This is an open-label, single-arm, phase 3b/4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.

开始日期2025-09-01

申办/合作机构

Alimentiv, Inc.

NCT06864403

/ Recruiting临床4期IIT

Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are:
Does mirikizumab reduce symptoms of pouch disorders
Participants will:
Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms

开始日期2025-08-12

申办/合作机构

The University of North Carolina at Chapel Hill

[+1]

NCT07059130

/ Not yet recruiting临床4期

Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis: A Phase IV Multicenter Interventional Study

This research study looks at how safe and effective a medicine called Mirikizumab is for treating older adults (aged 60 and above) who have moderate to severe Crohn's disease (CD) or ulcerative colitis (UC). These two conditions, known as inflammatory bowel diseases (IBD), cause inflammation (swelling and irritation) in the digestive tract. Older adults with these conditions often have other health issues and face increased risks and complications, making it challenging for them to use certain treatments.
Mirikizumab is already approved by the FDA for adults with IBD, but there's limited information about how well it works specifically for older adults. This study aims to fill that gap by seeing if Mirikizumab can help these patients safely manage their condition.
The study plans to enroll around 150 people from various locations across the United States. Everyone participating will receive Mirikizumab according to the standard, FDA-approved guidelines.
The main goal is to see how many participants achieve clinical remission, meaning their symptoms significantly improve or disappear, after 24 weeks of treatment. Researchers will also look at whether this remission lasts up to 48 weeks, how well symptoms are controlled without steroids, how treatment affects indicators of inflammation (such as blood tests), and how the participants feel overall based on their own reports.
The safety of Mirikizumab will also be closely monitored throughout the study by regularly checking for any side effects.
This study hopes to provide clearer information to help older adults with IBD and their doctors make better treatment decisions, ultimately improving health outcomes and quality of life.

开始日期2025-07-16

申办/合作机构

Eli Lilly & Co.

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272

项与米吉珠单抗相关的文献（医药）

2025-12-31·REDOX REPORT

M6a demethylase FTO regulates the oxidative stress, mitochondrial biogenesis of cardiomyocytes and PGC-1a stability in myocardial ischemia-reperfusion injury

Article

作者: Zhang, Feilong ; Chen, Lianglong ; Chen, Xuehai ; Jiang, Qiong ; Gong, Kezeng ; Xu, Zhe

OBJECTIVE:

Myocardial ischemia-reperfusion injury (MIRI) is a highly complex disease with high morbidity and mortality. Studying the molecular mechanism of MIRI and discovering new targets are crucial for the future treatment of MIRI.

METHODS:

We constructed the MIRI rat model and hypoxia/reoxygenation (H/R) injury cardiomyocytes model. RT-PCR and Western blot were used to investigate the expression of the fat mass and obesity-associated (FTO) gene. Electrocardiogram, echocardiography, triphenyltetrazolium chloride (TTC) staining and hematoxylin-eosin (HE) staining were used to assess the model and the effect of FTO overexpression. The generation of reactive oxygen species (ROS) and the levels of superoxide dismutase (SOD2), mitochondrial transcription factor (TFAM) and cytochrome c oxidase I (COXI) were detected to assess the oxidative stress and mitochondrial biogenesis. RNA immunoprecipitation (RIP) and RNA pulldown assays were used to identify the interaction of FTO and PGC-1a. The m6A dot blot, methylated RNA immunoprecipitation PCR (MeRIP-PCR) and RNA stability analysis were used to analyze the regulation of methylation of PGC-1a by FTO.

RESULTS:

FTO was downregulated in MIRI rats and H/R induced cardiomyocytes. Overexpression of FTO inhibited ROS level and increased the expression of SOD2, TFAM and COXI in vitro and in vivo. In addition, PGC-1a was identified as a downstream target of FTO. FTO enhanced the stability of PGC-1a mRNA through removing the m6A modification.

CONCLUSION:

Our study revealed the role of FTO regulates the oxidative stress and mitochondrial biogenesis via PGC-1a in MIRI, which may provide a new approach to mitigating MIRI.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost per remission for mirikizumab versus ustekinumab for moderately to severely active ulcerative colitis treatment from the United States commercial payer perspective

Article

作者: Upadhyay, Navneet ; Creveling, Thomas ; Fisher, Deborah A. ; Mittal, Neha ; Bires, Nicholas ; Chanan, Neha ; Kane, Sunanda ; Gulati, Ankit ; Koushik, Amit Kumar

INTRODUCTION:

Mirikizumab, approved for the treatment of moderately to severely active ulcerative colitis (UC), may be prescribed in a similar placement to ustekinumab in second-line settings. Payers may compare the economic value when making formulary decisions. This study estimated and compared the cost per remission of the second-line therapies mirikizumab versus ustekinumab in patients with UC.

METHODS:

An Excel-based analytic model was developed to estimate the cost per additional patient achieving clinical remission at the end of one year in biologic/Janus kinase inhibitor (JAKi)-experienced patients (second-line therapy) with UC from a United States commercial payer perspective. A network meta-analysis of published pivotal randomized clinical trials was used to derive the number needed to treat (NNT) for clinical response, clinical remission, and endoscopic remission/endoscopic improvement/mucosal healing for ustekinumab and mirikizumab in the study population. The model included the treatment cost (wholesale acquisition costs [WAC] and treatment administration costs) during the induction and maintenance phases. A scenario involving the availability of a ustekinumab biosimilar was also evaluated, assuming the NNT remained the same as ustekinumab but with a WAC set at 50% lower than its current WAC.

RESULTS:

The costs per patient achieving clinical remission for mirikizumab vs. ustekinumab as a second-line therapy were $461,096 vs. $67,273 during induction and $501,456 vs. $1,079,189 during maintenance. The cost per clinical remission in case of dose escalation during maintenance was lower for mirikizumab vs. ustekinumab ($501,456 vs. $1,569,127). Considering the ustekinumab 130 mg IV biosimilar, the scenario resulted in a lower cost per clinical remission for mirikizumab vs. a ustekinumab biosimilar during the maintenance phase ($501,456 vs. $539,594).

CONCLUSION:

Mirikizumab is projected to have a lower cost per remission during maintenance therapy than ustekinumab. Given the need for long-term treatment for this chronic condition, mirikizumab appears to be a cost-efficient treatment option.

2025-09-12·APOPTOSIS

Mitophagy: a novel avenue for herbal medicines alleviating myocardial ischemia/reperfusion injury.

Review

作者: Xu, Desheng ; Liu, Mengnan ; Li, Yuanyuan ; Men, Ling ; Zhou, Hua ; Luan, Jienan ; Liao, Mengqi ; Gong, Ming ; Wang, Yan ; Chen, Mingtai

Myocardial ischemia-reperfusion injury (MIRI) has a high incidence and is difficult to cure. Studies have shown that mitophagy is the key mechanism. This review systematically summarizes all documented herbal preparations and bioactive monomers targeting mitophagy for MIRI treatment, which may serve as a valuable reference for future research on herbal medicine-mediated mitophagy regulation. We conducted comprehensive literature searches in PubMed, Embase, Web of Science, and CNKI databases using the keywords "cardiovascular diseases," "mitophagy," "myocardial ischemia-reperfusion injury," "herbal medicine," "mechanism," and "therapeutic" for studies published within the last five years up to July 2025. Studies on herbal medicine interventions unrelated to mitophagy were excluded. Our analysis reveals that mitophagy plays a crucial role in attenuating the detrimental effects of MIRI. Furthermore, herbal medicine demonstrates therapeutic efficacy in maintaining homeostatic balance of mitophagy during MIRI. Herbal medicines can precisely regulate mitophagy via the PTEN-induced putative kinase 1 (PINK1)-parkin pathway, and modulate the expression of BCL2 interacting protein 3 (BNIP3), FUN14 domain-containing protein 1 (FUNDC1), NIP3-like protein X (NIX). Herbal medicines exert protective effects against MIRI through diverse mechanisms and signaling pathways by targeting mitophagy. While mitophagy represents a promising frontier for future cardiovascular research, current herbal medicine applications remain predominantly confined to animal and cellular models, with only limited clinical translation. The findings presented herein are anticipated to provide clinicians and cardiovascular researchers with valuable therapeutic strategies and novel research directions.

304

项与米吉珠单抗相关的新闻（医药）

2025-09-17

·GlobeNewswire-Health Care

Oruka Therapeutics Announces Positive Interim Phase 1 Results for ORKA-001

Half-life of approximately 100 days increases likelihood of once-per-year dosing Pharmacokinetic profile supports the ability to achieve exposures that could lead to higher efficacy and extended off-treatment remissions Well tolerated with a favorable safety profile consistent with the IL-23p19 class EVERLAST-A Phase 2a trial enrollment ongoing with data expected 2H 2026 MENLO PARK, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced interim data from its Phase 1 trial of ORKA-001, the Company’s long-acting IL-23p19 antibody, in a late-breaking abstract at the European Academy of Dermatology and Venerology (EADV) Congress in Paris, France. These results, as well as additional details on the EVERLAST-A trial design, will be presented in two oral presentations at the conference. “ORKA-001's approximately 100-day half-life exceeded our expectations and has the potential to enable multiple ‘upside’ scenarios for the program,” said Lawrence Klein, PhD, CEO of Oruka. “We are increasingly confident that ORKA-001 can redefine the standard of care in this important disease. I’m very pleased with how quickly our team has progressed this program and by the enthusiasm we are hearing from investigators and patients.” Interim results from the Phase 1 trial support the potential for ORKA-001 to change the PsO treatment paradigm. The ongoing EVERLAST-A Phase 2a trial is designed to test whether ORKA-001 can enable annual dosing, higher rates of skin clearance than standard of care, and long-term off-treatment remissions. Oruka expects to present initial data from EVERLAST-A in 2H 2026. Key Phase 1 Interim Findings The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and pharmacokinetics (PK) of ORKA-001 in healthy volunteers. The study enrolled 24 healthy adult participants into three single ascending subcutaneous dose cohorts of 300 mg, 600 mg, and 1200 mg. Interim results from the Phase 1 trial include: PK: ORKA-001 showed a half-life of approximately 100 days, greater than three times that of risankizumab, and a Cmax that exceeded risankizumab at an equivalent dose, based on previously reported risankizumab data. These properties increase the likelihood of achieving once-yearly maintenance dosing and demonstrate comparable exposures to the KNOCKOUT study, which could lead to best-in-class rates of skin clearance and extended off-treatment remissions.Pharmacodynamics (PD): Single doses of ORKA-001 demonstrated complete and sustained inhibition of STAT3 signaling, a downstream marker of IL-23 activity, in an ex vivo assay through 24 weeks (the longest follow-up available).Safety: ORKA-001 was well tolerated at all dose levels, with a favorable safety profile consistent with the anti-IL-23 class. There were no severe treatment-emergent adverse events (TEAEs) or serious adverse events. The only TEAEs to occur in more than two subjects were headache, upper respiratory tract infections, and transient erythema at the injection site. The study remains blinded, and all subjects remain on study. EVERLAST Phase 2 Trials of ORKA-001 in Plaque Psoriasis The ongoing EVERLAST-A trial is a randomized, double-blind, placebo-controlled Phase 2a trial designed to evaluate the safety and efficacy of a single dose level of ORKA-001 in moderate-to-severe PsO patients. Enrollment and dosing at sites across the U.S. and Canada are currently progressing well, and the Company expects to share initial data from EVERLAST-A in 2H 2026. Data presented at that time is expected to include PASI 100 at Week 16 for all patients and preliminary durability data that could show the potential for yearly dosing and off-treatment remissions. EVERLAST-A will enroll approximately 80 patients randomized 3:1 to receive 600 mg ORKA-001 at Week 0 and 4 or matching placebo. The primary endpoint is PASI 100 at Week 16. ORKA-001 exposures are expected to match or exceed exposures in the KNOCKOUT study, testing whether higher antibody exposures can lead to greater efficacy.At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to an arm where either (1) they do not receive another dose until disease recurrence or (2) they receive 300 mg ORKA-001 every six months. The “no-dose” arm will evaluate the possibility of both yearly dosing and extended off-treatment remissions (defined in the literature as clear skin over one year from last administration of a therapeutic). Patients who have not achieved PASI 100 at Week 28 will receive 300 mg ORKA-001 every six months.At Week 16, patients receiving placebo will cross over to 600 mg ORKA-001 at Week 16 and 20, followed by once-yearly dosing of ORKA-001, providing additional data on the efficacy of yearly dosing. In addition, Oruka expects to initiate a dose-ranging Phase 2b trial of ORKA-001 in moderate-to-severe PsO patients, EVERLAST-B, in 1H 2026. EVERLAST-B will evaluate three dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at Weeks 0 and 4, and 600 mg at Weeks 0 and 4, versus placebo. The primary endpoint is PASI 100 at Week 16. To expedite development, EVERLAST-B dosing is projected to begin enrolling before the completion of EVERLAST-A. Details of the oral presentations at EADV: Phase 1 Clinical Data of ORKA-001, a Novel Half-Life Extended IL-23p19 Monoclonal Antibody with Potential for Once-Yearly Dosing in Plaque PsoriasisAuthor: Dr. James KruegerPresentation ID: D2T01.4DLate-Breaking Presentation: Thursday, September 18, 16:45-17:00 CETLocation: Paris Nord EVERLAST-A: A Phase 2a Study Design of ORKA-001, a Novel Half-Life Extended IL-23p19 Monoclonal Antibody for Plaque PsoriasisAuthor: Dr. Andrew BlauveltPresentation ID: FC02.1lOral Presentation: Thursday, September 18, 11:35-11:45 CETLocation: W05-W06 About ORKA-001 ORKA-001 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice per year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance and extended off-treatment remissions. ORKA-001 is designed to match the validated biology of risankizumab by binding to a similar epitope with similar affinity, but has a significantly extended half-life of approximately 100 days. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Forward-Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, including its anticipated half-life, potential dosing intervals, ability to deliver off-treatment remissions, anticipated rates of disease clearance, and safety and tolerability profile; the competitive outlook; and anticipated trial design, enrollment targets and timelines to clinical development and data release milestones for ORKA-001. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including risks related to the design and conduct of clinical trials; risks that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results; risks related to the regulatory approval process and the timing of regulatory filings; risks related to Oruka’s ability to successfully establish, protect and defend its intellectual property; risks related to other matters that could affect the sufficiency of the company’s capital resources to fund operations; and changes in the competitive landscape. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, see the uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q and subsequent filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 alan.lada@orukatx.com

临床结果临床1期临床2期

2025-09-16

·PRNewswire

Innovent to Present Multiple R&D Results of General Biomedicine Pipeline at the 34th EADV Congress 2025

SAN FRANCISCO and SUZHOU, China, Sept. 15, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, announces that it will present multiple research results at the 34th European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France from September 17-20. Specifically, post hoc analysis of Phase 2 and Phase 3 clinical studies of IBI112 (IL-23p19 monoclonal antibody, picankibart), as well as preclinical study results of IBI3013 (IL-15 monoclonal antibody) and IAR129 (IL-4R/OX40L bispecific antibody) will be showcased via ePoster. Details are listed below: Title: Development and Characterization of IBI3013, a Novel Half-life Extended Monoclonal Antibody Targeting Interleukin-15 (IL-15) Abstract #: 1882 Presentation Form: ePoster Time: 2025 September 17, 07:00 AM (CEST) Title: Development and characterization of IAR129, a novel bispecific antibody co-blocking IL-4Ra and OX40L for atopic dermatitis Abstract #: 2648 Presentation Form: ePoster Time: 2025 September 17, 07:00 AM (CEST) Title: Efficacy and safety of picankibart in patients with psoriasis who had been treated with biologics: a multicenter, open-label Phase 2 trial Abstract #: 1706 Presentation Form: ePoster Time: 2025 September 17, 07:00 AM (CEST) Title: Efficacy of picankibart in moderate-to-severe plaque psoriasis patients with scalp psoriasis: a post-hoc analysis of a Phase 3, randomized, double-blind trial Abstract #: 4799 Presentation Form: ePoster Time: 2025 September 17, 07:00 AM (CEST) Title: Efficacy of picankibart in genital psoriasis: results from the Phase 3 randomized, double-blind CLEAR-1 study Abstract #: 6421 Presentation Form: ePoster Time: 2025 September 17, 07:00 AM (CEST) Title: Efficacy of a new IL-23p19 inhibitor picankibart in the treatment of nail psoriasis: a post-hoc analysis of phase 3 CLEAR-1 study Abstract #: 7526 Presentation Form: ePoster Time: 2025 September 17, 07:00 AM (CEST) Title: Efficacy of Picankibart in Moderate-to-Severe Plaque Psoriasis Between Biologic-Experienced and Biologic-Naive Patients: A 52-Week results from the Phase 3 CLEAR-1 Study Abstract #: 7541 Presentation Form: ePoster Time: 2025 September 17, 07:00 AM (CEST) Dr. Huizhong Xiong, Senior Director of Immunology at Innovent, stated, "We will continue exploring important disease driver pathways and their combinations, taking advantage of our diverse technology platforms to address unmet needs in various skin diseases. We hope that these differentiated monoclonal antibodies and innovative bispecific antibodies will bring meaningful benefits to patients in terms of efficacy, dosing frequency and symptom control after treatment cessation." Dr. Lei Qian, Chief R&D Officer of General Biomedicine at Innovent, stated, "The general biomedicine pipelines of Innovent Biologics demonstrate a well-established, echeloned and matrix-like layout across the fields of cardiovascular and metabolic diseases (CVM), autoimmune diseases, and ophthalmology. Specifically, in the field of autoimmune diseases, our cornerstone product, picankibart (an anti-IL-23p19 monoclonal antibody), is expected to receive marketing approval by the end of this year. As a best-in-class IL-23p19 inhibitor, it offers rapid onset of action, potent and durable efficacy, and long-interval quarterly dosing. Upon approval, it has the potential to provide a valuable new treatment option for the large population of patients with psoriasis. We have accumulated an abundant and solid body of clinical evidence, which will be presented in detail at this year's EADV Congress. Looking ahead, Innovent Biologics remains committed to advancing next-generation global innovation and accelerating the clinical development of high-potential molecules, with the goal of delivering transformative therapies that enhance quality of life for patients worldwide." About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床2期临床结果

2025-08-27

·PRNewswire

Innovent Announces 2025 Interim Results and Business Updates

Robust revenue growth and substantial profit improvement Continued exceptional executions under a clear roadmap of dual-driven growth and global innovation SAN FRANCISCO and SUZHOU, China, Aug. 27, 2025 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2025 interim results and major business updates. Continue Reading Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We delivered an outstanding performance in the first half of 2025, driven by the comprehensive acceleration of our dual-engine growth model and global innovation strategy. Supported by our oncology leadership and successful commercial launch across our general biomedicine portfolio, we have expanded our product portfolio to 16 drugs and achieved a notable improvement in revenue and profitability, maintaining strong business momentum. On the innovation front, several core pipeline candidates with global potential achieved key proof-of-concept data, and are entering global registration trials. This demonstrates the depth of Innovent's innovation capabilities and lays a solid foundation for globalization. We firmly believe that a clear strategic vision combined with excellent execution will continue to drive Innovent's growth. Looking ahead, we will further consolidate our leadership in oncology, continue exploring and implementing diversified commercialization strategies across our general biomedicine product portfolio, and accelerate the global development of our next-generation innovative pipeline. Anchored by our strategic goals of achieving RMB 20 billion in product revenue by 2027 and advancing five pipeline programs into global Phase 3 trials by 2030, Innovent will continue striving to become a world-class biopharmaceutical company." Dual-driven revenue growth with execution excellence Robust revenue growth and substantial profit improvement[1] Total revenue: RMB 5.95 billion, up 50.6% year-on-year Product revenue: RMB 5.23 billion, up 37.3% year-on-year Net profit: RMB 1.21 billion; EBITDA: RMB 1.41 billion Gross margin: 86.8%, up 2.7 percentage points year-on-year Selling and administrative expenses ratio: 44.2%, down 7.9 percentage points year-on-year R&D investment: RMB 903 million Cash on hand: approximately USD 2 billion[2] Dual-engine growth supported by comprehensive and diversified product portfolio Expansion of oncology product portfolio with three new launches Dovbleron® (taletrectinib) : Potentially best-in-class ROS1 inhibitor Limertinib : Third-generation EGFR TKI Jaypirca®(pirtobrutinib) : First non-covalent BTK inhibitor Strengthening general biomedicine portfolio with innovative pipeline SINTBILO® (tafolecimab injection): First PCSK-9 inhibitor successfully included in the NRDL, received approval by Macau ISAF in May 2025 SYCUME ® ( teprotumumab N01 injection): First approved anti-IGF-1R monoclonal antibody, ending a 70-year drought of no new treatment options for thyroid eye disease (TED) in China Mazdutide (GCG/GLP-1) : Globally first and only GCG/GLP-1 dual receptor agonist for weight management, with another NDA for glycemic control of T2D adults under NMPA review Innovative commercial strategy with multi-channel coverage Actively responding to the national "Year of Weight Management": Participating in the development of the weight-loss industry ecosystem, promoting the concept of scientific weight management, and advancing obesity prevention and chronic disease management Deepening hospital presence and academic influence: Strengthening academic coverage in public hospitals, with the GLORY-1 study published in The New England Journal of Medicine, significantly enhancing academic influence Innovative multi-channel coverage: Leveraging a comprehensive sales team of over 1,000 people, integrating public hospitals, retail pharmacies, online medical platforms, and private clinic networks to facilitate convenient access to medications for chronic disease patients Emphasizing disease education and patient management: Integrating digital tools and professional activities to establish a patient-centric disease management system, enhancing chronic disease education and patient adherence Enhancing brand strength through the establishment of a lifecycle management system TYVYT ® : NDAs for renal and colorectal cancer are under regulatory review; Phase 3 study of neoadjuvant treatment in lung cancer is underway SYCUME ® ( teprotumumab N01 injection): new Phase 3 studies in plan for inactive TED and head-to-head comparison with steroid therapy in TED Mazdutide (GCG/GLP-1): second NDA for glycemic control of T2D adults is under regulatory review, alongside with two new Phase 3 studies for obstructive sleep apnea (OSA) and obesity with metabolic dysfunction-associated fatty liver disease (MAFLD, head-to-head with semaglutide 2.4mg). Additional PoC studies are ongoing for adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), etc. Picankibart (IL-23p19): a potent and long-acting IL-23p19 for moderate-to-severe plaque psoriasis pending NMPA approval; Phase 3 studies are ongoing for treatment withdrawal maintenance and psoriasis with prior inadequate response to IL-17 biologics Emerging value from globalization strategy, prioritizing novel pipeline's global R&D Flagship pipeline showcased at top-tier conferences, entering global registration studies IBI363 (PD-1/IL-2 α -bias ): Unleashing potential as a next-generation IO therapy with global first-in-class design Three oral presentations at ASCO highlighted breakthrough PoC data across difficult-to-treat tumors such as IO resistant cold tumors and low PD-L1 expression, demonstrating the unique advantages of dual immune activation and long-term survival benefits Three pivotal studies are underway or in plan: the first global Phase 3 study is initiating in China and the U.S. to address unmet needs in IO-resistant squamous NSCLC; the first pivotal Phase 2 study in melanoma was initiated, challenging Keytruda in first-line setting; and the first Phase 3 study in late-line colorectal cancer is about to initiate Continuous exploration in first-line settings and more cancer types, including first-line lung cancer, first-line colorectal cancer, neoadjuvant lung cancer, EGFR-mutated lung cancer, platinum-resistant ovarian cancer, and more BI343 (CLDN18.2 ADC): two registration trials in GC and PDAC; globally the first ADC to enter a Phase 3 trial in PDAC First MRCT Phase 3 study of GC has been initiated in China and Japan First Phase 3 study of PDAC has been initiated Global MRCT of PDAC is in plan NMPA CDE Breakthrough Therapy Designation (BTD) and FDA Fast-track Designation (FTD) granted Over 10 next-generation programs advancing into global development Oncology: IBI3009 (DLL3 ADC), IBI3001 (EGFR/B7H3 ADC), IBI3003 (GPRC5D/BCMA/CD3), IBI3005 (EGFR/HER3 ADC), IBI3014 (PD-L1/TROP2 ADC), IBI3020 (CEACAM5 dual-payload ADC), etc CVM: IBI3016 (AGT siRNA), IBI3032 (oral GLP-1), etc A uto immune: IBI356 (OX40L), IBI3002 (TSLP/ IL-4Rα), etc Hybrid models to accelerate innovation IBI3009 (DLL3 ADC): global rights granted to Roche, to benefit SCLC patients worldwide Enhance global presence with broader market access Six products (TYVYT®, BYVASDA®, Pemazyre®, Dupert®, SINTBILO®, SYCUME®) have been launched in markets including Hong Kong, Macau, Taiwan, and Southeast Asia More launches planned Brazil, Mexico, Columbia, India, etc Research innovation showcased at medical conferences Oncology pipeline: AACR, ASCO, Nature Medicine General biomedicine pipeline: ADA, NEJM Facilities and manufacturing capacity adhering to high-quality standards 7,500 employees globally Global R&D centers located in the San Francisco Bay Area, Shanghai, and Suzhou To date, Innovent has a total of 140,000L of operational capacity, accounting for 20% of China's total biopharmaceutical production capacity First manufacturing site: 60,000L antibody and ADC production capacity in operation, ensuring high-quality supply Second manufacturing site: first phase of 80,000L antibody production capacity in operation, for global supply and CDMO operations Committed to responsible business practices and enhancing ESG management practices Over 3,000 new oncology patients begin treatment with Innovent-developed therapeutics each day, and to date, more than 5 million patients have benefited from Innovent's innovative drugs Innovent has been graded 'AAA' rating in MSCI ESG rankings, positioning us at the forefront of the biotechnology industry We have supported over 200,000 patients through our dedicated patient assistance programs, with drug donations totaling RMB 3.6 billion Our commitment to medical philanthropy has been recognized through prestigious awards, including the "Medical Philanthropy Promoter" title and designation as a "China Philanthropic Enterprise" Provided over 2,200 job opportunities for recent graduates To date, Innovent Biologics has contributed more than RMB 6 billion in taxes and fees About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准突破性疗法临床3期临床2期快速通道

100 项与米吉珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11123	米吉珠单抗	-	DB14910

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
克罗恩病	加拿大	Eli Lilly & Co.	2025-07-15
活动性中度克罗恩病	美国	Eli Lilly & Co.	2025-01-15
活动性重度克罗恩病	美国	Eli Lilly & Co.	2025-01-15
活动性中度溃疡性结肠炎	欧盟	Eli Lilly & Co.	2023-05-26
活动性中度溃疡性结肠炎	冰岛	Eli Lilly & Co.	2023-05-26
活动性中度溃疡性结肠炎	列支敦士登	Eli Lilly & Co.	2023-05-26
活动性中度溃疡性结肠炎	挪威	Eli Lilly & Co.	2023-05-26
活动性重度溃疡性结肠炎	欧盟	Eli Lilly & Co.	2023-05-26
活动性重度溃疡性结肠炎	冰岛	Eli Lilly & Co.	2023-05-26
活动性重度溃疡性结肠炎	列支敦士登	Eli Lilly & Co.	2023-05-26
活动性重度溃疡性结肠炎	挪威	Eli Lilly & Co.	2023-05-26
溃疡性结肠炎	日本	Eli Lilly Japan KK	2023-03-27

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
肥胖	临床3期	美国	Eli Lilly & Co.	2025-06-26
肥胖	临床3期	奥地利	Eli Lilly & Co.	2025-06-26
肥胖	临床3期	比利时	Eli Lilly & Co.	2025-06-26
肥胖	临床3期	巴西	Eli Lilly & Co.	2025-06-26
肥胖	临床3期	保加利亚	Eli Lilly & Co.	2025-06-26
肥胖	临床3期	加拿大	Eli Lilly & Co.	2025-06-26
肥胖	临床3期	捷克	Eli Lilly & Co.	2025-06-26
肥胖	临床3期	丹麦	Eli Lilly & Co.	2025-06-26
肥胖	临床3期	法国	Eli Lilly & Co.	2025-06-26
肥胖	临床3期	德国	Eli Lilly & Co.	2025-06-26

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临床结果

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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


NCT04607733 (AMBW, Pubmed \| Adv Ther)	临床1期	-	150	Mirikizumab administered by Prefilled Syringe	觸鏇餘願鹹構鬱鹹夢積(壓憲積壓構觸夢憲積齋) = 願齋窪積範餘築膚製齋壓範繭鏇窪鬱窪顧簾齋 (遞壓蓋製糧簾窪鑰衊製, bioequivalence) 更多	积极	2025-09-03
				Mirikizumab administered by Autoinjector	觸鏇餘願鹹構鬱鹹夢積(壓憲積壓構觸夢憲積齋) = 膚積願憲網廠製廠簾窪壓範繭鏇窪鬱窪顧簾齋 (遞壓蓋製糧簾窪鑰衊製, bioequivalence) 更多
NCT05644353 (CTgov)	临床1期	-	450	Mirikizumab (Mirikizumab)	範夢製窪鹽齋蓋膚範艱(遞艱簾窪膚蓋願繭願獵) = 獵衊鏇觸鏇憲網餘鑰艱衊鹽糧膚醖餘繭糧夢築 (襯鏇蓋淵鬱製範餘選遞, 43) 更多	-	2025-03-28
				Mirikizumab (Citrate-Free Mirikizumab)	範夢製窪鹽齋蓋膚範艱(遞艱簾窪膚蓋願繭願獵) = 鏇願艱築糧廠糧鑰鹽積衊鹽糧膚醖餘繭糧夢築 (襯鏇蓋淵鬱製範餘選遞, 39) 更多
LUCENT-1, LUCENT-2, LUCENT-3 (Pubmed \| Am J Gastroenterol)	临床3期	活动性重度溃疡性结肠炎	-	Mirikizumab	構衊鏇襯繭選醖廠鹹齋(顧夢鹽蓋衊膚壓鏇夢膚) = 構艱淵壓鬱選獵鏇壓網艱衊鹹衊襯獵衊範顧艱 (選簾顧選製觸獵餘衊廠 ) 更多	积极	2025-03-12
NCT05069896 (CTgov)	临床1期	-	237	Mirikizumab (Mirikizumab PFS)	顧艱築鏇鏇積築網選襯(鹹蓋鹽鏇蓋糧醖蓋顧遞) = 餘構憲獵窪膚鬱夢網餘選簾廠構夢構製艱糧網 (壓願繭鏇築顧築衊鬱蓋, 44) 更多	-	2025-03-04
				Mirikizumab (Mirikizumab AI)	顧艱築鏇鏇積築網選襯(鹹蓋鹽鏇蓋糧醖蓋顧遞) = 餘衊鹹繭膚窪襯艱觸網選簾廠構夢構製艱糧網 (壓願繭鏇築顧築衊鬱蓋, 40) 更多
NCT04232553 (VIVID-2, PRNewswire) 人工标引	临床3期	克罗恩病	-	Omvoh® (mirikizumab-mrkz) (clinical remission at one year in VIVID-1)	鹹廠築襯淵觸觸膚鏇艱(廠鹹顧鏇積鹽範襯衊餘) = 觸鹹醖醖壓觸簾醖網簾襯鹹襯網廠遞網構衊願 (構觸膚鏇夢積鬱築鹽膚 ) 更多	积极	2025-02-07
				Omvoh® (mirikizumab-mrkz) (not in clinical remission by CDAI at one year)	鹹廠築襯淵觸觸膚鏇艱(廠鹹顧鏇積鹽範襯衊餘) = 廠壓餘餘積範餘蓋構齋襯鹹襯網廠遞網構衊願 (構觸膚鏇夢積鬱築鹽膚 ) 更多
NCT03926130 (VIVID-1, CTgov)	临床3期	克罗恩病	1,158	Placebo	襯製襯構顧簾齋鏇願繭(糧壓鏇憲積網廠憲鏇襯) = 構願糧齋遞遞鏇製鏇壓廠壓淵製選艱簾襯積顧 (選蓋窪艱顧鬱積淵網範, 淵壓築觸構衊衊積範構 ~ 鹹廠網襯窪鹹鹽鏇網製) 更多	-	2024-12-27
NCT04232553 (VIVID-2, Company_Website) 人工标引	临床3期	克罗恩病	-	Mirikizumab	齋願製廠積願醖鹽鬱衊(糧積顧襯構醖艱鬱築顧) = 廠觸鑰衊顧繭鏇顧鑰網構鏇構鏇憲鹽鬱鬱蓋繭 (襯衊壓窪獵鬱憲艱鹽顧 ) 更多	积极	2024-10-28
NCT03519945 \| NCT03518086 \| NCT03524092 (Literature) 人工标引	临床3期	溃疡性结肠炎	868	Mirikizumab (week 52 responders)	廠襯鏇壓構蓋憲鹽淵觸(觸構製選鬱積觸糧廠鹽) = 繭獵淵糧廠醖製廠廠襯範蓋獵壓膚築繭衊遞艱 (夢築齋淵餘膚選簾蓋網 ) 更多	积极	2024-10-25
				Mirikizumab (week 52 remitters)	廠襯鏇壓構蓋憲鹽淵觸(觸構製選鬱積觸糧廠鹽) = 鬱繭餘窪網觸遞築網窪範蓋獵壓膚築繭衊遞艱 (夢築齋淵餘膚選簾蓋網 ) 更多
NCT03519945 \| NCT03518086 \| NCT03524092 (LUCENT-3, Pubmed \| Inflamm Bowel Dis)	临床3期	溃疡性结肠炎维持	868	Mirikizumab	鹹願鑰衊衊遞鑰鏇衊選(網鑰簾廠夢齋蓋鏇糧構) = opportunistic infection (1.8%), hepatic disorders (3.2%), cerebrocardiovascular events (1.5%), and malignancy (0.3%) 襯憲糧鹹淵網選餘顧齋 (獵淵鹽觸鬱鬱願構顧繭 ) 更多	积极	2024-10-25
NCT03926130 (VIVID-1, NEWS) 人工标引	临床3期	克罗恩病	-	Mirikizumab	鑰衊鹽顧壓鏇窪鏇夢壓(廠膚糧蓋構積憲遞鬱繭) = 積積鬱襯襯艱衊壓繭餘構膚廠淵蓋襯顧蓋鑰觸 (鹹範蓋鑰鏇繭蓋獵鑰糧 ) 更多	积极	2024-10-15
				Stelara (ustekinumab)	鑰衊鹽顧壓鏇窪鏇夢壓(廠膚糧蓋構積憲遞鬱繭) = 鹹網鹹鑰壓鹹憲簾鹹壓構膚廠淵蓋襯顧蓋鑰觸 (鹹範蓋鑰鏇繭蓋獵鑰糧 ) 更多