A Phase I/II Study of Natalizumab as a Single Agent in Children, Adolescents and Young Adults With Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma

The purpose of this study is to evaluate the safety and tolerability of Natalizumab in children, adolescent and young adult patients with pulmonary metastatic osteosarcoma (pOS) and to assess clinical response associated with this treatment as well as overall survival.

开始日期2024-12-01

申办/合作机构

The Case Comprehensive Cancer Center

NCT05658497

/ RecruitingN/A

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

开始日期2023-10-27

申办/合作机构

Biogen, Inc.

NCT05618301

/ Active, not recruiting临床1期IIT

A Pilot Safety and Feasibility Study to Evaluate Motixafortide (CXCR4/SDF-1 Inhibition) and Natalizumab (VLA-4/VCAM-1 Inhibition) as a Novel Regimen to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)

Hematopoietic stem cell (HSC)-based gene therapies now offer curative potential for patients with sickle cell disease (SCD), with decreased toxicity compared to allogeneic hematopoietic cell transplantation. However, effective HSC-based gene therapy depends on collecting sufficient HSCs to generate the therapeutic product, and currently available mobilization regimens carry unacceptable risk for patients with SCD or do not reliably yield optimal numbers of HSCs for gene therapy.
The investigators hypothesize that HSC mobilization with motixafortide (CXCR4i) alone and the combination of motixafortide plus natalizumab (VLA-4i) will be safe and tolerable in SCD patients. In addition, the investigators hypothesize that combined CXCR4 and VLA-4 blockade with motixafortide plus natalizumab will result in a rapid, robust, and synergistic increase in HSC mobilization to peripheral blood (PB) in patients with SCD, when compared to motixafortide alone.

开始日期2023-07-07

申办/合作机构

Washington University School of Medicine

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项与那他珠单抗相关的文献（医药）

2025-07-01·Multiple Sclerosis and Related Disorders

Comparison of CSF biomarkers in multiple sclerosis patients treated with natalizumab and rituximab

Article

作者: Hansson, Oskar ; Hellgren, Johan ; Jonsson, Magnus Förnvik ; Svenningsson, Anders ; Ahlström, Isabella ; Källén, Kristina ; Janelidze, Shorena ; Strandberg, Maria Compagno

BACKGROUND:

Patients with relapsing remitting multiple sclerosis (RRMS) treated with the high-efficacy drugs natalizumab (NTZ) or rituximab (RTX) generally show no evidence of disease activity. Currently, there is no head-to-head comparison between NTZ and RTX of neurodegenerative and neuroinflammatory biomarkers in cerebrospinal fluid (CSF).

OBJECTIVES:

To compare CSF biomarkers in a stable RRMS cohort treated with NTZ or RTX. A secondary objective was to explore potential associations between CSF biomarkers, fatigue, and cognition.

METHODS:

This Swedish multicentre cross-sectional study assessed kappa-free light chain (k-FLC) index, oligoclonal bands (OCBs), glial fibrillary acidic protein (GFAP) and neurofilament light (NfL) in CSF of 30 RRMS patients on NTZ or RTX for at least 24 months. A longitudinal comparison of biomarkers was performed for IgG Indices. Fatigue and cognition outcomes were explored in relation to CSF biomarkers.

RESULTS:

GFAP level was significantly higher in the NTZ group compared to RTX (mean difference (CI): 2 716 (155; 5278) ng/L, p=0.047). NfL concentration did not differ between the groups. OCBs and k-FLC index were present and elevated in 97 % and 87 % of participants, respectively. IgG-index was significantly reduced only for NTZ. No significant associations were found between fatigue, cognition and the biomarkers.

CONCLUSION:

Our results support that intrathecal inflammatory activity is still ongoing in patients with NTZ and RTX. Cross-sectional GFAP might indicate a lower risk for long-term disability in the RTX group. Our data should be interpreted with caution because of small sample size, making it difficult to control for multiple confounders.

2025-06-01·Multiple Sclerosis and Related Disorders

Serological screening and Vaccine Update in a cohort of Multiple Sclerosis Patients as a strategy to prevent infection reactivation during immunosuppressant therapy

Article

作者: Berezin, Eitan Naaman ; Reis, Gelvana Flávio Barreto ; de Castro, Andrea de Carvalho Anacleto Ferrari

INTRODUCTION:

Serological screening and vaccination play a crucial role in preventing infectious complications in patients with Multiple Sclerosis (MS). Standardization of tests and vaccination protocols are essential in patients undergoing treatment.

OBJECTIVE:

This study aimed to assess susceptibility to infectious diseases through serological tests and vaccine update of MS patients.

METHODS:

A cross-sectional study was conducted on patients treated by the neurology service of the Metropolitan University of Santos between February 2021 and June 2023. Serological screening and vaccine recommendations were performed by an infectious disease specialist.

RESULTS:

A total of 119 patients were included, with a mean age of 45.7 years. The sample was 68.1 % female and 31.9 % male, and vaccination update was performed for 64 (53.8 %) patients. MS treatments included: Glatiramer Acetate, Natalizumab, Fingolimod, Dimethyl Fumarate, Ocrelizumab and cladribine (Cladribine) and corticoid for MS flare-ups. Seroprevalence was: 66.0 % for the JC virus, 61.4 % Toxoplasmosis, 50.9 % Mononucleosis, 84.5 % Cytomegalovirus, 85.4 % Measles, 72.2 % Mumps, 92.6 % Rubella, and 94.2 % Varicella. No cases of HIV, HCV, HBV, HTLV or syphilis were detected. Vaccine cover was: 75 % influenza, 68.7 % Hepatitis B, 64.2 % Hepatitis A, 34.4 % HPV, 85 % COVID-19, 1.56 % Herpes Zoster, Diphtheria, Tetanus and Pertussis, 70 % DT, 6.5 % DTaP, 53 % anti-pneumococcal with Pn-23 and 31 % with Pn-13, 48.4 % Haemophilus influenzae b, 39 % Meningococcal C and 20.3 % ACWY.

CONCLUSION:

MS patients using immunosuppressant therapy may be susceptible to vaccine-preventable infectious diseases. The study demonstrates the feasibility of vaccine updates, and infectious diseases specialists can contribute assessing infection risks and providing individualized vaccines recommmendations.

2025-05-01·JOURNAL OF NEUROLOGY

Measuring cognitive change in secondary progressive MS: an analysis of the ASCEND cognition substudy

Article

作者: Leavitt, Victoria ; Cutter, Gary ; Bowen, James D ; Repovic, Pavle ; Mostert, Jop ; Comtois, Jacynthe ; Uitdehaag, Bernard ; Strijbis, Eva ; Koch, Marcus W ; Brieva, Luis ; Moral, Ester

BACKGROUND:

Cognitive impairment is common in multiple sclerosis (MS). Accurate measurement of cognitive change is essential for clinical trials.

METHODS:

The change in cognitive scores, clinical metrics of physical disability, and neuroradiological metrics was quantified in data from a phase-3 randomized controlled trial of natalizumab in secondary progressive MS (SPMS). The adults diagnosed with SPMS for ≥ 2 years and Expanded Disability Status Scale (EDSS) scores from 3 to 6.5 were randomized to receive natalizumab or placebo for 96 weeks. We evaluated change in Symbol Digit Modalities Test (SDMT), Paced Auditory Serial Addition Test (PASAT), Selective Reminding Test (SRT), Brief Visuospatial Memory Test (BVMT-R), two subjective cognitive measures, Beck Depression Inventory (BDI-FS), Timed 25-foot Walk Test, Nine Hole Peg Test, measures of brain volume, and T2 lesion volume.

RESULTS:

The outcomes were evaluated at baseline, 48-, and 96-week follow-up. There were no significant differences in cognitive change between treatment arms. SDMT and PASAT scores improved over 96-weeks: mean SDMT scores by 4.5 points (SD 9.3), mean PASAT scores by 2.4 points (SD 9.4). Verbal and visuospatial memory test performance showed no consistent change. All MRI measures showed decreased brain volumes. NHPT scores worsened little and T25FW showed steadily worsening scores.

CONCLUSIONS:

Improvements in SDMT and PASAT performance were observed regardless of treatment arm. These findings are consistent with prior studies in MS. As it is unlikely that cognition improves over time in people with a chronic neurologic disease, these results support the need for cognitive outcomes that overcome practice and learning effects to accurately quantify change.

221

项与那他珠单抗相关的新闻（医药）

2025-05-01

·Pharmaceutical Technology

Biogen’s Q1 revenue soars past estimates as rare disease pivot pays off

Spinal muscular atrophy treatment Spinraza (nusinersen) became Biogen’s best-selling drug in Q1 2025. Image credit: Shutterstock/ Tada Images. Biogen has unveiled Q1 2025 revenues above estimates, spurred by strong sales of rare disease assets amid a sales dropoff from its multiple sclerosis business. Quarterly revenues for the neurological disease drugmaker were $2.43bn, above analyst group William Blair’s estimates of $2.3bn. The Q1 sales performance represents a 6% increase compared to the same period in 2024, with Biogen ramping up commercial duties for existing drugs and buying assets during that time. One of those assets is Skyclarys, a drug picked up in a $7.3bn acquisition of Reata Pharmaceuticals in September 2023. The treatment for the neurodegenerative disorder Friedreich’s ataxia generated revenue of $124m in Q1, a value that had already taken into account the impact seen in US sales due to Medicare discount dynamics. Approved in the US, Europe, and UK, amongst others, Skyclarys has a high growth ceiling. GlobalData’s Pharma Intelligence Centre forecasts sales of $1.3bn by 2031. GlobalData is the parent company of Pharmaceutical Technology . Skyclarys is one of the drugs spurring a change of the guard in Biogen’s pipeline. The company is well known for its host of multiple sclerosis treatments, such as Vumerity (diroximel fumarate), Tysabri (natalizumab), and Avonex (interferon beta-1a). But, sales for these treatments have declined over the years as biosimilars entered the market. The company’s multiple sclerosis business shrank 11% in Q1 2025 compared to the same period last year. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Biogen is really, a tale of two companies in my view. There’s one company which has been a multiple sclerosis company, and that portfolio, as you all know, has been gradually declining,” said Biogen’s CEO Chris Vibacher in a Q1 earnings call. “But there’s a new Biogen emerging. And when I look at the rare disease business […] we actually have a commercial portfolio that we’re actively promoting that’s now gotten to be about 45% of our product revenue. And those products mostly have a very long runway to continue to grow,” Vibacher added. Alongside Skyclarys, Biogen’s rare disease business is headed by spinal muscular atrophy treatment Spinraza (nusinersen). Spinraza generated global Q1 2025 sales of $423.9m, up from $341.3m in Q1 2024. This increase, coupled with the decline of Tysabri, meant Spinraza was Biogen’s best-selling drug in Q1 2025. Leqembi’s “modest growth” Another key part of Biogen’s business model is its Alzheimer’s segment, now solely headed by Leqembi (lecanemab) after the company discontinued Aduhelm (aducanumab) at the start of 2024. Biogen splits revenue from Leqembi with co-developer Eisai equally, the latter reporting Q1 sales of $96m for the drug. The US, where Leqembi got a full approval in July 2023, accounted for $52m of those sales. Biogen has already secured key milestones for Leqembi this year. In January, the US Food and Drug Administration (FDA) approved maintenance dosing of Leqembi, a move expected to expand its market share. Then in April, the Leqembi was authorised for use in the European Union (EU). Biogen said the Q1 sales for Leqembi represented “continued sequential growth.” William Blair analyst Myles R. Minter said in a research note that: “Skyclarys had a strong quarter, but the commercial focus remains on Leqembi, which has seen only modest growth, in our view.” In the mergers and acquisitions space, Biogen failed a $469m takeover bid of Sage Therapeutics in January.

上市批准并购生物类似药

2025-04-30

·GlobeNewswire-Health Care

Sandoz reports Q1 2025 net sales in line with company expectations; full-year guidance confirmed

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Q1 2025 net sales of USD 2,480 million up by 3% in constant currencies (cc); stable in USDup by 5%[1] at a comparable growth rate (CGR), when adjusted for impact of 2024 acquisition of US biosimilar Cimerli® (ranibizumab) and 2024 divestment of China businessten largest-selling medicines grew by combined 4% and represented 33% of net sales Europe net sales grew by 7%[1]. International declined by 2%[1] and increased by 2% when adjusted for China divestment. Net sales in North America grew by 1%[1] and, adjusted for Cimerli acquisition, by 3%Anticipated biosimilar launches primarily weighted to second half of year. Launches include Wyost®/Jubbonti® (denosumab) in Europe and US, Tyruko® (natalizumab) in US[2] and Afqlir® (aflibercept) in EuropeFavorable moves towards regulatory streamlining of biosimilar development reflected in decision to minimize pembrolizumab Phase III trialFull-year impact of US government’s confirmed recent tariffs within guidanceFull-year 2025 guidance confirmed: mid single-digit net-sales growth[1] and core EBITDA margin of around 21% Basel, April 30, 2025 – Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in generic and biosimilar medicines, today presents its net-sales update for the first quarter of 2025. Richard Saynor, Chief Executive Officer of Sandoz, commented: “With Q1 sales in line with our expectations, we have now delivered fourteen consecutive quarters of top-line growth. This reconfirms our growing track record of execution and performance, driven by commercial excellence and an expanding biosimilar pipeline and portfolio, underpinned by our generics base. I’m looking forward to additional growth in the second quarter and further progress this year as we launch more biosimilar medicines. “With our business continuing to grow, we are confident of delivering more affordable medicines for patients and savings for society, while producing sustainable growth in sales, profitability and cash generation. It is the powerful combination of delivery and pioneering access for patients that makes us proud to be part of the Sandoz growth journey.” FULL-YEAR 2025 GUIDANCE The Company expects further major biosimilar launches later this year, while price erosion is expected to return to normalised levels of a low to mid-single-digit percentage. Sandoz anticipates core EBITDA-margin expansion to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the Company continues to expect: FY 2025 net sales to grow by a mid single-digit percentage[3] a core EBITDA margin in FY 2025 of around 21% This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government. FIRST-QUARTER NET SALES Net sales for the first quarter amounted to USD 2,480 million, representing growth of 3%[3]. Volume contributed six percentage points of growth, partly offset by price erosion of three percentage points. Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[3] Generics1,809731,869 -302Biosimilars67127623 81114Net Sales2,4801002,492 035 Generics overviewNet sales for the first quarter were USD 1,809 million, reflecting a stable performance[3] (+2% on a CGR basis). Generics represented 73% of total net sales (Q1 2024: 75%). Europe sales of generics grew in the first quarter, driven by the effect of launches in 2024. International net sales declined, with the impact from the divested China business outweighing growth in other markets. In North America, generics’ net-sales growth benefitted from the successful recent launch of paclitaxel. Biosimilars overviewNet sales for the first quarter were USD 671 million, reflecting growth of 11%[3] (+14% on a CGR basis). Biosimilars represented 27% of total net sales (Q1 2024: 25%). Strong Europe biosimilars’ net-sales growth benefitted from a number of good performances, including Hyrimoz® (adalimumab) and recently launched Pyzchiva® (ustekinumab), while International biosimilar net sales also saw a strong contribution from Omnitrope® (somatropin). North America biosimilar net sales declined, reflecting the withdrawal of Cimerli during the quarter; excluding the impact of the 2024 acquisition Cimerli, North America biosimilar net sales increased. Net sales by region Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[4] Europe1,372551,326 377International59024642 -8-22North America51821524 -113Net Sales2,4801002,492 035 Europe overviewNet sales for the first quarter amounted to USD 1,372 million, reflecting growth of 7%[4]. Europe net sales of generics grew in the first quarter, with higher growth in biosimilars primarily a result of recent launches, including Pyzchiva. International overviewNet sales for the first quarter amounted to USD 590 million, reflecting a decline of 2%[4]. Excluding the impact of the divestment of the China business, growth amounted to 2%[4]. Pricing increased in both generics and biosimilars during the quarter, with strong biosimilar net sales partly a result of the continued good performance from Omnitrope. North America overviewNet sales for the first quarter amounted to USD 518 million, reflecting growth of 1%[4]. Excluding the impact of the withdrawal of Cimerli, growth amounted to 3%[4]. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the impact of the 2024 acquisition of Cimerli. Price erosion was driven by reduced Cimerli and private-label adalimumab pricing. US TARIFFS The only tariffs applicable to the Company, as part of recent implementation from the US government, is a total 20% China tariff, implemented on March 4, 2025, and a tariff on any medicines coming from Canada but outside the scope of the United States-Mexico-Canada Agreement. These impacts have been incorporated within full-year guidance. The Sandoz manufacturing footprint consists of 15 sites, including 11 in Europe and one in the US, from which the latter does not export to Europe. US first-quarter net sales represented less than one-fifth of total net Q1 sales. REGULATORY STREAMLINING: BIOSIMILARS Reflecting encouraging and favourable developments, Sandoz has decided to minimize its ongoing Phase III trial in patients with untreated metastatic non-squamous non-small cell lung cancer for the proposed biosimilar, pembrolizumab. The ongoing Phase I pharmacokinetic trial is continuing as planned. This decision was partly based on communications with the US FDA, as well as a reflection paper published by the European Medicines Agency. The Company is assessing implications, including for its wider biosimilars pipeline. In April 2025, Sandoz announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of Enbrel®[5] (etanercept), first approved by the US FDA in 1998. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi®[6] (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. KEY LINKS A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here. CALENDAR The Company intends to publish its half-year results on August 7, 2025. [1] In constant currencies (cc).[2] Subject to FDA approval of John Cunningham virus assay.[3] In constant currencies (cc).[4] In constant currencies (cc).[5] Enbrel® is a registered trademark of Amgen, Inc.[6] Erelzi® is a registered trademark of Sandoz, Inc. CONTACTS Media Relations contactsInvestor Relations contactsglobal.mediarelations@sandoz.cominvestor.relations@sandoz.comAlex Kalomparis+41 79 279 02 85Craig Marks+44 7818 942 383Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 52 17Danja Spring+41 79 156 74 88Rupreet Sandhu+41 79 410 54 72 DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the latest Integrated Annual Report. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure more than 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. APPENDIX QUARTERLY NET SALES The Company intends to provide the net-sales performance by region by generics/biosimilars at each half-year and full-year results. FY 2024 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccGenerics 1,86901 1,835-11 1,85434 1,94614Biosimilars6232121 7203537 7413637 7692325Net Sales 2,49256 2,55579 2,5951112 2,71579 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccEurope 1,32642 1,30823 1,3621312 1,36778International642412 62759 63528 65306North America52466 6202223 5981718 6951314Net Sales 2,49256 2,55579 2,5951112 2,71579 Attachment Media release_Q1 2025 sales.pdf

生物类似药上市批准临床3期临床1期并购

2025-03-24

·生物谷

重磅！2025年10大药物专利即将到期，市场独占权保卫战开启，涉及强生、再生元、诺华、阿斯利康等

每年，制药行业都会迎来一系列重磅药物的专利到期，这一现象被称为“专利悬崖”。2025年，这一悬崖尤为引人注目，多款年销售额数十亿美元的药物将面临生物类似药和仿制药的激烈竞争。这不仅对制药公司的财务状况构成挑战，也为患者带来了更多的治疗选择和潜在的价格下降。 1. Stelara（乌司奴单抗）：强生的免疫学重磅药物适应症：银屑病关节炎、斑块型银屑病、克罗恩病、溃疡性结肠炎公司：强生 2024年美国销售额：67.2亿美元 Stelara是强生的免疫学重磅药物，主要用于治疗银屑病关节炎、斑块型银屑病、克罗恩病和溃疡性结肠炎。2024年，Stelara在美国的销售额高达67.2亿美元，成为自2023年艾伯维的Humira专利到期以来，美国市场最大的专利悬崖事件。尽管强生通过一系列法律和解协议成功延长了Stelara的市场独占权，但2025年将有多款生物类似药上市，竞争将异常激烈。强生对Stelara的未来表现仍持乐观态度。公司CEO Joaquin Duato在财报电话会议上表示，尽管面临生物类似药的竞争，强生预计2025年仍能实现3%的年增长率。强生还计划通过推广其新一代免疫学药物Tremfya来弥补Stelara的收入损失。Tremfya目前已获批用于银屑病关节炎和斑块型银屑病，并正在申请扩展至克罗恩病适应症。强生全球创新药物主席Jennifer Taubert指出，Humira的市场侵蚀曲线可能是预测Stelara专利悬崖的最佳模型。 2. Eylea（阿柏西普）：再生元的眼科药物适应症：湿性年龄相关性黄斑变性、糖尿病性黄斑水肿、视网膜静脉阻塞、早产儿视网膜病变、糖尿病性视网膜病变公司：再生元 2024年美国销售额：47.7亿美元 Eylea是再生元的眼科药物，主要用于治疗湿性年龄相关性黄斑变性、糖尿病性黄斑水肿等眼部疾病。2024年，Eylea在美国的销售额为47.7亿美元。然而，Eylea的销售增长已经因罗氏的Vabysmo竞争而停滞。Vabysmo自2022年推出以来，迅速抢占市场份额，2024年销售额超过40亿美元。随着生物类似药的上市，Eylea的销售压力将进一步加大。2024年11月，安进在美国推出了首款Eylea生物类似药Pavblu，上市后前九周销售额即达到3100万美元。再生元还面临来自其他生物类似药的竞争，包括Biocon的Yesafili和Biogen与Samsung Bioepis的Opuviz。再生元计划通过提升其长效版本Eylea HD的市场地位来应对竞争。再生元CEO Len Schleifer博士表示，Eylea HD是Eylea的重大进步，但仍需更多支持以对抗Vabysmo和生物类似药的竞争。图片来源自：千库网 3. Prolia/Xgeva（地舒单抗）：安进的骨科药物适应症：高骨折风险的骨质疏松症、前列腺癌或乳腺癌患者接受激素消融治疗的骨质流失；预防癌症骨转移患者的骨骼相关事件、骨巨细胞瘤、恶性肿瘤高钙血症公司：安进 2024年美国销售额：43.9亿美元 Prolia和Xgeva是安进的重磅骨科药物，主要用于治疗骨质疏松症和预防癌症骨转移患者的骨骼相关事件。2024年，这两款药物在美国的销售额合计为43.9亿美元，其中Prolia销售额为43.7亿美元，同比增长8%，Xgeva销售额为22.3亿美元，同比增长5%。然而，随着生物类似药的上市，安进将面临市场份额的侵蚀。2024年3月，Sandoz率先获得FDA批准，推出首款可互换的Prolia和Xgeva生物类似药Jubbonti和Wyost。安进已与多家生物类似药开发商达成和解，以延缓竞争。例如，安进与Celltrion达成协议，允许后者在2025年6月1日或更早推出其denosumab生物类似药。尽管面临竞争，安进仍通过其强大的生物类似药业务和多元化产品组合来应对挑战。 4. Entresto（沙库巴曲/缬沙坦）：诺华的心力衰竭药物适应症：心力衰竭公司：诺华 2024年美国销售额：40.5亿美元 Entresto是诺华的心力衰竭治疗药物，2024年在美国的销售额为40.5亿美元。尽管诺华正在为仿制药的竞争做准备，但其关键组合专利将于2025年7月到期，预计将在2025年中期失去美国市场独占权。诺华已与多家仿制药商达成和解，但仍面临来自Torrent、Dr. Reddy’s Laboratories等公司的竞争。诺华CEO Vas Narasimhan表示，Entresto的仿制药竞争是不可避免的，但公司已通过多元化产品线和市场策略做好了准备。此外，Entresto是首批受《通胀削减法案》Medicare谈判定价影响的药物之一。Narasimhan认为，尽管价格削减可能对收入产生影响，但公司已规划了其他收入来源以应对这一挑战。 5. Soliris（依库组单抗）：阿斯利康的罕见病药物适应症：阵发性夜间血红蛋白尿、非典型溶血性尿毒症综合征、全身性重症肌无力、视神经脊髓炎谱系障碍公司：阿斯利康 2024年美国销售额：15.2亿美元 Soliris是阿斯利康的罕见病药物，主要用于治疗阵发性夜间血红蛋白尿和非典型溶血性尿毒症综合征。2024年，Soliris在美国的销售额为15.2亿美元。随着生物类似药的上市，Soliris的销售将面临压力。安进的Soliris生物类似药Bkemv已于2024年获得FDA批准，并计划在2025年第二季度上市。阿斯利康通过其后续药物Ultomiris来应对Soliris的专利悬崖。Ultomiris于2018年获批，用于治疗与Soliris相同的疾病，并在2024年以39亿美元的销售额超过了Soliris的25.9亿美元。阿斯利康希望凭借Soliris、Ultomiris以及新获批的Voydeya，继续在罕见病市场保持主导地位。图片来源自：千库网 6. Promacta（艾曲波帕）：诺华的血小板减少症药物适应症：血小板减少症、再生障碍性贫血公司：诺华 2024年美国销售额：11.8亿美元 Promacta是诺华的血小板减少症治疗药物，2024年在美国的销售额为11.8亿美元。诺华预计Promacta将在2025年中期失去美国市场独占权。2024年4月，FDA批准了Annora的首个Promacta仿制药，并授予其180天的市场独占期。 Promacta自2008年获批以来，逐渐成为诺华的重磅药物之一。2024年，Promacta的全球销售额达到22亿美元，其中美国市场贡献了12亿美元。诺华计划通过扩展Promacta的适应症和市场推广来应对仿制药的竞争。 7. Simponi/Simponi ARIA（戈利木单抗）：强生的免疫学药物适应症：类风湿性关节炎、银屑病关节炎、强直性脊柱炎、溃疡性结肠炎、多关节型青少年特发性关节炎公司：强生 2024年美国销售额：10.8亿美元 Simponi是强生的免疫学药物，主要用于治疗类风湿性关节炎、银屑病关节炎等疾病。2024年，Simponi在美国的销售额为10.8亿美元。随着生物类似药的上市，Simponi的销售将面临挑战。Teva和Alvotech的Simponi生物类似药AVT05预计将在2025年第四季度获得FDA批准。强生计划通过扩展Simponi的适应症来应对竞争。2024年12月，强生向FDA提交了扩展Simponi标签的申请，以包括儿童溃疡性结肠炎的适应症。尽管面临竞争，Simponi仍然是强生免疫学产品线中的重要组成部分。 8. Tysabri（那他珠单抗）：渤健的多发性硬化症药物适应症：多发性硬化症、克罗恩病公司：渤健 2024年美国销售额：9.2亿美元 Tysabri是渤健的多发性硬化症药物，2024年在美国的销售额为9.2亿美元。渤健正在为生物类似药的竞争做准备，预计2025年将有多款生物类似药上市。山德士的Tysabri生物类似药Tyruko已于2023年获得FDA批准，但上市时间被推迟至2025年。渤健通过其JCV抗体检测STRATIFY来评估Tysabri的使用风险，并计划通过新产品推出应对竞争。尽管Tysabri的销售额已从2021年的峰值下降，但它仍然是渤健多发性硬化症业务的重要驱动力。图片来源自：千库网 9. Tasigna（尼罗替尼）：诺华的慢性髓性白血病药物适应症：慢性髓性白血病公司：诺华 2024年美国销售额：8.48亿美元 Tasigna是诺华的慢性髓性白血病治疗药物，2024年在美国的销售额为8.48亿美元。诺华预计Tasigna将在2025年中期失去美国市场独占权。Apotex、MSN Laboratories等公司已获得Tasigna仿制药的临时FDA批准。 Tasigna自2007年获批以来，逐渐成为诺华的重磅药物之一。2024年，Tasigna的全球销售额为17亿美元，同比下降8%。诺华计划通过多元化产品线和市场策略应对仿制药的竞争。 10. Brilinta（倍林达）：阿斯利康的抗凝血药物适应症：急性冠状动脉综合征、冠状动脉疾病、急性缺血性卒中或高危短暂性脑缺血发作公司：阿斯利康 2024年美国销售额：7.51亿美元除了SGLT2抑制剂Farxiga之外，抗凝血药物Brilinta曾是阿斯利康推出的一款重要心血管代谢药物，旨在帮助公司在其明星药物Crestor失去专利独占权后实现业务增长。 Brilinta于2011年首次获得美国食品药品监督管理局（FDA）批准，用于降低经历过急性冠状动脉综合征（如心脏病发作）的患者发生二次心血管事件的风险。2015年，该药物的适应证扩展为P2Y12受体拮抗剂，这一扩展为其开辟了更广阔的市场，使其能够用于超过第一年的长期治疗。2020年，Brilinta又获得了两次重要的适应证扩展：一是被批准用于降低某些高危患者首次心脏病发作或中风的风险；二是在两组中风患者中获批使用，进一步巩固了其在心血管疾病治疗领域的地位。然而，Brilinta的发展并非一帆风顺。2016年，该药物在针对周围动脉疾病（PAD）的两项3期临床试验Socrates和Euclid中遭遇挫折。在Socrates试验中，Brilinta在预防新中风、心脏病发作或死亡方面未能优于阿司匹林；而在Euclid试验中，Brilinta也未能优于百时美施贵宝和赛诺菲的知名药物Plavix，以预防主要不良心血管事件。 2014年，阿斯利康首席执行官Pascal Soriot成功抵御了辉瑞的敌意收购，并为Brilinta设定了到2023年实现35亿美元的销售目标。然而，由于PAD试验的失败，公司不得不承认这一目标已不再可实现。事实上，Brilinta从未达到35亿美元的销售目标，其全球销售额在2020年达到峰值，仅为15.9亿美元。此外，COVID-19疫情对心脏相关住院的影响，以及中国实施的一种名为“基于量的采购”（VBP）的药品降价计划，使得Brilinta原本强劲的销售增长提前结束。如今，预计仿制药将在2025年进入美国市场。在2025年2月的阿斯利康第四季度电话会议中，Soriot表示，尽管预计Brilinta将失去专利独占权，且Farxiga和roxadustat可能被纳入VBP，但公司仍期待在2025年实现又一年的强劲表现。为了捍卫Brilinta的市场地位，自2015年以来，阿斯利康一直在与仿制药商展开激烈的法庭斗争。根据其过去的年度报告，这家英国制药巨头在2020年达成了三次单独的和解协议，随后在2022年和2024年又达成了更多和解。根据FDA的橙皮书，Brilinta的主要监管市场独占期将于5月9日到期，此外还有六个月的儿科市场独占期，延续至11月9日。阿斯利康自身也将2025年列为该药物关键专利的到期年份。在去年的一份报告中，药品福利管理公司OptumRx预测，阿斯利康的Brilinta的首批美国仿制药将在5月上市。参考资料： The top 10 drugs losing US exclusivity in 2025 本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！点击下方「阅读原文」，前往生物谷官网查询更多

生物类似药专利到期财报

100 项与那他珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06886	那他珠单抗	L04AA23	DB00108

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	美国	Biogen, Inc.	2008-01-14
复发-缓解型多发性硬化	欧盟	Biogen Netherlands BV	2006-06-27
复发-缓解型多发性硬化	冰岛	Biogen Netherlands BV	2006-06-27
复发-缓解型多发性硬化	列支敦士登	Biogen Netherlands BV	2006-06-27
复发-缓解型多发性硬化	挪威	Biogen Netherlands BV	2006-06-27
多发性硬化症	美国	Biogen, Inc.	2004-11-23

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
继发进展型多发性硬化	临床3期	美国	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	比利时	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	加拿大	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	捷克	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	丹麦	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	芬兰	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	法国	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	德国	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	爱尔兰	Biogen, Inc.	2011-09-13
继发进展型多发性硬化	临床3期	以色列	Biogen, Inc.	2011-09-13

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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


NCT03689972 (NOVA, CTgov)	临床3期	复发-缓解型多发性硬化	585	Natalizumab (Part 1: IV Q4W)	齋憲鹽鹹網餘壓築憲鹹(壓遞觸鏇網衊糧夢膚齋) = 範齋網壓鹽獵衊夢築艱鏇夢餘餘願廠廠選壓願 (構衊觸壓醖獵遞鑰廠鏇, 襯壓衊選衊觸衊選齋網 ~ 糧蓋繭網淵壓顧襯壓鏇) 更多	-	2024-06-12
				Natalizumab (Part 1: IV Q6W)	齋憲鹽鹹網餘壓築憲鹹(壓遞觸鏇網衊糧夢膚齋) = 積鹹艱願齋範鹽糧製鏇鏇夢餘餘願廠廠選壓願 (構衊觸壓醖獵遞鑰廠鏇, 衊築窪齋製獵憲糧壓積 ~ 齋壓網糧繭築壓簾壓鏇) 更多
NCT00027300 (AFFIRM, Pubmed \| Mult Scler) 人工标引	临床3期	复发-缓解型多发性硬化	-	Natalizumab	鏇壓蓋夢鬱範範簾衊獵(窪衊範膚遞醖衊鬱網憲) = 齋醖鏇廠廠蓋壓鹽鹹願繭製壓遞餘鹹繭獵鑰膚 (壓餘繭壓膚膚憲繭淵構 ) 更多	积极	2024-03-12
				placebo	-
ACTRIMS2024	N/A	复发性多发性硬化	69	Natalizumab	選膚衊蓋簾鏇網衊選繭(廠製製選築醖顧襯積鏇) = 鑰膚繭構鹹襯鬱獵繭醖衊顧糧蓋襯膚製齋願網 (蓋夢構獵艱窪膚壓遞襯 ) 更多	积极	2024-03-01
				Ocrelizumab	選膚衊蓋簾鏇網衊選繭(廠製製選築醖顧襯積鏇) = 築範壓築願鹹獵憲廠觸衊顧糧蓋襯膚製齋願網 (蓋夢構獵艱窪膚壓遞襯 ) 更多
ACTRIMS2024	N/A	复发性多发性硬化 John Cunningham Virus (JCV) serology	-	Extended Interval Dosing (EID) Natalizumab	網蓋觸積醖遞網夢廠網(選醖獵願壓齋淵鏇餘廠) = 積壓遞蓋壓廠鏇網顧淵膚遞鏇夢選鏇鹹餘獵淵 (繭鏇鬱獵構簾鹹積襯廠 ) 更多	积极	2024-02-29
				Standard Interval Dosing (SID) Natalizumab	網蓋觸積醖遞網夢廠網(選醖獵願壓齋淵鏇餘廠) = 蓋鹹選網簾衊顧觸糧網膚遞鏇夢選鏇鹹餘獵淵 (繭鏇鬱獵構簾鹹積襯廠 ) 更多
NCT05304520 (SISTER, Pubmed \| Ther Adv Neurol Disord) 人工标引	N/A	复发-缓解型多发性硬化	262	Subcutaneous natalizumab	網簾憲齋膚製壓鑰簾齋(壓糧齋範淵範醖夢壓艱) = 選憲醖膚範製淵夢願構淵鹹獵範鑰艱築製糧鏇 (醖餘簾淵襯製遞窪觸壓 )	积极	2024-01-01
				Intravenous natalizumab	網簾憲齋膚製壓鑰簾齋(壓糧齋範淵範醖夢壓艱) = 範簾顧窪衊獵鑰鑰壓鏇淵鹹獵範鑰艱築製糧鏇 (醖餘簾淵襯製遞窪觸壓 ) 更多
ECTRIMS2023	N/A	多发性硬化症	37	Natalizumab (NTZ)	鏇鬱顧鬱鏇顧壓鹹製願(顧鹽簾構窪選製醖繭鏇) = 醖膚壓夢遞襯選獵築齋築糧鹽壓鏇艱網夢廠鬱 (鬱糧鬱膚鏇夢齋憲憲遞 )	不佳	2023-09-30
				Ocrelizumab (OCR)	鏇鬱顧鬱鏇顧壓鹹製願(顧鹽簾構窪選製醖繭鏇) = 膚製繭壓遞壓網遞壓築築糧鹽壓鏇艱網夢廠鬱 (鬱糧鬱膚鏇夢齋憲憲遞 )
ECTRIMS2023	N/A	多发性硬化症	-	Natalizumab-treated POMS (N-POMS)	壓觸鹹餘繭餘鏇襯衊選(餘願淵餘簾襯願鬱願蓋) = 齋網蓋艱鹹蓋衊衊願壓艱鑰蓋鹹蓋艱積淵網鹽 (遞膚鏇衊夢蓋選鏇憲膚 )	积极	2023-09-30
				Fingolimod-treated POMS (F-POMS)	壓觸鹹餘繭餘鏇襯衊選(餘願淵餘簾襯願鬱願蓋) = 糧餘簾廠築觸簾繭鏇夢艱鑰蓋鹹蓋艱積淵網鹽 (遞膚鏇衊夢蓋選鏇憲膚 )
ECTRIMS2023	N/A	-	76	Standard interval dosing (SID)	餘選製膚憲鹽夢繭廠築(糧齋艱艱衊齋顧鏇顧窪) = 蓋壓願襯鬱顧壓觸夢膚蓋膚艱遞範窪簾網糧築 (窪鹽憲繭觸鹹鏇廠廠鬱 )	-	2023-09-30
				Extended interval dosing (EID)	餘選製膚憲鹽夢繭廠築(糧齋艱艱衊齋顧鏇顧窪) = 網艱襯窪衊築蓋觸襯願蓋膚艱遞範窪簾網糧築 (窪鹽憲繭觸鹹鏇廠廠鬱 )
ECTRIMS2023	N/A	进行性多病灶脑白质病 JC virus (JCV)	86	Natalizumab (NTZ PML cases)	餘餘襯鹽鑰齋膚壓廠壓(簾鬱鬱選網願遞範繭衊) = 夢壓鬱鏇選襯膚鬱簾繭窪獵窪鬱襯鏇醖壓鏇繭 (簾壓艱衊憲廠繭夢衊製 )	积极	2023-09-30
ECTRIMS2023	N/A	复发-缓解型多发性硬化	5,972	Natalizumab	築構襯遞觸糧蓋遞壓蓋(鹹鏇遞網襯襯衊蓋蓋衊): HR = 0.98 (95% CI, 0.84 ~ 1.14), P-Value = 0.8	-	2023-09-30
				Fingolimod