A Phase 1 Clinical Study in Healthy Females of Nonchildbearing Potential to Compare the Pharmacokinetics of Sotatercept (MK-7962) Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation

The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given.

开始日期2025-05-16

申办/合作机构

Merck Sharp & Dohme LLC

NCT06925750

/ Not yet recruiting临床2期

An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH.
A past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. One of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight.
This is an extension study, which means people who took part in MK-7962-024 (LIGHTRAY) may be able to join this study. In this extension study, people will get weight-banded doses of sotatercept. The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.

开始日期2025-05-15

申办/合作机构

Merck Sharp & Dohme LLC

NCT06814145

/ Recruiting临床2期

A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF).
Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time.
The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.

开始日期2025-04-16

申办/合作机构

Merck Sharp & Dohme LLC

100 项与索特西普相关的临床结果

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100 项与索特西普相关的转化医学

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100 项与索特西普相关的专利（医药）

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152

项与索特西普相关的文献（医药）

2025-05-01·JHLT Open

Sotatercept Use in a Patient with Pulmonary Arterial Hypertension Undergoing Lung Transplantation

Article

作者: Rosenheck, Justin P ; Franco, Veronica ; Goyal, Kashika ; Henn, Matthew ; Burcham, Pamela ; Homsy, Elie ; Fallah, Tara ; Visovatti, Scott ; Choi, Kukbin

Pulmonary arterial hypertension (PAH) is one of the common indications for lung transplantation. Sotatercept is a new medication with a novel mechanism of action and was recently approved for the treatment of PAH. Sotatercept is associated with significant adverse effects including thrombocytopenia and erythrocytosis which can impact outcomes of lung transplantation. This is the first described case of a patient undergoing lung transplantation while receiving sotatercept for PAH.

2025-05-01·EUROPEAN JOURNAL OF CLINICAL INVESTIGATION

Sotatercept in pulmonary hypertension and beyond

Review

作者: Madonna, Rosalinda ; Ghelardoni, Sandra

Abstract:

Sotatercept binds free activins by mimicking the extracellular domain of the activin receptor type IIA (ACTRIIA). Additional ligands are BMP/TGF‐beta, GDF8, GDF11 and BMP10. The binding with activins leads to the inhibition of the signalling pathway and the deactivation of the bone morphogenic protein (BMP) receptor type 2. In this way, sotatercept activates an antiproliferative signalling to the cells of the pulmonary arteries and arterioles with the aim of rebalancing the proliferative and antiproliferative pathway that characterizes the pulmonary arterial hypertension (PAH). Sotatercept is indicated for the treatment of group 1 PAH in combination with drugs that act through the endothelin receptor, nitric oxide or prostacyclin. Its effects, demonstrated in the STELLAR study, are the improvement of exercise capacity and the FC‐WHO functional class, together with the reduction of the risk of clinical worsening events. In addition to its antiremodeling effects on the pulmonary circulation, sotatercept has several haematological effects that could suggest its use in the treatment of some blood disorders other than PAH. In this review, we will discuss the effects of the drug on PAH and in parallel provide an in‐depth overview of its application in haematological disorders, focusing on clinical and preclinical studies.

2025-04-22·CIRCULATION

Exploring Integrin α5β1 as a Potential Therapeutic Target for Pulmonary Arterial Hypertension: Insights From Comprehensive Multicenter Preclinical Studies

Article

作者: Mougin, Manon ; Pelletier, Andréanne ; Romanet, Charlotte ; Moy, Terence I. ; El Kabbout, Reem ; Yamamoto, Keiko ; Akram, Muzaffar ; Lippa, Blaise ; Théberge, Charlie ; Breuils-Bonnet, Sandra ; Sauvaget, Mélanie ; Lin, Fu-Yang ; Potus, François ; McTeague, T. Andrew ; Lu, Min ; Shimauchi, Tsukasa ; Martineau, Sandra ; Qiao, Qi ; Ray, Adrian S. ; Goodwin, Bryan ; Provencher, Steeve ; Grobs, Yann ; Lemay, Sarah-Eve ; Yokokawa, Tetsuro ; Bonnet, Sébastien ; Montesinos, Mónica S. ; Bourgeois, Alice ; Dowling, James E. ; Wang, Hua ; Boucherat, Olivier

BACKGROUND::

Pulmonary arterial hypertension (PAH) is characterized by obliterative vascular remodeling of the small pulmonary arteries (PAs) and progressive increase in pulmonary vascular resistance leading to right ventricular failure. Although several drugs are approved for the treatment of PAH, mortality rates remain high. Accumulating evidence supports a pathological function of integrins in vessel remodeling, which are gaining renewed interest as drug targets. However, their role in PAH remains largely unexplored.

METHODS::

The expression of the RGD (arginylglycylaspartic acid)–binding integrin α5β1 was assessed in PAs, PA smooth muscle cells, and PA endothelial cells from patients with PAH and controls using NanoString, immunoblotting, and Mesoscale Discovery assays. RNA sequencing was conducted to identify gene networks regulated by α5β1 inhibition in PAH PA smooth muscle cells. The therapeutic efficacy of α5β1 inhibition was evaluated using a novel small molecule inhibitor and selective neutralizing antibodies in Sugen/hypoxia and monocrotaline rat models, with validation by an external contract research organization. Comparisons were made against standard-of-care therapies (ie, macitentan, tadalafil) and sotatercept and efficacy was assessed using echocardiographic, hemodynamic, and histological assessments. Ex vivo studies using human precision-cut lung slices were performed to further assess the effects of α5β1 inhibition on pulmonary vascular remodeling.

RESULTS::

We found that the arginine-glycine-aspartate RGD-binding integrin α5β1 is upregulated in PA endothelial cells and PA smooth muscle cells from patients with PAH and remodeled PAs from animal models. Blockade of the integrin α5β1 or depletion of the α5 subunit downregulated FOXM1 (forkhead box protein M1)–regulated gene networks, resulting in mitotic defects and inhibition of the pro-proliferative and apoptosis-resistant phenotype of PAH cells. We demonstrated that α5β1 integrin blockade safely attenuates pulmonary vascular remodeling and improves hemodynamics and right ventricular function and matched or exceeded the efficacy of standard of care and sotatercept in multiple preclinical models. Ex vivo studies further validated its potential in reversing advanced remodeling in human precision-cut lung slices.

CONCLUSIONS::

These findings establish α5β1 integrin as a pivotal driver of PAH pathology and we propose its inhibition as a novel, safe, and effective therapeutic strategy for PAH.

341

项与索特西普相关的新闻（医药）

2025-04-30

·药明康德

立足「新药摇篮」，药明康德波士顿基地的赋能与责任 | Bilingual

作为生物医药健康产业的赋能者和贡献者，药明康德的赋能脚步遍布全球——在亚洲、欧洲、北美等地的运营基地，我们正通过独特的CRDMO业务模式加速合作伙伴的新药研发，守护全球病患的健康与福祉。而药明康德在走过的每一片土地，留下的不仅有赋能合作伙伴开发的一款款新药，还有对地球健康的悉心守护。▲药明康德波士顿基地员工参加“世界地球日”公益活动，守护查尔斯河沿岸生态系统健康波士顿是美国马萨诸塞州首府和最大城市，这座毗邻大西洋的美丽城市已经成为全球瞩目的医药创新引擎和新药摇篮。这里不仅云集了哈佛大学、麻省理工学院等顶尖学府和科研机构，以及麻省总医院等全球知名医院，还是近千家生物技术公司的汇聚高地。在这座生物医药创新之城，前沿学术成果与产业创新交融，推动着前沿疗法源源不断地从象牙塔走向企业，最终造福全球患者。2015年，药明康德在波士顿建立办公室，链接这片活力四射的热土和药明康德的全球运营网络，更近距离为当地乃至北美地区合作伙伴提供研发服务。2020年，药明康德生物学平台运营基地正式落地波士顿，为全球合作伙伴提供从靶点到苗头化合物（Hit）的全方位生物学服务和解决方案，成为这个全球顶级生命健康产业集群的一部分，以一体化的CRDMO赋能平台加速推动产业创新。如今，药明康德波士顿基地已经拥有了一支容纳多个业务部门的团队。作为药明康德全球运营体系的一部分，波士顿基地通过与全球其他基地的紧密协作，为生物医药创新贡献自己的力量，也赢得了当地创新生态的积极反馈。“我想要感谢药明康德。我们创立的每一家公司，都得到了药明康德的赋能推动。”波士顿当地知名风险投资机构Longwood Fund联合创始人兼普通合伙人Christoph Westphal博士说道。他曾参与创立多家新锐，如Momenta、Alnylam、Acceleron，其中不少成立于产业的逆风期。如今，Alnylam已是RNAi疗法领域的明星公司；Momenta公司则在2020年以高达约65亿美元的金额被强生公司收购，其中关键管线nipocalimab针对全身性重症肌无力（gMG）适应症已向FDA和EMA同步递交上市申请，并在今日获FDA批准，有望成为重磅疗法；Acceleron则在2021年以115亿美元被默沙东纳入麾下，由其研发的肺动脉高压疗法sotatercept已于2023年3月获FDA批准，有望成为该领域的基石性疗法。▲Longwood Fund联合创始人兼普通合伙人Christoph Westphal博士出席2024年药明康德全球论坛行业领袖Mathai Mammen博士也曾公开称赞药明康德的赋能精神。“我长期以来一直是药明康德的支持者，我非常认同药明康德的核心使命。药明康德正在助力企业改变人类健康的轨迹。这是一项意义深远的使命，我们很荣幸能够参与其中。”Mathai Mammen博士如今执掌总部位于波士顿的抗癌药研发公司Parabilis Medicines（前身为FogPharma），这家公司在2024年获得1.45亿美元E轮融资，主导在研项目FOG-001是一款潜在“first-in-class”的β-catenin与T细胞因子（TCF）相互作用抑制剂，目前FOG-001治疗实体瘤的1/2期临床试验正在进行。▲Parabilis Medicines总裁兼首席执行官Mathai Mammen博士出席2025年药明康德全球论坛正如药明康德在全球的每一个基地的负责任运营，在波士顿，药明康德同样在运营的各个环节践行着绿色承诺，并且在社区活动中为当地的生态与环境带来积极影响。查尔斯河是一条流经波士顿的重要河流，这条最终汇入大西洋的河流早已成为当地人的日常休闲景点，也构成了这座城市绿色生态的动脉。在过去的这个周末，药明康德波士顿基地员工冒雨参加本年度的查尔斯河清洁活动（Charles River Cleanup），与参与活动的多家跨国药企一道，以生态圈的集体力量，为守护沿河生态系统的健康做出贡献。药明康德团队在波士顿参与世界地球日活动，是其在全球各基地可持续举措的缩影。本月，药明康德新加坡、德国慕尼黑、美国圣地亚哥、美国新泽西等基地的成员同样组织或参与当地的相关活动，回馈社区；此外，在日常运营的每一天，药明康德各基地同样秉持可持续发展理念，通过一系列工艺优化与资源再利用手段执行环保举措。在通过一体化赋能平台的能力与技术为行业、客户与病患创造价值的同时，药明康德将继续积极践行对可持续发展的承诺，共建可持续的地球未来。As a global enabler of biopharmaceutical innovation, WuXi AppTec has built a strong presence across North America, Europe, and Asia. In every region we operate, we not only empower our partners to accelerate the discovery of life-changing therapies through our CRDMO model but also uphold our commitment to sustainability and community engagement.Boston, the capital of Massachusetts and a powerhouse of biomedical innovation, is home to leading institutions such as Harvard University, MIT, and Massachusetts General Hospital, along with nearly 1,000 biotech companies. Here, academic excellence and industrial innovation merge to drive groundbreaking therapies from research labs to patients worldwide.In 2015, WuXi AppTec established its Boston office to better serve partners across North America. In 2020, our biology platform site officially opened, offering integrated Target-to-Hit drug discovery solutions. Today, WuXi AppTec Boston site hosts a multi-functional team deeply embedded in the local ecosystem, accelerating global healthcare innovation.Our commitment to innovation has been recognized by industry leaders. "I do want to thank WuXi AppTec. Every single one of our companies that we founded has been accelerated by WuXi AppTec," said Christoph Westphal, Co-Founder and General Partner at Longwood Fund, who helped launch companies like Momenta, Alnylam, and Acceleron—many during industry downturns. Today, these companies have become major success stories, with landmark therapies impacting millions of patients.Similarly, Dr. Mathai Mammen, CEO and Chairman of Parabilis Medicines (formerly FogPharma), emphasized: "I've long been a supporter of WuXi AppTec, in part because I deeply align with its core mission. WuXi AppTec is helping companies change the trajectory of human health—an incredibly meaningful mission, and we are proud to be part of it." Parabilis recently secured $145 million in Series E financing, with its lead program FOG-001 advancing through clinical development for solid tumors.Beyond scientific innovation, WuXi AppTec Boston is committed to community stewardship. This past weekend, our employees braved the rain to participate in the Charles River Cleanup, an environmental volunteer initiative, working alongside other leading pharmaceutical companies. The Charles River, a vital ecological artery flowing into the Atlantic, is central to Boston’s green identity—and preserving it reflects our belief in protecting both human and planetary health.This is only part of WuXi AppTec's broader global commitment. Throughout April, colleagues from our Singapore, Munich, San Diego, and New Jersey sites also organized and participated in local sustainability initiatives. Every day, across all sites, we also integrate eco-friendly practices into our operations—reinforcing that while we create value for industry, partners, and patients, we are equally committed to building a sustainable future for our planet.免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

核酸药物并购

2025-04-27

·空之客

【医苑观畴】2025年一季度海外药企进展更新：默沙东MRK

1整体表现MRK在HPV疫苗持续下滑和K药正式触顶的情况下，业绩和市值进入“戴维斯双杀”节奏，一年内市值从高点$330b以上回落到$200b左右。收入和净利润都已经同比下滑（24Q1有$-0.26的EPS影响来自Harpoon收购）。2已上市产品K药基本已经释放了夕阳最后一缕余热，外加Sotatercept上市后带来了些许增量，但在Gardasil崩盘、Sitagliptin专利悬崖、Molnupiravir归零等巨大下滑动能面前，几乎是螳臂当车。K药虽然同比仍有微涨，但环比首度下滑，尽管有一季度渠道商采购周期的影响、但也只有$250m、不影响触顶结论，看来峰值有可能就要止步于$30b这个结界，而今年药王必然让位于Semaglutide，公司也明确定义了目前已经处于“Keytruda LOE period”。肿瘤板块的其他产品这个季度也表现疲软，PARP抑制剂Olaparib和HIF-2α抑制剂Belzutifan的爬坡势头都在放缓。从去年年中开始，HPV在中国市场爆雷后持续下挫，成为整个公司业绩最大的拖累，公司也明确因此收回了此前峰值$11b的预期。进一步的，年初中止向智飞发货时，预计在年中要重新进行评估，而本季度电话会基本上明确了大概率不会恢复发货，也就意味着在中国市场将彻底躺平摆烂。HPV以外的传染病产品也乏善可陈，四痘疫苗ProQuad持续走平，被寄予厚望的新一代肺炎疫苗V-114和V-116的竞争力尚未成型、跟Prevnar完全不在一个数量级。其他如Sitagliptin等上个时代的顶梁柱在GLP-1和SGLT-2面前已毫无招架之力（本季度有一次性收入影响），不过PAH药物Sotatercept表现持续抢眼，单季$280m、销售开始首年累计$700m，不过新患开始走平（本季1,400、上季1,500）。3在研管线Sotatercept继续领先本季度的研发进展，去年底已宣布提前终止的三期临床ZENITH试验，在NEJM上发表了试验结果，一共入组了172例在最大耐受背景PAH治疗下高死亡风险的WHO FC III或IV级PAH成人患者，主要终点为全因死亡、肺移植或因PAH恶化住院（≥24小时）的复合终点，Sotatercept和安慰剂相比主要终点发生率为17.4% vs 54.7%，HR=0.24，疗效堪称绝伦！心血管代谢板块的另一大新闻，则是继去年底引进翰森的小分子GLP-1后，本季度又以$200m upfront + $1.77b milestone的价码引进恒瑞的小分子Lp(a)，坚定不能失去这一巨大市场的决心。更有趣的是，在面对分析师提问“近期的交易标的是否都并没有那么创新”时，MRK管理层的回复总有那么点“王顾左右而言他”的味道，拼命往联用和协同上扯，就是不愿意正面评论翰森和恒瑞的这几个资产到底是不是足够创新。除此以外，还值得关注的包括：HIV药物Doravirine+Islatravir联用公布了非劣于抗逆转录标准疗法的三期临床结果，Pixar注射Pembrolizumab非劣于静脉注射剂型的对照三期临床结果等。番外关税很显然，关税问题已经成为所有药企电话会的必备话题。然而对于一家两大支柱产品都面临停滞或崩盘威胁的巨头，关税什么的纯粹是不值一提的小小添堵，君不见Rob在电话会的说辞，包括但不限于“我们会脱钩供应链、影响不大”“价格杠杆完全没卵用”“当局要我们干啥我们就干啥”，最终落脚到“关税这种问题你问我有神马用”……MRK十多年以来凭借登顶药王的K药稳坐MNC靠前的位置，然而随着K药进入专利悬崖期、而另一根支柱的HPV疫苗在中国市场轰然坍塌，使得PAH和ADC等后续产品的接棒一下子变得迫在眉睫。然而，面对K药这300亿的天量压力，这些新生代真的扛得住吗？默沙东MRK往期季报分析：【医苑观畴】主流技术方向谁说了算：2022年上半年全球大药企核心产品管线进展总览【医苑观畴】主流技术方向谁说了算：2022年下半年全球大药企核心产品管线进展总览【医苑观畴】2023年上半年全球大药企核心进展总览【医苑观畴】2024年一季度海外药企进展更新：默沙东MRK【医苑观畴】2024年二季度海外药企进展更新：默沙东MRK【医苑观畴】2024年三季度海外药企进展更新：默沙东MRK【医苑观畴】2024年全年及四季度海外药企进展更新：默沙东MRK

疫苗临床3期并购信使RNA

2025-04-25

·医药健闻

罗氏向美国政府寻求豁免进口关税；默沙东关税影响将导致约2亿美元的增量成本；波士顿科学宣布重要人事变动 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态瑞士制药巨头罗氏（Roche）正在向美国政府请愿，要求豁免进口关税，称其运往美国的产品被其在美国制造并出口的药物和诊断试剂所抵消。罗氏首席执行官Thomas Schinecker表示，“只要我们在美国生产的产品与进口的数量相同……我们不会受到关税的影响。这是我们试图与美国政府进行的讨论。”他认为，美国推动在该国使用的所有商品都在美国生产，将会推高制造成本。罗氏2025年第一季度的销售额达到了154.4亿瑞士法郎，按固定汇率（CER）计算同比增长6%。默沙东公布2025年第一季度财报显示，销售额155.29亿美元，同比减少2%；根据美国通用会计准则（GAAP）计算，净利润50.79亿美元，同比增加7%。该公司预计2025年该公司将因已宣布的关税损失2亿美元。其抗癌重磅药物Keytruda的销售额为72亿美元；治疗罕见肺病的药物Winrevair的营收达2.8亿美元。默沙东预计将于今年晚些时候推出一款更易于使用的Keytruda版本，并押注肥胖症和心血管疾病的新型疗法。瑞思迈(Resmed)首席执行官淡化了美国总统特朗普的关税政策对该公司净利润的影响，称根据适用于某些医疗设备的现有美国规定，瑞思迈的产品将受到保护，免受这些新关税的影响。瑞思迈的医疗设备为有睡眠问题和其他呼吸系统问题的患者提供帮助。德国默克集团(Merck KGaA)表示，正就收购美国生物制药公司SpringWorks Therapeutics公司进行后期谈判，交易金额约为35亿美元。这笔交易可能使其获得最近获批的罕见病药物，并扩大其实验性癌症治疗产品组合。默克在一份声明中表示，双方尚未做出最终决定，也未达成任何具有法律约束力的协议。波士顿科学公司宣布，执行副总裁兼首席财务官（CFO）丹·布伦南（Dan Brennan）在公司工作近30年后即将退休。布伦南将于6月底卸任首席财务官一职，并将继续担任高级顾问直至2025年10月初。现任投资者关系高级副总裁乔恩·蒙森 (Jon Monson) 将于 2025 年 6 月 30 日接替布伦南担任执行副总裁兼首席财务官。瑞士医疗器械企业Ypsomed宣布，同意以5.177亿美元的价格将其糖尿病护理业务出售给TecMed。Ypsomed是全球领先的自我医疗注射和输注系统开发和制造商，拥有35年多经验，是著名的糖尿病解决方案提供商。而收购方TecMed是一家专注于胰岛素输注系统的企业。此次出售包括Ypsomed Diabetes Care的相关子公司及其贴片泵开发活动。该交易预计将在今年下半年完成交易。赛诺菲(Sanofi)公布2025年第一季度业绩。季度集团净销售额98.95亿欧元，上年同期为89.33亿欧元，同比增长10.8%。季度营业利润22.85亿欧元，上年同期为12.36亿欧元。季度归属公司股东的净利润18.72亿欧元，上年同期为11.33亿欧元。阳光诺和公告，拟通过发行股份及可转换公司债券方式购买江苏朗研生命科技控股有限公司100%股权，并向不超过35名特定投资者发行股份募集配套资金。本次交易预计构成《上市公司重大资产重组管理办法》规定的重大资产重组，且构成关联交易，不会导致公司实际控制人发生变更。产业动态张文宏教授在第三届感染病学术周上宣布，我国科研团队发表最新研究成果，首次获得比美国NIH用于临床研究的抗猴痘药物更强更广谱的新型抗病毒药物，突破了该领域一直没有确切疗效的抗病毒药物的瓶颈，为未来正痘病毒（如天花及其同类病毒）的潜在风险做了重要的技术储备。目前该药物即将进入临床审批阶段。康方生物双抗药物依沃西单抗（PD-1/VEGF双抗）又一次在头对头试验中战胜了PD-1，这次挑战的对象是百济神州的替雷利珠单抗联合疗法。依沃西单抗联合化疗对比替雷利珠单抗联合化疗一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）的注册性三期临床研究（AK112-306/HARMONi-6），头对头试验显示强阳性结果，研究结果具有统计学显著获益和重大临床获益。中国国家药监局药品审评中心官网公示，诺诚健华申报的1类新药卓乐替尼片上市申请拟纳入优先审评，拟定适应症为：治疗成人和12岁及以上青少年实体瘤患者：-携带神经营养酪氨酸受体激酶（NTRK）融合基因-患有局部晚期、转移性疾病或手术切除可能导致严重并发症的以及-无满意替代治疗或既往治疗失败的患者。卓乐替尼片是诺诚健华在研的第二代泛TRK抑制剂，该项上市申请已于4月16日获受理。九洲药业公告，全资子公司浙江九洲药物科技有限公司收到国家药品监督管理局颁发的关于富马酸伏诺拉生的《化学原料药上市申请批准通知书》。该药品主要用于治疗胃酸相关性疾病，公司已累计研发投入约736万元。2023年，富马酸伏诺拉生片在中国公立医疗机构终端销售额超6亿元。国家药品监督管理局（NMPA）药品审评中心（CDE）网站公示信息显示：合源生物自主研发的纳基奥仑赛注射液（源瑞达）的新药临床试验申请（IND）已获得默示许可，用于治疗难治性狼疮肾炎（Lupus Nephritis, LN）。截至目前，纳基奥仑赛注射液在自身免疫性疾病适应症治疗领域中已经获得3张IND批件，分别针对系统性红斑狼疮相关的免疫性血小板减少症（SLE-ITP）、自身免疫性溶血性贫血（AIHA），以及此次获批的系统性红斑狼疮肾炎。广生堂公告，2025年4月24日，控股子公司广生中霖收到国家药品监督管理局下发的《药物临床试验批准通知书》，同意GST-HG131联合GST-HG141用于慢性乙型肝炎的治疗的临床试验。中国生物制药有限公司宣布，集团联合开发的派安普利单抗注射液已获得美国食品药品监督管理局(FDA)批准上市：与顺铂或卡铂和吉西他滨联合用药，用于复发或转移性非角化性鼻咽癌(NPC)成人患者的一线治疗；作为单药治疗，适用于接受过铂类化疗期间或之后出现疾病进展，且至少接受过一种其他先前治疗的转移性非角化性鼻咽癌成人患者。艾伯维（AbbVie）宣布，已向美国FDA提交了TrenibotE的生物制品许可申请（BLA），用于治疗中重度眉间纹。若获批准，TrenibotE将成为首款血清型E神经毒素，为患者提供一种起效迅速、作用时间较短的神经毒素选择。美国政府正采取行动，旨在将人造食用色素从美国人的饮食中去除。美国卫生与公众服务部和美国食品药品管理局(FDA)公布多项措施，将逐步取消食品中的石油基合成色素，包括红色40号、黄色5号和6号、绿色3号以及蓝色1号和2号。FDA表示，将与食品行业合作，在明年年底前将这些色素从食品供应中去除。该机构将在未来几周内批准四种新的天然色素添加剂，并加快对其他添加剂的评估和批准。联系美通社+86-10-5953 9500info@prnasia.com

财报高管变更并购

100 项与索特西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09670	-	-	DB12118

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
抑郁症	加拿大	Merck Canada, Inc.	2024-08-01
肺动脉高压	美国	Merck Sharp & Dohme LLC	2024-03-26

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
家族性肺动脉高压	临床3期	美国	Acceleron Pharma, Inc.	2021-12-01
家族性肺动脉高压	临床3期	澳大利亚	Acceleron Pharma, Inc.	2021-12-01
家族性肺动脉高压	临床3期	比利时	Acceleron Pharma, Inc.	2021-12-01
家族性肺动脉高压	临床3期	加拿大	Acceleron Pharma, Inc.	2021-12-01
家族性肺动脉高压	临床3期	法国	Acceleron Pharma, Inc.	2021-12-01
家族性肺动脉高压	临床3期	德国	Acceleron Pharma, Inc.	2021-12-01
家族性肺动脉高压	临床3期	以色列	Acceleron Pharma, Inc.	2021-12-01
家族性肺动脉高压	临床3期	意大利	Acceleron Pharma, Inc.	2021-12-01
家族性肺动脉高压	临床3期	墨西哥	Acceleron Pharma, Inc.	2021-12-01
家族性肺动脉高压	临床3期	荷兰	Acceleron Pharma, Inc.	2021-12-01

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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


NCT04896008 (ZENITH, NEWS \| Pubmed) 人工标引	临床3期	肺动脉高压	172	Winrevair	製糧淵鑰糧憲獵簾鏇積(願衊壓範廠範鑰繭餘積): Difference (%) = -76 更多	积极	2025-03-31
				placebo
NCT04896008 (ZENITH, Company_Website) 人工标引	临床3期	肺动脉高压	-	sotatercept-csrk	繭襯選廠齋選構糧蓋鏇(窪獵構繭餘壓鏇築製醖) = ZENITH met its primary endpoint of time to first morbidity or mortality event (all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours). 糧艱齋簾獵齋衊觸壓積 (鏇淵網獵蓋餘範蓋糧衊 ) 达到	积极	2024-11-26
				Placebo
NCT01999582 (CTgov)	临床2期	贫血	50	Sotatercept (Group 1: Sotatercept 0.1 mg/kg Intravenous (IV) Injection)	遞獵鬱襯蓋積餘壓選襯(積構選遞齋網廠鑰願顧) = 衊築窪網蓋鹹襯獵網獵壓齋鹽網淵繭簾壓繭窪 (遞襯艱鹽糧積網壓範鏇, 7096.55) 更多	-	2024-06-24
				Sotatercept (Group 1: Sotatercept 0.13 mg/kg Subcutaneous (SC) Injection)	遞獵鬱襯蓋積餘壓選襯(積構選遞齋網廠鑰願顧) = 襯蓋醖夢窪遞糧襯艱憲壓齋鹽網淵繭簾壓繭窪 (遞襯艱鹽糧積網壓範鏇, 1839.92) 更多
NCT03496207 (PULSAR, ATS2024)	临床2期	肺动脉高压 BMPR2 \| N-terminal pro B-type natriuretic peptide (NT-proBNP) \| BMPR2 mRNA	106	Sotatercept 0.3 mg/kg	鹽壓憲壓淵遞鏇糧簾鬱(餘築積壓夢膚繭鑰衊鏇) = 糧顧積願醖蓋廠範鏇襯醖觸鏇築鹹鬱鏇選艱齋 (膚艱艱壓衊觸網憲獵鹽 )	积极	2024-05-19
				Sotatercept 0.7 mg/kg	鹽壓憲壓淵遞鏇糧簾鬱(餘築積壓夢膚繭鑰衊鏇) = 遞鹽餘餘鑰壓壓艱膚構醖觸鏇築鹹鬱鏇選艱齋 (膚艱艱壓衊觸網憲獵鹽 )
NCT04576988 (STELLAR, ATS2024)	临床3期	肺动脉高压	-	Immediate access to sotatercept	範範築淵鬱壓艱願糧觸(艱鬱積願膚簾鏇觸窪醖) = 憲窪網醖醖憲顧餘製餘觸獵夢淵廠憲醖窪觸觸 (願積膚鬱艱簾遞選壓淵 )	积极	2024-05-19
				Delayed access to sotatercept	範範築淵鬱壓艱願糧觸(艱鬱積願膚簾鏇觸窪醖) = 襯鹽鏇觸蓋觸齋淵網夢觸獵夢淵廠憲醖窪觸觸 (願積膚鬱艱簾遞選壓淵 )
NCT03738150 (SPECTRA, Pubmed) 人工标引	临床2期	肺动脉高压	21	Sotatercept	壓遞糧憲淵衊願醖選願(製鏇範糧鬱淵鏇簾網範) = 顧觸夢網鬱膚製願醖築遞顧壓獵鏇蓋憲繭製鏇 (餘醖餘夢糧構製膚繭願, 27.72 ~ 177.76)	积极	2024-04-04
NCT04576988 (STELLAR, FDA_CDER) 人工标引	临床3期	肺动脉高压	323	WINREVAIR	鹽網築糧艱鹹廠網鹹膚(範餘鬱積獵艱繭艱醖願) = 觸遞繭築鹽膚獵繭襯獵觸淵窪顧壓選膚壓膚觸 (淵積範餘齋衊餘鹹鹹繭 ) 更多	积极	2024-03-26
				Placebo	製範齋憲觸醖蓋鹹夢淵(蓋願憲醖選獵淵憲膚夢) = 窪壓願簾鏇醖簾鹽襯遞齋選齋窪網網製廠繭觸 (網繭範憲鬱鹹醖淵蓋獵 ) 更多
NCT01146574 (CTgov)	临床2期	贫血	50	placebo (Part 1-Placebo)	網築網製壓齋觸遞繭觸 = 顧網鬱積餘積觸積築簾衊艱糧淵遞鏇選獵製積 (選願鹹築觸鹽醖鬱壓繭, 鑰襯鹽憲鑰窪鹽蓋顧膚 ~ 鏇網積鬱構廠憲簾顧夢) 更多	-	2024-03-01
				1-ACE-011 (Part 1-ACE-011 0.1 mg/kg)	觸糧願夢構壓構製餘鬱(範蓋獵鹹鏇構鹽糧願願) = 衊顧襯憲膚夢網願鹹膚艱獵範蓋餘夢願構淵積 (糧鏇艱製觸淵鑰鬱糧鹽, 0.576) 更多
NCT04576988 (STELLAR, Pubmed \| Adv Ther)	临床3期	肺动脉高压	-	Sotatercept plus background therapy (BGT)	齋醖餘窪齋願糧蓋壓築(餘廠範鹹範糧鏇鹽觸觸) = 鏇醖鏇願艱衊壓夢鹽蓋遞簾壓廠選蓋鏇廠齋構 (築夢繭顧艱襯膚鹹築獵 ) 更多	积极	2024-01-01
				Placebo plus background therapy (BGT)	齋醖餘窪齋願糧蓋壓築(餘廠範鹹範糧鏇鹽觸觸) = 積膚構網簾簾構網網遞遞簾壓廠選蓋鏇廠齋構 (築夢繭顧艱襯膚鹹築獵 ) 更多