A Randomized, Open-label, Phase 3 Trial of Petosemtamab + FOLFIRI/mFOLFOX6 Versus Cetuximab or Bevacizumab + FOLFIRI/mFOLFOX6 as Second-line Treatment in Participants With RAS and BRAF Wild-type, Recurrent, Unresectable or Metastatic Colorectal Cancer

The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer that has recurred after previous treatment and that cannot be safely removed by surgery or has spread to other parts of the body.
Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or doctor's choice of standard-of-care (SOC) cetuximab or bevacizumab + chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective.
The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

开始日期2026-09-15

申办/合作机构

Genmab A/S

NCT07702032

/ Recruiting临床3期

A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer

The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon that cannot be safely removed by surgery or has spread to other parts of the body.
Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or standard-of-care cetuximab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

开始日期2026-08-11

申办/合作机构

Genmab A/S

NCT07353957

/ Withdrawn临床2期

A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer in Combination With Pembrolizumab as First-Line Treatment

The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer.

开始日期2026-03-27

申办/合作机构

Merus NV

100 项与 Petosemtamab 相关的临床结果

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100 项与 Petosemtamab 相关的转化医学

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100 项与 Petosemtamab 相关的专利（医药）

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项与 Petosemtamab 相关的文献（医药）

2026-12-31·mAbs

Antibodies to watch in 2026

Review

作者: Pinto, Kieran ; Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Chenoweth, Alicia ; Hsu, Yu-Shin

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

2026-08-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Immunotherapeutic strategies in HPV-positive and HPV-negative recurrent/metastatic oropharyngeal squamous cell carcinoma: From PD-1 blockade to EGFR-directed bispecifics and therapeutic HPV vaccines

Review

作者: Del Mastro, Lucia ; Gili, Riccardo ; Di Bello, Armando ; Caterino, Marianna ; Cassano, Alessandra ; Bassolino, Antonio ; Fasano, Morena ; Polidori, Sara ; Falcicchia, Renato ; Tortora, Giampaolo

Oropharyngeal squamous cell carcinoma (OPSCC) comprises two biologically distinct entities, HPV-positive and HPV-negative disease, which differ in etiology, immune microenvironment, molecular drivers, and clinical behavior. This narrative review summarizes current evidence on immunotherapeutic strategies in OPSCC, focusing on subtype-specific biological rationale and emerging treatment approaches. A literature search of PubMed/MEDLINE, Embase, Cochrane Library, ClinicalTrials.gov, and major oncology meeting abstracts was conducted for studies published from January 2000 to February 2026. PD-1/PD-L1 inhibitors represent the current standard of care in recurrent/metastatic disease, with HPV-positive tumors generally showing more favorable outcomes, likely reflecting a more inflamed and antigen-rich tumor microenvironment. However, HPV status remains primarily a prognostic rather than a validated predictive biomarker for checkpoint inhibitor benefit. In contrast, HPV-negative OPSCC is more frequently characterized by immune exclusion, EGFR dependence, hypoxia, and activation of MET/HGF and TGF-β pathways, supporting the development of EGFR-centered and bifunctional strategies to overcome resistance. Emerging agents such as ficerafusp alfa, petosemtamab, and amivantamab have demonstrated promising early clinical activity, particularly in biomarker-enriched or post-immunotherapy settings. In HPV-positive disease, therapeutic vaccines targeting E6/E7 oncoproteins have shown encouraging immunogenicity and preliminary antitumor activity, especially when combined with PD-1 blockade. Overall, the immunotherapeutic landscape of OPSCC is evolving toward a biomarker-driven framework integrating viral status, immune contexture and pathway activation to enable more precise and personalized treatment strategies.

2026-05-01·CURRENT OPINION IN ONCOLOGY

Recent highlights and breakthroughs in immunotherapy for head and neck cancers

Review

作者: Vuille, Joanna A ; Szturz, Petr

Purpose of review:

This review highlights recent advances in immunotherapy for head and neck oncology, focusing on pivotal studies, both early-stage and late-stage, published or presented in 2025.

Recent findings:

Noteworthy results were reported with immune checkpoint inhibitors in mucosal squamous cell carcinoma of the head and neck (SCCHN) (KEYNOTE-689 and NIVOPOSTOP trials evaluating pembrolizumab and nivolumab, respectively, in the perioperative setting); in nasopharyngeal carcinoma (DIPPER and DIAMOND trials evaluating camrelizumab and toripalimab, respectively, in the curative setting with radiotherapy, and tagitanlimab in recurrent and/or metastatic disease); in cutaneous squamous cell carcinoma of the head and neck region (C-POST trial in the adjuvant setting and the combination of avelumab with cetuximab in the palliative setting); and in BRAF V600E-mutated anaplastic thyroid carcinoma (pembrolizumab with dabrafenib and trametinib). Passive immunotherapy targeting tumor-associated antigens also showed encouraging activity in R/M-SCCHN (petosemtamab, ficerafusp-alfa, amivantamab, enfortumab vedotin) and in heavily pretreated R/M nasopharyngeal carcinoma (antibody-drug conjugates becotatug vedotin and izalontamab brengitecan [iza-bren]).

Summary:

Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors.

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项与 Petosemtamab 相关的新闻（医药）

2026-08-25

·新药猎人笔记

80亿美金作业没人抄，真正原因找到了！

前两天写，Genmab斥80亿美元收购Merus，核心资产是 III 期的EGFR×LGR5双抗 Petosemtamab。令人困惑的是，靶点、数据与商业价值均已明牌，本该被跟进者挤爆的赛道，追兵却寥寥无几。胖猫表示很困惑！（具体可见：80亿美金的作业摆在桌上，为啥没人抄？）直到有大神说：去翻翻他们专利就知道了！翻完拍大腿，直呼，斯国一！等不了了，追更！（说的不到位的，老铁们提意见）简单来说就是，能让药起效的唯一姿势，刚好全在Merus布局的专利雷区里。你绕开专利，药就废了；你想让药管用，一脚踩进去就是侵权。一句话就是专利布局好牛逼！ 01 Petosemtamab怎么布局专利？ Petosemtamab最核心专利家族WO2017069628，最早优先权日为 2015 年10月。对应的核心分子是 PB10651 = MF3755 × MF5816；其中MF3755是靶向EGFR的臂，MF5816是靶向LGR5的臂。 Merus显然不是新手，没傻到只去保一条具体的抗体全长序列，而是由内向外布了极严密的防御网。单看中美两国，跟进者的思路似乎很简单：MF3755和MF5816都不碰，重筛两个 binder。把CDR和epitope区分开，不就绕过去了吗？但想做全球商业化，欧洲（EP3365373B1）的专利这一关就能直接把路封死。欧洲EP3365373B1的核心权利要求1，压根没限制具体的序列。而是直接落到了一个variable domain 结合EGFR，另一个variable domain结合 LGR5的bispecific antibody这个层级。也就是说保护的是靶点组合，你说他气人不气人！无论是不是重新筛的两支不同的抗体，只要仍然是EGFR×LGR5双抗，出海到欧洲就又重新撞上这个专利。专利防御的最高境界莫过于此！不需要在全世界每个地方都拿最宽的 Claim，只要在关键核心市场把靶点组合卡住，足以让所有全球follower算不过来账。 02 越想绕专利，越可能把药效一起绕掉欧洲、澳大利亚、香港这些地方，Merus 拿到的保护，直接是EGFR×LGR5靶点组合。只要还做这个组合，换序列、换 CDR、换表位通通不行。退一万步讲，暂时抛开这些市场，只看中美日韩这些偏向序列/CDR 保护的地区呢？把CDR表位换、亲和力重调、价数重新设计，做个离它十万八千里的新分子，这总行了吧？这时候真正的灵魂拷问才浮出水面，Petosemtamab 到底凭什么起效？它的机制，绝不是简单的拼凑。这个药真正厉害的地方在于双臂一旦同时结合两个受体，会强行改变EGFR空间构型，诱导EGFR迅速内吞并走向降解。这种降解不是碰巧发生的，背后是微观上的精准拿捏。表位踩得不准、空间构型不对、受体就不能被彻底拖去降解！差之毫厘，神药就变成了废柴。这就变成了一块极难平衡的跷跷板！离 Petosemtamab越近，biology越确定，专利风险越高；离它越远，专利可能绕过，biology的确定性却直接掉进黑盒。 Follow者最擅长的工程化微调，在这里彻底失效。为绕开专利做改动，改着改着，直接被逼回了从零摸索的Discovery。更绝的是，Merus早就把关键表位全部占了。哪怕换了新序列，只要还在同一个功能区，FTO照样是一脚踩进雷区。最终，所有人都会撞进一个尴尬的死循环，越想保住被临床验证过的 biology，就越容易一头扎进专利雷区；越想拉开专利安全距离，分子就越会被踹回从零探索的原点。 03 专利外围墙顺便多聊一句，Merus后来围绕 Petosemtamab 铺了一整套专利。从HNSCC、胃癌/食管癌等适应症，到联用Topo I、ICI、化疗，再到EGFR-high 患者筛选、制剂及给药方案，层层加码。这些专利虽不是命门，但这恰恰展现了一个顶级资产的护城河是怎么建起来的。专利保护从不是单点突破，而是系统工程，极考验药企做药软实力。 04 作业为什么没人抄？答案很明确了回头看Genmab那笔80亿美元交易，表面上买的是亮眼的临床数据、稳妥的 III 期管线和未来的商业空间；但真正值钱、又难被财务模型量化的，是 Petosemtamab 早就把最容易的分子设计空间用专利占死了。答案人人都能看见；但照着抄，专利直接卡死；换条路走，又得把所有的试错成本从头背一遍。 80亿美元的作业就摊在桌上，知道这道题难，更难的是对方把标准解法全部锁死了。必须换一套完全不同的步骤，还有一丢丢机会算出同样的结果。只能直呼，我太难了文中提到的资料已传到星球，老朋友们自取，欢迎新朋友加入胖猫的知识星球，更多资料、机会等您来～一起进步，有机成长！

2026-08-21

·药研Dealbook

医药研发日报（2026-08-21）

GLOBAL PHARMA R&D DAILY医药研发日报第 04 期｜ 2026-08-21 ｜周五收录窗口：2026-08-20 08:00 → 2026-08-21 08:00（北京时间）优先领域：肿瘤 · 神经系统 · 自身免疫 · 代谢 📌 本期要点 1. 中国 NMPA 同日两款 1 类创新药获批：恒瑞口服补体因子 B 抑制剂富马酸立康可泮（HRS-5965 / licancopan）用于 PNH，与三生国健抗 IL-1β 单抗安弗利奇塔单抗（SSGJ-613）用于难治性急性痛风性关节炎，均于 8/20 盘后披露，标志自免/罕见病源头创新加速兑现。 2. 全球新启动密集：ClinicalTrials.gov 8/20 当日 First Posted 出现多项 III 期——Genmab Petosemtamab（EGFR×LGR5 双抗，肠癌）、AZ AZD6234（淀粉样蛋白受体激动剂，肥胖）、礼来 Brenipatide（MDD），反映肿瘤、代谢、神经三线同步铺开。 3. 中国 IND / 临床批件活跃：恒瑞三款创新药齐获临床批准（SHR-7012 / SHR-8203 / HRS-3095），舒泰神子公司 STSP-0601 获 FDA 临床试验许可（伴抑制物血友病）。 4. 阴性 / 失败事件：本期无新增。但需警惕两起“旧闻重发”陷阱——Moderna/Merck mRNA 疫苗 III 期属上一窗口（8/19，已收录于 0820 日报）；翰森 HS-20093 骨肉瘤 III 期官方发布日为 2026-07-28，8/20 中文媒体为旧闻重发，已排除。一、批准上市【T1】恒瑞医药：富马酸立康可泮（HRS-5965 / licancopan）获 NMPA 批准上市（PNH）事件：8/20 盘后，恒瑞医药（600276.SH / 01276.HK）公告，子公司成都盛迪医药自主研发的 1 类化药富马酸立康可泮胶囊获 NMPA 批准上市，用于既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者。该药为口服补体因子 B（Factor B）抑制剂，通过阻断旁路途径 C3 转化酶组装，同时抑制血管内与血管外溶血。关键数据：基于随机 III 期 HRS-5965-301（N=78 例补体抑制剂初治 PNH，对比静脉依库珠单抗 24 周）。主要终点：第 18–24 周至少 3/4 次 Hb≥12 g/dL 且无需输血者占 70.0% vs 11.1%（P<0.0001）；Hb 提升≥2 g/dL 者 95.0% vs 55.6%（P<0.0001）；第 2 周后所有立康可泮组患者无输血 vs 86.1%。结果于 EHA 2026 公布。累计研发投入约 2.78 亿元。为什么值得看：PNH 为《第一批罕见病目录》病种。立康可泮是国内第 4 款口服 Factor B 抑制剂（继诺华 Fabhalta、朗来兰诺可泮、海思科思普可泮之后），但凭“近端旁路抑制”机制在头对头依库珠单抗中显示 Hb 与免输血双重优效，直接切入 C5 抑制剂残留血管外溶血的临床痛点。其面向 C5 经治贫血人群的补充申请仍在 NMPA 审评，获批后将扩大可及人群。来源：中国证券报·恒瑞获批公告｜ AllSci 获批解读｜ NMPA 官网 Verified 新药批准罕见病/代谢【T2】三生国健 / 三生制药：安弗利奇塔单抗（SSGJ-613，益赛那）获 NMPA 批准上市（急性痛风性关节炎）事件：8/20，NMPA 批准三生制药（01530.HK）附属三生国健（688336.SH）自主研发的 1 类生物制品安弗利奇塔单抗注射液（皮下注射，商品名益赛那，研发代号 SSGJ-613）上市，适用于对 NSAIDs / 秋水仙碱禁忌、不耐受或疗效不佳，且不适合反复使用激素的成人痛风性关节炎急性发作。该药为重组抗 IL-1β 人源化单抗，中和 IL-1β 阻断急性痛风核心炎症通路。关键数据：III 期显示 200 mg 单次给药 6 小时快速起效，急性期镇痛非劣于阳性对照（复方倍他米松）；12 周痛风急性发作风险下降 77%，首次发作中位时间未达到（阳性对照 57 天）。国内第 2 款获批 IL-1β 单抗（首款为金赛药业伏欣奇拜单抗）。为什么值得看：痛风患者约 4270 万且年轻化，部分合并肾/消化道/心血管基础病对传统一线药受限。安弗利奇塔单抗以“单次给药兼顾急性期镇痛 + 长效防复发、规避激素”切入难治人群，标志本土抗体企业在自免炎症赛道从仿制走向差异化创新；亦反映痛风创新药从“降尿酸（URAT1）”与“精准抗炎（IL-1β）”双轨并行的产业拐点。来源：医药魔方·获批｜同花顺·国产第二款 IL-1β ｜ NMPA 官网 Verified 新药批准自免/代谢撤市 / 撤回适应症 / 安全性标签：本期无新增。FDA、EMA 本窗口内无新治疗性新药批准（GENGLYCOS、Pasatru 均为 8/19，已收录于 0820 日报）；EMA CHMP 8 月会议（8/17–8/20）刚结束，积极意见预计会后数日内公布，本窗口尚未检索到新 EC 上市许可。 🧭 影响与观点 1. PNH 口服 Factor B 赛道：从“有药”迈向“近端全抑制”。立康可泮以头对头依库珠单抗的 Hb 与免输血双重优效，验证“旁路近端抑制”相对 C5 末端抑制的机制优势（同时解决血管外溶血）。但国内该品类已聚齐 4 款口服 Factor B 抑制剂，未来竞争核心是起效速度、给药便利、C5 经治人群拓展及真实世界依从性。 2. 痛风 IL-1β：精准抗炎填补难治人群空白。安弗利奇塔单抗作为国产第 2 款 IL-1β 单抗，与金赛伏欣奇拜单抗、恒瑞 SHR-1905、信达 IBI-110 等共同构成快速兑现的痛风创新矩阵；其“单次给药防复发 + 规避激素”的差异化定位，有望在合并基础病的难治亚急性人群中替代传统方案。下游值得关注同靶点产品的定价与准入节奏。二、临床数据读出 🔴 III 期主要终点：本期无新增读出。 🟠 II 期疗效读出：本期无新增读出。 🟡 I 期安全性 / 初步疗效：本期无新增读出。排除说明（判重 / 时间窗）：① Moderna/Merck INTerpath-001（个体化 mRNA 疫苗 III 期 RFS+DMFS 阳性，8/19 晚间）→ 属上一窗口（0820 日报已收录），不重复；② 翰森制药 HS-20093 骨肉瘤 ARTEMIS-011（B7-H3 ADC III 期 PFS 阳性）→ 公司官方新闻稿落款为 “SHANGHAI, July 28, 2026”，8/20 中文媒体为旧闻重发，真实事件不在本窗口，已排除（注：该药确为目前唯一跨癌种双 III 期阳性的 B7-H3 ADC，值得持续跟踪其 BLA 与全球进展）。本期无 III 期成功 / 失败 / 重大安全性读出，故无新增“影响与观点”条目；相关观点见上方批准上市板块。三、进临床（新开展） 🔴 III 期新启动（First Posted 2026-08-20） Genmab：Petosemtamab（MCLA-158，EGFR×LGR5 双抗）+ 化疗 vs 西妥昔/贝伐 + 化疗｜转移性结直肠癌（LiGeR-CRC2）靶点 / 机制：EGFR×LGR5 双特异性抗体。适应症：RAS/BRAF 野生型、复发不可切除或转移性结直肠癌。设计：NCT07775287，随机、多中心，N=600，NOT_YET_RECRUITING。对照：西妥昔单抗或贝伐珠单抗 + 化疗。申办：Genmab。来源：ClinicalTrials.gov NCT07775287 Verified AstraZeneca：AZD6234（淀粉样蛋白受体激动剂）+ 肠促胰岛素疗法｜肥胖 / 超重机制：长效淀粉样蛋白（amylin）受体激动剂，作为肠促胰岛素（GLP-1 等）背景治疗的 adjunct。适应症：肥胖或超重伴体重相关合并症（±2 型糖尿病）。设计：NCT07776509，N=500，NOT_YET_RECRUITING。申办：AstraZeneca。来源：ClinicalTrials.gov NCT07776509 Verified Eli Lilly：Brenipatide（LY3537031）｜重性抑郁障碍（RENEW-MDD-2）机制：（公司未完整披露靶点；RENEW-MDD 系列为复发延缓 III 期）。适应症：成人重性抑郁障碍（MDD）。设计：NCT07775300，随机、双盲、安慰剂对照，评估标准治疗基础上联合 Brenipatide 延缓复发的疗效与安全性，N=1000，NOT_YET_RECRUITING，First Posted 2026-08-20，启动 2026-08。申办：Eli Lilly。来源：ClinicalTrials.gov NCT07775300 Verified 🟠 II 期新启动（First Posted 2026-08-20） Novartis：GIA632｜皮肤型扁平苔藓适应症：中重度皮肤型扁平苔藓（cutaneous lichen planus，自免/皮肤）。设计：NCT07775924，多剂量范围，N=259，NOT_YET_RECRUITING。申办：Novartis。来源：ClinicalTrials.gov NCT07775924 Verified 中山大学：SHR-A1811（恒瑞 Trastuzumab Rezetecan，HER2 ADC）+ 卡铂 ± 贝伐 vs 研究者选择化疗｜铂敏感复发性卵巢癌靶点 / 机制：HER2 ADC（恒瑞 SHR-A1811）。适应症：铂敏感复发性卵巢癌（PSOC）。设计：NCT07776171，N=176，NOT_YET_RECRUITING，对照为卡铂+紫杉醇/脂质体阿霉素/吉西他滨。申办：中山大学（药物来自恒瑞）。来源：ClinicalTrials.gov NCT07776171 Verified 🟡 I 期新启动（First Posted 2026-08-20，重点项） YolTech：YOLT-203（体内 CRISPR 基因编辑）｜1 型原发性高草酸尿症（PH1）机制：体内（in vivo）基因编辑疗法，新机制 / 高关注。适应症：原发性高草酸尿症 1 型（PH1，罕见遗传代谢病）。设计：NCT07776626，N=9，RECRUITING。申办：YolTech Therapeutics（未上市）。来源：ClinicalTrials.gov NCT07776626 Verified 石药（01093.HK）：SYH2092 注射液｜超重 / 肥胖（健康人）机制：（公司未披露，代谢赛道）。适应症：超重或肥胖。设计：NCT07776041，N=46，NOT_YET_RECRUITING，健康受试者。申办：CSPC Megalith Biopharmaceutical。来源：ClinicalTrials.gov NCT07776041 Verified 翰森制药（03692.HK）：HS-20117-2 注射液｜晚期实体瘤机制：（未披露）。适应症：晚期实体瘤。设计：NCT07775703，N=60，RECRUITING。申办：Hansoh BioMedical R&D。来源：ClinicalTrials.gov NCT07775703 Verified 北京基因键 / 解放军总医院 / 深圳问尔等｜国内 I 期新启动 • 北京基因键 GKL-006 注射液（NCT07777211，晚期胰腺癌，I/IIa，N=52，ACTIVE_NOT_RECRUITING）— NCT07777211• 解放军总医院 SL1617 注射液（NCT07775508，CD19/CD20 CAR-T，B 细胞淋巴瘤，I 期，N=18，RECRUITING）— NCT07775508• 深圳问尔 Wingor hUC-MSCs（NCT07775391，原发性卵巢功能不全 POI，I/IIa，N=59，RECRUITING）— NCT07775391 同期其他 First Posted 2026-08-20 工业界 I 期（简要）：Merck Enlicitide/MK-0616（口服 PCSK9，NCT07776665）、BMS Navlimetostat（EZH1/2，NCT07777133）、H. Lundbeck Lu AH69593（PK，NCT07775261）。 Verified 均为 ClinicalTrials.gov 登记核验（First Posted 口径）。 🟢 IND 获批 / 临床试验批件（8/20，中国 + FDA）恒瑞医药：SHR-7012 / SHR-8203 / HRS-3095 三款创新药齐获 NMPA 临床批准 • SHR-7012 注射液（CXSL2600557，皮肤型红斑狼疮 CLE；公司称国内外暂无同靶点药上市）。• SHR-8203 注射液（晚期实体瘤，抗肿瘤；公司称国内外尚无同类药上市，具 First-in-class 潜力）。• HRS-3095 片（创新药，适应症以公告为准）。来源：中国证券报·恒瑞公告｜每日经济新闻·恒瑞早参 Verified 舒泰神（300204.SZ）子公司贝捷泰：STSP-0601 获 FDA 临床试验许可（伴抑制物血友病 A/B 出血）项目：STSP-0601，国家 1 类治疗用生物制品；此前已获 NMPA 药品注册证书，本次获 FDA 正式函件同意开展治疗伴抑制物血友病 A 或 B 患者出血的临床试验，标志海外临床布局迈出关键一步。来源：每日经济新闻·NO.4 Verified FDA IND 🔵 启动筹备信号步长制药（603858.SH）：BC008-1A（PD-1/TIGIT 双抗）新增适应症临床申请获 NMPA 受理项目：BC008-1A 注射液（重组抗 PD-1/TIGIT 人源化双特异性抗体），新增适应症“联合贝伐珠单抗用于成人复发 CNS WHO 4 级脑胶质瘤”的临床试验申请获受理（CXSL2600878）。注：此为本日受理信号，尚未取得临床批件。来源：中国证券报·步长公告受理信号 ⚠️ 试验暂停 / 终止本期无新增试验暂停 / 终止 / CRL / III 期失败事件。值得跟踪的近期 CMC 类拒批（非本窗口）：Xspray Dasynoc（8/19 CRL，已收录 0820 日报）、ITM-11（8/11 CRL，早于窗口）。 🇨🇳 中国端 T+1 补查（近 48 小时）扫描渠道：NMPA / CDE 官网、巨潮资讯、上交所、深交所、港交所披露易、主要创新药公司官网（恒瑞、三生、石药、翰森、舒泰神、步长等）。补录进入正文事件：恒瑞 HRS-5965 获批上市、三生国健 Anfrilicitamab 获批、恒瑞三款 IND（SHR-7012 / SHR-8203 / HRS-3095）、舒泰神 STSP-0601 获 FDA IND、步长 BC008-1A 临床申请受理——均已在上文正文收录。排除线索（时间早于窗口 / 非创新）：① 中国生物制药 4 款 1/2 类创新药获批（安煦罗伐昔替尼等）→ 实为 2026 上半年业绩披露中的存量获批汇总，非窗口内新增；② 康希诺吸附破伤风疫苗获注册证书 → 常规疫苗注册，非 1 类创新药，不纳入主批准；③ 翰森 HS-20093 骨肉瘤 III 期 → 官方发布日 2026-07-28，8/20 媒体旧闻重发，已排除。 🔭 后续关注 1. 恒瑞｜HRS-5965（立康可泮）：C5 经治贫血人群补充申请审评进展；商业化定价与 PNH 可及性。2. 三生｜Anfrilicitamab（SSGJ-613）：获批后商业化落地节奏；痛风 IL-1β 赛道（金赛、恒瑞 SHR-1905、信达 IBI-110）竞争格局。3. Genmab｜Petosemtamab（LiGeR-CRC2）：III 期 CRC 入组与读出（预计 2027+）。4. AZ｜AZD6234：肥胖 III 期入组与初步疗效信号。5. 礼来｜Brenipatide（RENEW-MDD-2）：MDD III 期复发延缓主要终点读出时间。6. 恒瑞｜SHR-A1811（卵巢癌 II 期）：铂敏感复发卵巢癌 PFS 数据。7. YolTech｜YOLT-203：PH1 体内基因编辑 I 期安全性与 editing 效率。8. 翰森｜HS-20093（B7-H3 ADC）：骨肉瘤 ARTEMIS-011 完整数据（国际肿瘤会议）、中国 BLA 沟通、GSK 全球 EMBOLD Sarcoma 进展。 📅 未来 30 天重点会议日期会议地点重点关注官方来源 2026-08-28 ~ 08-31 ESC Congress 2026（欧洲心脏病学会）欧洲（地点以官网为准）心血管代谢（血脂/心衰/抗凝） escradio.org 2026-09-12 ~ 09-15 WCLC 2026（世界肺癌大会） Seoul, Korea 肺癌靶向/免疫/ADC 数据 iaslc.org 注：会议列表沿用前报并标注待官方复核；ESMO 2026（通常 10 月）超出 30 天窗口，本期待补。 📈 本期关联上市公司公司上市地 / 代码关联项目本期事件恒瑞医药 600276.SH / 01276.HK HRS-5965 / SHR-7012 / SHR-8203 / HRS-3095 / SHR-A1811 1 类新药获批 + 三款 IND + 卵巢癌 II 期新启动三生制药 / 三生国健 01530.HK / 688336.SH Anfrilicitamab（SSGJ-613） 1 类生物制品获批上市舒泰神 300204.SZ STSP-0601 获 FDA 临床试验许可步长制药 603858.SH BC008-1A 新增适应症临床申请获受理 Genmab GMAB（Nasdaq） Petosemtamab（MCLA-158） III 期 CRC 新启动 AstraZeneca AZN（LSE/Nasdaq） AZD6234 III 期肥胖新启动 Eli Lilly LLY（NYSE） Brenipatide（LY3537031） III 期 MDD 新启动 Novartis NVS（SIX/NYSE） GIA632 II 期皮肤扁平苔藓新启动石药集团 01093.HK SYH2092 I 期肥胖新启动翰森制药 03692.HK HS-20117-2 I 期实体瘤新启动 Merck / BMS / Lundbeck MRK / BMY / HLUY MK-0616 / Navlimetostat / Lu AH69593 I 期新启动（First Posted 8/20） YolTech / 北京基因键 / 深圳问尔 / 解放军总医院未上市 / 未上市 / 未上市 / 医院 YOLT-203 / GKL-006 / hUC-MSCs / SL1617 I 期新启动（First Posted 8/20）代码均经公开来源核实；未上市公司注明“未上市”。本报告不含市值、涨跌与投资建议。医药研发日报 · 第 04 期（2026-08-21）｜本日报由 WorkBuddy 自动化生成，仅供参考，不构成任何投资建议或用药指导。数据以一手来源为准。扫描下方二维码，加入药研Dealbook交流群，与更多医药投研、BD同路人一起交流、学习与成长。本文基于公开资料进行行业研究与信息交流，不构成任何投资建议、证券研究报告或交易依据。部分前瞻性判断存在不确定性，请以公司、监管机构及交易所最新正式披露为准。

2026-08-06

·ir.genmab.com

Genmab Announces Financial Results for the First Half of 2026

August 6, 2026 Copenhagen, Denmark; Interim Report for the Six Months Ended June 30, 2026 Highlights Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant improvement in progression-free survival Genmab revenue increased 25% compared to the first six months of 2025, to $2,051 million Genmab 2026 financial guidance updated “The second quarter of 2026 delivered clinical progress for our late-stage portfolio. Epcoritamab continued to demonstrate its potential as a core therapy across the spectrum of B-cell malignancies, with strong data across multiple treatment settings and patient populations. At the same time, new data further support the development of Rina-S® (rinatabart sesutecan) in combination in advanced ovarian cancer. Together, these results reflect our continued commitment to delivering meaningful advances for patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half of 2026 Revenue was $2,051 million for the first six months of 2026 compared to $1,640 million for the first six months of 2025. The increase of $411 million, or 25%, was primarily driven by higher DARZALEX® and Kesimpta® royalties and higher EPKINLY® net product sales. Royalty revenue was $1,708 million in the first six months of 2026 compared to $1,378 million in the first six months of 2025, an increase of $330 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta. Net sales of DARZALEX by J&J were $8,171 million in the first six months of 2026 compared to $6,776 million in the first six months of 2025, an increase of $1,395 million or 21%. Global net sales of EPKINLY/TEPKINLY® were $312 million in the first six months of 2026 compared to $211 million in the first six months of 2025, an increase of $101 million or 48%. Cost of product sales were $149 million for the first six months of 2026 compared to $99 million for the first six months of 2025. The increase of $50 million, or 51%, was primarily driven by the profit-sharing amounts payable to AbbVie related to EPKINLY sales. Adjusted operating expenses, excluding Acquisition and integration related charges, were $1,270 million for the first six months of 2026 compared to $993 million for the first six months of 2025. The increase of $277 million, or 28%, was primarily driven by investment in our product pipeline, including the advancement of Rina-S and petosemtamab, and our global commercialization capabilities in preparation for their anticipated launches. Acquisition and integration related charges related to the integration of Merus were $77 million in the first six months of 2026. Amortization of acquired intangible assets was $24 million for the first six months of 2026 compared to $6 million for the first six months of 2025. The increase of $18 million, was primarily driven by the amortization of the Merus technology platform. Operating profit was $555 million in the first six months of 2026 compared to $548 million in the first six months of 2025. Adjusted operating profit, which excludes Acquisition and integration related charges and Amortization of acquired intangible assets, was $656 million in the first six months of 2026 compared to $554 million in the first six months of 2025. Outlook Genmab is updating its revenue, adjusted operating expenses and adjusted operating profit guidance for 2026. The improved guidance is driven by higher total royalty revenues from DARZALEX and net sales of EPKINLY. 2026 FULL YEAR OUTLOOK 1 Net product sales/Collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak® ex-U.S. net product sales plus Genmab's share of U.S. gross profits. 2 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $90 million and 2) amortization of intangible assets acquired through acquisitions of $47 million. 3 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $65 million and 2) amortization of intangible assets acquired through acquisitions of $45 million. Non-IFRS Financial Measures Our Adjusted operating expenses and Adjusted operating profit excludes acquisition and integration related charges and amortization of acquired intangible assets. These charges were recognized in prior periods and will likely reoccur in future periods. These items are excluded from operating expenses and operating profit because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Non-IFRS information is intended to portray the results of our baseline performance, supplement or enhance management's, analysts' and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with IFRS and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure. Conference Call Genmab will hold a conference call to discuss the results for the first six months of 2026 today, Thursday, August 6, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register-conf.media-server.com/register/BId9cf2ff8aa3c489ca2ad2007d64a1964. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations. Contact Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs T: +1 609 524 0065; E: mmp@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations T: +45 3377 9558; E: acn@genmab.com The Interim Report contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®; HexElect®; KYSO®, RAINFOL™, ProfoundBio™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. Tivdak® is a trademark of Seagen Inc.; EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Biclonics® and BIZENGRI® are registered trademarks of Merus N.V. Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, RYBREVANT FASPRO™,TECVAYLI® and TALVEY® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC. Download the full Interim Report for the First Half of 2026 on attachment or at www.genmab.com/investor-relations CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark Attachment 060826_CA34_Genmab Interim Report H1 2026

财报临床结果临床3期

100 项与 Petosemtamab 相关的药物交易

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研发状态

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
RAS/BRAF基因野生型结直肠癌	临床3期	美国	Genmab A/S	2026-08-11
复发性头颈部鳞状细胞癌	临床3期	美国	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	日本	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	阿根廷	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	澳大利亚	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	比利时	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	巴西	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	加拿大	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	智利	-	2024-09-25
复发性头颈部鳞状细胞癌	临床3期	克罗地亚	-	2024-09-25

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临床结果

适应症

分期

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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


NCT07353957 (MCLA-158-CL04, ASCO2026)	临床2期	转移性非小细胞肺癌一线 PD-L1 high	80	Petosemtamab plus pembrolizumab (PD-L1 high (TPS ≥50%) + metastatic non-small cell lung cancer)	淵膚製繭構蓋選餘淵夢(膚範憲淵廠願繭醖製簾) = 壓鏇窪窪齋鏇遞範願廠觸構艱鏇壓淵選壓願遞 (餘淵夢糧夢膚觸構壓鏇 )	积极	2026-05-29
Company_Website 人工标引	临床2期	微卫星稳定型结直肠癌 Microsatellite Stable (MSS) \| BRAF Gene Mutation Negative \| KRAS Gene Mutation Negative \| ... 更多	54	Petosemtamab + FOLFOX/FOLFIRI (1L treatment)	壓鬱膚齋簾鑰艱衊糧範(鏇齋壓選憲壓憲襯壓襯) = 淵餘積構憲選簾遞餘網窪簾膚製獵壓壓襯餘糧 (憲襯齋鏇觸齋餘觸築齋 ) 更多	积极	2025-10-24
				Petosemtamab + FOLFOX/FOLFIRI (2L treatment)	壓鬱膚齋簾鑰艱衊糧範(鏇齋壓選憲壓憲襯壓襯) = 糧膚鹽鏇壓糧築餘鑰壓窪簾膚製獵壓壓襯餘糧 (憲襯齋鏇觸齋餘觸築齋 ) 更多
NCT03526835 (LiGeR-HN1, ASCO2025)	临床2期	食管癌 \| 晚期恶性实体瘤 \| 头颈部鳞状细胞癌 ... 一线 PD-L1+ 更多	45	Petosemtamab 1500 mg	糧艱襯觸構艱獵膚淵膚(鬱糧壓鹽構築願齋窪襯) = 範積憲鹹壓衊積鹽觸觸艱淵夢鹹膚築夢糧襯蓋 (積選餘範衊糧糧願遞顧 ) 更多	积极	2025-05-30
NCT03526835 (NEWS) 人工标引	临床1/2期	头颈部鳞状细胞癌一线 PD-L1 Positive	43	petosemtamab + Keytruda	遞鏇構醖築鹹築餘醖淵(鬱艱繭淵艱範夢齋鹹蓋) = 鬱獵餘範鬱遞構壓鏇淵憲衊糧範願網觸夢遞廠 (窪製糧繭網網醖淵簾積 ) 更多	积极	2025-05-28
				Keytruda (历史数据)	遞鏇構醖築鹹築餘醖淵(鬱艱繭淵艱範夢齋鹹蓋) = 鬱齋簾膚艱積網憲糧壓憲衊糧範願網觸夢遞廠 (窪製糧繭網網醖淵簾積 )
Company_Website 人工标引	临床1/2期	PD-L1阳性头颈部鳞状细胞癌三线 PD-L1 Expression	82	Petosemtamab 1500 mg Q2W	齋構選鑰遞鬱鏇糧網窪(餘範衊範鏇艱膚製鑰鹽) = 鑰遞膚壓廠鏇顧觸願艱築淵鹹淵淵餘顧遞積築 (遞遞鹹壓醖衊艱窪憲鏇, 27–46) 更多	积极	2024-12-07
				Petosemtamab 1100 mg Q2W	齋構選鑰遞鬱鏇糧網窪(餘範衊範鏇艱膚製鑰鹽) = 艱襯遞膚鏇衊鏇鑰鹹願築淵鹹淵淵餘顧遞積築 (遞遞鹹壓醖衊艱窪憲鏇, 8–35) 更多
NCT03526835 (ESMO_ASIA2024) 人工标引	临床1/2期	头颈部鳞状细胞癌二线	54	Petosemtamab 1500 mg (single-arm cohort)	醖鏇鹽壓膚憲窪願憲淵(鏇鬱觸衊廠糧襯夢網夢) = 艱醖壓構衊襯製艱齋鑰範齋觸鹹憲醖願衊衊齋 (膚鑰鹽積鬱範壓廠鹹壓 ) 更多	积极	2024-12-07
				Petosemtamab 1500 mg (dose-comparison cohort)	醖鏇鹽壓膚憲窪願憲淵(鏇鬱觸衊廠糧襯夢網夢) = 選糧鹹範窪憲網鏇鹹鏇範齋觸鹹憲醖願衊衊齋 (膚鑰鹽積鬱範壓廠鹹壓 )
NCT03526835 (GlobeNewswire) 人工标引	临床2期	头颈部鳞状细胞癌二线	54	Petosemtamab 1500 mg	繭願鬱廠衊鏇觸廠網鹹(積鏇範糧膚醖鏇蓋構衊) = 廠顧遞夢獵壓築築壓積構觸淵觸糧鹽壓壓製願 (艱構鹽廠構蓋獵廠蓋艱 ) 更多	积极	2024-12-01
				Petosemtamab 1100 mg	艱選觸範構願醖衊鏇製(網衊醖簾餘顧鹽築築鑰) = 膚製網願選顧鹽遞獵壓積築鹹鹽鑰襯鬱衊壓鑰 (憲醖顧餘夢獵鏇獵鏇範 )
NCT03526835 (phase 2 study, ASCO2024) 人工标引	临床2期	头颈部鳞状细胞癌一线	26	Petosemtamab/Pembrolizumab	壓窪艱簾鬱願窪構構觸(構鏇憲餘顧積窪壓餘鏇) = 製願顧鏇壓範糧獵壓鹹齋鬱廠夢選繭遞餘襯鬱 (夢夢網壓膚獵簾廠觸簾 ) 更多	积极	2024-05-24
NCT03526835 (AACR2023) 人工标引	临床1/2期	食管腺癌 \| 胃腺癌三线 EGFR Expression	-	Petosemtamab 1500 mg	齋廠窪夢積壓築鹽鏇獵(壓淵廠鑰膚餘齋膚鹽膚) = the most frequent AEs regardless of causality (all grades/G3-4) were rash (33%/0%), hypotension (26%/6%), dyspnea (26%/4%), nausea (26%/1%), dermatitis acneiform (24%/1%), blood magnesium decreased (19%/5%), erythema (19%/0%), diarrhea (19%/0%); IRRs (composite term) were reported in 74%/21% of pts, mostly at the first infusion, and all resolved. 範憲製築糧艱壓製廠淵 (淵醖糧鑰顧遞鹽廠製範 )	积极	2023-04-14
AACR2023 人工标引	N/A	晚期头颈部鳞状细胞癌	49	MCLA-158	鹹廠鬱積醖願顧夢遞淵(憲壓醖夢積憲淵選醖醖) = 鬱餘鬱艱糧艱顧網壓製憲醖淵鏇廠廠餘襯艱蓋 (遞築醖獵簾繭艱製衊衊 ) 更多	积极	2023-04-14