A Phase III, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Switching to Picankibart in Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy

This multicenter, randomized, double-blind, active-controlled study aims to evaluate the efficacy and safety of picankibart in Chinese patients with plaque psoriasis who demonstrated inadequate responses to interleukin-17 (IL-17) monoclonal antibody therapy and subsequently switched to picankibart. The trial will enroll approximate 310 participants with confirmed plaque psoriasis diagnosis and a poor response to IL-17 monoclonal antibody treatment. The study includes a 4-week screening phase, followed by an active treatment period of either 36 weeks, and concludes with a safety follow-up assessment at Week 48.

开始日期2025-05-27

申办/合作机构

信达生物医药科技（杭州）有限公司

NCT06049810

/ Completed临床3期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Withdrawal and Retreatment Phase III Clinical Trial Evaluating the Efficacy and Safety of Subcutaneous Injection of IBI112 in the Treatment of Moderate to Severe Plaque Psoriasis.

The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis

开始日期2023-10-10

申办/合作机构

信达生物制药（苏州）有限公司

NCT05970978

/ Completed临床2期

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IBI112 in Participants With Psoriasis Who Were Treated With Biologics and Switched to IBI112

This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. The whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety follow-up visit at Week 44.

开始日期2023-08-28

申办/合作机构

信达生物制药（苏州）有限公司

100 项与匹康奇拜单抗相关的临床结果

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100 项与匹康奇拜单抗相关的转化医学

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100 项与匹康奇拜单抗相关的专利（医药）

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项与匹康奇拜单抗相关的文献（医药）

2025-07-03·Journal of Crohns & Colitis

Impact of mirikizumab treatment on fatigue in patients with moderately to severely active Crohn’s disease: results from the phase 3 VIVID-1 study

Article

作者: Vadhariya, Aisha ; Traxler, Kristina ; Yu, Guanglei ; Armuzzi, Alessandro ; Protic, Marijana ; Gisbert, Javier P ; Fischer, Monika ; Hisamatsu, Tadakazu ; Zang, Huaiyu ; Walsh, Alissa ; Bossuyt, Peter ; Regueiro, Miguel ; Juillerat, Pascal

Abstract:

Background:

Fatigue is a debilitating multifactorial symptom experienced by patients with Crohn’s disease (CD). Mirikizumab, an anti-interleukin-23p19 antibody, demonstrated significant efficacy and safety in the patients with moderately to severely active CD. This analysis investigated the impact of mirikizumab on fatigue and the association between changes in clinical, endoscopic, and patient-reported outcomes with improvement in fatigue from baseline in the Phase 3 VIVID-1 study.

Methods:

Adult patients with moderately to severely active CD that failed at least 1 biologic agent or conventional therapy were randomized to receive mirikizumab or placebo. Fatigue was assessed via the validated Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. Fatigue associations with patient-reported outcomes, endoscopic, and clinical measures were assessed via Pearson correlation analysis.

Results:

At Week 12, 43% and 33%, and at Week 52, 46% and 36% of mirikizumab-treated patients achieved ≥ 6 and ≥ 9 fatigue score improvements vs placebo (Week 12, 31%, 22%; Week 52, 20%, 16%), respectively. Baseline fatigue scores were strongly associated with depressive symptoms and moderately associated with quality of life (QoL) at baseline. Improvements in fatigue at Weeks 12 and 52 were strongly associated with QoL and patient-reported outcomes and weakly with objective markers of inflammation and disease activity.

Conclusions:

Mirikizumab-treated patients with CD achieved higher rates of clinically meaningful improvement in fatigue vs placebo at Weeks 12 and 52, which correlated with improvement in clinical and patient-reported outcomes. Baseline fatigue severity was strongly associated with depressive symptoms in VIVID-1 (NCT03926130).

2025-05-01·RHEUMATOLOGY

Multi-domain effectiveness of guselkumab evaluated via composite indices through 1 year in patients with PsA and inadequate response to TNFi: post hoc analysis of COSMOS

Article

作者: Coates, Laura C ; Selmi, Carlo ; Baraliakos, Xenofon ; López-Medina, Clementina ; Lavie, Frédéric ; Rampakakis, Emmanouil ; Aletaha, Daniel ; Sharaf, Mohamed ; Gossec, Laure

Abstract:

Objective:

Evaluate guselkumab efficacy, an anti-interleukin-23p19-subunit antibody, in patients with active psoriatic arthritis (PsA) and inadequate response to 1 or 2 tumour necrosis factor inhibitors (TNFi-IR), utilizing composite indices assessing disease activity across disease domains.

Methods:

In the Phase IIIb COSMOS trial, 285 adults with TNFi-IR PsA were randomized (2:1) to receive guselkumab 100 mg or placebo at Week (W)0, W4, then every 8 weeks through W44. Patients receiving placebo crossed over to guselkumab at W24. In this post hoc analysis, composite indices evaluated included the Disease Activity Index for Psoriatic Arthritis (DAPSA), Disease Activity Score 28 (DAS28), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Disease Activity Score (PASDAS), GRAPPA Composite score (GRACE), modified Composite Psoriatic Disease Activity Index (mCPDAI), minimal disease activity (MDA), and very low disease activity (VLDA). Through W24, treatment failure rules were applied. Through W48, non-responder imputation was used for missing data.

Results:

Greater proportions of guselkumab- than placebo-randomized patients achieved composite index endpoints relating to low disease activity (LDA; 14.8–52.4% vs 3.1–28.1%) or remission (3.7–5.3% vs 0.0–2.1%) at W24. Among guselkumab-randomized patients, LDA rates increased to W48 (DAPSA, 44.4%; DAS28, 47.8%; PASDAS, 34.4%; GRACE, 33.3%; mCPDAI, 40.2%), and 27.0% and 64.0% achieved MDA and a PsARC response, respectively. In the placebo→guselkumab crossover group, W48 response rates were similar to the guselkumab-randomized group.

Conclusion:

Guselkumab treatment provided substantial benefits across multiple disease domains, with increasing proportions of patients achieving LDA/remission over 1 year, highlighting the effectiveness of guselkumab despite previous inadequate response to TNFi.

2024-08-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

Mirikizumab Exposure–Response Relationships in Patients with Moderately‐to‐Severely Active Ulcerative Colitis in Randomized Phase II and III Studies

Article

作者: Adams, David H. ; Zhang, Xin Cindy ; Crandall, Wallace ; Chua, Laiyi ; Friedrich, Stuart

Mirikizumab is a humanized anti‐interleukin‐23p19 monoclonal antibody being developed for ulcerative colitis (UC) and Crohn's disease. We characterized the relationship of mirikizumab systemic exposure with efficacy and safety end points in patients with UC using phase II (NCT02589665) and III (NCT03518086, NCT03524092) trial data. Exposure–response models were developed for clinical remission, clinical response, endoscopic remission, and change in modified Mayo score following induction (50–1,000 mg i.v. every 4 weeks) and maintenance (200 mg s.c. every 4 or 12 weeks) treatment. These models evaluated observed and pharmacokinetic model‐predicted mirikizumab exposures as the exposure measure. Key safety event rates were compared across mirikizumab exposure quartiles in the phase III trial. Mirikizumab efficacy in patients with UC showed an apparent positive association with systemic exposure following both induction and maintenance. However, further analysis found this relationship to be overstated by the presence of confounding factors that were not among the tested patient covariates. While prior biologic experience and baseline disease severity showed statistically significant influences on estimated placebo effect, no patient factors affected the mirikizumab effect parameters in any of the phase III exposure–response models. There was no apparent mirikizumab concentration relationship with any adverse event of special interest. When the phase II and III data and confounding are considered together, efficacy was unlikely to be strongly affected by variation in exposures across individual patients at the phase III dose. Together with the previously demonstrated mirikizumab exposure insensitivity to patient factors, these findings indicate that mirikizumab dose adjustment to patient characteristics is not required.

122

项与匹康奇拜单抗相关的新闻（医药）

2025-09-14

·丁香园 Insight 数据库

信达生物：凭什么总能踩中风口？

回望 2018 年，信达刚刚崭露头角，全年营收仅有 1.03 亿元，而到 2024 年已经飙升至 94.22 亿元，短短 6 年时间实现了近百倍增长。今年上半年，信达继续保持高增长态势，营收大涨 51%，达到了 59.53 亿元。按照这一势头，它全年营收将首次突破百亿人民币大关，正式跻身创新药企百亿俱乐部。来源：Insight 整理与此同时，资本市场对信达也投出了信任票。从年初到现在，它的股价一路走高，涨幅一度超过 255%，市值也维持在 1500 亿港元以上。来源：信达生物官网亮眼的业绩增长与市值突破背后，是信达精准眼光和强大执行力的体现。从 PD-1 到 GLP-1，再到 IO+ADC 联合疗法，信达总能踩中医药行业的每一个风口从 PD1 到 GLP-1，两次踩中风口在创新药的江湖中，踩准一个风口已属不易，连续踩中多个风口那更是凤毛麟角。信达成立于 2011 年，而信迪利单抗立项在 2012 年，这是它踩中的第一个风口。众所周知，新药研发是一件高投入、长周期的事情，耗时十年以上都是常态，但信迪利单抗从首次进入临床到获批上市，仅仅用了 2 年时间，这一速度在全球范围内都令人难以望其项背。 2016 年 8 月，信迪利单抗的首个临床试验申请获药监局批准，2018 年 12 月经典型霍奇金淋巴瘤适应症便成功斩获批准，成为国内第二款上市的 PD1 单抗。目前该产品已经获批了 8 个适应症，其中 7 项被纳入国家医保目录。来源：Insight 数据库作为信达首个获批上市的生物新药，信迪利单抗累计收入了 165 亿元，几乎占了公司总营收的一半。来源：Insight 整理上个十年，信迪利单抗撑起了信达大部分业绩，那么下个十年，减重新药玛仕度肽则有望接棒，成为信达业绩的增长利器。这也是它踩中的第二个风口。信达与玛仕度肽的缘分，最早可以追溯到 2018 年。彼时礼来正专注于开发替尔泊肽，他们希望信达能够接手玛仕度肽的研发工作。虽然从未涉足过代谢领域，但经过近一年的探索和验证，再加上国内存在较大的尚未满足的临床需求，信达于是决定重金押注玛仕度肽。 2019 年 9 月，信达与礼来达成许可协议，获得玛仕度肽在中国的开发和商业化权益。2020 年 2 月，信达便向 CDE 提交了肥胖和 2 型糖尿病的临床试验申请，时隔两年，又提交了这款 FIC 新药的上市申请。今年 6 月，该产品成功在国内获批上市，用于成人患者的长期体重控制。来源：Insight 数据库玛仕度肽是全球首款 GCG/GLP-1双受体激动减重药物，在激动 GLP-1 受体抑制食欲减少热量摄入的基础上，还可以通过激活 GCG 受体，促进脂肪燃烧，降低内脏脂肪含量，从而进一步增强减重效果。临床研究结果表明，该产品不仅降糖减重效果显著，体重降幅最高达 21%，还具备独特肝脏益处，可以全面改善血糖、血压、血脂等心血管代谢指标。目前，除糖尿病和肥胖外，信达还正在探索玛仕度肽在代谢功能障碍相关脂肪性、阻塞型睡眠暂停、心力衰竭等适应症中的疗效。有分析师预测，2030 年玛仕度肽销售额有望突破 50 亿元。来源：海通国际证券新的爆款已经提前锁定 2027 年手握 20 款商业化品种，产品收入达到 200 亿人民币；2030年至少推动 5 个管线进入全球多中心 III 期临床研究，海外销售占比 40%，市值冲进药企前 30 名，成为世界一流的生物制药企业。这是信达为自己设立的三年规划和五年目标，其背后不仅是对信迪利单抗、玛仕度肽等已上市产品的信心，也是对管线中其他在研产品潜力的期待。目前，在持续高额研发投入下，信达已经拥有 16 款商业化产品，其中包括 12 款新药、3 款生物类似药和 1 款改良新产品。这些产品上半年销售额为 52.34 亿元，与去年同期相比，增长了 37.3%。在研管线方面，信达围绕肿瘤、代谢、自免和眼科，布局了不少潜力产品。来源：Insight 整理肿瘤领域，信达着力打造 IO+ADC 竞争优势，丰富的抗体和 ADC 布局将成为其持续突破的关键。尤其值得注意的是，其自主研发的、即将开展临床 III 期的全球 FIC 新药 IBI363 被寄予厚望，有望成为新一代 IO基石药物。 IBI363 是一款全球首创 PD-1/IL 2α bias 双特异性融合蛋白，采用独特的 PD1 单抗和 IL-2 融合设计，通过「松刹车」和「踩油门」实现效应 T 细胞的双重激活。IBI363 的 IL-2 臂经过了设计改造，保留了其对 IL-2α 的亲和力，但削弱了对 IL-2Rβ 和 IL-2Rγ 的结合能力，以此降低毒性；而 PD-1 结合臂可以同时实现对 PD-1 的阻断和 IL-2 的选择性递送。 IBI363 已经在多个 IO 治疗耐药热肿瘤、冷肿瘤中显示出 BIC 潜力。今年 6 月，信达在 ASCO 大会上以口头报告形式公布了 IBI363 的最新临床数据，其在黑色素瘤、结直肠癌和非小细胞肺癌中，均展示出了良好的疗效和长期获益趋势。信达计划在今年下半年启动 IBI363 在在 IO 耐药鳞状非小细胞肺癌的首个全球关键 III 期临床研究，三线 MSS 肠癌的 III 期临床研究也在计划中。一代大药呼之欲出。来源：信达生物官网另外，信达肿瘤管线中还有很多全球进度领先的产品，包括全球首个开展胰腺癌 III 期研究的 CLDN18.2 ADC IBI343；全球首个进入临床的 EGFR/B7H3 ADC IBI3001；全球首个进入临床的 CEACAM5 dp ADC IBI3020；具有全球最佳潜力的 GPRC5D/BCMA/CD3 三抗 IBI3003。慢病领域，除玛仕度肽外，信达还布局了替古索司他（IBI128）、IBI3032、匹康奇拜单抗 (IBI112) 、IBI356 和 IBI3002 等 FIC/BIC 产品。替古索司他是信达从韩国 LG 公司引进的一款黄嘌呤氧化酶抑制剂（XOI），可以从上游抑制和减少尿酸生成，治疗痛风患者高尿酸血症，计划在今年下半年启动中国 III 期研究。 IBI3032 是信达自主开发的小分子口服 GLP-1R 激动剂，目前已经获 FDA 批准 IND，今年第三季度计划同步开展中美 I 期临床研究。匹康奇拜单抗是一款 IL-23p19 单抗，起效快速，强效维持，季度针方便给药。2024 年 9 月，斑块状银屑病适应症已经申报上市。 IBI356 是一款 OX40L 单抗，IBI3002 是一款 TSLP/IL-4Rα 双抗，目前都在开展自免 I 期临床。结语信达生物的风口哲学，本质是战略前瞻性、资源整合力和商业化韧性的三重奏。不管是 PD1，还是 GLP-1，信达其实都不是布局最早的，但它的执行速度绝对可以排在前列。在快速变化的生物医药行业，只有那些具备前瞻眼光、强大执行力和不断进化能力的企业，才能一次次抓住所谓的风口。真正的捕风者，从不止步于追赶风口，而是在无人区播种下一个风口的种子。未来，随着 IBI363 等核心资产价值的逐步兑现，信达生物将驶向更广阔的全球市场。这家全能型 biopharma，已经站上了新的台阶。参考来源： 1. 丁香园 Insight 数据库 2. 信达生物历年财报 3. 信尔美® 研发故事：用一个分子，回应现代减重难题（信达生物） 4. 商业化进入快速收获期，丰富后期管线蓄势待发（海通国际）5. 信达生物俞德超：生物医药创新的挑战与机遇（为溪进化派）6. IO + ADC 全球创新领先，减重等慢病开花（浙商证券）7. 二代 IO 重磅潜力凸显，全球化 Biopharma 扬帆起航（国投证券）封面来源：企业logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：月牙 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

抗体药物偶联物上市批准财报申请上市临床结果

2025-08-28

·医药观澜

信达生物2025中期报告：超10款创新管线陆续步入全球开发

8月27日，信达生物公布2025年度中期业绩和公司业务进展。信达生物制药集团创始人、董事会主席、首席执行官俞德超博士表示，2025年上半年，信达生物交出了一份令人振奋的成绩单，双轮驱动与全球创新战略全面提速。公司的产品线扩充至16款药物，实现了收入和盈利的显著跃升。在创新端，多款具备全球化潜力的核心管线取得关键性概念验证数据，并逐渐迈入全球注册临床开发，标志着信达生物创新力的厚积薄发，也为全球化拓展夯实了根基。展望未来，公司将进一步稳固在肿瘤领域的领导地位，继续推动综合产品线商业化多元创新策略的探索和落地，并加快新一代创新管线的全球开发进程。信达生物将锚定“2030年5个管线进入全球3期临床研究”的战略目标，持续努力。 2025上半年，信达生物有多款产品获得重要进展，丰富了其产品矩阵：肿瘤领域三款新品成功上市：ROS1抑制剂他雷替尼胶囊、第三代EGFR TKI 肺癌靶向药利厄替尼片、血液瘤非共价BTK抑制剂匹妥布替尼片；慢病领域注入创新动力：PCSK-9抑制剂托莱西单抗注射液于2025年5月获得澳门药监局（ISAF）批准上市；替妥尤单抗N01注射液成为治疗甲状腺眼病（TED）的突破性创新药；针对GCG/GLP-1的双靶点减重药物玛仕度肽注射液另一项针对2型糖尿病的上市申请（NDA）正在NMPA审评中。其他产品进展还包括：信迪利单抗注射液：肾癌、结肠癌两项新增NDA审评中，肺癌新辅助3期研究进行中玛仕度肽：糖尿病NDA审评中，新增第6和第7项临床3期研究（OSA、肥胖合并MAFLD），更多PoC研究进行中（青少年肥胖、MASH、心衰等）；匹康奇拜单抗：即将获批的银屑病强效长效IL-23p19生物制剂；临床3期研究探索治疗后撤药维持、IL-17响应不佳人群治疗潜力；替妥尤单抗N01注射液：计划新开3期临床研究，探索治疗静止期甲状腺眼病，及头对头激素治疗甲状腺眼病的临床潜力。 IBI363(PD-1/IL-2α-bias)：新一代IO疗法 - ASCO三项口头报告亮相，针对免疫治疗失败、冷肿瘤、PD-L1低表达均读出突破性PoC数据，展现出双免疫激活和长期生存获益的独特优势； - 三项注册临床研究陆续开出：首个全球注册3期临床研究在中美启动，解决全球IO耐药肺鳞癌未满足需求；首个黑色素瘤关键2期临床研究已启动，挑战一线疗法Keytruda；首个后线肠癌注册3期临床研究即将启动； - 持续拓宽适应症至一线疗法及更多癌种，包括一线肺癌，一线肠癌，肺癌新辅助，EGFR突变肺癌，铂耐药卵巢癌等治疗潜力 IBI343（CLDN18.2 ADC）：胃癌、胰腺癌双注册临床，首个胃癌国际多中心3期临床研究进行中、首个胰腺癌3期注册临床研究启动、胰腺癌全球多中心3期临床研究规划中。该产品还获CDE突破性疗法、FDA快速审评通道多项资格超十款创新管线陆续步入全球开发肿瘤：IBI3009(DLL3 ADC), IBI3001 (EGFR/B7H3 ADC)，IBI3003（GPRC5D/BCMA/CD3）, IBI3005（EGFR/HER3 ADC）, IBI3014(PD-L1/TROP2 ADC) ，IBI3020（CEACAM5双载荷ADC）等自免：IBI356（靶向OX40L的免疫分子），IBI3002（TSLP/IL-4Rα双抗）等心血管及代谢（CVM）：IBI3016（AGT siRNA），IBI3032（口服小分子GLP-1）等。参考资料：[1]信达生物2025年度中期业绩亮点. From https://www.prnasia.com/story/501110-1.shtml 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。

临床3期ASCO会议上市批准申请上市抗体药物偶联物

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 项与匹康奇拜单抗相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
斑块状银屑病	申请上市	中国	信达生物制药	2024-09-26
溃疡性结肠炎	临床2期	中国	信达生物制药（苏州）有限公司	2022-07-01
银屑病关节炎	临床申请批准	中国	信达生物医药科技（杭州）有限公司	2025-09-15
克罗恩病	临床申请批准	中国	信达生物制药（苏州）有限公司	2020-05-06

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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


NCT05970978 (PRNewswire) 人工标引	临床2期	斑块状银屑病	152	picankibart (sPGA ≥2 or BSA ≥3%)	衊網鹽選遞網構構衊顧(餘遞簾鑰觸襯鬱製艱築) = 鑰鹹蓋製窪餘鑰製淵襯夢窪餘鑰鏇構夢鬱簾繭 (夢鹽範獵廠選窪願願製 ) 更多	积极	2024-10-28
				picankibart (sPGA ≥2 and BSA ≥3%)	衊齋鏇壓艱淵醖獵淵壓(網壓憲鬱廠鏇繭積鏇遞) = 鏇窪網壓簾膚選壓艱網範鑰夢淵廠網繭淵蓋網 (憲鹹醖鬱鬱憲顧壓餘製 ) 更多
NCT05377580 (PRNewswire) 人工标引	临床2期	溃疡性结肠炎	150	Placebo	鑰醖齋壓壓繭餘壓鹽顧(製窪艱選構襯構窪顧鑰) = 獵鏇襯顧築範獵艱鹽廠膚簾範積鹽鹽顧齋窪艱 (膚獵願壓艱築憲壓鏇餘 ) 达到更多	积极	2024-10-16
				Picankibart 200 mg	鑰醖齋壓壓繭餘壓鹽顧(製窪艱選構襯構窪顧鑰) = 構醖範憲壓鑰鹽鬱鑰範膚簾範積鹽鹽顧齋窪艱 (膚獵願壓艱築憲壓鏇餘 ) 达到更多
NCT05645627 (CLEAR-1, NEWS) 人工标引	临床3期	斑块状银屑病	500	IBI112	觸鹹蓋衊醖壓鏇廠簾觸(網餘簾鏇製膚製衊積願) = 窪窪艱範鬱鹹艱衊衊網廠壓醖範鹹顧艱淵鹽衊 (膚廠鹽餘積醖鑰鹹鑰鬱 ) 达到更多	积极	2024-05-28
				Placebo	觸鹹蓋衊醖壓鏇廠簾觸(網餘簾鏇製膚製衊積願) = 衊醖觸膚淵獵窪壓壓觸廠壓醖範鹹顧艱淵鹽衊 (膚廠鹽餘積醖鑰鹹鑰鬱 ) 达到更多
NCT04511624 (Pubmed \| Expert Opin Investig Drugs) 人工标引	临床1期	银屑病	46	IBI112	製艱壓構膚膚鬱窪餘積(淵築膚糧鹽糧廠鬱鏇襯) = 鏇鑰廠鹹憲鬱憲鏇積簾鬱獵夢膚齋鑰觸製願餘 (製網壓範齋簾糧憲膚願 ) 更多	积极	2023-06-29
				placebo	-
Corporate Publications 人工标引	N/A	银屑病	-	IBI112 50mg q12w	遞願襯繭遞壓膚顧範鑰(鏇壓蓋構襯夢鹹簾膚艱) = 66.7%~86.0% 的受试者实现PASI90 鏇鏇蓋淵遞製獵廠網醖 (憲鑰顧糧網網積願襯廠 ) 更多	积极	2023-03-01
				IBI112 100mg q12w
NCT05003531 (CIBI112A201, PRNewswire) 人工标引	临床2期	斑块状银屑病	250	Picankibart	鬱顧簾廠鏇觸艱齋壓鏇(築夢鹹襯壓遞遞顧遞範) = 鏇醖簾鹹選構淵觸鏇觸築鏇繭鹽餘獵鹽鹽鹹積 (鬱蓋蓋膚廠製壓廠衊憲 ) 更多	积极	2022-08-09
				Placebo	-