This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi. The second randomization allows identification of optimal sequential use of biologics (treatment strategies).

开始日期2025-08-01

申办/合作机构

Duke University

[+1]

NCT06016517

/ Not yet recruitingN/AIIT

Application of the Personalized N-of-1 Trial Design in Patients with Rheumatoid Arthritis

The goal of this N-of-1 study is to learn about treatment for individual patients who have rheumatoid arthritis (RA,) for which many treatments are available. The treatments are different in how they work, the way they are given, side- effects, and cost. While treatment guidelines are available, finding the best treatment order of treatments is often based on physician choice. The main question this study aims to answer are:
* What are the effects of different treatments on RA symptoms and condition for each individual patient
* What is the effectiveness of different treatments across all patients enrolled in the N-of-1 study
Participants will be enrolled and randomized to a sequence of three U.S. Food and Drug Administration (FDA) approved RA medications: 1. etanercept, 2. adalimumab, 3. upadacitinib 4. tocilizumab. Participants will be asked to complete questionnaires about their condition and quality of life weekly (either in clinic or remotely) and report their level of pain daily (remotely).

开始日期2025-05-15

申办/合作机构

Tufts Medical Center, Inc.

ChiCTR2500101334

/ Suspended临床4期IIT

Efficacy and safety of Etanercept (Recombinant Human Tumor Necrosis Factor-a Receptor?:IgG Fc Fusion Protein for Injection) in the treatment of knee osteoarthritis

开始日期2025-05-01

申办/合作机构

西安交通大学医学院第二附属医院

100 项与依那西普相关的临床结果

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100 项与依那西普相关的转化医学

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100 项与依那西普相关的专利（医药）

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8,425

项与依那西普相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Successful treatment of etanercept- and adalimumab-resistant pyoderma gangrenosum with spesolimab, moderate-dose corticosteroids, and minocycline

Article

作者: Zhang, Hanlin ; Wu, Chao ; Jin, Hongzhong

PURPOSE:

Pyoderma gangrenosum (PG) is a rare, neutrophilic dermatosis characterized by rapidly developing, painful ulcers. This study explores the potential of spesolimab, an anti-IL-36R antibody, as a therapeutic option for refractory PG.

MATERIALS AND METHODS:

We report a case of a 48-year-old male with refractory PG who failed to respond to etanercept and adalimumab. Upon admission, the patient presented with extensive, painful ulcerations on the trunk and extremities. He was started on oral methylprednisolone (32 mg/day) and minocycline (50 mg twice daily). After a week, minimal improvement was observed. After reviewing the screening results and discussing treatment options, the patient received two doses of spesolimab (900 mg intravenously) administered two weeks apart.

RESULTS:

Marked clinical improvement was observed after spesolimab initiation. Complete ulcer healing was achieved within six weeks of starting spesolimab, with no adverse effects reported.

CONCLUSIONS:

This case demonstrates the potential efficacy of spesolimab for treating refractory PG, particularly in patients unresponsive to TNF-α inhibitors. Despite the added complexity of the patient's underlying HBV infection and elevated M-protein, no HBV reactivation or other hematologic complications occurred. Further studies are needed to validate its role in managing PG and other neutrophilic dermatoses.

2025-07-01·JOURNAL OF NEUROIMMUNOLOGY

Relapsing-remitting multiple sclerosis as a potential consequence of thalidomide treatment: A case report

Article

作者: Marques, Rodolfo Francisco ; Lemos, Josemary Cavalcante ; Lana-Peixoto, Marco A ; Talim, Natalia ; Pedrosa, Denison Alves

We present the first reported case of central nervous system (CNS) demyelination associated with thalidomide. A 29-year-old female with a history of prurigo nodularis was prescribed thalidomide after the failure of other therapies. Three weeks later, she developed right hemiparesis and sensory disturbances in the right upper and lower extremities. Brain and spinal cord MRI showed hyperintense and gadolinium enhanced lesions. She was diagnosed with clinically isolated syndrome and treated with IV pulses of methylprednisolone with full recovery. Due to suspected association between her symptoms and thalidomide, the drug was discontinued. Three years later she returned to our Outpatient Clinic after being treated at another hospital for a new attack, characterized by muscle weakness and sensory disturbance in the lower limbs. Brain and spinal cord MRI showed new lesions, fulfilling the criteria for multiple sclerosis. We believe the association between thalidomide and CNS demyelination may be due to its tumor necrosis factor-α (TNF-α) inhibition effect. Biologic TNF-α inhibitors have been reported to cause CNS lesions, with cases of optic neuritis, transverse myelitis, multiple sclerosis, and neuromyelitis optica spectrum disorder developing after initiation of drugs such as etanercept, adalimumab, infliximab and golimumab. This report shows that thalidomide should be considered a potential cause of CNS demyelination, similar to biologic TNF-α inhibitors, and should be avoided in patients with a heightened risk.

2025-07-01·ANALYTICA CHIMICA ACTA

Rapid baseline hump-free analysis of therapeutic proteins in a wide molecular weight range by SDS - capillary agarose gel electrophoresis

Article

作者: Sárközy, Dániel ; Guttman, András ; Farkas, Anna

BACKGROUND:

Sodium dodecyl sulfate capillary gel electrophoresis traditionally employs entangled polymer networks (CE-SDS) or borate cross-linked gels (SDS-CGE) for size-based protein analysis. However, the separation of SDS proteins in these transiently cross-linked sieving matrices requires long analysis times and in addition, baseline humps/waves frequently occur making peak identification and quantification challenging. The analytical biopharma community has been trying to solve this problem for a decade, making it clear that a novel gel composition was required to provide baseline hump-free separation of SDS-proteins by capillary electrophoresis of higher MW biopharmaceuticals.

RESULTS:

Using a transiently cross-linked agarose matrix shown in this paper enabled rapid separation of therapeutic proteins with excellent resolution, but more importantly, eliminated the commonly observed baseline disturbances of dextran-based gel formulations. Using capillaries as short as 10 cm effective length, the tetrahydroxyborate cross-linked agarose matrix supported fast analysis (∼5 min) of an intact anti-SARS-CoV-2 therapeutic antibody and its subunits with excellent run-to-run migration time (RSD <0.3 %) and peak area (RSD <5 %) reproducibility. High resolution between the closely migrating non-glycosylated heavy chain and the heavy chain fragments was also obtained (RS = 1.65). The high molecular weight thyroglobulin (660 kDa), and the highly glycosylated fusion protein of etanercept were also successfully analyzed with borate-agarose-based gels, exploiting the stable baseline at the upper molecular weight range of the separation trace.

SIGNIFICANCE:

This paper reports for the first time on a baseline hump-free approach for rapid analysis of therapeutic proteins in a wide MW range by SDS capillary agarose gel electrophoresis. The unique potential of tetrahydroxyborate-stabilized agarose gels revolutionizes capillary SDS gel electrophoresis analysis of mAbs and more complex new modalities, offering a robust and efficient platform for high-resolution protein separation, paving the way for advancements in baseline hump-free therapeutic protein characterization and consequently good quantification.

382

项与依那西普相关的新闻（医药）

2025-05-27

·CPHI制药在线

新一波专利悬崖面前，制药巨头安危分析

关注并星标CPHI制药在线制药领域是一个花无百日红的场所，不仅是因为“江山代有才人出”，也因为“风流总被雨打风吹去”。一款曾经“一览众山小”的重磅药物，在专利到期之后面对的通常会是“故国不堪回首月明中”的落寞。药品专利，这个起初旨在维护制药公司利益的保护伞，在逐渐走向专利悬崖的后期，却成为这些公司如芒在背的威胁。专利悬崖对大型制药公司，尤其是对那些依赖几款超级重磅炸弹药物的制药公司构成非常严重的威胁。当这些药物的专利到期后，仿制药制造商迅速进入市场，推出价格远低于原研药的替代品。这将直接导致原研药销售额的骤降，并削弱了这些开发商的盈利能力。由于超级重磅炸弹药物通常占公司总收入的相当大部分，一旦失去专利保护，公司可能难以在短期内通过新药研发或收购来弥补收入缺口。因此专利悬崖不仅威胁到公司的财务稳定，还可能影响其研发投入和市场竞争力。放眼大时代，2026-2030 年，生物制药行业将进入动荡时期，众多超重磅药物将在这一时期失去美国市场独占权。几乎所有大型制药公司都将或多或少受到头顶的这把专利到期达摩克利斯之剑的影响，但受威胁程度疾徐不一。诺和诺德、赛诺菲、吉利德、礼来和拜耳可能是2030年前“受灾”程度最小的五家制药巨头（表1，图1-2）。根据 Evaluate Pharma 的数据和Scrip的分析，预计从2026年至2030年，这五家制药商因专利到期遭受的损失将不超过各自2025年美国市场预测收入的15% 。在诺和等五家制药公司“事大如天醉亦休”地置身其外的同时，感受“日长似岁”般煎熬的制药巨头将面临渡劫。这些公司可能会因 2026 年至 2030 年美国专利到期药物而损失50% 以上的收入，其中葛兰素史克、百时美施贵宝和默沙东将面临最大危局。葛兰素史克的 Tivicay（多替拉韦）和 Dovato（拉米夫定）、百时美施贵宝的 Eliquis（阿哌沙班）和 Opdivo（纳武利尤单抗）以及默沙东的药王 Keytruda（帕博利珠单抗）等超级重磅药物可能将在这个时间段面临仿制药或生物类似药的竞争。表1. 全球大型制药公司2026-2030年受专利悬崖影响数据（数据来源：Evaluate Pharma）图1. 2025年预计美国市场收入中遭受2026-2030年间市场独占权丧失威胁的比例。（数据来源：Evaluate Pharma)图2. 大型制药公司2025年预计收入中面临2026-2030年间市场独占权丧失威胁的绝对数额。（数据来源：Evaluate Pharma）A.安全榜1.诺和诺德（2% 风险）诺和诺德的支柱性产品无疑是其Semaglutide产品组合，尤其是Ozempic和Wegovy。虽然诺和诺德将在GLP-1市场遭遇礼来和众多后来者的严峻挑战，以及Medicare价格谈判的潜在影响，但从专利悬崖的角度来看，诺和面临的压力要比默沙东小得多。Semaglutide在美国市场的核心专利保护预计将延续到2031年，这将赋予诺和诺德宝贵的开发新产品的黄金时间，在享受semaglutide巨大红利的同时，将利润投入到新一代产品的开发中，例如GLP-1/胰淀素类似物联合疗法CagriSema。2.赛诺菲（9% 风险）赛诺菲CEO Paul Hudson在今年1月召开的摩根大通医疗保健大会的演讲中就曾信誓旦旦地表态，“就独占权丧失而言，赛诺菲是业内最低的”。赛诺菲的当家花魁Dupixent (dupilumab) 仍处在生命周期的黄金时代，被批准用于从牛皮癣到哮喘等多种炎症疾病，最近还获得了慢性阻塞性肺病 (COPD)的批准，进一步夯实了这款超重磅药物的盈利能力。Dupixent 的专利保护期将持续到 2030 年代初。其活性成分专利将于 2031 年到期，其他专利有效时间则更长。Evaluate Pharma 的数据显示，赛诺菲预计的2025 年美国收入中只有 9% 会因 2026 年至 2030 年期间的市场独占丧失而损失，但这些损失多数来自“帐中副将”，例如乙型血友病药物Alprolix（重组凝血因子IX-Fc融合蛋白）和慢性移植物抗宿主病药物Rezurock（belumosudil），预计它们将分别在 2028 年和 2029 年失去独占权。3.吉利德（9%风险）吉利德追求的目标之一是在其核心 HIV 业务之外成功实现更多多元化，这个志向是建立在其HIV 业务一直在实现增长的基础之上的。吉利德最畅销的联合疗法的专利目前还一眼望不到底，2033 年底之前可保无虞。Biktarvy 在 2024 年的销售额为 134 亿美元，占吉利德总收入的将近48%。吉利德表示，在Biktarvy收入曲线进入下行阶段之前，他们将有能力推出新一代长效HIV药物。吉利德2025 年美国收入中只有9%将遭受到2026-2030年市场独占权丧失的影响，包括2027 年到期的CD19 靶向CAR-T疗法，而考虑到 CAR-T 疗法制造的复杂性，Tecartus未必在市场独占期到来之后立即面临生物类似药的竞争。4.拜耳（风险 13%）处在多事之秋的拜耳，其重磅产品血液稀释剂 Xarelto（rivaroxaban）市场独占期在2024年4月已经到来，令拜耳更加感受到压力重重。但遭受亏损的拜耳有望在2027年实现业务增长。拜耳CEO Bill Anderson 认为，用于治疗与 2 型糖尿病相关的慢性肾病的盐皮质激素受体拮抗剂 Kerendia（finerenone）和前列腺癌药物 Nubeqa（darolutamide）等新药将有助于推动拜耳回春。此外，BridgeBio 的 acoramidis 在欧洲将由拜耳负责商业化（欧洲商品名Beyonttra），针对转甲状腺素蛋白淀粉样心肌病 (ATTR-CM)。拜耳的elinzanetant针对更年期相关的中度至重度血管舒缩症状的申请正在等待FDA的监管审批。5.礼来（风险 15%）礼来的旗舰产品Mounjaro和Zepbound相对于其直接竞争对手，诺和诺德的Ozempic和Wegovy更加年轻。其活性成分tirzepatide的专利至少要到2036年才到期，这位礼来长期盈利提供了关键保障。礼来公司在 2026-2030 年期间也将面临一些畅销药物的专利损失，包括预计在 2027 年失去市场独占的糖尿病重磅药物 Trulicity（dulaglutide），其2024 年为礼来创造了 52.5 亿美元的收入；以及在 2030 年失去专利保护的牛皮癣药物 Taltz（ixekizumab），其2024 年销售额达到36 亿美元。B.风险榜1.默沙东（78%）Keytruda，默沙东的这款支柱产品免疫检查点抑制剂肿瘤学产品2024年销售额高达295亿美元，而默沙东全年销售额为642亿美元。也就是说，Keytruda以一己之力贡献了默沙东全部销售额的46%，这是一个非常卓越的成就，但同样也包藏祸机，因为Keytruda在美国的关键专利将在2028年到期，Keytruda专利悬崖危机成为默沙东目前的头号挑战。随着 Keytruda、Sitagliptin/Metformin和 Letermovir 的专利即将到期，默沙东未来五年将面临严峻挑战。另一个主要收入来源 HPV 疫苗 Gardasil 9 因中国市场饱和而表现不佳，导致默沙东于 2024 年 2 月暂停发货以清理库存，在 2025 年可能会恢复增长。为了保持增长，默沙东抗体药物偶联物 (ADC) 方面投入了大量资金，包括与科伦生物科技和第一三共的合作。2.GSK（62%）葛兰素史克的dolutegravir一直是其HIV 药物组合的主要产品，是葛兰素史克四个最畅销的 HIV 品牌 Tivicay（13.5亿英镑）、Triumeq（13.3亿英镑）、Juluca（6.85亿英镑）和 Dovato （22.4亿英镑）中的成分。但其关键专利可能将于2027年到期。3.BMS (55%)百时美施贵宝的Eliquis (Apixaban) 和 Opdivo 正面临专利悬崖危机，2024 年这两款药物的营收为 234 亿美元，占公司总营收的近一半。Eliquis面临即将到来的仿制药竞争，Eliquis是BMS与辉瑞共同商业化的产品，是一种用于预防成人血栓的小分子药物，2012年获得FDA批准，2023年实现全球122亿美元的销售额。其专利已于2022年到期，但得益于补充保护证书（Supplementary Protection Certificate）的荫护，其保护期已延长到2026年。实际上，Eliquis仿制药已经获得了FDA的临时批准，但BMS与仿制药商已经达成和解，仿制药不会在2027年之前上市。作为回应，BMS 实施了积极的成本削减措施，包括 2024 年 4 月的 15 亿美元成本削减计划和 2025 年 2 月的额外 20 亿美元削减计划，包含削减产品线和裁员。BMS 还将重点转向神经科学，以 140 亿美元收购了 Karuna Therapeutics，并投资了精神分裂症药物 Cobenfy。C.2025-2031年间失去市场独占权的重要药物2025年• Entresto (sacubitril/valsartan，诺华，2015年获批，2024年全球销售额：78.2亿美元，下同)• Farxiga (Dapagliflozin，诺华，2014年获批，2型糖尿病，38.4亿美元)• Prolia (denosumab，安进，2010年获批，骨质疏松症，43.7亿美元)• Xgeva (denosumab，安进，2010年获批，肿瘤，22.3亿美元) 2026年• Eliquis (apixaban，BMS/辉瑞，2012年获批，血栓，122亿美元)• Revlimid (lenalidomide，BMS，2005年获批，骨髓增生异常综合征、多发性骨髓瘤、淋巴瘤、滤泡性淋巴瘤等，57.7亿美元) 2027年• Trulicity (dulaglutide，礼来，2014年获批，2型糖尿病，52.5亿美元)• Ocrevus (ocrelizumab ，罗氏，2017年获批，多发性硬化症，67亿美元)• Ibrance (Palbociclib，辉瑞，2015年获批，乳腺癌，43.7亿美元)• Xtandi (enzalutamide，安斯泰来/辉瑞，2012年获批，前列腺癌，63亿美元)• Imbruvica (ibrutinib，艾伯维/强生，2013年获批，慢性淋巴细胞白血病等，49亿美元)• Dolutegravir药物组合 (GSK，2013年获批，HIV，56亿英镑) 2028年• Keytruda (pembrolizumab，默沙东，2014年获批，肿瘤，295亿美元)• Opdivo (nivolumab，BMS，2014年获批，肿瘤，93亿美元)• Gardasil 9 (human papillomavirus 9-valent vaccine ，2014年获批，默沙东，86亿美元) 2029年• Darzalex (daratumumab，强生/Genmab，2015年获批，多发性骨髓瘤，117亿美元)• Cosentyx (secukinumab，诺华，2015年获批，斑块性银屑病等，61.4亿美元)• Enbrel (etanercept，安进，1998年获批，类风湿性关节炎等，33.2亿美元) 2031年• Dupixent (dupilumab，赛诺菲/再生元，2017年获批，特应性皮炎、哮喘、慢性阻塞性肺病等，131亿欧元)Ref. 1、Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results. Merck Press Release. 04. 02. 2025. 2、Merrill, J. et al. Five Companies Heading Toward 2030 With Wind At Their Back. Scrip. 26. 02. 2025. 3、2024 Financial report of various pharmaceuticals. 4、Pharma patent cliff. LinkedIn: Joanna-sadowska-phdEND【企业推荐】智药研习社直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

专利到期并购生物类似药

2025-05-21

·EINPresswire

Sandoz launches Pyzchiva® autoinjector, first commercially available in Europe for ustekinumab biosimilars

MEDIA RELEASE Pyzchiva® first ustekinumab biosimilar in Europe commercially available in pre-filled pen (autoinjector), offering improved self-administration experience for better treatment adherence and quality of life [1-10] Autoinjector includes unique features to improve comfort, independence and convenience for patients with chronic inflammatory diseases [1-10] Launch strengthens Sandoz biosimilar leadership position in immunology and commitment to patient-centric innovation Basel, May 21, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced the European launch of its Pyzchiva®* (ustekinumab) autoinjector.[1-2] This is the first ustekinumab biosimilar in Europe commercially available in an autoinjector. Developed and registered by Samsung Bioepis, Pyzchiva® is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients aged six years and older, weighing over 60 kg.[1] The Pyzchiva® autoinjector supports a more comfortable self-administration experience [1-10] with accurate automatic dosing [1,3,4], less frequent injection pain [1,9,10], a compact design [1,3,4,6,7], and flexible storage options [1], offering the potential for improved adherence to patient treatment plans. Christophe Delenta, President Europe, Sandoz, said: “Access to medicine does not end when it reaches the hands of the patient. The Pyzchiva® autoinjector, with its thoughtful and advanced features, addresses the real-world needs of patients in managing chronic inflammatory diseases. This launch marks another important milestone as we strengthen our leadership in immunology biosimilars and reaffirm our commitment to pioneering access across Europe’s evolving healthcare landscape.” Europe has the highest prevalence of psoriasis worldwide, affecting an estimated 6.4 million people.[11-13] Inflammatory bowel diseases, such as Crohn’s disease, are also common in Europe, affecting an estimated 2.5 to 3 million people.[14] Non-adherence to biologic therapies can lead to disease progression, increased flares and reduced quality of life, while contributing to increased healthcare utilization, including hospitalizations and additional treatments, thereby escalating healthcare costs.[15,16] Pyzchiva® is a key biosimilar value driver for the Sandoz growth strategy. It has been launched in 23 markets in Europe. The autoinjector is now available in Spain and will continue to roll out across Europe. Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva® in Brazil, the US, the European Economic Area (EEA), Switzerland and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply. ABOUT PYZCHIVA® (USTEKINUMAB) Pyzchiva® (ustekinumab) has been developed as a biosimilar with equivalent efficacy and comparable safety to the reference medicine Stelara®**, a human monoclonal antibody against interleukin (IL)-12/23. Pyzchiva® is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg. The Pyzchiva® autoinjector is a pre-filled pen delivered through the Molly®*** platform of SHL Medical AG. It is available as a 90 mg in 1 mL autoinjector or a 45 mg in 0.5 mL autoinjector.[1,2] Pyzchiva® is also available as a 130mg concentrate in a vial for solution for infusion, a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe. *Pyzchiva® is a trademark of Samsung Bioepis Co. Ltd. **Stelara® is a trademark of Johnson & Johnson ***Pyzchiva® will be delivered by SHL Medical’s patented Molly® technology. Molly® is a registered trademark of SHL Medical AG 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 revise any forward-looking statements, except as required by law. REFERENCES [1] Pyzchiva® (ustekinumab) Summary of Product Characteristics. Available at: ema.europa.eu/en/documents/product-information/pyzchiva-epar-product-information_en.pdf (Accessed May 2025). [2] Samsung Bioepis. Data on file. [3] SHL Medical AG. Molly® autoinjector white paper. Available at: shl-medical.com/news-insights/downloads (Accessed May 2025). [4] SHL Medical AG. Molly® SE autoinjector letter. April 16, 2025. Data on file. [5] Paul C, Stalder JF, Thaçi D, et al. Patient satisfaction with injection devices: a randomized controlled study comparing two different etanercept delivery systems in moderate to severe psoriasis. J Eur Acad Dermatol Venereol . 2012;26:448–455. [6] Tischer B, Mehl A. Patients’ and nurses’ preferences for autoinjectors for rheumatoid arthritis: results of a European survey. Patient Prefer Adherence . 2018;12:1413–1424. [7] Thakur K, Sandhu SK, Sharma A. Patient Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: Findings from a Patient Survey in Europe. Rheumatol Ther . 2016;3:245–256. [8] Lopez A, Mounier M, Bouvier AM, et al.Adherence to anti-TNF therapy in inflammatory bowel diseases: a systematic review. Inflamm Bowel Dis . 2013;19:1528–1533. [9] Arendt-Nielsen L, Petersen-Felix S, Fischer M, Bak P. Pain following controlled cutaneous insertion of needles with different diameters. Somatosens Mot Res . 2006;23:37–43. [10] Gill HS, Prausnitz MR. Does needle size matter? J Diabetes Sci Technol . 2007;1:725–729. [11] International Federation of Psoriasis Associations (IFPA). Speaking up for psoriatic disease in Europe. Available at: ifpa-pso.com/content/tools/20072022_IFPA-FORUM_Briefing-Book_Speaking-up.pdf (Accessed May 2025). [12] Frede N, Gerdes S, Schön MP, et al. Psoriasis and psoriatic arthritis have a major impact on quality of life and depressive symptoms: a cross-sectional study of 300 patients. Rheumatol Ther . 2023;10:1655–1668. [13] Palfreeman AC, McNamee KE, McCann FE. New developments in the management of psoriasis and psoriatic arthritis: a focus on apremilast. Drug Des Devel Ther . 2013;7:201–210. [14] Burisch J, Jess T, Martinato M, et al. The burden of inflammatory bowel disease in Europe. J Crohns Colitis . 2013;7:322–337. [15] Vangeli E, Bakhshi S, Baker A, et al. A systematic review of factors associated with non-adherence to treatment for immune-mediated inflammatory diseases. Adv Ther . 2015;32:983–1028. [16] Maniadakis N, Toth E, Schiff M, et al. A targeted literature review examining biologic therapy compliance and persistence in chronic inflammatory diseases. Adv Ther . 2018;35:1333–1355. 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 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. CONTACTS Global Media Relations Investor Relations Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Alex Kalomparis +41 79 279 0285 Craig Marks +44 7818 942 383 Joerg E. Allgaeuer +49 171 838 4838 Rupreet Sandhu +41 79 410 5472 Attachment Media release_Pyzchiva autoinjector European launch.pdf Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准引进/卖出免疫疗法

2025-05-21

·医药投资部落

下一个国产创新药爆款大BD

这一轮创新药行情的反转，以“对外BD”作为最大的底层逻辑。2025年5月20日，一向在行业中并非热门公司的三生制药，以一笔首付款达到创纪录的12亿美元的BD交易，直接震撼了全市场，也彻底引爆了股价。三生制药只是中国药企对外BD大潮中的一员。从港股的科伦博泰、康方生物，到A股的百利天恒，这些近年来股价表现极为突出的创新药公司，无一不是通过大额的创新药管线对外BD，实现了企业发展历程中的转折性里程碑。即使是恒瑞医药这样国产制药企业中的龙头，也走上了对外BD的道路，并且成交频繁，斩获颇丰。同一款药物，美国市场的售价可能是中国市场的20倍，欧洲市场的售价是可能是中国市场的10~15倍，这是所有创新药都必须“出海”的理由。但是在A股和港股的诸多创新药企业中，有能力独自完成全球多中心试验并独立在欧美市场执行商业化销售的，实在是凤毛麟角。于是，和跨国药企联手，在比较优势的分工理论下，形成“中国药企负责早期研发、跨国药企负责后期临床和商业化”的合作，成为诸多中国药企的首选战略。在多家中国药企已经通过和跨国药企的BD合作，实现市值和股价的腾飞之后，还有哪些在研的中国管线具备对外大额BD授权的潜力，无疑是一个值得重点关注的方向。来凯医药：LEA-102LAE102是一款来凯医药自主研发的靶向激活素II型受体A（ActRIIA）的单克隆抗体，也是全球范围内除了礼来的Bimagrumab之外，为数不多的已经进入临床试验阶段的靶向ActRII的在研管线。相比于GLP-1类药物只能单纯地减重，激活素II型受体这一靶点的最大魅力在于：在减少体重的同时，不仅不会同比例减少受试者的肌肉，反而具有增加肌肉的效果。之所以把这款管线放在第一个，是因为已经有巨头药企已经入局。2024年的11月，来凯医药与礼来公司签署了临床合作协议，礼来将负责在美国执行LAE102的一项I期临床试验并承担相关费用，而来凯医药保留了LAE102的全球权益。这是一种在行业中不多见的合作方式。一般来说，都是Biotech自己掏钱在美国做完I期临床，有了初步数据之后，卖给跨国药企。但是现在是礼来主动出钱出人，帮着做完美国的I期临床，但是却没有任何权益。对于这种合作形式，行业的普遍解读，是来凯医药在待价而沽，因为LEA-102这款管线的潜在买家，肯定不止礼来一个。2024年的美国ADA年会的现场，来凯医药展示了一组“人体组织工程肌肉功能研究平台”相关研究成果的壁报，合作者是代谢领域另一家巨头公司诺和诺德。理论上，目前被礼来的竞争搞得压力很大的诺和诺德，也完全具有涉足ActRII靶点的动机。目前，来凯医药的LAE102已经在美国启动了I期临床试验。考虑到礼来此前曾经以高达19.25亿美元的对价，收购了一款同样是靶向ActRII的抗体Bimagrumab，一旦来凯医药的LAE102读出积极的临床数据，其达成大额BD的预期也是非常之高。亚盛医药：APG-2575目前为止，全球范围内仅有艾伯维与罗氏合作开发的维奈克拉（Venetoclax）这一款bcl-2抑制剂获批上市。亚盛医药的APG-2575，已经在2024年底提交了中国市场的上市申请，正在全力冲刺“全球第二款bcl-2抑制剂”这个殊荣。目前，全球bcl-2抑制剂市场仅有Venetoclax一家独大，年度销售金额超过20亿美元，在这种形势下，APG-2575具有很高的对外授权的预期。从研究进展而言，APG-2575已经披露与阿卡替尼联用治疗CLL/SLL适应症的临床研究结果，数据都非常不错，甚至对经Venetoclax治疗后复发/难治或不耐受的患者也有很好的治疗效果。作为阿卡替尼的拥有者，阿斯利康完全存在引进一款bcl-2抑制剂的需求，以便与竞争对手的“伊布替尼+Venetoclax”的联合疗法相抗衡。同时，亚盛医药在BD市场上的表现，是有优秀的历史战绩的。2024年6月，亚盛医药将旗下另一款重磅药物奥雷巴替尼，授权给跨国药企武田，总交易金额超过90亿人民币，包含7.2亿元的选择权付款，和共计86.4亿元的选择权行使费及额外的潜在里程碑付款。随着APG-2575的日益成熟，相信亚盛医药也将实质性推进这款药物的对外BD。荣昌生物：泰它西普相比于大部分对外BD的国产管线都集中于肿瘤领域，荣昌生物的泰它西普是一款不多见的自免领域的潜在大药。泰它西普是荣昌生物自主研发的全球首款、同类首创（First-in-class）的注射用重组 B 淋巴细胞刺激因子/增殖诱导配体双靶点的新型融合蛋白产品。目前，围绕着T淋巴细胞相关的自身免疫疾病，已经诞生了阿达木单抗、英夫利昔单抗、依那西普等一系列重磅炸弹药物，全球合计销售额超过400亿美元。同样和自身免疫疾病的发生与进展密切相关的B淋巴细胞方向，目前还没有诞生一个爆款产品。截至目前为止，泰它西普在自免疾病领域的适应症布局非常广泛，其中已经有系统性红斑狼疮（SLE）、IgA肾病、重症肌无力（MG）、干燥综合征（pSS）四大适应症，获得FDA批准在美国开展Ⅲ期临床试验。迪哲医药：舒沃替尼迪哲药业的舒沃替尼，是一款选择性EGFR酪氨酸激酶抑制剂，目前已经在中国获批用于治疗EGFR 20号外显子插入突变非小细胞肺癌。2024年11月，迪哲医药向美国FDA递交舒沃替尼的新药上市申请（NDA），并于2025年1月7日通过FDA立卷审查，获得优先审评资格。获得优先审评，意味着审批周期将从标准10个月缩短至6个月左右，预计2025年年中可以完成审批。目前，全球市场获批针对EGFR 20号外显子插入突变的NSCLC的治疗药物，只有强生的埃万妥单抗和舒沃替尼两款药物获批上市，而舒沃替尼是唯一的小分子药物，且相较前者在疗效、安全性和用药便利性方面均具备优势。一旦在美国市场获批上市，这款药物的确定性将非常之高，因此也完全可以谈下一个大额的BD交易。后记以上，只是列举了部分具备对外BD预期的在研国产创新药管线。经历了短短十几年发展的中国创新药行业，虽然一度饱受"me-too"式的无效内卷而陷入暂时性的发展低潮，但是仍然有相当一部分中国药企，在各自的细分领域已经悄悄摸到了前沿，已经逐步具备了深度参与全球竞争的能力。未来可期！医药研究报告分享营收集与分享全市场主流医药研究报告每天仅需0.8元畅享超过2000篇存量精选医药研究报告每年新增额外500篇

临床1期引进/卖出临床2期

100 项与依那西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00742	依那西普	L04AB01	DB00005

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
银屑病	中国	C.H. Boehringer Sohn AG & Co. KG	2010-02-26
非放射性轴性脊柱关节炎	澳大利亚	Pfizer Australia Pty Ltd.	2003-03-18
多关节型幼年特发性关节炎	美国	Immunex Corp.	2002-01-15
强直性脊柱炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	挪威	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
幼年特发性关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02

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
疼痛	临床3期	美国	Amgen, Inc.	2016-11-29
疼痛	临床3期	波多黎各	Amgen, Inc.	2016-11-29
青少年少关节慢性关节炎	临床3期	澳大利亚	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	比利时	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	哥伦比亚	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	捷克	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	法国	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	德国	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	匈牙利	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	意大利	Pfizer Inc.	2009-09-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2024	N/A	幼年特发性关节炎一线	118	Etanercept (ETN)	衊衊齋餘憲遞積艱鏇淵(鏇齋選構簾積膚鏇憲範) = 鹹襯積構壓築築艱憲憲憲鏇鹽鹹窪鏇繭鹽鬱衊 (衊蓋夢遞襯壓觸鏇憲築 )	积极	2024-06-05
				Adalimumab (ADA)	衊衊齋餘憲遞積艱鏇淵(鏇齋選構簾積膚鏇憲範) = 顧夢憲鬱淵獵鹽願構蓋憲鏇鹽鹹窪鏇繭鹽鬱衊 (衊蓋夢遞襯壓觸鏇憲築 )
EULAR2024	N/A	-	-	Etanercept bio-originator	壓觸遞鏇壓壓遞夢觸選(淵製窪顧淵積觸鹽夢簾) = 28% vs 22%, mostly injection site reactions 衊憲糧顧衊顧構構簾憲 (夢築廠膚鹽鏇壓齋襯衊 ) 更多	-	2024-06-05
				Etanercept biosimilar SB4
EULAR2024	N/A	IL-17A	135	Adalimumab (ADA)	構鏇艱鹽願鏇選積繭襯(獵築衊製鹽憲廠築鏇繭) = 鏇選鹹廠獵製簾鏇顧觸積選醖壓築衊襯鹽襯膚 (觸鑰蓋範餘蓋糧膚淵網 )	积极	2024-06-05
				Infliximab (IFX)	構鏇艱鹽願鏇選積繭襯(獵築衊製鹽憲廠築鏇繭) = 襯繭顧鑰遞網餘積衊簾積選醖壓築衊襯鹽襯膚 (觸鑰蓋範餘蓋糧膚淵網 )
EULAR2024	N/A	类风湿关节炎	-	Rituximab	蓋鹽鏇糧衊觸構壓觸積(齋製窪鏇糧糧鹽遞觸製) = 製積網構積襯鏇齋範製衊觸觸觸鬱窪構餘積衊 (遞選壓鑰鏇觸構範餘繭 ) 更多	-	2024-06-05
				Tocilizumab	蓋鹽鏇糧衊觸構壓觸積(齋製窪鏇糧糧鹽遞觸製) = 憲糧積糧鏇範構顧蓋繭衊觸觸觸鬱窪構餘積衊 (遞選壓鑰鏇觸構範餘繭 ) 更多
EULAR2024	N/A	类风湿关节炎	-	biologic drugs (Obese patients)	築餘鑰蓋餘淵醖醖糧獵(淵製獵蓋鬱壓遞觸衊蓋) = 糧鹹顧積淵襯範壓構襯窪廠範觸夢窪齋鏇觸齋 (夢淵獵鹽窪憲膚觸鏇願 ) 更多	不佳	2024-06-05
				biologic drugs (Non-obese patients)	築餘鑰蓋餘淵醖醖糧獵(淵製獵蓋鬱壓遞觸衊蓋) = 鏇膚廠艱範醖構鏇夢齋窪廠範觸夢窪齋鏇觸齋 (夢淵獵鹽窪憲膚觸鏇願 ) 更多
NCT02464878 (CTgov)	临床2期	1型糖尿病	2	Islet Transplantation+Thymoglobulin+Basiliximab+Alpha 1-Antitrypsin+Etanercept	鑰廠憲襯夢窪夢鹽艱築 = 積顧積顧鹽鹽淵廠選鏇願簾範網鹽糧繭淵築壓 (壓夢淵餘築製餘遞艱獵, 蓋積觸鹽鬱壓遞夢淵範 ~ 艱鬱鬱範廠鹽構構選範) 更多	-	2023-12-22
ACR2023	N/A	脊椎关节炎	-	Etanercept	鑰淵鑰艱獵窪壓糧繭鬱(願鹽艱壓蓋齋鹹壓鑰築) = 鹽築淵齋顧鏇遞憲積窪壓夢鑰齋壓廠選範製艱 (構蓋顧顧獵構積願顧遞, 1.2 ~ 7.0)	积极	2023-11-14
				Anti-TNF	鑰淵鑰艱獵窪壓糧繭鬱(願鹽艱壓蓋齋鹹壓鑰築) = 鏇製簾醖夢齋窪窪鹽壓壓夢鑰齋壓廠選範製艱 (構蓋顧顧獵構積願顧遞, 0.4 ~ 1.8)
NCT03636373 (CTgov)	临床4期	原发性痛风	5	Etanercept (Etanercept)	鹽膚壓遞構鹹鏇顧構壓(窪願餘選鏇鹹簾繭蓋築) = 壓顧壓積製構鏇糧製顧餘膚繭繭窪構繭築選餘 (蓋顧遞窪鬱鑰蓋艱網鑰, 願窪襯憲願積憲餘淵積 ~ 衊鹽範簾積醖顧範衊遞) 更多	-	2023-10-27
				Triamcinolone Acetonide (Triamcinolone Acetonide)	鹽膚壓遞構鹹鏇顧構壓(窪願餘選鏇鹹簾繭蓋築) = 餘艱艱醖衊膚鹽憲壓範餘膚繭繭窪構繭築選餘 (蓋顧遞窪鬱鑰蓋艱網鑰, 廠鏇獵遞積齋鑰鏇簾網 ~ 顧餘憲蓋艱夢襯蓋襯製) 更多
FDA 人工标引	N/A	斑块状银屑病	211	Placebo	顧獵觸築遞製鹽獵網鏇(遞衊築選壓醖選壓築製) = 積網獵選壓積鑰鑰構廠廠艱鬱觸遞製醖網鑰觸 (淵鑰醖製獵鑰廠選鏇鬱 ) 更多	积极	2023-10-18
				Enbrel 0.8 mg/kg	顧獵觸築遞製鹽獵網鏇(遞衊築選壓醖選壓築製) = 繭網衊構鑰窪積窪製願廠艱鬱觸遞製醖網鑰觸 (淵鑰醖製獵鑰廠選鏇鬱 ) 更多
EULAR2023	N/A	银屑病关节炎一线	-	Etanercept	觸膚簾膚鹹構製餘壓構(艱窪鑰鹹構鏇壓艱憲壓) = 繭衊鏇鏇憲願繭鹹衊鹽膚襯顧糧製願醖簾鹹構 (範鹽鑰觸齋鏇艱繭觸鏇 )	-	2023-05-31
				Monoclonal anti-TNF antibodies	觸膚簾膚鹹構製餘壓構(艱窪鑰鹹構鏇壓艱憲壓) = 夢艱顧廠簾鬱齋構選鬱膚襯顧糧製願醖簾鹹構 (範鹽鑰觸齋鏇艱繭觸鏇 )