A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

开始日期2026-02-03

申办/合作机构

AstraZeneca PLC

NCT07143604

/ Active, not recruiting临床2期

A Phase II, Multicentre, Open-label, Single-arm Study of AZD0901 Monotherapy in Second-or Later-Lines Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

开始日期2025-08-29

申办/合作机构

AstraZeneca PLC

NCT07069712

/ Recruiting临床2期

A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)

GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.

开始日期2025-07-17

申办/合作机构

AstraZeneca PLC

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100 项与 Sonesitatug vedotin 相关的专利（医药）

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项与 Sonesitatug vedotin 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.

2025-02-01·LANCET ONCOLOGY

Claudin 18.2-targeting antibody–drug conjugate CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer (KYM901): a multicentre, open-label, single-arm, phase 1 trial

Article

作者: Wang, Zhen-Ning ; Shi, Xi ; Yang, Jian-Wei ; Luo, Su-Xia ; Liu, Fu-Rong ; Chen, Zhen-Dong ; Wu, Xiao-Jie ; Zhuang, Zhi-Xiang ; Ruan, Dan-Yun ; Chen, Bo ; Liang, Xiao-Hua ; Xu, Rui-Hua ; Liu, Fu-Nan ; Kumar, Rakesh ; Wei, Xiao-Li ; Zheng, Yu-Long ; Liu, Wei ; Zhang, Yan-Qiao ; Wang, Jun-Ye ; Zhang, Dong-Sheng ; Wang, Yong-Sheng ; Liu, Jian

BACKGROUND:

CMG901 is a novel first-in-class antibody-drug conjugate with a humanised anticlaudin 18.2 antibody linked to microtubule-disrupting agent monomethyl auristatin E. We aimed to assess the antitumour activity and safety of CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer and other solid tumours.

METHODS:

KYM901 is a multicentre, open-label, single-arm, phase 1 trial consisting of dose-escalation and dose-expansion stages. Patients with advanced solid tumours, including gastric or gastro-oesophageal junction and pancreatic cancers, were recruited from 31 hospital sites in China. Eligible patients were aged 18 years or older, were refractory to standard therapy or had no available standard-of-care regimen, and had an Eastern Cooperative Oncology Group performance status score of 0-1, a life expectancy of at least 3 months, and at least one measurable lesion. Patients received intravenous CMG901 every 3 weeks (0·3-3·4 mg/kg in dose escalation and 2·2-3·0 mg/kg in dose expansion) until disease progression, unacceptable toxic effects, initiation of new antitumour therapy, study withdrawal, or death. Primary endpoints were adverse events and dose-limiting toxic effects in the dose-escalation phase, and objective response rate and recommended phase 2 dose in the dose-expansion phase. Confirmed objective response was defined as a partial or complete response that was verified by follow-up imaging at least 4 weeks after the initial assessment. Safety was assessed in all patients who received at least one dose of CMG901 with at least one post-dose safety evaluation. Antitumour activity was assessed in all patients who received at least one dose of CMG901 (full analysis set) and in all CMG901-treated patients with at least one post-dose imaging evaluation and no major protocol deviations (efficacy analysis set). Dose-expansion data for patients with pancreatic cancer will be published separately. Due to small sample sizes, results in patients with other solid tumours (n=2) are not planned for publication. This ongoing trial is registered with ClinicalTrials.gov, NCT04805307.

FINDINGS:

Between Dec 24, 2020, and Feb 23, 2023, 27 patients were enrolled in the dose-escalation phase (median age 57·0 years [IQR 48·0-63·0]; 14 [52%] male, 13 [48%] female) and 107 patients with gastric or gastro-oesophageal junction cancer in the dose-expansion phase (median age 56·0 years [44·0-64·0]; 57 [53%] male, 50 [47%] female). As of Feb 24, 2024, one dose-limiting toxic effect (grade 3 pancreatitis) occurred at 2·2 mg/kg, and the maximum tolerated dose was not reached in the dose-escalation phase. All 27 patients reported at least one treatment-emergent adverse event, most frequently vomiting (19 [70%]), decreased appetite (16 [59%]), proteinuria (16 [59%]), and anaemia (15 [56%]), and five (19%) had drug-related grade 3 or worse treatment-emergent adverse events. In 107 patients, grade 3 or worse treatment-emergent adverse events occurred in 73 (68%) patients and serious adverse events occurred in 54 (50%) patients in dose expansion. The most common grade 3-4 adverse events were neutrophil count decreased (22 [21%]), anaemia (15 [14%]), and vomiting (11 [10%]). One treatment-related death was reported. At median follow-up of 9·0 months (IQR 4·4-12·9), among 113 patients with gastric or gastro-oesophageal junction cancer in the 2·2-3·0 mg/kg cohort full analysis set across both the dose-escalation and dose-expansion phases, the confirmed objective response rate was 28% (95% CI 20-38; 32 of 113 patients). In the 109 patients included in the efficacy analysis set, the confirmed objective response rate was 29% (95% CI 21-39; 32 of 109 patients). Based on overall safety, activity, and pharmacokinetics of CMG901, 2·2 mg/kg was the proposed recommended phase 2 dose.

INTERPRETATION:

CMG901 showed a manageable safety profile and had promising antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer.

FUNDING:

KYM Biosciences.

2024-09-01·Cell Reports Medicine

CMG901, a Claudin18.2-specific antibody-drug conjugate, for the treatment of solid tumors

Article

作者: Wang, Ying ; Chen, Bo ; Zhang, Libo ; Xu, Ruihua ; He, Yanyun ; Liu, Wei ; Song, Qin ; Wei, Xiaoli ; Li, Zhiyao ; Liu, Furong ; Xu, Gang ; Wang, Changyu

Claudin18.2 has been recently recognized as a potential therapeutic target for gastric/gastroesophageal junction or pancreatic cancer. Here, we develop a Claudin18.2-directed antibody-drug conjugate (ADC), CMG901, with a potent microtubule-targeting agent MMAE (monomethyl auristatin E) and evaluate its preclinical profiles. In vitro studies show that CMG901 binds specifically to Claudin18.2 on the cell surface and kills tumor cells through direct cytotoxicity, antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and bystander killing activity. In vivo pharmacological studies show significant antitumor activity in patient-derived xenograft (PDX) models. Toxicity studies show that the major adverse effects related to CMG901 are reversible hematopoietic changes attributed to MMAE. The highest non-severely toxic dose (HNSTD) is 6 mg/kg in cynomolgus monkeys and 10 mg/kg in rats once every 3 weeks. CMG901's favorable preclinical profile supports its entry into the human clinical study. CMG901 is currently under phase 3 investigation in patients with advanced gastric/gastroesophageal junction adenocarcinoma expressing Claudin18.2 (NCT06346392).

562

项与 Sonesitatug vedotin 相关的新闻（医药）

2026-04-03

·丁香园 Insight 数据库

阿斯利康自研 ADC 新药在国内启动首个 III 期临床

4 月 3 日，药物临床试验登记与信息公示平台官网显示，阿斯利康登记了一项 AZD5335 用于叶酸受体 α（FRα）阳性（高表达及低表达）的经 1-3 线治疗后铂耐药高级别卵巢上皮癌患者治疗的 III 期临床（登记号：CTR20261196）。来源：药物临床试验登记与信息公示平台官网本次启动的是 TREVI-OC-01 研究的国内临床部分，TREVI-OC-01 是一项随机、开放性、III 期研究，旨在既往接受过 1-3 线全身治疗方案的 FRα 高表达和 FRα 低表达的铂耐药复发性卵巢癌受试者中评价 AZD5335 相较于标准治疗（SoC）的有效性和安全性。其中在 FRα 高表达队列中，AZD5335 比较的对象是索米妥昔单抗，在 FRα 低表达队列是与研究者选择的化疗方案进行比较。该研究计划在国内入组 165 名受试者，国际拟入组 1100 人，主要终点是 PFS。 AZD5335 是阿斯利康自主研发的一种由 FRα 靶向抗体与拓扑异构酶 1 抑制剂（TOP1i）有效载荷连接而成的 ADC，平均 DAR 为 8。在 2025 年 ESMO 大会上，阿斯利康公布了 AZD5335 在铂耐药卵巢癌患者中的首次人体研究数据。该研究分为两个部分： A 部分（FRα 表达未筛选，既往治疗线数不限）每 3 周静脉给药一次，共 5个剂量水平（0.8‒3.0 mg/kg）； B1 部分（FRα 筛选，既往治疗线数≤3，随机分配至不同剂量组）剂量分别为 1.6、2.0 和 2.4 mg/kg，直至疾病进展或出现不可耐受的毒性反应。该期研究共纳入 189 名患者，结果显示 AZD5335 在 1.6 mg/kg、2 mg/kg 和 2.4 mg/kg 剂量组的总缓解率（ORR）分别为 56%、56.1% 和 49.2%。安全性方面，最常见的可能与治疗相关的不良事件（TRAE）包括恶心、疲乏、中性粒细胞减少症、呕吐和贫血。来源：企业官网 Insight 数据库显示，目前全球范围内仅有 1 款 FRα ADC 获批上市，即艾伯维的索米妥昔单抗，但仅用于 FRα 阳性的铂类耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。除此之外，还有 4 款 FRα ADC 推进至临床 III 期，来自礼来、阿斯利康、百奥泰、Genmab。来源：丁香园 Insight 数据库值得一提的是，目前阿斯利康 ADC 管线中共有 2 款产品处于商业化阶段，分别是和第一三共合作开发的德达博妥单抗以及德曲妥珠单抗。除此之外，还有 3 款已经启动 III 期临床，分别是 AZD5335、Puxitatug samrotecan 和 Sonesitatug vedotin。来源：丁香园 Insight 数据库封面来源：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：ccai PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

2026-04-03

·谭谈药市

【太平洋医药|点评】康诺亚：康悦达商业化加速，核心管线取得关键进展

报告摘要事件：公司近期发布2025年年度报告：2025年公司实现营业收入7.16亿元，同比增长67.31%；主因核心产品康悦达®销售额达3.15亿元，同比增长775%；此外，管线对外授权合作收入4.02亿元，占总收入56%。受益于高毛利生物药销售占比提升及规模化生产降本，毛利率达87.7%。康悦达®纳入国家医保，商业化快速推进康悦达®（司普奇拜单抗）针对中重度特应性皮炎（AD）、慢性鼻窦炎伴鼻息肉（CRSwNP）和季节性过敏性鼻炎（AR）三项适应症已于2025年底全部纳入国家医保，自2026年1月起执行。截至2026年3月16日，公司商业化团队规模逾480人，已覆盖超1500家医院，其中可院内用药医院超600家，并布局650家以上药房。核心管线取得关键进展，NewCo合作模式成功 CMG901（Claudin 18.2 ADC）：该产品由阿斯利康负责全球开发，针对CLDN18.2阳性二线及以上胃癌的全球III期临床数据预计2026年上半年读出，2026年下半年有望在全球提交新药上市申请，或将成为中国首个在全球上市的ADC。同时，CMG901针对一线胃癌的全球III期联合疗法已于2026年2月完成首例患者给药，触发4500万美元里程碑付款。 CM512（TSLP×IL13双抗）：中国针对CRSwNP的II期临床数据读出时间预计为2026年上半年，下半年可能启动CRSwNP的III期临床，并将进行针对哮喘和COPD的中国临床II期期中分析。美国针对哮喘的I/II期临床将于2026年Q2完成入组。 CM336（BCMA x CD3双抗）：2024年11月，康诺亚与Ouro Medicines就CM336大中华区外全球权益达成合作协议。2026年3月，吉利德收购Ouro Medicines，获得CM336大中华区外全球权益，康诺亚将获得约2.5亿美元首付款+约0.7亿美元里程碑付款，至多6.1亿美元的里程碑付款+销售净额的分层特许权使用费由吉利德继续履行。NewCo合作模式的成功证明了在保证公司长期利益的前提下，借助外部资源加速资产价值实现的可行性。盈利预测和估值建议：考虑公司核心产品纳入医保后快速放量，NewCo合作模式获得成功，以及重点管线进入关键阶段，我们预计公司2026/2027/2028年营业收入分别为28.13/20.68/24.48亿元，同比增速为293%/-26%/18%。根据DCF估值模型，参考10年期中国香港政府债券收益率，港股医药板块平均收益率，假设WACC=11.17%，永续增长率2.50%，测算得出合理市值为260.82亿元，对应目标股价87.31元。维持“买入”评级。风险提示: 创新药研发不及预期风险；新产品放量不及预期风险；医保支付政策调整带来的风险；地缘政治风险。相关研究报告【太平洋医药|深度】康诺亚：重磅产品商业化加速，下一代自免双抗潜力大投资评级说明 1、行业评级看好：预计未来6个月内，行业整体回报高于沪深300指数5%以上；中性：预计未来6个月内，行业整体回报介于沪深300指数－5%与5%之间；看淡：预计未来6个月内，行业整体回报低于沪深300指数5%以下。 2、公司评级买入：预计未来6个月内，个股相对沪深300指数涨幅在15%以上；增持：预计未来6个月内，个股相对沪深300指数涨幅介于5%与15%之间；持有：预计未来6个月内，个股相对沪深300指数涨幅介于-5%与5%之间；减持：预计未来6个月内，个股相对沪深300指数涨幅介于-5%与-15%之间；卖出：预计未来6个月内，个股相对沪深300指数涨幅低于-15%以下。公司地址云南省昆明市盘龙区北京路926号同德广场写字楼31楼报告信息注：文中报告节选自太平洋证券研究所已公开发布研究报告，具体报告内容及相关风险提示等详见完整版报告。证券研究报告：《康诺亚：重磅产品商业化加速，下一代自免双抗潜力大》对外发布日期：2026年04月03日证券分析师：谭紫媚资格编号：S1190520090001 邮箱：tanzm@tpyzq.com 证券分析师：张懿资格编号：S1190523100002 邮箱：zhangyi@tpyzq.com 报告发布机构：太平洋证券股份有限公司免责声明太平洋证券股份有限公司（以下简称“我公司”或“太平洋证券”）具备中国证券监督管理委员会核准的证券投资咨询业务资格。本报告仅向与太平洋证券签署服务协议的签约客户发布，为太平洋证券签约客户的专属研究产品，若您并非太平洋证券签约客户，请取消接收、订阅或使用本报告中的任何信息；太平洋证券不会因接收人收到、阅读或关注媒体推送本报告中的内容而视其为太平洋证券的客户。在任何情况下，本报告中的信息或所表述的意见并不构成对任何机构和个人的投资建议，投资者应自主作出投资决策并自行承担投资风险，任何形式的分享证券投资收益或者分担证券投资损失的书面或口头承诺均为无效。本报告信息均来源于公开资料，我公司对这些信息的准确性和完整性不作任何保证。负责准备本报告以及撰写本报告的所有研究分析师或工作人员在此保证，本研究报告中关于任何发行商或证券所发表的观点均如实反映研究人员的个人观点。报告中的内容和意见仅供参考，并不构成对所述证券买卖的出价或询价。我公司及其雇员对使用本报告及其内容所引发的任何直接或间接损失概不负责。我公司或关联机构可能会持有报告中所提到的公司所发行的证券头寸并进行交易，还可能为这些公司提供或争取提供投资银行业务服务。本报告版权归太平洋证券股份有限公司所有，未经书面许可任何机构和个人不得以任何形式翻版、复制、刊登。任何人使用本报告，视为同意以上声明。微信号｜tantanyaoshi

2026-04-02

·搜狐新闻

乐普生物-B（02157.HK）：4月2日南向资金增持282.3万股

证券之星消息，4月2日南向资金增持282.3万股乐普生物-B（02157.HK）。近5个交易日中，获南向资金增持的有4天，累计净增持595.2万股。近20个交易日中，获南向资金增持的有12天，累计净增持1417.9万股。截至目前，南向资金持有乐普生物-B（02157.HK）4.98亿股，占公司已发行普通股的27.59%。乐普生物科技股份有限公司是一家主要从事医药产品销售及新药研发的公司。该公司聚焦于肿瘤治疗领域，尤其是靶向治疗及免疫治疗。该公司致力于通过抗体药物偶联物（ADC）技术开发平台开发创新型ADC。该公司的临床阶段候选药物涵盖靶向疗法药物和一种免疫治疗药物，具体包括MRG003、MRG002、CMG901、MRG004A、CG0070、MRG006A、MRG007、CTM012等。以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成投资建议。返回搜狐，查看更多

100 项与 Sonesitatug vedotin 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
食管腺癌	临床3期	美国	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	中国	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	日本	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	澳大利亚	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	奥地利	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	比利时	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	巴西	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	加拿大	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	法国	阿斯利康全球研发（中国）有限公司	2026-02-03
食管腺癌	临床3期	德国	AstraZeneca PLC	2026-02-03

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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


NCT04805307 (KYM901, Pubmed) 人工标引	临床1期	胃食管交界处癌 \| 晚期胃癌二线 CLDN18.2 Positive	134	CMG901	鹽廠餘餘膚構憲鏇淵鹹(襯簾鹹淵簾醖選獵憲艱) = 繭鬱遞觸衊廠遞淵夢醖鏇衊糧築齋淵鑰遞淵廠 (觸廠憲獵鏇觸鹽鹽鬱窪, 21 ~ 39) 更多	积极	2025-01-06
				CMG901 (dose-escalation phase)	獵衊齋顧網淵積膚繭艱(夢簾繭簾繭簾鑰遞簾顧) = 齋網蓋網窪遞醖構鹽齋鹽廠襯醖網衊鏇醖齋積 (鏇選繭網願壓鑰願獵築 )
NCT04805307 (KYM901, NEWS) 人工标引	临床1期	晚期胃癌	113	CMG901	糧夢壓糧顧簾選選壓鏇(鬱憲壓選遞網獵繭夢鬱) = 襯構壓鹹醖衊衊鹽範餘觸憲遞構餘簾衊醖艱構 (夢鹹築觸積遞衊網繭夢 ) 更多	积极	2024-06-03
				CMG901 (2.2 mg/kg)	糧夢壓糧顧簾選選壓鏇(鬱憲壓選遞網獵繭夢鬱) = 憲網窪壓蓋鹽鏇窪廠膚觸憲遞構餘簾衊醖艱構 (夢鹹築觸積遞衊網繭夢 )
NCT04805307 (ASCO_GI2023) 人工标引	临床1期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胰腺癌 \| CLDN18.2阳性胃癌 CLDN18.2-positive	27	CMG901	範鏇醖積鬱醖構淵淵構(鹽顧襯壓構醖築鹽積製) = 餘選窪構憲壓鑰鑰醖構餘獵醖製膚艱淵製醖簾 (餘蓋廠鑰蓋齋廠鹽夢網 )	积极	2023-01-24
				CMG901 (CLDN18.2-positive Gastric/GEJ Cancer)	築窪鏇憲蓋蓋蓋淵餘艱(獵獵顧衊鏇夢鏇廠窪艱) = 鑰築蓋衊繭積繭夢窪餘遞願範襯選構壓窪網憲 (觸鏇鏇鬱遞壓顧鑰齋醖 ) 更多