The purpose of this study is to assess the effects of selpercatinib on cachexia and anorexia in patients diagnosed with NSCLC, colorectal cancer, or pancreatic cancer.

开始日期2025-11-30

申办/合作机构

University of Oklahoma

[+1]

NCT07010393

/ Not yet recruiting临床4期IIT

A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma

This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion/mutation, isolated TERT mutation, triple-negative BRAF/RET/TERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0/1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.

开始日期2025-07-01

申办/合作机构

福建医科大学

NCT06532149

/ RecruitingN/AIIT

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)

Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients.
The aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC

开始日期2024-08-05

申办/合作机构-

100 项与塞普替尼相关的临床结果

登录后查看更多信息

100 项与塞普替尼相关的转化医学

登录后查看更多信息

100 项与塞普替尼相关的专利（医药）

登录后查看更多信息

451

项与塞普替尼相关的文献（医药）

2025-12-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

LC-MS/MS method development and validation for novel targeted anticancer therapies adagrasib, capmatinib, ensartinib, entrectinib, larotrectinib, lorlatinib, pralsetinib, selpercatinib and sotorasib

Article

作者: Beijnen, Jos H ; Meertens, Marinda ; Huitema, Alwin D R ; Rosing, Hilde ; de Vries, Niels ; de Jong, L Daniëlle

A reversed-phase liquid chromatography-tandem mass spectrometry method was developed and validated for quantifying nine novel oral targeted anticancer agents mainly indicated for non-small cell lung cancer: adagrasib, capmatinib, ensartinib, entrectinib, larotrectinib, lorlatinib, pralsetinib, selpercatinib and sotorasib in human plasma for therapeutic drug monitoring. Chromatographic separation used an Acquity BEH C18 column with step gradient of 0.1 % formic acid in water and acetonitrile-methanol (50:50, v/v), at a 0.5 mL/min flow rate. Plasma samples were pretreated via precipitation with acetonitrile and diluted in 0.1 % formic acid in water. The reversed-phase chromatography was coupled with tandem mass spectrometry in positive ion mode. The assay was successfully validated over the following ranges: 100 - 10,000 ng/mL for adagrasib, capmatinib, entrectinib, pralsetinib, selpercatinib; 50 - 50,000 ng/mL for ensartinib; 10 - 1000 ng/mL for larotrectinib, lorlatinib; and 10 - 10,000 ng/mL for sotorasib. Accuracy and precision met the predefined criteria. Stability tests confirmed that all analytes were stable in plasma for up to 157 days at -20°C except for entrectinib, which was stable for 35 days at -20°C. At room temperature, the analytes were at least stable in plasma for 7 days, however, for adagrasib, entrectinib and sotorasib, stability for up to 3 days could be demonstrated. We recommend sending these samples on dry ice or refrigerated. After the validation, 74 plasma samples were measured in the application phase and all results but one fell within the validated ranges. This assay allows simultaneous quantification of nine novel targeted therapies and supports therapeutic drug monitoring.

2025-10-01·BIOORGANIC CHEMISTRY

Overcoming resistance in RET-altered cancers through rational inhibitor design and combination therapies

Review

作者: Sun, Yiqi ; Yang, Liyan ; Li, Jinqi ; Jiang, Wenjie ; Wang, Ting ; Shi, Jianyou

RET tyrosine kinase, a key regulator of cellular signaling, is abnormally activated due to mutations or fusions in various cancers, making it an important therapeutic target. Traditional multi-kinase inhibitors (MKIs, such as cabozantinib and vandetanib) exhibit significant side effects due to non-selective inhibition of targets like VEGFR, and also suffer from resistance associated with RET mutations (e.g., V804L/M, G810C/S/R), both of which limit their clinical application. Second-generation RET inhibitors (such as selpercatinib and pralsetinib) significantly improve efficacy and safety by precisely targeting the RET ATP binding domain, and have the ability to penetrate the blood-brain barrier, showing remarkable effects on patients with brain metastases. However, they still face challenges of drug resistance due to solvent front mutations (G810C/S/R) and activation of bypass signals. To overcome drug resistance, the design strategies of novel inhibitors focus on multi-target inhibition (such as PLM-101 targeting RET/YES1/FLT3, TPX-0046 targeting RET/SRC), structural optimization (such as helical ring derivatives enhancing binding stability), and natural compound screening (such as ZINC series molecules). The combination therapy strategy effectively reverses drug resistance and enhances efficacy by inhibiting bypass pathways (such as MET, FGFR, Hedgehog-Gli) or epigenetic regulation (such as CDK8/STAT1). For instance, selpercatinib combined with crizotinib can inhibit MET amplification-driven resistance, while arsenic trioxide combined with pralsetinib restores sensitivity by inhibiting the HH-Gli pathway. Current clinical trials show that novel RET inhibitors such as SY-5007 have a significant objective response rate in advanced RET fusion-positive non-small cell lung cancer and are safer than traditional drugs. In the future, it is necessary to further develop broad-spectrum mutation coverage and highly selective inhibitors, and explore individualized combination treatment regimens to improve prognosis. This article systematically reviews the progress, resistance mechanisms and coping strategies of RET-targeted therapy, providing a theoretical basis and direction for the development of precision anti-cancer drugs.

2025-09-01·DERMATOLOGIC SURGERY

Pincer Nail in All 20 Nails in a Patient on Selective RET Inhibitor Selpercatinib Treated With Partial Avulsion and Matricectomy

Article

作者: Porter, Hannah J. ; Jellinek, Nathaniel ; Baltz, Julia O.

722

项与塞普替尼相关的新闻（医药）

2025-09-18

·信达生物

信达生物合作伙伴Ollin公布眼科双抗IBI324（抗VEGF/ANG-2双特异性抗体）临床进展

2025年9月18日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、代谢及心血管、眼科等重大疾病领域创新药物的生物制药公司，宣布其合作伙伴Ollin公布了IBI324（Ollin 研发代码：OLN324）的临床进展。 IBI324（OLN324）是一款更高效价、更高摩尔剂量的血管内皮生长因子（VEGF）/ 血管生成素-2（Ang2）双特异性抗体，目前正处于临床Ib期开发阶段，适应症为湿性年龄相关性黄斑变性（wAMD）和糖尿病黄斑水肿（DME）——分别是导致老年人和劳动年龄人群视力丧失的首要原因。 JADE 研究是一项在美国开展的随机Ib期概念验证 (PoC) 临床试验，旨在评估OLN324与法瑞西单抗（faricimab）在解剖学指标和疗效持久性方面的潜在差异。Ollin已完成JADE研究的入组工作，该研究纳入约150名受试者（wAMD or DME）。预计该研究的初步结果将于2026年第一季度公布。在抗VEGF疗法已证实的核心疗效基础上，OLN324相较于当前市场主流药物法瑞西单抗，具有显著更高的抗Ang2效价，同时采用更小的蛋白分子形式，这使得OLN324具备成为 “同类最优”（best-in-class）疾病控制药物的潜力。为实现更广泛的靶点覆盖及延长治疗持久性的潜在目标，OLN324的临床试验采用了高于法瑞西单抗的摩尔剂量。这些特性使OLN324有望成为具有差异化优势的一线标准治疗方案。美国视网膜顾问集团（Retina Consultants of America）研究主席、Ollin 科学顾问委员会成员 Charles C. Wykoff 医学博士表示：“VEGF和Ang2在推动湿性年龄相关性黄斑变性和糖尿病黄斑水肿发生发展的血管病变过程中均发挥着重要作用。与单纯抑制VEGF相比，双靶点抑制有望更好地改善解剖学治疗结局，并实现更持久的疾病控制。美国食品药品监督管理局批准的首款VEGF/Ang2抑制剂法瑞西单抗的临床应用情况表明，视网膜专科医生和患者对通过作用于多种疾病驱动因素以改善治疗结局的新型药物抱有浓厚兴趣。目前，患者在临床治疗方面仍有显著的未被满足需求，存在进一步改善的空间。Ollin开展的临床Ib期研究从一开始就聚焦于探索OLN324相较于法瑞西单抗的潜在差异化优势。” 信达生物综合管线首席研发官钱镭博士表示：“我们对合作伙伴Ollin推动下的 OLN324（IBI324）研发进展感到振奋，尤其是JADE Ib期临床试验成功完成入组 —— 这是一个重要里程碑，充分验证了双方的紧密合作成果。作为新一代 VEGF/Ang2双特异性抗体，OLN324（IBI324）有望在解剖学治疗结局和疗效持久性方面优于法瑞西单抗等现有标准治疗药物。信达生物将继续与Ollin保持协同，加快OLN324的研发进程，推动这一急需的治疗方案在全球范围内上市。” 在一项已完成的临床I期单剂量及多剂量递增研究中，IBI324（OLN324）显示出改善糖尿病黄斑水肿患者视力和解剖学指标的潜力，且安全性良好。IBI324（OLN324）由信达生物自研，目前正与Ollin合作进行开发。 About Ollin - 滑动查看更多介绍 - Ollin Biosciences™成立于 2023 年，是一家处于临床研发阶段的生物制药企业，核心业务聚焦于获取并开发针对致盲性眼病的 “疾病领域最优（best-in-disease）” 疗法。依托差异化的研发管线、世界顶尖的专业团队及实力雄厚的投资方联盟，Ollin正不断突破眼科领域的技术边界，重新定义该领域的发展可能。如需了解更多详情，可访问公司官网：www.ollin.bio。关于信达生物 - 滑动查看更多介绍 - “始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有16个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）和玛仕度肽注射液（信尔美®）。目前，同时还有2个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及17余万普通患者，药物捐赠总价值34亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。声明： 1.信达不推荐任何未获批的药品/适应症使用。 2.雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®）和匹妥布替尼片（捷帕力®）由礼来公司研发。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

临床1期临床结果

2025-09-16

·信达生物

信达生物将在第34届欧洲皮肤病学会（EADV）2025年会公布综合管线免疫领域多项研究数据

2025年9月16日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、代谢及心血管、眼科等重大疾病领域创新药物的生物制药公司，今日宣布，将在2025年欧洲皮肤病学会（EADV）年会上公布综合管线的多项最新研究数据，包括匹康奇拜单抗(抗IL-23p19单抗，研发代号：IBI112)的临床II期及III期研究事后分析，IBI3013（IL-15单抗）和IAR129（IL-4R/OX40L双抗）的临床前研究。本次大会将于2025年9月17-20日在法国巴黎召开。具体信息如下：标题：IBI3013，靶向IL-15的新型半衰期延长单克隆抗体用于白癜风治疗的临床前特征研究摘要编号：1882 展示形式：壁报展示（ePoster）时间：2025年9月17日（星期三）07:00 AM (CEST) 标题：IAR129，双阻断IL-4R和OX40L的新型双特异性抗体用于治疗特应性皮炎的临床前研究摘要编号：2648 展示形式：壁报展示（ePoster）时间：2025年9月17日（星期三）07:00 AM (CEST) 标题：评估既往接受生物制剂治疗的银屑病患者使用匹康奇拜单抗的疗效及安全性：一项多中心、开放2期研究摘要编号：1706 展示形式：壁报展示（ePoster）时间：2025年9月17日（星期三）07:00 AM (CEST) 标题：评估匹康奇拜单抗治疗伴有头皮银屑病的中重度斑块状银屑病患者的疗效：一项随机、双盲III期研究的事后分析摘要编号：4799 展示形式：壁报展示（ePoster）时间：2025年9月17日（星期三）07:00 AM (CEST) 标题：评估匹康奇拜单抗治疗会阴部银屑病的疗效：来自随机、双盲III期CLEAR-1研究的结果摘要编号：6421 展示形式：壁报展示（ePoster）时间：2025年9月17日（星期三）07:00 AM (CEST) 标题：新型IL-23p19抑制剂匹康奇拜单抗治疗甲银屑病的疗效：一项III期CLEAR-1研究的事后分析摘要编号：7526 展示形式：壁报展示（ePoster）时间：2025年9月17日（星期三）07:00 AM (CEST) 标题：匹康奇拜单抗在生物制剂经治患者和初治患者中治疗中重度斑块状银屑病患者的疗效：来自III期CLEAR-1研究的52周结果摘要编号：7541 展示形式：壁报展示（ePoster）时间：2025年9月17日（星期三）07:00 AM (CEST) 信达生物制药集团免疫学高级总监熊慧中博士表示：“信达生物的研发团队探索重要的疾病相关信号通路及其组合，结合国清院多种先进的技术平台，解决皮肤病的未满足需求。我们希望具有差异化的单克隆抗体和新型双特异性抗体给各类皮肤病患者带来疗效、给药频率，以及停药后维持等方面的有意义获益。” 信达生物制药集团综合管线首席研发官钱镭博士表示：“信达生物的综合管线在心血管及代谢（CVM）、自免和眼科领域都呈现出成梯队、矩阵式的完善布局。其中在自免领域，基石产品匹康奇拜单抗即将在今年年底获批上市，这款同类最佳的 IL-23p19 抑制剂具备起效迅速、强效长期维持、长间隔季度给药的优势，届时将为广阔的银屑病患者带来新的治疗选择，我们也积累了丰富扎实的临床证据在本次EADV大会上集中展示。除此之外，信达生物聚焦下一代全球创新，将加速推进更多高潜分子的临床开发，希望给全球患者带来更多改善生命质量的创新疗法。” 关于信达生物 - 滑动查看更多介绍 - “始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有16个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）和玛仕度肽注射液（信尔美®）。目前，同时还有2个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及17余万普通患者，药物捐赠总价值34亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。声明： 1.信达生物不推荐未获批的药品/适应症的使用。 2.雷莫西尤单抗注射液（希冉择®）、塞普替尼胶囊（睿妥®）和匹妥布替尼片（捷帕力®）由礼来公司研发前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

临床3期临床2期临床成功

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 项与塞普替尼相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11713	塞普替尼	L01XE	DB15685

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
RET融合阳性实体瘤	美国	Eli Lilly & Co.	2024-04-10
转移性非小细胞肺癌	美国	Eli Lilly & Co.	2022-09-21
转移性实体瘤	美国	Eli Lilly & Co.	2022-09-21
甲状腺髓样癌	美国	Eli Lilly & Co.	2022-09-21
RET融合阳性非小细胞肺癌	欧盟	Eli Lilly Nederland BV	2021-02-11
RET融合阳性非小细胞肺癌	冰岛	Eli Lilly Nederland BV	2021-02-11
RET融合阳性非小细胞肺癌	列支敦士登	Eli Lilly Nederland BV	2021-02-11
RET融合阳性非小细胞肺癌	挪威	Eli Lilly Nederland BV	2021-02-11
RET融合阳性甲状腺癌	欧盟	Eli Lilly Nederland BV	2021-02-11
RET融合阳性甲状腺癌	冰岛	Eli Lilly Nederland BV	2021-02-11
RET融合阳性甲状腺癌	列支敦士登	Eli Lilly Nederland BV	2021-02-11
RET融合阳性甲状腺癌	挪威	Eli Lilly Nederland BV	2021-02-11
非小细胞肺癌	美国	Eli Lilly & Co.	2020-05-08
RET突变阳性甲状腺髓样癌	美国	Eli Lilly & Co.	2020-05-08
甲状腺癌	美国	Eli Lilly & Co.	2020-05-08

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
RET融合阳性肺腺癌	临床3期	美国	Eli Lilly & Co.	2021-12-20
RET融合阳性肺腺癌	临床3期	中国	Eli Lilly & Co.	2021-12-20
RET融合阳性肺腺癌	临床3期	日本	Eli Lilly & Co.	2021-12-20
RET融合阳性肺腺癌	临床3期	澳大利亚	Eli Lilly & Co.	2021-12-20
RET融合阳性肺腺癌	临床3期	奥地利	Eli Lilly & Co.	2021-12-20
RET融合阳性肺腺癌	临床3期	比利时	Eli Lilly & Co.	2021-12-20
RET融合阳性肺腺癌	临床3期	巴西	Eli Lilly & Co.	2021-12-20
RET融合阳性肺腺癌	临床3期	加拿大	Eli Lilly & Co.	2021-12-20
RET融合阳性肺腺癌	临床3期	捷克	Eli Lilly & Co.	2021-12-20
RET融合阳性肺腺癌	临床3期	丹麦	Eli Lilly & Co.	2021-12-20

登录后查看更多信息

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


NCT05469100 (CTgov)	临床1期	肾功能不全	37	Selpercatinib (Selpercatinib (Control; Normal Renal Function))	艱顧夢獵簾艱築繭鏇選(獵選獵觸醖簾鏇選簾淵) = 鹹廠獵糧製製遞顧鬱選積艱鏇範鏇網選憲窪憲 (蓋夢選鹹顧襯選壓製獵, 52.1) 更多	-	2025-09-18
				Selpercatinib (Selpercatinib (Mild Renal Impairment))	艱顧夢獵簾艱築繭鏇選(獵選獵觸醖簾鏇選簾淵) = 鑰網觸窪繭蓋鑰願顧廠積艱鏇範鏇網選憲窪憲 (蓋夢選鹹顧襯選壓製獵, 36.0) 更多
NCT05906836 (CTgov)	临床1期	-	28	Rosuvastatin+Selpercatinib	顧遞觸顧衊淵築醖蓋範(蓋遞選窪網壓選壓膚願) = 艱齋齋憲範鬱築齋鬱襯襯膚繭繭糧獵窪獵齋觸 (淵築壓壓積選蓋糧糧繭, 38) 更多	-	2025-09-16
RET MAP registry (ASCO2025)	N/A	非小细胞肺癌	354	Selpercatinib	網艱糧簾簾鹹廠鏇廠獵(窪艱遞壓觸醖鹹夢憲範) = recurrent toxicity may occur in one-third of patients 廠製鹽夢膚膚鏇壓廠選 (顧範餘鑰糧廠遞構餘簾 ) 更多	不佳	2025-05-30
				Pralsetinib
GEMINI (ASCO2025)	N/A	非小细胞肺癌 \| 乳糜胸 \| 心包炎一线 RET fusion-positive	103	Selpercatinib	醖廠糧鬱鹽範鹽淵鏇鹽(夢築齋選鹹鑰廠衊積餘) = We identified chylous effusion as an AE following RETi exposure in 12% of pts in our cohort, including 2 cases of chylopericardium. These adverse events can occur with either selpercatinib or pralsetinib, and making a differential diagnosis, including ruling out disease progression, is crucial for effective management. 夢糧膚廠壓糧鑰壓壓鬱 (範觸遞網襯顧網醖艱窪 ) 更多	积极	2025-05-30
				Pralsetinib
NCT05338515 (CTgov)	临床1期	-	18	Selpercatinib (320 mg Selpercatinib)	糧顧製製憲鹽膚鏇蓋鹹 = 網網選衊餘顧願網遞鬱製淵壓簾築窪製醖獵願 (鬱糧構選遞網艱觸鏇蓋, 蓋窪積壓夢鹽糧壓積艱 ~ 壓淵憲鏇簾築壓構膚顧) 更多	-	2025-05-18
				Selpercatinib (640 mg Selpercatinib)	糧顧製製憲鹽膚鏇蓋鹹 = 遞鏇淵壓夢憲網醖襯顧製淵壓簾築窪製醖獵願 (鬱糧構選遞網艱觸鏇蓋, 壓觸膚壓觸壓廠簾願鏇 ~ 願艱憲顧製遞觸艱夢窪) 更多
ATS2025	N/A	转移性甲状腺髓样癌 RET	-	Selpercatinib 160 mg twice daily	鏇糧網膚製膚遞鏇膚鏇(鹹網襯艱淵蓋觸簾範觸) = Given the suspicion that selpercatinib induced the chylous effusion, the dosage was reduced from 160 mg twice daily to 80 mg twice daily. Follow-up lung ultrasound demonstrated progressive reduction of the pleural effusion over one month, with complete resolution within three months. The patient did not experience respiratory symptoms, and no pleural effusion recurrence was observed on chest CT during the subsequent 12-month follow-up. 鹽醖鏇鏇鏇餘製觸鏇願 (齋廠顧願積廠壓顧憲鏇 )	-	2025-05-16
				Selpercatinib 80 mg twice daily
NCT05630287 (CTgov)	临床1期	-	12	Selpercatinib	艱網願蓋餘遞窪糧範蓋(範網糧選觸齋壓鏇襯簾) = 夢窪廠鬱選窪糧蓋鹹積鏇憲積鏇壓簾構顧餘憲 (網膚獵鏇廠憲壓廠鏇繭, 26.6) 更多	-	2025-04-23
NCT05436912 (CTgov)	临床1期	肝损伤	36	Selpercatinib (160 mg Selpercatinib: Mild Hepatic Impairment)	糧鹽廠繭齋憲膚遞鏇膚(簾觸夢壓構淵壓齋鹽窪) = 齋淵淵範餘壓鹹繭積壓鏇艱網鏇糧構鏇醖餘鹽 (壓淵淵壓簾壓鬱淵淵夢, 78.0) 更多	-	2025-04-13
				Selpercatinib (160 mg Selpercatinib: Moderate Hepatic Impairment)	糧鹽廠繭齋憲膚遞鏇膚(簾觸夢壓構淵壓齋鹽窪) = 窪遞淵膚繭衊膚蓋顧蓋鏇艱網鏇糧構鏇醖餘鹽 (壓淵淵壓簾壓鬱淵淵夢, 185.6) 更多
NCT05324124 (CTgov)	临床1期	-	46	Selpercatinib (Selpercatinib Fasted (Reference))	積餘積淵選獵鹽蓋憲鹹(衊築醖窪鏇選壓鏇遞獵) = 醖憲築淵築觸壓遞選鹽選繭簾鬱廠糧夢壓簾廠 (膚鏇蓋簾齋廠衊夢範廠, 32) 更多	-	2025-03-21
				Selpercatinib (Selpercatinib Fed (Test))	積餘積淵選獵鹽蓋憲鹹(衊築醖窪鏇選壓鏇遞獵) = 觸鹹範築築範艱簾蓋鹽選繭簾鬱廠糧夢壓簾廠 (膚鏇蓋簾齋廠衊夢範廠, 44) 更多