter of 2025 compared to the second quarter of 2024, were mainly due to a decrease in non-recurring milestone payments related to certain biosimilar projects, and a decrease in our generics projects. Selling and Marketing (S&M) expenses in the second quarter of 2025 were $654 million, flat compared to the second quarter of 2024. General and Administrative (G&A) expenses in the second quarter of 2025 were $305 million, an increase of 8% compared to the second quarter of 2024. This increase was mainly due to costs related to optimization activities of our global organization and operations in connection with Teva’s Transformation programs. Operating Income in the second quarter of 2025 was $455 million, compared to an operating loss of $5 million in the second quarter of 2024. Operating income as a percentage of revenues was 10.9% in the second quarter of 2025, compared to an operating loss as a percentage of revenues of 0.1% in the second quarter of 2024. This increase was mainly due to a goodwill impairment charge recorded in the second quarter of 2024, as well as higher gross profit in the second quarter of 2025, partially offset by higher legal settlements and loss contingencies in the second quarter of 2025. Non-GAAP operating income in the second quarter of 2025 was $1,133 million representing a non-GAAP operating margin of 27.1% compared to non-GAAP operating income of $1,056 million representing a non-GAAP operating margin of 25.3% in the second quarter of 2024. The increase in non-GAAP operating margin in the second quarter of 2025 was mainly due to higher gross profit margin as well as lower operating expenses as a percentage of revenues. Financial expenses, net in the second quarter of 2025, were $252 million, mainly comprised of net-interest expenses of $203 million. In the second quarter of 2024, financial expenses, net were $241 million, mainly comprised of net-interest expenses of $233 million. In the second quarter of 2025, we recognized a tax benefit of $78 million, on a pre-tax income of $203 million. In the second quarter of 2024, we recognized a tax expense of $630 million, on a pre-tax loss of $246 million. Non-GAAP tax rate in the second quarter of 2025 was 16.4%, compared to 15.4% in the second quarter of 2024. Our non-GAAP tax rate in the second quarter of 2025 was mainly affected by releases of uncertain tax positions, foreign exchange impact on deferred tax positions and interest and inflation adjustments related to the agreement with the Israeli Tax Authorities (“ITA”). Our non-GAAP tax rate in the second quarter of 2024 was mainly affected by the generation of profits in various jurisdictions with different tax rates, tax benefits in Israel and other countries, as well as infrequent or non-recurring items. We expect our annual non-GAAP tax rate for 2025 to be between 15%-18%, slightly higher than our non-GAAP tax rate for 2024, which was 15.3%, mainly due to a net tax benefit related to deferred tax assets resulting from intellectual property-related integration plans in 2024. Net income attributable to Teva and diluted earnings per share in the second quarter of 2025 were $282 million and $0.24, respectively, compared to net loss attributable to Teva and loss per share of $846 million and $0.75, respectively, in the second quarter of 2024. This change was mainly due to higher income taxes in the second quarter of 2024, as well as higher operating income in the second quarter of 2025, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the second quarter of 2025 were $769 million and $0.66, respectively, compared to $697 million and $0.61, respectively, in the second quarter of 2024. Adjusted EBITDA was $1,233 million in the second quarter of 2025, an increase of 6%, compared to $1,168 million in the second quarter of 2024. As of June 30, 2025 and 2024, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,179 million shares and 1,167 million shares, respectively. Non-GAAP information: non-GAAP adjustments in the second quarter of 2025 were $486 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the second quarter of 2025 were adjusted to exclude the following items: Amortization of purchased intangible assets of $148 million, of which $138 million is included in cost of sales and the remaining $10 million in S&M expenses;Impairment of long lived assets of $99 million;Legal settlements and loss contingencies of $166 million;Contingent consideration expenses of $19 million;Equity compensation expenses of $38 million;Restructuring expenses of $154 million;Financial expenses of $37 million;Other non-GAAP items of $53 million;Corresponding tax effects and unusual tax items of $228 million. We believe that excluding such items facilitates investors’ understanding of our business including underlying performance trends, thereby improving the comparability of our business performance results between reporting periods. For a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and for additional information, see the tables below and the information included under “Non-GAAP Financial Measures.” Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP. Cash flow generated from operating activities during the second quarter of 2025 was $227 million, compared to $103 million in the second quarter of 2024. The higher cash flow generated from operating activities in the second quarter of 2025 resulted mainly from higher profit in our U.S. segment, and a positive impact from accounts receivables, net of SR&A, mainly due to collection timing, partially offset by higher sequential inventory levels, as well as higher tax payments. During the second quarter of 2025, we generated free cash flow of $476 million, which we define as comprising $227 million in cash flow generated from operating activities, $336 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $9 million of proceeds from divestitures of businesses and other assets, partially offset by $96 million in cash used for capital investment. During the second quarter of 2024, we generated free cash flow of $324 million, which we define as comprising $103 million in cash flow generated from operating activities, $317 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $1 million in divestitures of businesses and other assets, partially offset by $97 million in cash used for capital investment. The increase in the second quarter of 2025 resulted mainly from higher cash flow generated from operating activities. As of June 30, 2025, our debt was $17,227 million, compared to $17,783 million as of December 31, 2024. This decrease was mainly due to repayment at maturity of $1,368 million of our senior notes, partially offset by $780 million of exchange rate fluctuations. Additionally, during the second quarter of 2025, we repurchased $2,290 million aggregate principal amount of notes upon consummation of a cash tender offer, and issued $2,305 million of senior notes, net of discount and issuance costs. The portion of total debt classified as short-term as of June 30, 2025 was 3% compared to 10% as of December 31, 2024. Our average debt maturity was approximately 5.95 years as of June 30, 2025, compared to 5.5 years as of December 31, 2024. Segment Results for the Second Quarter of 2025 United States Segment The following table presents revenues, expenses and profit for our United States segment for the three months ended June 30, 2025 and 2024: Three months ended June 30, 2025 2024 (U.S. $ in millions / % of Segment Revenues)Revenues$2,151100% $2,110100%Cost of sales 90141.9% 94344.7%Gross profit 1,25058.1% 1,16755.3%R&D expenses 1527.0% 1708.1%S&M expenses 27913.0% 27012.8%G&A expenses 1135.2% 1004.7%Other §§ (1)§Segment profit*$70632.8% $62929.8%* Segment profit does not include amortization and certain other items. § Represents an amount less than $0.5 million or 0.5%, as applicable. Revenues from our United States segment in the second quarter of 2025 were $2,151 million, an increase of $41 million, or 2%, compared to the second quarter of 2024. This increase was mainly due to higher revenues from our innovative products, mainly AUSTEDO, UZEDY and AJOVY, partially offset by lower revenues from generic products and COPAXONE. Revenues by Major Products and Activities The following table presents revenues for our United States segment by major products and activities for the three months ended June 30, 2025 and 2024: Three months ended June 30, Percentage Change 2025 2024 2025-2024 (U.S. $ in millions) Generic products (including biosimilars) $961 $1,023 (6%)AJOVY 63 42 53%AUSTEDO 495 407 22%BENDEKA® and TREANDA® 40 41 (3%)COPAXONE 62 81 (23%)UZEDY 54 24 120%Anda 365 373 (2%)Other 111 119 (7%)Total $2,151 $2,110 2% Generic products (including biosimilars) revenues in our United States segment in the second quarter of 2025 were $961 million, a decrease of 6% compared to the second quarter of 2024. This decrease was mainly driven by lower revenues from lenalidomide capsules (the generic version of Revlimid®) and liraglutide injection 1.8mg (an authorized generic of Victoza®), driven primarily by increased competition, partially offset by higher revenues from our portfolio of biosimilar products. Among the most significant generic products we sold in the United States in the second quarter of 2025 were lenalidomide capsules (the generic version of Revlimid®), epinephrine injectable solution (the generic equivalent of EpiPen® and EpiPen Jr®) and Truxima® (the biosimilar to Rituxan®). In the second quarter of 2025, our total prescriptions were approximately 266 million (based on trailing twelve months), representing 6.9% of total U.S. generic prescriptions, compared to approximately 303 million (based on trailing twelve months), representing 7.9% of total U.S. generic prescriptions in the second quarter of 2024, all according to IQVIA data. On April 7 2025, Teva and Samsung Bioepis Co., Ltd. announced the availability of, and subsequently launched, EPYSQLI® (eculizumab-aagh), a biosimilar to Soliris® (eculizumab) in the U.S., for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. AJOVY revenues in our United States segment in the second quarter of 2025 were $63 million, an increase of 53% compared to the second quarter of 2024, mainly due to an increase in sales allowance due to a non-recurring item in the second quarter of 2024 and growth in volume in the second quarter of 2025. In the second quarter of 2025, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 31.0% of the subcutaneous injectable anti- CGRP class, compared to 28.6% in the second quarter of 2024. AUSTEDO revenues in our United States segment in the second quarter of 2025 were $495 million, an increase of 22%, compared to $407 million in the second quarter of 2024. This increase was mainly due to growth in volumes, including the approval of AUSTEDO XR as a one pill, once-daily treatment in 2024. AUSTEDO XR (deutetrabenazine) extended-release tablets were approved by the FDA on February 17, 2023 in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. The FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg in May 2024 and in 18 mg in July 2024. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, which is additional to the currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041. On January 17, 2025, the Centers for Medicare and Medicaid Services (“CMS”) released a list of prescription medicines selected for price-setting discussions, which included AUSTEDO and AUSTEDO XR. The price-setting process has commenced, and the revised prices set by the U.S. Government, which will apply to eligible Medicare patients, are expected to become effective on January 1, 2027. As the price-setting process is still in its early stages, the extent to which prices for AUSTEDO and AUSTEDO XR will change as a result of such discussions remains uncertain. UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the second quarter of 2025 were $54 million, an increase of 120% compared to the second quarter of 2024, mainly due to growth in volume. BENDEKA and TREANDA combined revenues in our United States segment in the second quarter of 2025 were $40 million, a decrease of 3% compared to the second quarter of 2024, mainly due to competition from alternative therapies, as well as from generic bendamustine products. COPAXONE revenues in our United States segment in the second quarter of 2025 were $62 million, a decrease of 23% compared to the second quarter of 2024, mainly due to market share erosion and competition. Anda revenues from third-party products in our United States segment in the second quarter of 2025 were $365 million, a decrease of 2%, compared to $373 million in the second quarter of 2024. This decrease was mainly due to lower volumes. Anda, our distribution business in the United States, distributes generic and innovative medicines and OTC pharmaceutical products from Teva and various third-party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. United States Gross Profit Gross profit from our United States segment in the second quarter of 2025 was $1,250 million, an increase of 7%, compared to $1,167 million in the second quarter of 2024. Gross profit margin for our United States segment in the second quarter of 2025 increased to 58.1%, compared to 55.3% in the second quarter of 2024. This increase was mainly due to a favorable mix of products primarily driven by higher revenues from AUSTEDO. United States Profit Profit from our United States segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items. Profit from our United States segment in the second quarter of 2025 was $706 million, an increase of 12% compared to $629 million in the second quarter of 2024. This increase was mainly due to higher gross profit, as discussed above. Europe Segment Our Europe segment includes the European Union, the United Kingdom and certain other European countries. The following table presents revenues, expenses and profit for our Europe segment for the three months ended June 30, 2025 and 2024: Three months ended June 30, 2025 2024 (U.S. $ in millions / % of Segment Revenues)Revenues$1,298100% $1,213100%Cost of sales 58144.8% 53644.2%Gross profit 71755.2% 67755.8%R&D expenses 594.6% 625.1%S&M expenses 22817.5% 20917.2%G&A expenses 665.1% 645.3%Other §§ §§Segment profit*$36428.0% $34228.2%* Segment profit does not include amortization and certain other items. § Represents an amount less than $0.5 million or 0.5%, as applicable. Revenues from our Europe segment in the second quarter of 2025 were $1,298 million, an increase of 7%, or $85 million, compared to the second quarter of 2024. In local currency terms, revenues increased by 3% compared to the second quarter of 2024, mainly due to the sale of certain product rights, higher revenues from AJOVY and higher revenues from generic products. In the second quarter of 2025, revenues were positively impacted by exchange rate fluctuations of $46 million, net of hedging effects, compared to the second quarter of 2024. Revenues in the second quarter of 2025, included $25 million from a negative hedging impact, which is included in “Other” in the table below. Revenues in the second quarter of 2024 included $3 million from a positive hedging impact, which is included in “Other” in the table below. Revenues by Major Products and Activities The following table presents revenues for our Europe segment by major products and activities for the three months ended June 30, 2025 and 2024: Three months ended June 30, Percentage Change 2025 2024 2025-2024 (U.S. $ in millions) Generic products (including OTC and biosimilars) $1,040 $970 7%AJOVY 71 52 38%COPAXONE 50 53 (6%)Respiratory products 55 57 (3%)Other* 81 81 1%Total $1,298 $1,213 7%*Other revenues in the second quarter of 2025 include the sale of certain product rights. Generic products revenues (including OTC and biosimilar products) in our Europe segment in the second quarter of 2025, were $1,040 million, an increase of 7% compared to the second quarter of 2024. In local currency terms, revenues increased by 1%, mainly due to OTC price increases, as well as revenues from recently launched products, partially offset by lower volumes. AJOVY revenues in our Europe segment in the second quarter of 2025 increased by 38% to $71 million, compared to $52 million in the second quarter of 2024. In local currency terms, revenues increased by 30% due to growth in volume. COPAXONE revenues in our Europe segment in the second quarter of 2025 were $50 million, a decrease of 6% compared to the second quarter of 2024. In local currency terms revenues decreased by 11%, due to price reductions and a decline in volume resulting from the availability of alternative therapies and competing glatiramer acetate products. Respiratory products revenues in our Europe segment in the second quarter of 2025 were $55 million, a decrease of 3% compared to the second quarter of 2024. In local currency terms, revenues decreased by 8%, mainly due to net price reductions and lower volumes. Europe Gross Profit Gross profit from our Europe segment in the second quarter of 2025 was $717 million, an increase of 6% compared to $677 million in the second quarter of 2024. Gross profit margin for our Europe segment in the second quarter of 2025 decreased to 55.2%, compared to 55.8% in the second quarter of 2024. This decrease was mainly due to a negative impact from hedging activities, and an unfavorable mix of products, partially offset by the sale of certain product rights. Europe Profit Profit from our Europe segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items. Profit from our Europe segment in the second quarter of 2025 was $364 million, an increase of 6%, compared to $342 million in the second quarter of 2024. This increase was mainly due to higher gross profit, partially offset by higher S&M expenses. International Markets Segment Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries. The countries in our International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, and branded generics-oriented markets, such as Russia and certain Latin America markets. As previously disclosed, on March 31, 2025, we closed the agreement with JKI Co. Ltd., established by the fund managed and operated by private equity firm J-Will Partners Co. Ltd., to sell our Teva-Takeda business venture in Japan, which includes generic and legacy products. The following table presents revenues, expenses and profit for our International Markets segment for the three months ended June 30, 2025 and 2024: Three months ended June 30, 2025 2024 (U.S. $ in millions / % of Segment Revenues)Revenues$495100% $593100%Cost of sales 25150.8% 30751.7%Gross profit 24349.2% 28648.3%R&D expenses 244.9% 305.1%S&M expenses 11423.0% 14524.5%G&A expenses 326.6% 386.4%Other (1)§ §§Segment profit*$7414.9% $7312.3%* Segment profit does not include amortization and certain other items. § Represents an amount less than $0.5 million or 0.5%, as applicable. Revenues from our International Markets segment in the second quarter of 2025 were $495 million, a decrease of 17% compared to the second quarter of 2024. In local currency terms, revenues decreased by 16% compared to the second quarter of 2024. This decrease was mainly due to the divestment of our business venture in Japan. In the second quarter of 2025, revenues were negatively impacted by exchange rate fluctuations of $2 million, including hedging effects, compared to the second quarter of 2024. Revenues in the second quarter of 2025 included $8 million from a negative hedging impact, compared to a negative hedging impact of $5 million in the second quarter of 2024, which are included in “Other” in the table below. The following table presents revenues for our International Markets segment by major products and activities for the three months ended June 30, 2025 and 2024: Three months ended June 30, Percentage Change 2025 2024 2025-2024 (U.S. $ in millions) Generic products (including OTC and biosimilars) $410 $486 (16%)AJOVY 20 22 (7%)AUSTEDO 3 12 (76%)COPAXONE 7 14 (50%)Other 55 59 (6%)Total $495 $593 (17%) Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $410 million in the second quarter of 2025, a decrease of 16%, in both U.S. dollars and local currency terms compared to the second quarter of 2024, mainly due to the divestment of our business venture in Japan. AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. AJOVY revenues in our International Markets segment in the second quarter of 2025 were $20 million, compared to $22 million in the second quarter of 2024, mainly due to timing of shipments. AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022, for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. In February 2024, we announced a strategic partnership for the marketing and distribution of AUSTEDO in China. In April 2025, AUSTEDO received marketing authorization in South Korea. We continue to pursue additional submissions in various other markets. AUSTEDO revenues in our International Markets segment in the second quarter of 2025 were $3 million compared to $12 million in the second quarter of 2024. In local currency terms, revenues decreased by 75%, mainly due to timing of shipments. COPAXONE revenues in our International Markets segment in the second quarter of 2025 were $7 million compared to $14 million in the second quarter of 2024. International Markets Gross Profit Gross profit from our International Markets segment in the second quarter of 2025 was $243 million, a decrease of 15% compared to $286 million in the second quarter of 2024. Gross profit margin for our International Markets segment in the second quarter of 2025 increased to 49.2%, compared to 48.3% in the second quarter of 2024. This increase was primarily due to a favorable mix of products, mainly in connection with the divestment of our business venture in Japan. International Markets Profit Profit of our International Markets segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items. Profit from our International Markets segment in the second quarter of 2025 was $74 million, an increase of 1%, compared to $73 million in the second quarter of 2024. This increase was mainly due to lower operating expenses, partially offset by a decrease in gross profit, mainly as a result of the divestment of our business venture in Japan. Other Activities We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our United States, Europe or International Markets segments described above. On January 31, 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale. The intention to divest is in alignment with our Pivot to Growth strategy. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all. Revenues from other activities in the second quarter of 2025 were $232 million, a decrease of 7% in U.S. dollars compared to the second quarter of 2024. In local currency terms, revenues decreased by 9%. API sales to third parties in the second quarter of 2025 were $135 million, reflecting a decrease of 11% in both U.S. dollars and local currency terms, compared to the second quarter of 2024, mainly due to lower demand and timing of shipments. Outlook for 2025 Non-GAAP Results $ billions, except EPS or as noted January 2025 Outlook May 2025 OutlookJuly 2025 OutlookRevenues* $16.8 - $17.4 $16.8 - $17.2$16.8 - $17.2AUSTEDO ($m)* 1,900-2,050 1,950-2,0502,000-2,050AJOVY ($m)* ~600 ~600630-640UZEDY ($m)* ~160 ~160190-200COPAXONE ($m)* ~370 ~370~370Operating Income 4.1 - 4.6 4.3 - 4.64.3 - 4.6Adjusted EBITDA 4.5 - 5.0 4.7 - 5.04.7 - 5.0Tax Rate 15%-18% 15%-18%15%-18%Finance Expenses ~0.9 ~0.9~0.9Diluted EPS ($) 2.35 - 2.65 2.45 - 2.652.50 - 2.65Free Cash Flow** 1.6 – 1.9 1.6 – 1.91.6 – 1.9CAPEX* ~0.5 ~0.5~0.5Foreign Exchange Volatile swings in FX can negatively impact revenue and income * Revenues and CAPEX presented on a GAAP basis ** Free Cash Flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables. Conference Call Teva will host a conference call and live webcast along with a slide presentation on Wednesday, July 30, 2025 at 8:00 a.m. ET to discuss its second quarter 2025 financial results and overall business environment. A question & answer session will follow. In order to participate, please register in advance here to obtain a local or toll‐free phone number and your personal pin. A live webcast of the call will be available on Teva's website at: www.tevapharm.com Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva's website. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com. Some amounts in this press release may not add up due to rounding. All percentages have been calculated using unrounded amounts. Non-GAAP Financial Measures This press release contains certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("GAAP"). These non-GAAP financial measures, including, but not limited to, non-GAAP operating income, non-GAAP operating margin, non-GAAP gross profit, non-GAAP gross profit margin, Adjusted EBITDA, free cash flow, non-GAAP tax rate, non-GAAP net income (loss) attributable to Teva and non-GAAP diluted EPS, are presented in order to facilitate investors' understanding of our business. We utilize certain non-GAAP financial measures to evaluate performance, in conjunction with other performance metrics. The following are examples of how we utilize the non-GAAP measures: our management and board of directors use the non-GAAP measures to evaluate our operational performance, to compare against work plans and budgets, and ultimately to evaluate the performance of management; our annual budgets are prepared on a non-GAAP basis; and senior management’s annual compensation is derived, in part, using these non-GAAP measures. See the attached tables for a reconciliation of the GAAP results to the adjusted non-GAAP measures. Investors should consider non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. We are not providing forward looking guidance for GAAP reported financial measures or a quantitative reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP measure because we are unable to predict with reasonable certainty the ultimate outcome of certain significant items including, but not limited to, the amortization of purchased intangible assets, legal settlements and loss contingencies, impairment of long-lived assets and goodwill impairment, without unreasonable effort. These items are uncertain, depend on various factors, and could be material to our results computed in accordance with GAAP. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. These forward-looking statements include statements concerning our plans, strategies, objectives, future performance and financial and operating targets, and any other information that is not historical information. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; concentration of our customer base and commercial alliances among our customers; competition faced by our generic medicines from other pharmaceutical companies and changes in regulatory policy that may result in additional costs and delays; delays in launches of new generic products; our ability to develop and commercialize additional pharmaceutical products; competition for our innovative medicines; our ability to achieve expected results from investments in our product pipeline; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines, and to execute on our organizational transformation and to achieve expected cost savings; and the effectiveness of our patents and other measures to protect our intellectual property rights, including any potential challenges to our Orange Book patent listings in the U.S.;our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and our potential need to raise additional funds in the future, which may not be available on acceptable terms or at all;our business and operations in general, including: the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto; the widespread outbreak of an illness or any other communicable disease, or any other public health crisis; effectiveness of our optimization efforts; significant disruptions of information technology systems, including cybersecurity attacks and breaches of our data security; interruptions in our supply chain or problems with internal or third party manufacturing; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism, such as the ongoing conflict between Russia and Ukraine and the state of war declared in Israel; our ability to attract, hire, integrate and retain highly skilled personnel; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets or business units and close or divest plants and facilities, as well as our ability to successfully and cost-effectively consummate such sales and divestitures, including our planned divestiture of our API business;compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; the effects of governmental and civil proceedings and litigation which we are, or in the future become, party to; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage , including as a result of the One Big Beautiful Bill signed into law in the U.S. in July 2025 (“OBBBA”), which is expected to result in stricter Medicaid eligibility requirements and work requirements, which may result in reduced Medicaid enrollment and a resulting decline in coverage for purchases of our medicines, and U.S. Executive Orders issued in April and May 2025 intended to reduce the prices paid by Americans for prescription medicines, including most-favored-nation pricing; increased legal and regulatory action in connection with public concern over the abuse of opioid medications; our ability to timely make payments required under our nationwide opioids settlement agreement and provide our generic version of Narcan® (naloxone hydrochloride nasal spray) in the amounts and at the times required under the terms of such agreement; scrutiny from competition and pricing authorities around the world, including our ability to comply with and operate under our deferred prosecution agreement (“DPA”) with the U.S. Department of Justice (“DOJ”); potential liability for intellectual property right infringement; product liability claims; failure to comply with complex Medicare, Medicaid and other governmental programs reporting and payment obligations; compliance with sanctions and trade control laws; environmental risks; and the impact of ESG issues;the impact of the state of war declared in Israel and the military activity in the Middle East, including the risk of disruptions to our operations and facilities, such as our manufacturing and R&D facilities, located in Israel, the impact of our employees who are military reservists being called to active military duty, and the impact of the war on the economic, social and political stability of Israel;other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our long-lived assets; the impact of geopolitical conflicts including the state of war declared in Israel and the conflict between Russia and Ukraine; potential significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; our exposure to changes in international trade policies, including the imposition of tariffs in the jurisdictions in which we operate, and the effects of such developments on sales of our products and the pricing and availability of our raw materials; and the impact of any future failure to establish and maintain effective internal control over our financial reporting; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Consolidated Statements of Income(U.S. dollars in millions, except share and per share data)(Unaudited) Three months ended Six months ended June 30, June 30, 2025 2024 2025 2024 Net revenues 4,176 4,164 8,067 7,983 Cost of sales 2,074 2,140 4,088 4,188 Gross profit 2,102 2,024 3,979 3,795 Research and development expenses 244 269 490 511 Selling and marketing expenses 654 656 1,276 1,265 General and administrative expenses 305 283 603 561 Intangible assets impairments 42 61 163 141 Goodwill impairment - 400 - 400 Other asset impairments, restructuring and other items 232 280 210 954 Legal settlements and loss contingencies 166 83 252 188 Other loss (income) 4 (2) 9 (1) Operating income (loss) 455 (5) 975 (223) Financial expenses, net 252 241 477 491 Income (loss) before income taxes 203 (246) 497 (713) Income taxes (benefit) (78) 630 (4) 578 Share in (profits) losses of associated companies, net (1) (2) (1) 2 Net income (loss) 283 (874) 503 (1,294) Net income (loss) attributable to redeemable and non-redeemable non-controlling interests § (29) 6 (309) Net income (loss) attributable to Teva 282 (846) 497 (985) Earnings (loss) per share attributable to Teva:Basic ($)0.25 (0.75) 0.43 (0.87) Diluted ($)0.24 (0.75) 0.43 (0.87) Weighted average number of shares (in millions):Basic1,147 1,133 1,142 1,128 Diluted1,161 1,133 1,159 1,128 Non-GAAP net income attributable to Teva for diluted earnings per share:* 769 697 1,371 1,245 Non-GAAP earnings per share attributable to Teva:*Diluted ($)0.66 0.61 1.18 1.09 Non-GAAP average number of shares (in millions):Diluted1,161 1,151 1,159 1,146 Amounts may not add up due to rounding. § Represents an amount less than $0.5 million. * See reconciliation attached. CONSOLIDATED BALANCE SHEETS (U.S. dollars in millions, except for share data) (Unaudited) June 30, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $2,161 $3,300 Accounts receivables, net of allowance for credit losses of $84 million and $78 million as of June 30, 2025 and December 31, 2024, respectively. 3,564 3,059 Inventories 3,497 3,007 Prepaid expenses 1,084 1,006 Other current assets 472 409 Assets held for sale 1,842 1,771 Total current assets 12,620 12,552 Deferred income taxes 1,781 1,799 Other non-current assets 470 462 Property, plant and equipment, net 4,810 4,581 Operating lease right-of-use assets, net 358 367 Identifiable intangible assets, net 4,142 4,418 Goodwill 15,949 15,147 Total assets $40,131 $39,326 LIABILITIES AND EQUITY Current liabilities: Short-term debt $464 $1,781 Sales reserves and allowances 4,050 3,678 Accounts payables 2,498 2,203 Employee-related obligations 481 624 Accrued expenses 3,095 2,792 Other current liabilities 940 1,020 Liabilities held for sale 334 698 Total current liabilities 11,861 12,796 Long-term liabilities: Deferred income taxes 440 483 Other taxes and long-term liabilities 3,938 4,028 Senior notes and loans 16,763 16,002 Operating lease liabilities 296 296 Total long-term liabilities 21,436 20,809 Redeemable non-controlling interests — 340 Equity: Teva shareholders’ equity: 6,827 5,373 Non-controlling interests 7 7 Total equity 6,834 5,380 Total liabilities and equity $40,131 $39,326 Amounts may not add up due to rounding. TEVA PHARMACEUTICAL INDUSTRIES LIMITED CONSOLIDATED STATEMENTS OF CASH FLOWS (U.S. dollars in millions) (Unaudited) Three months ended Six months ended June 30, June 30, 2025 2024 2025 2024 Operating activities: Net income (loss)$ 283 (874) $ 503 (1,294) Adjustments to reconcile net income (loss) to net cash provided by operations: Depreciation and amortization 251 259 494 531 Impairment of goodwill - 400 - 400 Impairment of long-lived assets and assets held for sale 99 130 177 809 Net change in operating assets and liabilities (336) (10) (1,035) (507) Deferred income taxes – net and uncertain tax positions (211) (424) (183) (613) Stock-based compensation 38 32 72 60 Other items* 105 592 94 594 Net loss (gain) from sale of business and long-lived assets (2) (1) - (1) Net cash provided by (used in) operating activities 227 103 122 (21) Investing activities: Beneficial interest collected in exchange for securitized trade receivables 336 317 658 612 Purchases of property, plant and equipment and intangible assets (96) (97) (223) (221) Proceeds from sale of business and long-lived assets, net 9 1 26 1 Acquisition of businesses, net of cash acquired - - - (15) Purchases of investments and other assets (16) (43) (27) (55) Other investing activities 3 - 3 - Net cash provided by (used in) investing activities 236 178 437 322 Financing activities: Repayment of senior notes and loans and other long-term liabilities (2,300) (956) (3,668) (956) Proceeds from senior notes, net of issuance costs 2,305 - 2,305 - Purchase of shares from redeemable and non-redeemable non-controlling interests - - (38) (64) Dividends paid to redeemable and non-redeemable non-controlling interests - - (340) (78) Other financing activities 1 (10) 3 (19) Net cash provided by (used in) financing activities 6 (966) (1,738) (1,117) Translation adjustment on cash and cash equivalents (5) (49) 40 (153) Net change in cash and cash equivalents 464 (733) (1,139) (969) Balance of cash, cash equivalents at beginning of period 1,697 2,991 3,300 3,227 Balance of cash, cash equivalents at end of period$ 2,161 2,258 $ 2,161 2,258 Non-cash financing and investing activities: Beneficial interest obtained in exchange for securitized accounts receivables$ 329 320 $ 641 632 *Adjustment in the three months period ended June 30, 2024 was mainly related to an agreement with the Israeli Tax Authorities. Amounts may not add up due to rounding. The accompanying notes are an integral part of the financial statements. Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva Three months ended Six months ended June 30, June 30, ($ in millions except per share amounts) 2025 2024 2025 2024 Net income (Loss) attributable to Teva($)282 (846) ($)497 (985) Increase (decrease) for excluded items: Amortization of purchased intangible assets 148 146 292 298 Legal settlements and loss contingencies(1) 166 83 249 188 Goodwill impairment(2) - 400 - 400 Impairment of long-lived assets(3) 99 130 177 809 Restructuring costs(4) 154 18 168 31 Equity compensation 38 32 72 60 Contingent consideration(5) 19 192 30 271 Accelerated depreciation - - - 7 Financial expenses 37 12 51 24 Redeemable and non-redeemable non-controlling interests(6) - (33) 2 (317) Other non-GAAP items(7) 53 59 116 106 Corresponding tax effects and unusual tax items(8) (228)503 ($)(283)353 Non-GAAP net income attributable to Teva($)769 697 1,371 1,245 Non-GAAP tax rate(9) 16.4% 15.4% ($)16.9% 15.2% GAAP diluted earnings (loss) per share attributable to Teva($)0.24 (0.75) 0.43 (0.87) EPS difference(10) 0.42 1.35 ($)0.75 1.96 Non-GAAP diluted EPS attributable to Teva(10)($)0.66 0.61 1.18 1.09 Non-GAAP average number of shares (in millions)(10) 1,161 1,151 1,159 1,146 (1)For the three and six months ended June 30, 2025, adjustments of legal settlements and loss contingencies mainly consisted of (a) an update to the estimated settlement provision for the opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments) in the amount of $47 million and $97 million, respectively (b) an update to the estimated provision recorded for the claims brought by attorneys general representing states and territories throughout the United States in the generic drug antitrust litigation in the amount of $55 million. (2)A goodwill impairment charge of $400 million related to our Teva’s API reporting unit was recognized in the three and six months ended June 30, 2024. (3)For the three months ended June 30, 2025, the adjustment for impairment of long-lived assets consisted of (a) impairment of long-lived assets of $42 million mainly related to products in the U.S. and Europe, and (b) $55 million related to the held for sale measurement of the API business (including its R&D, manufacturing and commercial activities), which includes a favorable impact related to the expected gain from the reclassification of currency translation adjustments. For the six months ended June 30, 2025, the adjustment for impairment of long-lived assets was mainly related to products in the U.S. and Europe. For the six months ended June 30, 2024, adjustments for impairment of long-lived assets primarily consisted of $644 million related to the classification of our business venture in Japan as held for sale. (4)In the three and six months ended June 30, 2025, Teva recorded $154 million and $168 million, respectively, of restructuring expenses primarily related to optimization activities in connection with Teva's Transformation programs related to Teva’s global organization and operations mainly through headcount reduction. (5)In the three and six months ended June 30, 2024, adjustments for contingent consideration primarily related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide capsules (the generic version of Revlimid®), of $174 million and $238 million, respectively. (6)For the six months ended June 30, 2024, the adjustment is related to non-controlling interests portion of long-lived assets impairment of $644 million related to the classification of our business venture in Japan as held for sale. (7)Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, primarily related to the rationalization of our plants, accelerated depreciation, certain inventory write-offs, material litigation fees and other unusual events. (8)Adjustments for corresponding tax effects and unusual tax items exclusively consisted of the tax impact directly attributable to the pre-tax items that are excluded from non-GAAP net income included in the other adjustments to this table. For the three months ended June 30, 2024, adjustments of $503 million mainly related to the settlement agreement with the ITA to settle certain litigation with respect to taxes payable for the Company’s taxable years 2008 through 2020, in an amount of $495 million. (9)Non-GAAP tax rate is tax expenses (benefit) excluding the impact of non-GAAP tax adjustments presented above as a percentage of income (loss) before income taxes excluding the impact of non-GAAP adjustments presented above. (10)EPS difference and diluted non-GAAP EPS are calculated by dividing our non-GAAP net income attributable to Teva by our non-GAAP diluted weighted average number of shares. Reconciliation of gross profit to Non-GAAP gross profit (Unaudited) Three months ended Six months ended June 30, June 30, ($ in millions) 2025 2024 2025 2024 Gross profit$2,102 2,024 $3,979 3,795 Gross profit margin 50.3%48.6% 49.3%47.5% Increase (decrease) for excluded items: (1) Amortization of purchased intangible assets 138 136 273 273 Equity compensation 6 7 12 13 Other non-GAAP items 32 37 69 87 Non-GAAP gross profit$2,278 2,205 $4,332 4,168 Non-GAAP gross profit margin (2) 54.6%52.9% 53.7%52.2% (1) For further explanations, refer to the footnotes under the "Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva" table. (2) Non-GAAP gross profit margin is non-GAAP gross profit as a percentage of revenue. Reconciliation of operating income (loss) to Non-GAAP operating income (loss) (Unaudited) Three months ended Six months ended June 30, June 30, ($ in millions) 2025 2024 2025 2024 Operating income (loss)($)455 (5) ($)975 (223) Operating margin 10.9%(0.1%) 12.1%(2.8%) Increase (decrease) for excluded items: (1) Amortization of purchased intangible assets 148 146 292 298 Legal settlements and loss contingencies 166 83 249 188 Goodwill impairment - 400 - 400 Impairment of long-lived assets 99 130 177 809 Restructuring costs 154 18 168 31 Equity compensation 38 32 72 60 Contingent consideration 19 192 30 271 Loss (gain) on sale of business - - 13 § Other non-GAAP items 53 59 103 113 Non-GAAP operating income (loss)($)1,133 1,056 ($)2,079 1,948 Non-GAAP operating margin(2) 27.1%25.3% 25.8%24.4% § Represents an amount less than $0.5 million. (1) For further explanations, refer to the footnotes under the "Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva" table. (2) Non-GAAP operating margin is Non-GAAP operating income as a percentage of revenues. Reconciliation of net income (loss) to adjusted EBITDA (Unaudited) Three months ended Six months ended June 30, June 30, ($ in millions) 2025 2024 2025 2024 Net income (loss) $283 (874) $503 (1,294) Increase (decrease) for excluded items:(1) Financial expenses 252 241 477 491 Income taxes (78)630 (4)578 Share in profits (losses) of associated companies –net(1)(2) (1)2 Depreciation 103 113 201 233 Amortization 148 146 292 298 EBITDA 705 254 1,468 308 Legal settlements and loss contingencies166 83 249 188 Goodwill impairment - 400 - 400 Impairment of long lived assets 99 130 177 809 Restructuring costs 154 18 168 31 Equity compensation 38 32 72 60 Contingent consideration 19 192 30 271 Other non-GAAP items 50 59 110 106 Adjusted EBITDA$1,233 1,168 2,274 2,173 (1) For further explanations, refer to the footnotes under the "Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva" table. Segment Information (Unaudited) United States Europe International Markets Three months ended June 30, Three months ended June 30, Three months ended June 30, 2025 2024 2025 2024 2025 2024 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues$2,151 $2,110 $1,298 $1,213 $495 $593Cost of sales 901 943 581 536 251 307Gross profit 1,250 1,167 717 677 243 286R&D expenses 152 170 59 62 24 30S&M expenses 279 270 228 209 114 145G&A expenses 113 100 66 64 32 38Other § (1) § § (1) §Segment profit$706 $629 $364 $342 $74 $73 § Represents an amount less than $0.5 million. Segment Information Unaudited United States Europe International Markets Six months ended June 30, Six months ended June 30, Six months ended June 30, 2025 2024 2025 2024 2025 2024 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues$4,060 $3,835 $2,492 $2,485 $1,077 $1,190 Cost of sales 1,752 1,809 1,117 1,070 556 607 Gross profit 2,308 2,025 1,374 1,415 521 583 R&D expenses 306 324 120 118 49 58 S&M expenses 552 530 427 403 232 263 G&A expenses 208 193 135 130 72 73 Other income 3 (1) § § (2) (1)Segment profit$1,239 $979 $693 $764 $171 $190 § Represents an amount less than $0.5 million. Reconciliation of our segment profit to consolidated income (loss) before income taxes Three months ended June 30, 2025 2024 (U.S.$ in millions) United States profit $706 $629 Europe profit 364 342 International Markets profit 74 73 Total reportable segment profit 1,144 1,043 Profit (loss) of other activities (11) 12 Total segment profit 1,133 1,056 Amounts not allocated to segments: Amortization 148 146 Other asset impairments, restructuring and other items 232 280 Goodwill impairment - 400 Intangible asset impairments 42 61 Legal settlements and loss contingencies 166 83 Other unallocated amounts 91 91 Consolidated operating income (loss) 455 (5) Financial expenses - net 252 241 Consolidated income (loss) before income taxes $203 $(246) Reconciliation of our segment profit to consolidated income (loss) before income taxes Six months ended June 30, 2025 2024 (U.S.$ in millions) United States profit $1,239 $979 Europe profit 693 764 International Markets profit 171 190 Total reportable segment profit 2,102 1,933 Profit (loss) of other activities (23) 15 Total segment profit 2,079 1,948 Amounts not allocated to segments: Amortization 292 298 Other asset impairments, restructuring and other items210 954 Goodwill impairment - 400 Intangible asset impairments 163 141 Legal settlements and loss contingencies 249 188 Other unallocated amounts 190 190 Consolidated operating income (loss) 975 (223) Financial expenses - net 477 491 Consolidated income (loss) before income taxes $497 $(713) Segment revenues by major products and activities(Unaudited) Three months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) United States segment Generic products (including biosimilars) $961 $1,023 (6%)AJOVY 63 42 53%AUSTEDO 495 407 22%BENDEKA and TREANDA 40 41 (3%)COPAXONE 62 81 (23%)UZEDY 54 24 120%Anda 365 373 (2%)Other 111 119 (7%)Total 2,151 2,110 2% Three months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) Europe segment Generic products (including OTC and biosimilars) $1,040 $970 7%AJOVY 71 52 38%COPAXONE 50 53 (6%)Respiratory products 55 57 (3%)Other* 81 81 1%Total 1,298 1,213 7% *Other revenues in the second quarter of 2025 include the sale of certain product rights. Three months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) International Markets segment Generic products (including OTC and biosimilars) $410 $486 (16%)AJOVY 20 22 (7%)AUSTEDO 3 12 (76%)COPAXONE 7 14 (50%)Other* 55 59 (6%)Total 495 593 (17%) Segment revenues by major products and activities(Unaudited) Six months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) United States segment Generic products $1,809 $1,831 (1%)AJOVY 117 87 34%AUSTEDO 891 689 29%BENDEKA / TREANDA 76 87 (12%)COPAXONE 116 111 5%UZEDY 93 40 134%Anda 738 754 (2%)Other 220 237 (7%)Total 4,060 3,835 6% Six months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) Europe segment Generic products $2,029 $1,974 3%AJOVY 129 102 26%COPAXONE 92 110 (17%)Respiratory products 110 123 (11%)Other* 132 175 (25%)Total 2,492 2,485 0% *Other revenues in the first six months of 2025 include the sale of certain product rights. Six months ended June 30, PercentageChange 2025 2024 2025-2024 (U.S.$ in millions) International Markets segment Generic products $878 $963 (9%)AJOVY 48 39 25%AUSTEDO 18 26 (33%)COPAXONE 17 25 (32%)Other* 116 136 (15%)Total 1,077 1,190 (9%) *Other revenues in the first six months of 2025 include the sale of certain product rights. Free cash flow reconciliation (Unaudited) Three months ended June 30, 2025 2024 (U.S. $ in millions) Net cash provided by (used in) operating activities 227 103 Beneficial interest collected in exchange for securitized accounts receivables 336 317 Capital investment (96) (97)Proceeds from divestitures of businesses and other assets, net 9 1 Free cash flow$476 $324 Free cash flow reconciliation (Unaudited) Six months ended June 30, 2025 2024 (U.S. $ in millions) Net cash provided by (used in) operating activities 122 (21)Beneficial interest collected in exchange for securitized trade receivables 658 612 Capital investment (223) (221)Proceeds from divestitures of businesses and other assets, net 26 1 Acquisition of businesses, net of cash acquired - (15) Free cash flow$583 $356 Teva Media Inquiries TevaCommunicationsNorthAmerica@tevapharm.com Teva Investor Relations Inquires TevaIR@Tevapharm.com A PDF accompanying this announcement is available at http://ml-eu.globenewswire.com/Resource/Download/626fd803-b4ed-4646-b41e-cf6b0e93ecff

临床3期财报生物类似药上市批准

2025-07-29

·Business Wire

Incyte Reports 2025 Second Quarter Financial Results and Provides Updates on Key Clinical Programs

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today reports 2025 second quarter financial results, and provides a status update on the Company’s clinical development portfolio. "...Our second quarter results reflect strong growth for Jakafi® (ruxolitinib), Opzelura® (ruxolitinib) cream and Niktimvo™ (axatilimab), positioning us well to deliver on our 2025 objectives," said Bill Meury, Chief Executive Officer, Incyte. "As I begin my tenure as CEO, I look forward to leading Incyte through its next phase of growth and value creation for patients, partners and shareholders. Our second quarter results reflect strong growth for Jakafi® (ruxolitinib), Opzelura® (ruxolitinib) cream and Niktimvo™ (axatilimab), positioning us well to deliver on our 2025 objectives," said Bill Meury, Chief Executive Officer, Incyte. "During the quarter, we achieved two regulatory milestones with the approvals of Zynyz® (retifanlimab-dlwr) for squamous cell anal carcinoma and Monjuvi® (tafasitamab-cxix) for follicular lymphoma, further expanding our ability to address patients' needs. Continued progress and diversification of our portfolio, including advancements with povorcitinib and mutCALR, are strengthening the foundation for sustainable, long-term growth.” Key Commercial Highlights Jakafi: Net product revenues for the second quarter 2025 of $764 million (+8% Y/Y): Opzelura: Net product revenues for the second quarter 2025 of $164 million (+35% Y/Y): Pipeline Updates Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights MPN and GVHD Programs Indication and status Ruxolitinib XR (QD) (JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD Ruxolitinib + INCB57643 (JAK1/JAK2 + BETi) Myelofibrosis: Phase 2 Ruxolitinib + axatilimab1 (JAK1/JAK2 + anti-CSF-1R) Chronic GVHD: Phase 2 Steroids + axatilimab1 (Steroids + anti-CSF-1R) Chronic GVHD: Phase 3 INCA033989 (mutCALR) Myelofibrosis, essential thrombocythemia: Phase 1 INCB160058 (JAK2V617Fi) Myeloproliferative Neoplasms (MPNs): Phase 1 1 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals. Other Hematology/Oncology – key highlights Heme/Oncology Programs Indication and status Tafasitamab (Monjuvi®/Minjuvi®) (CD19) Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND) First-line DLBCL: Phase 3 (frontMIND) Retifanlimab (Zynyz®)1 (PD-1) Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304) MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204) INCB123667 (CDK2i) Solid tumors with CCNE1 amplification/Cyclin E overexpression: Phase 1 INCB161734 (KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation: Phase 1 INCA33890 (TGFßR2×PD-1)2 Advanced or metastatic solid tumors: Phase 1 1 Retifanlimab licensed from MacroGenics. 2 Development in collaboration with Merus. Inflammation and Autoimmunity (IAI) – key highlights Ruxolitinib Cream Povorcitinib (INCB54707) IAI and Dermatology Programs Indication and status Ruxolitinib cream (Opzelura)1 (JAK1/JAK2) Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3); sNDA under review in the U.S. Hidradenitis suppurativa: Phase 3 (TRuE-HS1, TRuE-HS2) Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2) Povorcitinib (JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2) Vitiligo: Phase 3 (STOP-V1, STOP-V2) Prurigo nodularis: Phase 3 (STOP-PN1, STOP-PN2) Chronic spontaneous urticaria: Phase 2 Asthma: Phase 2 INCA034460 (anti-CD122) Vitiligo: Phase 1 1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration. Other Other Program Indication and Phase Zilurgisertib (ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2 2025 Second Quarter Financial Results The financial measures presented in this press release for the three and six months ended June 30, 2025 and 2024 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry. As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP. Financial Highlights Financial Highlights (unaudited, in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Total GAAP revenues $ 1,215,529 $ 1,043,759 $ 2,268,427 $ 1,924,648 Total GAAP operating income (loss) 530,314 (478,130 ) 735,482 (386,232 ) Total Non-GAAP operating income (loss) 382,579 (378,801 ) 666,220 (217,618 ) GAAP net income (loss) 404,999 (444,601 ) 563,202 (275,053 ) Non-GAAP net income (loss) 311,927 (396,132 ) 541,386 (263,413 ) GAAP basic EPS $ 2.09 $ (2.04 ) $ 2.91 $ (1.24 ) Non-GAAP basic EPS $ 1.61 $ (1.82 ) $ 2.79 $ (1.19 ) GAAP diluted EPS1 $ 2.04 $ (2.04 ) $ 2.84 $ (1.24 ) Non-GAAP diluted EPS1 $ 1.57 $ (1.82 ) $ 2.73 $ (1.19 ) 1 All stock options and stock awards were excluded from the diluted share calculation for the three and six months ended June 30, 2024 because their effect would have been anti-dilutive, as we were in a net loss position. Revenue Details Revenue Details (unaudited, in thousands) Three Months Ended June 30, % Change (as reported) % Change (constant currency)1 Six Months Ended June 30, % Change (as reported) % Change (constant currency)1 2025 2024 2025 2024 Net product revenues: Jakafi $ 763,788 $ 705,973 8 % NA $ 1,473,200 $ 1,277,812 15 % NA Opzelura 164,499 121,695 35 % 34 % 283,204 207,419 37 % 36 % Iclusig 32,729 26,862 22 % 16 % 62,273 57,205 9 % 8 % Pemazyre 22,192 20,269 9 % 8 % 40,632 37,945 7 % 7 % Minjuvi/ Monjuvi 31,131 31,116 0 % (1 %) 60,682 54,990 10 % 10 % Niktimvo 36,154 — NM NA 49,767 — NM NA Zynyz 8,921 651 1,270 % NA 11,930 1,118 967 % NA Total net product revenues 1,059,414 906,566 17 % 16 % 1,981,688 1,636,489 21 % 21 % Royalty revenues: Jakavi 109,714 99,317 10 % 7 % 201,859 188,912 7 % 8 % Olumiant 33,482 31,702 6 % 4 % 64,282 62,291 3 % 5 % Tabrecta 6,632 5,298 25 % NA 13,045 10,532 24 % NA Other 1,287 876 47 % NM 2,553 1,424 79 % NM Total royalty revenues 151,115 137,193 10 % 281,739 263,159 7 % Total net product and royalty revenues 1,210,529 1,043,759 16 % 2,263,427 1,899,648 19 % Milestone and contract revenues 5,000 — NM NM 5,000 25,000 (80 %) (80 %) Total GAAP revenues $ 1,215,529 $ 1,043,759 16 % $ 2,268,427 $ 1,924,648 18 % NM = not meaningful NA = not applicable 1 Percentage change in constant currency is calculated using 2024 foreign exchange rates to recalculate 2025 results. Product and Royalty Revenues Total net product revenues for the quarter ended June 30, 2025 increased 17% over the prior year comparative period. Total net product and royalty revenues for the quarter ended June 30, 2025 increased 16% over the prior year comparative period, primarily driven by the following: Jakafi net product revenue increased 8% versus the prior year comparable period, driven by an increase in paid demand of 8% reflecting continued demand growth in all indications. Jakafi inventory levels were within normal range at the end of the second quarter of 2025. Opzelura net product revenue increased 35% due to increased patient demand and refills in the U.S. in both AD and vitiligo, and increased contribution from ex-U.S. driven by continued uptake in France, and growth from the recent launches in Italy and Spain. Opzelura inventory levels were within normal range at the end of the second quarter of 2025. Niktimvo net product revenue reflects continued strong uptake of the product following its commercial launch during the first quarter of 2025. Zynyz net product revenue increase driven by the approval of the product in squamous cell anal carcinoma in the second quarter of 2025. Total royalty revenues for the quarter increased 10% versus the prior year comparable period, primarily driven by growth in Jakavi royalty revenue. Operating Expenses Operating Expense Summary (unaudited, in thousands) Three Months Ended June 30, % Change Six Months Ended June 30, % Change 2025 2024 2025 2024 GAAP cost of product revenues $ 78,766 $ 76,634 3 % $ 151,954 $ 137,590 10 % Non-GAAP cost of product revenues1 72,544 70,899 2 % 139,489 125,858 11 % Contract dispute settlement (242,251 ) — NM (242,251 ) — NM Non-GAAP contract dispute settlement2 — — NM — — NM GAAP research and development 494,917 1,138,380 (57 %) 932,196 1,567,640 (41 %) Non-GAAP research and development3 455,635 1,089,089 (58 %) 855,655 1,477,526 (42 %) GAAP selling, general and administrative 331,022 305,982 8 % 656,713 606,238 8 % Non-GAAP selling, general and administrative4 304,771 262,572 16 % 607,063 539,907 12 % GAAP loss (gain) on change in fair value of acquisition-related contingent consideration 22,761 893 NM 34,333 437 NM Non-GAAP loss (gain) on change in fair value of acquisition-related contingent consideration — — NM — — NM GAAP (profit) and loss sharing under collaboration agreements — — NM — (1,025 ) NM 1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation. 2 Non-GAAP contract dispute settlement excludes the contract dispute settlement reached with Novartis. 3 Non-GAAP research and development expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments. 4 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation, MorphoSys transition costs, and Escient acquisition related compensation expense related to cash settled unvested Escient equity awards and severance payments. Cost of product revenues GAAP and Non-GAAP cost of product revenues for the quarter ended June 30, 2025 increased 3% and 2% respectively, compared to the same period in 2024, primarily driven by growth in net product revenues, the Niktimvo profit share and increased manufacturing related costs, partially offset by the impact of the contract dispute settlement with Novartis. Contract dispute settlement In May 2025, Incyte and Novartis entered into a settlement agreement with respect to litigation relating to the duration of royalty payments owed under the Collaboration and License Agreement between Incyte and Novartis. Under the settlement agreement, the royalty rate payable by Incyte on future net sales of Jakafi in the United Stated is reduced by 50% beginning January 1, 2025 and Incyte paid Novartis $280.0 million as the settlement of disputed royalties on net sales of Jakafi in the United States through December 31, 2024. The reduced royalty paid for the quarter ending March 31, 2025, was approximately $14.9 million. The difference of $242.2 million between the accrued royalties and the total amount paid by us to Novartis as disclosed above was recorded in contract dispute settlement on the condensed consolidated statement of operations for the three and six months ended June 30, 2025. Research and development expenses GAAP and Non-GAAP research and development expenses for the quarter ended June 30, 2025 decreased 57% and 58%, respectively, compared to the same period in 2024, primarily due to $691.9 million of expense relating to the Escient acquisition that occurred during the quarter ended June 30, 2024. Excluding the upfront consideration paid related to the Escient transaction and other upfront and milestone payments, research and development expenses for the quarter ended June 30, 2025 increased 8% compared to the same period in 2024 primarily driven by continued investment in our late stage development assets. Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended June 30, 2025 increased 8% and 16%, respectively, compared to the same period in 2024, primarily due to increased legal costs relating to the Novartis contract dispute settlement and other matters and timing of consumer marketing activities. The 2024 Non-GAAP selling, general and administrative expenses exclude $21.5 million of expense relating to the Escient acquisition that occurred during the second quarter of 2024. Other Financial Information Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended June 30, 2025, compared to the same period in 2024, was primarily due to fluctuations in foreign currency exchange rates impacting future revenue projections of Iclusig. Operating income GAAP and Non-GAAP operating income for the three months ended June 30, 2025 increased 211% and 201%, respectively, compared to the same period in 2024, driven primarily by the aforementioned costs relating to the Escient acquisition in 2024, the Novartis contract dispute settlement in 2025 and growth in net product revenues. Cash, cash equivalents and marketable securities position As of June 30, 2025 and December 31, 2024, cash, cash equivalents and marketable securities totaled $2.4 billion and $2.2 billion, respectively. The balance reflects the Novartis contract dispute settlement payment made during the second quarter of 2025, which offsets cash flows from operating activities. 2025 Financial Guidance Incyte's guidance for the fiscal year 2025 is summarized below. Incyte is raising its revenue guidance for Jakafi to account for higher demand in the first half of 2025. Incyte is also raising its revenue guidance for other oncology products, to reflect the strength of the Niktimvo launch, higher demand for Zynyz in the first half of the year and the positive impact of foreign currency exchange rates. Incyte is updating its cost of product revenues guidance to reflect the reduction in the Jakafi royalty rate payable to Novartis, as a result of the contract dispute settlement. Furthermore, Incyte is updating its expense guidance for research and development to reflect the increase due to upfront and ongoing expenses related to new collaborations with Genesis and Biotheryx. Current Previous Jakafi net product revenues $3,000 - $3,050 million $2,950 - $3,000 million Opzelura net product revenues Unchanged $630 - $670 million Other oncology net product revenues(1) $500 - $520 million $415 - $455 million GAAP Cost of product revenues 8.0% - 9.0% of net product revenues 8.5% - 9.0% of net product revenues Non-GAAP Cost of product revenues(2) 7.0% - 8.0% of net product revenues 7.5% - 8.0% of net product revenues GAAP Research and development expenses $1,965 - $1,995 million $1,930 - $1,960 million Non-GAAP Research and development expenses(3) $1,815 - $1,840 million $1,780 - $1,805 million GAAP Selling, general and administrative expenses Unchanged $1,280 - $1,310 million Non-GAAP Selling, general and administrative expenses(3) Unchanged $1,160 - $1,185 million 1Pemazyre in the U.S., EU and Japan; Niktimvo, Monjuvi and Zynyz in the U.S.; and Iclusig and Minjuvi in the EU. 2Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation. 3Adjusted to exclude the estimated cost of stock-based compensation. Conference Call and Webcast Information Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13754581. If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13754581. The conference call will also be webcast live and can be accessed at investor.incyte.com. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. About Jakafi® (ruxolitinib) Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is a registered trademark of Incyte. About Opzelura® (ruxolitinib) Cream Opzelura® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. About Monjuvi® (tafasitamab-cxix) Monjuvi® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In the U.S., Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. XmAb® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are registered trademarks of Incyte. About Pemazyre® (pemigatinib) Pemazyre® (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe and Japan. Pemazyre is a trademark of Incyte. About Iclusig® (ponatinib) tablets Iclusig® (ponatinib) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. About Zynyz® (retifanlimab-dlwr) Zynyz® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S. Zynyz is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Zynyz is marketed by Incyte in the United States. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a registered trademark of Incyte. About Niktimvo™ (axatilimab-csfr) Niktimvo™ (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications. Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). Niktimvo is a trademark of Incyte. All other trademarks are the property of their respective owners. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte’s potential for continued performance and growth; Incyte’s ability to achieve both its full-year and long-term objectives; Incyte’s financial guidance for 2025, including its expectations regarding sales of and demand for Jakafi and Opzelura; expected revenue contribution from Niktimvo and other hematology and oncology products; Incyte’s potential to have more than 10 high impact launches by 2030; the disease modifying/curative potential of INCA033989 and plans to develop same; the potential blockbuster opportunity presented by povorcitinib and plans to develop same, including the submission of an NDA in early 2026; the possibility for H2 of 2025 to be transformational for Incyte in terms of regulatory approvals, data readouts and initiation of pivotal studies; the potential and progress of programs in our pipeline; ongoing clinical trials and clinical trials to be initiated; expectations regarding discussions with regulators, regulatory submissions and regulatory approvals; and 2025 newsflow items. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA, EMA and other regulatory agencies; Incyte’s dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte’s products and the products of Incyte’s collaboration partners; the acceptance of Incyte’s products and the products of Incyte’s collaboration partners in the marketplace; market competition; unexpected variations in the demand for Incyte’s products and the products of Incyte’s collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products and the products of Incyte’s collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte’s and its collaboration partners’ ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements. INCYTE CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP GAAP Revenues: Product revenues, net $ 1,059,414 $ 906,566 $ 1,981,688 $ 1,636,489 Product royalty revenues 151,115 137,193 281,739 263,159 Milestone and contract revenues 5,000 — 5,000 25,000 Total revenues 1,215,529 1,043,759 2,268,427 1,924,648 Costs, expenses and other: Cost of product revenues (including definite-lived intangible amortization) 78,766 76,634 151,954 137,590 Contract dispute settlement (242,251 ) — (242,251 ) — Research and development 494,917 1,138,380 932,196 1,567,640 Selling, general and administrative 331,022 305,982 656,713 606,238 Loss on change in fair value of acquisition-related contingent consideration 22,761 893 34,333 437 (Profit) and loss sharing under collaboration agreements — — — (1,025 ) Total costs, expenses and other 685,215 1,521,889 1,532,945 2,310,880 Income (loss) from operations 530,314 (478,130 ) 735,482 (386,232 ) Interest income 25,136 41,476 48,065 88,246 Interest expense (594 ) (657 ) (1,254 ) (1,087 ) (Loss) gain on equity investments (4,151 ) 39,241 (5,494 ) 139,188 Other, net 7,307 8,293 15,403 6,267 Income (loss) before provision for income taxes 558,012 (389,777 ) 792,202 (153,618 ) Provision for income taxes 153,013 54,824 229,000 121,435 Net income (loss) $ 404,999 $ (444,601 ) $ 563,202 $ (275,053 ) Net income (loss) per share: Basic $ 2.09 $ (2.04 ) $ 2.91 $ (1.24 ) Diluted $ 2.04 $ (2.04 ) $ 2.84 $ (1.24 ) Shares used in computing net income (loss) per share: Basic 193,995 218,175 193,853 221,329 Diluted 198,744 218,175 198,526 221,329 INCYTE CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) June 30, 2025 December 31, 2024 ASSETS Cash, cash equivalents and marketable securities $ 2,421,738 $ 2,158,092 Accounts receivable 842,892 853,154 Property and equipment, net 798,543 763,411 Finance lease right-of-use assets, net 29,001 30,803 Inventory 451,531 407,199 Prepaid expenses and other assets 330,044 181,382 Equity investments 13,313 18,814 Other intangible assets, net 126,419 113,803 Goodwill 155,593 155,593 Deferred income tax asset 652,280 762,071 Total assets $ 5,821,354 $ 5,444,322 LIABILITIES AND STOCKHOLDERS’ EQUITY Accounts payable, accrued expenses and other liabilities $ 1,407,216 $ 1,765,733 Finance lease liabilities 36,235 37,961 Acquisition-related contingent consideration 207,000 193,000 Stockholders’ equity 4,170,903 3,447,628 Total liabilities and stockholders’ equity $ 5,821,354 $ 5,444,322 INCYTE CORPORATION RECONCILIATION OF GAAP NET (LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION (unaudited, in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP Net Income (Loss) $ 404,999 $ (444,601 ) $ 563,202 $ (275,053 ) Adjustments1: Non-cash stock compensation from equity awards (R&D)2 37,700 34,541 74,424 71,333 Non-cash stock compensation from equity awards (SG&A)2 26,071 21,748 49,470 44,121 Non-cash stock compensation from equity awards (COGS)2 838 351 1,697 964 Non-cash interest3 81 144 163 252 Loss (gain) on equity investments4 4,151 (39,241 ) 5,494 (139,188 ) Amortization of acquired product rights5 5,384 5,384 10,768 10,768 Loss on change in fair value of contingent consideration6 22,761 893 34,333 437 Contract dispute settlement7 (242,251 ) — (242,251 ) — MorphoSys transition costs8 — 2,373 — 6,952 Escient acquisition related compensation expense9 1,762 34,039 2,297 34,039 Tax effect of Non-GAAP pre-tax adjustments10 50,431 (11,763 ) 41,789 (18,038 ) Non-GAAP Net Income (Loss) $ 311,927 $ (396,132 ) $ 541,386 $ (263,413 ) Non-GAAP net income (loss) per share: Basic $ 1.61 $ (1.82 ) $ 2.79 $ (1.19 ) Diluted11 $ 1.57 $ (1.82 ) $ 2.73 $ (1.19 ) Shares used in computing Non-GAAP net income (loss) per share: Basic 193,995 218,175 193,853 221,329 Diluted11 198,744 218,175 198,526 221,329 1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and six months ended June 30, 2025 are milestones of $5,000 and $5,000 earned from our collaborative partners, as compared to $0 and $25,000 of milestones earned for the three and six months ended June 30, 2024. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and six months ended June 30, 2025 are upfront consideration and milestones of $12,550 and $28,050, respectively, related to our collaborative partners as compared to upfront consideration and milestones of $414 and $1,414, respectively, for the three and six months ended June 30, 2024. 2 As included within the Cost of product revenues (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. 3 As included within the Interest expense line item in the Condensed Consolidated Statements of Operations. 4 As included within the (Loss) gain on equity investments line item in the Condensed Consolidated Statements of Operations. 5 As included within the Cost of product revenues (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years. 6 As included within the Loss on change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. 7 As included within the Contract dispute settlement line item in the Condensed Consolidated Statements of Operations. 8 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is $2,232 and $6,263 for the three and six months ended June 30, 2024, and $141 and $689 is included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and six months ended June 30, 2024. MorphoSys transition costs primarily represent employee related costs to transition research and development and selling, general and administrative activities to us under the former collaboration agreement with MorphoSys. 9 Included within the Research and development line item in the Condensed Consolidated Statements of Operations (in thousands) is $1,582 and $2,117 for the three and six months ended June 30, 2025, and included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations is $180 for the three and six months ended June 30, 2025. Included within the Research and development line item in the Condensed Consolidated Statements of Operations is $12,518 for the three and six months ended June 30, 2024, and included within the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations is $21,521 for the three and six months ended June 30, 2024. Escient acquisition related compensation expense represents non-recurring charges associated with (i) cash settled unvested Escient equity awards in connection with the acquisition, and (ii) severance payments to former Escient employees. 10 Income tax effects of Non-GAAP pre-tax adjustments are calculated using an estimated annual effective tax rate, taking into consideration any permanent items and valuation allowances against related deferred tax assets. 11 All stock options and stock awards were excluded from the diluted share calculation for the three and six months ended June 30, 2024 because their effect would have been anti-dilutive, as we were in a net loss position.

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KEGG	Wiki	ATC	Drug Bank
D02994	利妥昔单抗	L01XC02	DB00073

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
心脏移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
肝移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
肺移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
胰腺移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
肾移植排斥反应	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
小肠移植排斥	日本	Zenyaku Kogyo Co., Ltd.	2023-12-22
狼疮性肾炎	日本	Zenyaku Kogyo Co., Ltd.	2023-08-23
视神经脊髓炎	日本	Zenyaku Kogyo Co., Ltd.	2022-06-20
巴西天疱疮	日本	Zenyaku Kogyo Co., Ltd.	2021-12-24
家族性寻常型天疱疮	日本	Zenyaku Kogyo Co., Ltd.	2021-12-24
获得性血栓性血小板减少性紫癜	日本	Zenyaku Kogyo Co., Ltd.	2020-02-21
CD20阳性B细胞慢性淋巴细胞白血病	日本	Zenyaku Kogyo Co., Ltd.	2019-03-26
淋巴细胞白血病	日本	IDEC Pharmaceuticals Corp.	2019-03-26
淋巴细胞白血病	日本	Genentech, Inc.	2019-03-26
慢性特发性血小板减少性紫癜	日本	Zenyaku Kogyo Co., Ltd.	2017-06-26
血小板减少性紫癜	日本	IDEC Pharmaceuticals Corp.	2017-06-26
血小板减少性紫癜	日本	Genentech, Inc.	2017-06-26
肾病综合征	日本	Zenyaku Kogyo Co., Ltd.	2014-08-29
肾病综合征	日本	Genentech, Inc.	2014-08-29
肾病综合征	日本	IDEC Pharmaceuticals Corp.	2014-08-29

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
载脂蛋白C-Iii缺乏症	临床3期	美国	Genmab A/S	2024-02-05
载脂蛋白C-Iii缺乏症	临床3期	中国	Genmab A/S	2024-02-05
载脂蛋白C-Iii缺乏症	临床3期	日本	Genmab A/S	2024-02-05
载脂蛋白C-Iii缺乏症	临床3期	澳大利亚	Genmab A/S	2024-02-05
载脂蛋白C-Iii缺乏症	临床3期	比利时	Genmab A/S	2024-02-05
载脂蛋白C-Iii缺乏症	临床3期	保加利亚	Genmab A/S	2024-02-05
载脂蛋白C-Iii缺乏症	临床3期	加拿大	Genmab A/S	2024-02-05
载脂蛋白C-Iii缺乏症	临床3期	克罗地亚	Genmab A/S	2024-02-05
载脂蛋白C-Iii缺乏症	临床3期	捷克	Genmab A/S	2024-02-05
载脂蛋白C-Iii缺乏症	临床3期	丹麦	Genmab A/S	2024-02-05

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02911142 (CTgov)	临床1/2期	原发性渗出性淋巴瘤	17	Lenalidomide+EPOCH+etoposide+cyclophosphamide+etoposide phosphate+prednisone+doxorubicin+Vincristine+rituximab (DA-EPOCH-R) (All Participants)	淵積膚範醖夢壓積鏇窪 = 憲構齋簾觸醖選衊鑰積鑰遞製襯鬱蓋築膚築製 (製鹽願襯襯窪夢淵淵獵, 壓壓廠壓鹽齋鏇願範獵 ~ 鬱觸壓鬱鬱鹽鑰廠選築) 更多	-	2025-07-28
				Lenalidomide+Cyclophosphamide+Etoposide Phosphate+Prednisone+Doxorubicin+Rituximab+Vincristine (Lenalidomide+Etoposide Phosphate, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin & Rituximab)	製膚衊築積鹽範齋遞鑰(繭範夢構齋範遞齋鏇鹽) = 衊夢蓋獵顧繭顧齋蓋選網糧鹹齋鬱壓鬱衊觸蓋 (壓選壓願窪選遞淵夢鑰, 積窪鑰醖壓壓艱糧蓋窪 ~ 顧築顧構鹽範蓋鬱糧網) 更多
NCT00878254 (CTgov)	临床2期	套细胞淋巴瘤	25	G-CSF+Mesna+Etoposide+Cyclophosphamide+Leucovorin+Doxorubicin+ifosfamide+Methotrexate+Rituximab+Vincristine+Cytarabine	衊願願繭範製憲積襯襯(觸糧衊膚餘襯簾鹽衊廠) = 範艱鹽窪築窪艱壓範願廠衊衊顧顧顧範醖膚餘 (鑰選廠網構窪顧築鹽夢, 廠衊選築獵齋鑰醖壓襯 ~ 鏇觸膚壓蓋獵醖願選築) 更多	-	2025-07-23
NCT00001379 (CTgov)	临床2期	淋巴瘤样肉芽肿病	94	interferon+etoposide+cyclophosphamide+prednisone+doxorubicin+vincristine+rituximab (EPOCH-R) (Participants Treated With Initial Interferon Therapy)	築膚蓋蓋窪餘鑰鬱餘築 = 築觸糧範憲鬱廠齋鹽餘鹽願衊壓築觸積範遞夢 (鹹蓋範鏇選網築醖襯廠, 製顧獵構觸顧蓋夢選觸 ~ 餘鏇製構糧鏇選夢淵網) 更多	-	2025-06-19
				Etoposide+Cyclophosphamide+Prednisone+Doxorubicin+Rituximab+Vincristine (Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy)	築膚蓋蓋窪餘鑰鬱餘築 = 夢顧鏇蓋遞餘衊夢網顧鹽願衊壓築觸積範遞夢 (鹹蓋範鏇選網築醖襯廠, 製膚憲憲範鹹壓襯齋製 ~ 獵積膚夢觸鹽製蓋構網) 更多
NCT05168475 (BIOVAS, CTgov)	临床2期	过敏性紫癜 \| 原发性中枢神经系统血管炎 \| 大动脉炎 ... 更多	22	Tocilizumab+Rituximab (Infliximab)	積襯鏇鬱淵膚鏇鬱淵壓 = 製鹽鬱醖製鬱鑰築構夢醖獵構選網壓簾觸鏇鬱 (範醖鹹範觸構襯夢繭醖, 製鹽醖膚齋鹹構艱壓窪 ~ 簾鬱憲顧夢觸廠觸製觸) 更多	-	2025-06-17
				Infliximab+Tocilizumab (Rituximab)	積襯鏇鬱淵膚鏇鬱淵壓 = 簾積襯願鹽衊壓襯願鬱醖獵構選網壓簾觸鏇鬱 (範醖鹹範觸構襯夢繭醖, 築廠簾膚顧齋網鑰夢鑰 ~ 廠顧構構積蓋鏇蓋醖襯) 更多
NCT04182204 (POLARGO, EHA2025) 人工标引	临床3期	难治性弥漫性大 B 细胞淋巴瘤	255	Pola-R-GemOx	積淵願鑰製繭鑰願積糧(積膚襯簾膚蓋鏇鏇鑰構) = 餘網餘範齋簾鬱網獵鏇製繭襯廠鹽鏇憲襯遞鏇 (簾觸窪壓繭衊製選積鏇, 13.3 ~ NE) 更多	积极	2025-06-13
				R-GemOx	積淵願鑰製繭鑰願積糧(積膚襯簾膚蓋鏇鏇鑰構) = 鏇蓋憲選餘淵範衊餘顧製繭襯廠鹽鏇憲襯遞鏇 (簾觸窪壓繭衊製選積鏇, 8.9 ~ 15.8) 更多
NCT03863184 (CTgov)	临床2期	套细胞淋巴瘤	37	Lenalidomide+Acalabrutinib+Rituximab (ALR in Combination)	壓簾網築壓繭網壓觸鑰 = 夢膚築壓鹽憲醖鬱齋獵艱鏇憲壓鹹夢選製顧築 (繭製廠衊選齋鑰壓選齋, 膚鏇鏇鏇窪艱構簾窪廠 ~ 顧網憲網憲範觸顧艱鹹)	-	2025-06-06
				Lenalidomide+Acalabrutinib+Obinutuzumab (ALO in Combination)	壓簾網築壓繭網壓觸鑰 = 築鑰願範窪鑰範襯觸鏇艱鏇憲壓鹹夢選製顧築 (繭製廠衊選齋鑰壓選齋, 遞鬱願廠構餘齋壓齋壓 ~ 繭糧鏇觸範鏇壓範糧鏇)
NCT02005471 (MURANO, Pubmed \| Blood)	临床3期	复发性慢性淋巴细胞白血病	-	Venetoclax-rituximab (VenR)	觸醖遞積積選顧鬱範壓(餘鑰艱選襯窪蓋鏇鬱繭) = 襯餘醖憲鹹網範簾繭構鏇糧鹹壓夢範餘餘網遞 (選鏇鹹積願網窪鏇憲製 ) 更多	积极	2025-06-05
				Bendamustine-rituximab (BR)	觸醖遞積積選顧鬱範壓(餘鑰艱選襯窪蓋鏇鬱繭) = 糧遞窪憲顧構遞艱鏇淵鏇糧鹹壓夢範餘餘網遞 (選鏇鹹積願網窪鏇憲製 ) 更多
NCT02356159 (CTgov)	临床1/2期	霍奇金淋巴瘤 \| 多发性骨髓瘤 \| 急性白血病 ... 更多	34	Epinephrine+PET+Acetaminophen+prednisone+EPOCH-F+Palifermin+Diphenhydramine+Rituximab (2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose)	憲構夢衊鏇鏇鏇鹽鹹鏇 = 襯壓鹽壓廠淵顧夢憲範顧醖廠顧襯淵餘積壓夢 (鑰顧齋選繭衊糧範夢夢, 窪鏇餘窪糧製選糧顧醖 ~ 鏇遞廠鏇齋範糧壓鑰顧)	-	2025-06-05
				Epinephrine+PET+Acetaminophen+prednisone+EPOCH-F+Palifermin+Diphenhydramine+Rituximab (1/Phase 1: Dose Escalation Arm - Palifermin)	醖鹹願選選鑰遞願積繭 = 齋築製鏇製餘餘製願築繭窪鹹製廠鑰鹹齋膚鑰 (窪齋憲醖鑰顧憲夢製觸, 鬱願壓襯夢築襯鬱積廠 ~ 觸積顧獵衊築構構網觸)
ASCO2025	临床4期	肿瘤	21	Bevacizumab (Innovator)	選蓋鹹鑰網鹹觸廠遞鹽(鬱襯淵構鏇築獵鬱觸遞) = 觸淵蓋觸鏇選淵遞鑰蓋醖糧製獵簾膚築鑰鹹製 (膚鏇簾鏇鏇壓襯獵獵窪 ) 更多	积极	2025-05-30
				Rituximab (Innovator)	選蓋鹹鑰網鹹觸廠遞鹽(鬱襯淵構鏇築獵鬱觸遞) = 蓋膚簾鹽蓋簾觸積壓淵醖糧製獵簾膚築鑰鹹製 (膚鏇簾鏇鏇壓襯獵獵窪 ) 更多
ASCO2025	N/A	滤泡性淋巴瘤维持 GELF criteria \| FLIPI-1	95	Rituximab maintenance therapy	糧壓蓋簾餘餘艱簾繭鹽(衊壓齋壓製顧襯鹽憲齋) = 壓鹽鑰蓋廠淵衊鹹淵鹽壓遞醖積膚壓蓋構鹽鏇 (艱鹹網構膚廠獵顧衊窪 ) 更多	积极	2025-05-30
				rituximab (Non-maintenance group)	糧壓蓋簾餘餘艱簾繭鹽(衊壓齋壓製顧襯鹽憲齋) = 窪餘憲簾餘積膚廠衊醖壓遞醖積膚壓蓋構鹽鏇 (艱鹹網構膚廠獵顧衊窪 ) 更多