Sacituzumab Tirumotecan (MK-2870) Monotherapy in Patients With Advanced or Metastatic Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-Based Combination Therapy: A Multicenter, Phase II Investigator-Initiated Registration-directed Trial (METROPOLIS；NCCH2503/MK018)

Small bowel adenocarcinoma is a rare cancer with a poor prognosis. For patients with locally advanced or metastatic disease, the usual first treatment is chemotherapy with platinum-based combinations such as FOLFOX or CapeOX. However, once the cancer grows after this treatment or the side effects become too severe, there is no widely accepted standard second-line therapy, and outcomes are generally poor. New treatment options are therefore urgently needed.
In a recent translational research study conducted by Fujii, Shoji, et al., immunohistochemical staining for TROP2 was performed in 51 patients with pathologically diagnosed small bowel adenocarcinoma, and TROP2 positivity was confirmed in 43 cases (84.3%). Furthermore, patient-derived organoids were established using tumor tissues obtained from patients with small bowel adenocarcinoma, and the in vitro efficacy of sacituzumab tirumotecan was evaluated. A concentration-dependent growth-inhibitory effect was observed, with significant sensitivity observed in the nanomolar concentration range. Therefore, treatment with sacituzumab tirumotecan targeting TROP2 is expected to improve the prognosis of patients with small bowel adenocarcinoma.
The METROPOLIS trial is a multicenter, single-arm, phase II investigator-initiated trial designed to evaluate the efficacy and safety of sacituzumab tirumotecan in patients with locally advanced or metastatic small bowel adenocarcinoma that has progressed during or after, or is intolerant to, platinum-based combination chemotherapy (FOLFOX or CapeOX). Eligible patients are adults (aged 18 years or older) with histologically or cytologically confirmed small bowel adenocarcinoma, a good performance status, adequate organ function, and at least one measurable lesion on a CT scan. Patients who have genomic alterations that make them candidates for previously approved "tumor-agnostic" targeted drugs (for example, high microsatellite instability or high tumor mutational burden) must already have tried and not benefited from, or not tolerated, those treatments. TROP2 positivity is not required for study participation; however, assessment of TROP2 expression is mandatory for exploratory biomarker analyses.
Sacituzumab tirumotecan at 4 mg/kg is administered intravenously on Days 1 and 15 of each 28-day cycle and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. Tumor scans with contrast-enhanced CT will be performed every 8 weeks up to week 24 and every 12 weeks thereafter to monitor the response of the sacituzumab tirumotecan. The primary objective is to determine the proportion of patients achieving a tumor response to sacituzumab tirumotecan, as assessed by independent radiologic review. Key secondary objectives include progression-free survival, overall survival, duration of response, and safety profiling.
In addition, this study includes a prespecified translational research program. Tumor samples will be examined for TROP2 using immunohistochemistry, and researchers will investigate the relationship between TROP2 and the effects of sacituzumab tirumotecan. Blood and tissue samples will also be collected before treatment, during treatment, and at the time of cancer progression, when possible, for detailed "multi-omics" analyses. These translational studies aim to elucidate why some patients respond whereas others do not, and to identify biomarkers that could inform future treatment strategies for small bowel adenocarcinoma.
The METROPOLIS trial has been approved by the Institutional Review Board of the National Cancer Center, Japan, as well as by the ethics committees at participating sites. This trial is conducted with funding and sacituzumab tirumotecan supplied by MERCK SHARP & DOHME LLC. Enrollment began in January 2027 and is planned to continue through December 2028, with patients followed for at least 12 months after the last participant is enrolled.

开始日期2027-01-01

申办/合作机构

National Cancer Center

NCT07521670

/ Not yet recruiting临床2期IIT

A Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma and Papillary Thyroid Carcinoma (STRAP, ATLAS2501 NCCH2413/MK016)

This is an open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab Tirumotecan (sac-TMT) monotherapy in patients with recurrent or metastatic adenoid cystic carcinoma (ACC) of salivary gland origin and papillary thyroid carcinoma (PTC). A total of 68 patients will be enrolled over in 18-month period, with 34 patients in Cohort A (ACC) and 34 in Cohort B (PTC). All participants will receive sac-TMT at a dose of 4 mg/kg administered intravenously on Days 1 and 15 of each 28-day cycle.
The primary endpoint is the objective response rate (ORR), defined as the proportion of patients achieving a complete or partial response as assessed by the site investigators. Secondary endpoints include progression-free survival, overall survival, disease control rate, safety and tolerability, dose intensity, and relative dose intensity.

开始日期2026-11-01

申办/合作机构

National Cancer Centre of Singapore Pte Ltd.

[+2]

NCT07716917

/ Not yet recruiting临床2期IIT

RINGQUEST: Exploring Understudied Genitourinary Tumors With Sacituzumab Tirumotecan; a Single-arm, Basket, Phase II Study

RINGQUEST is a Phase 2, open-label, single arm, basket, investigator-initiated clinical trial of sacituzumab tirumotecan in patients with:
* Cohort 1: papillary renal carcinoma (pRCC).
* Cohort 2: less frequent bladder tumors such as variant histology urothelial carcinoma (VH-UC). The most common VH-UC are nested, microcystic, micropapillary, lymphoepithelioma-like, plasmacytoid, giant cell, poorly differentiated, lipid-rich, clear cell, sarcomatoid) bladder cancer and non-urothelial bladder cancer of epithelial origin including squamous cell carcinoma and adenocarcinoma (urachal and non-urachal).

开始日期2026-10-01

申办/合作机构

Mfar Constructions Pvt Ltd.

[+1]

100 项与芦康沙妥珠单抗相关的临床结果

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100 项与芦康沙妥珠单抗相关的专利（医药）

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项与芦康沙妥珠单抗相关的文献（医药）

2026-05-01·LANCET

Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial

Article

作者: Wang, Haiyong ; Fan, Yun ; Yao, Yu ; Wei, Youneng ; Su, Cuiyun ; Zhou, Caicun ; Jin, Xiaoping ; Xiong, Anwen ; Yang, Yunpeng ; Yu, Yan ; Zhang, Lemeng ; Qing, Yan ; Du, Xiaobo ; Pu, Xingxiang ; Ge, Junyou ; Che, Guowei ; Chen, Bolin ; Yu, Qitao ; Fang, Yong ; Liu, Zhentian ; Li, Xingya ; Zhou, Ming ; Cui, Jiuwei ; Chen, Peng ; Huang, Zhangzhou ; Wang, Hui ; Jiang, Guanming ; Zhong, Hua ; Yi, Tienan ; Luo, Hui ; Yao, Wenxiu ; Liu, Chunling ; Wang, Qiming ; Zheng, Wei ; He, Lang ; Song, Xia

BACKGROUND:

Sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2-targeting antibody-drug conjugate, combined with programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitors, has shown promising antitumour activity as first-line therapy for non-small-cell lung cancer (NSCLC) in early-phase studies. Our aim was to evaluate the efficacy and safety of sac-TMT plus pembrolizumab as first-line treatment for patients with PD-L1-positive advanced NSCLC without targetable genomic alterations.

METHODS:

In this randomised, open-label, phase 3 trial (OptiTROP-Lung05) conducted across 68 hospitals in China, eligible patients had locally advanced or metastatic NSCLC without targetable genomic alterations and a PD-L1 tumour proportion score (TPS) of 1% or greater. Patients were randomly assigned (1:1) to receive sac-TMT (4 mg/kg on days 1, 15, and 29) plus pembrolizumab (400 mg fixed dose on day 1), or pembrolizumab alone, administered intravenously every 6 weeks. The primary endpoint was progression-free survival, as assessed by blinded independent central review in the intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT06448312). Recruitment is complete, with the trial ongoing and the final analysis to be reported later.

FINDINGS:

Between June 7, 2024, and March 27, 2025, 741 patients were screened and 413 eligible patients were randomly assigned to receive sac-TMT plus pembrolizumab (n=208) or pembrolizumab alone (n=205). At the prespecified interim analysis, conducted after a median follow-up of 10·5 months (IQR 8·7-12·5), median progression-free survival was significantly longer with sac-TMT plus pembrolizumab than with pembrolizumab alone (not reached vs 5·7 months; stratified hazard ratio [HR] 0·35 [95% CI 0·26-0·47]; p<0·0001). The progression-free survival benefit was broadly consistent across subgroups, including patients with PD-L1 TPS of 1-49% (HR 0·28 [95% CI 0·19-0·41]) and those with PD-L1 TPS of 50% or greater (HR 0·47 [0·29-0·77]). Grade 3 or higher treatment-emergent adverse events occurred in 115 (55%) of 208 patients in the sac-TMT plus pembrolizumab group and 64 (31%) of 204 patients in the pembrolizumab group.

INTERPRETATION:

Among patients with PD-L1-positive advanced NSCLC without targetable genomic alterations, first-line treatment with sac-TMT plus pembrolizumab significantly prolonged progression-free survival compared with pembrolizumab alone. Therefore, sac-TMT plus pembrolizumab has the potential to redefine first-line treatment for patients with PD-L1-positive advanced NSCLC without targetable genomic alterations.

FUNDING:

Sichuan Kelun-Biotech Biopharmaceutical.

2026-03-23·Zhonghua zhong liu za zhi [Chinese journal of oncology]

[Expert consensus on the clinical application of TROP2-targeted antibody-drug conjugates in non-small cell lung cancer (2026 edition)].

Review

Antibody-drug conjugates (ADCs) have demonstrated groundbreaking progress in the treatment of non-small cell lung cancer (NSCLC). Trophoblast cell surface antigen 2 (TROP2) has emerged as a pivotal therapeutic target, and TROP2-directed ADCs, including Sacituzumab Tirumotecan, Datopotamab Deruxtecan, and Sacituzumab Govitecan have shown substantial antitumor activity and survival benefits in clinical studies. To further standardize the clinical use and safety management of TROP2 ADCs, this expert consensus systematically reviews current evidence regarding their efficacy and safety in NSCLC. Particular emphasis is placed on strategies for the prevention and management of treatment-related adverse events such as mucositis, myelosuppression, and gastrointestinal toxicities, aiming to provide guidance for the rational and safe application of TROP2 ADCs in NSCLC.

2026-03-01·ANNALS OF ONCOLOGY

Sacituzumab tirumotecan in participants with advanced or metastatic urothelial carcinoma and disease progression after chemotherapy and immune checkpoint inhibitors

Article

作者: Ge, Y ; Liu, T ; Zhang, S ; Wang, X ; Yuan, F ; Seneviratne, L ; Li, Y ; Li, X ; Wang, S ; Jiang, K ; Zhang, M ; Chen, X ; Ge, J ; Blumenthal, G ; Liu, Y ; Zhou, F ; Ye, D ; Akala, O ; Zhang, X ; Jiang, S ; Chen, M ; Shi, Y ; Yu, G ; Zhu, Y

BACKGROUND:

Trophoblast cell-surface antigen 2 (TROP2) is overexpressed in advanced or metastatic urothelial cancer (UC), representing a promising therapeutic target. Sacituzumab tirumotecan (sac-TMT) is a TROP2-directed antibody-drug conjugate with a unique, bifunctional linker that maximizes payload delivery to tumor cells. We present preliminary results for sac-TMT monotherapy from cohort 9 of the phase 1/2 2870-001/KL264-01 study in participants with advanced or metastatic UC.

PARTICIPANTS AND METHODS:

Eligible participants with locally advanced or metastatic UC and disease progression on one or more prior line of platinum-based chemotherapy and anti-programmed cell death protein 1/programmed cell death-ligand 1 therapy received sac-TMT 5 mg/kg intravenously every 2 weeks until disease progression, unacceptable toxicity, or participant/physician decision. The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST version 1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

By data cut-off (17 February 2025), 49 participants were treated with sac-TMT; 37 (76%) had received two or more prior lines of therapy. Median follow-up for this analysis was 18.8 months. The confirmed ORR was 31% [95% confidence interval (CI), 18% to 45%] and the disease control rate was 71% (95% CI 57% to 83%). Median DOR was not reached [range 2.1-22.2+ (+ indicates censored data for the longest DOR, suggesting that patients may have achieved longer remission duration) months], and the 12-month probability of sustained response was 53%. Median PFS and OS were 5.5 months (95% CI 3.6-7.2 months) and 12.1 months (95% CI, 9.9-15.3 months), with 18-month rates of 26% and 33%, respectively. Grade 3/4 treatment-related adverse events (AEs) occurred in 31 participants (63%), and the most common (≥5%) were anemia (41%), decreased neutrophil count (35%), decreased white blood cell count (20%), stomatitis (12%), and decreased platelet count (8%). There were no grade 5 treatment-related AEs or febrile neutropenia events.

CONCLUSIONS:

Sac-TMT 5 mg/kg monotherapy every 2 weeks demonstrated promising antitumor activity in participants with heavily pretreated advanced or metastatic UC, with a manageable safety profile, warranting further evaluation of sac-TMT in this population.

3,791

项与芦康沙妥珠单抗相关的新闻（医药）

13 小时之前

·医药速览

Trop2赛道再添猛将：糖岭生物TL001获批IND，糖定点偶联发力

2026年7月22日，上海糖岭生物医药有限责任公司宣布，其首款产品——靶向TROP2的ADC药物注射用TL001正式获得国家药品监督管理局（NMPA）的药物临床试验批准（IND），适应症为晚期实体瘤，包括但不限于TROP2高表达的胃癌、膀胱癌、非小细胞肺癌、小细胞肺癌、结直肠癌、胰腺癌、宫颈癌、三阴性乳腺癌、尿路上皮癌等。这是糖岭生物自2021年成立以来，首个进入临床阶段的自研管线。从“糖”开始的创新之路糖岭生物由中国科学院上海药物研究所黄蔚研究员于2021年创立，总部位于上海张江。公司专注于ADC定点偶联技术的研发，核心思路是利用抗体Fc区域的Asn297糖基化位点来连接药物载荷。 2012年黄蔚回国加入中科院上海药物研究所，课题组在2017年研发出第一代糖基化偶联技术OligosacLink™。但团队并未急于商业化，而是继续深耕，直到2021年才推出第二代技术——DisacLink™。核心技术：两代糖定点偶联平台糖岭生物的技术核心分为两代：第一代：OligosacLink™（两酶三步法）通过特异性酶催化，可快速实现DAR值为4/8/12的ADC制备，保持了抗体的ADCC活性及FcRn功能。第二代：DisacLink™（单酶一步法/两步法）使用糖岭生物开发的二糖底物，在特异性酶催化下，仅通过一步反应即可完成ADC制备，反应简单高效，不依赖生物正交反应。利用该方法制备的ADC具有亲水性高、稳定性好、肿瘤抑制活性强等特点。有评价称，使用糖岭二代糖定点技术制备的ADC分子，其亲水性甚至可与裸抗相媲美。此外，糖岭还布局了赖氨酸K位点定点偶联、N端及C端选择性修饰等技术。 TL001的IND之路 2026年5月18日，注射用TL001的新药申请获国家药监局药品审评中心（CDE）受理，受理号为CXSL2600542。注册分类为1类治疗用生物制品。短短两个月后，TL001正式获批IND，标志着糖岭生物从“技术输出者”迈向了“自主研发者”的关键一步。靶点选择：TROP2——ADC领域的黄金靶点 TROP2（滋养层细胞表面抗原2）是在多种实体瘤中高表达的跨膜糖蛋白，已成为ADC药物研发的热门靶点之一。目前全球已有IMMU-132（戈沙妥珠单抗）、Dato-DXd、SKB264（芦康沙妥珠单抗）等多款TROP2 ADC获批上市，主要用于三阴性乳腺癌和非小细胞肺癌等适应症。 TL001选择TROP2作为靶点，意味着其面临的是一个竞争激烈但市场空间巨大的赛道。糖岭生物能否凭借其糖定点偶联技术的差异化优势，在TROP2 ADC领域占据一席之地，值得持续关注。推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。 ©2021 医药速览保留所有权利往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学

16 小时之前

·米内网

【聚焦】科伦1类新药再下一城，1600亿市场波澜四起

精彩内容近日，CDE官网显示，科伦药业的1类新药注射用SKB500获得临床试验默示许可，拟联合替雷利珠单抗注射液加或不加化疗用于小细胞肺癌。米内网数据显示，2025年中国三大终端六大市场抗肿瘤药（化+生）销售额超1600亿元，2026Q1同比增长9.13%。来源：CDE官网注射用SKB500由科伦药业自主研发，是一款靶向B7-H3的新型ADC，采用定点可裂解连接子并搭载强效的拓扑异构酶Ⅰ抑制剂。米内网数据显示，注射用SKB500于2024年12月首次获批临床，其拟用于小细胞肺癌、食管鳞状细胞癌的Ⅱ期临床试验、拟用于晚期实体瘤的Ⅰ期临床试验正稳步推进中。近日，该新药再获临床试验默示许可（受理号：CXSL2600525），适应症为拟联合替雷利珠单抗注射液加或不加化疗用于小细胞肺癌。近年来，抗肿瘤药（化+生）在中国三大终端六大市场（统计范围详见本文末）销售规模稳步扩容，2025年创下历史新高的超1600亿元；2026Q1同比增长9.13%，从小类格局上看，抗体药物、蛋白激酶抑制剂占据市场大头，市场份额分别达45.26%和32.41%。近年来中国三大终端六大市场抗肿瘤药（化+生）销售趋势（单位：万元）来源：米内网格局数据库 2026Q1中国三大终端六大市场抗肿瘤药（化+生）一级集团格局中，罗氏、正大制药、齐鲁制药、阿斯利康和信达生物依次位列TOP1-TOP5，合计市占比超30%；科伦药业排名TOP43，销售额增速达99.55%。产品格局方面，贝伐珠单抗注射液、注射用曲妥珠单抗、甲磺酸奥希替尼片、替雷利珠单抗注射液先后排名第一至第四，销售额均超过15亿元。 2026Q1中国三大终端六大市场抗肿瘤药（化+生）产品TOP10 来源：米内网格局数据库科伦药业持续加码创新研发，以推动创新成果加速转化。截至目前，公司已有3款1类新药获批上市，其中，注射用芦康沙妥珠单抗为国内首款完全获批上市的国产ADC，塔戈利单抗注射液为全球首款获批用于治疗鼻咽癌的PD-L1单抗，注射用博度曲妥珠单抗为国内首款可广泛覆盖二线及以上HER2+BC患者的国产HER2 ADC。此外，科伦药业还有约30款1类新药处于获批IND及以上阶段，剂型上以注射剂为主，遍及肿瘤、神经、消化、感染、肌肉-骨骼系统、血液和造血系统等疾病领域。科伦药业1类新药研发情况来源：米内网综合数据库从最高研发进度看，富马酸仑博替尼胶囊已报产在审，拟用于非小细胞肺癌，米内网预测其有望于2026年9月传来上市喜讯；注射用SKB500（食管鳞状细胞癌、小细胞肺癌）、注射用SKB571（非小细胞肺癌、消化道肿瘤）、注射用SKB518（妇科恶性肿瘤、肺癌）、注射用SKB315（胃/胃食管结合部腺癌）、KL280006注射液（尿毒症瘙痒）、KL130008胶囊（类风湿关节炎）等均已步入Ⅱ期临床。资料来源：米内网数据库、CDE官网注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月24日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com 稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

21 小时之前

·求实药社

最被低估的医药龙头！营收300多亿，市值却不到1000亿

2025年，中国生物制药营收318.34亿元，翰森制药150.28亿元，前者是后者的2.12倍。2026年7月下旬，翰森市值约1993亿港元，中国生物制药约953亿港元，后者不到前者一半。这个价差通常被归因为"创新药纯度"，但这只解释了一部分。核心问题是：这1000亿港元的折价里，多少是基本面的实账，多少是预期差。基本面短期难改，但预期随时会改。01营收2.12倍，归母利润0.42倍，中间蒸发的就是这1000亿先摆两张利润表。中国生物制药2025年营收318.34亿，同比增长10.3%，毛利率82.1%，销售费用率34.5%，创新产品收入占比47.8%。翰森营收150.28亿，同比增长22.6%，毛利率90.0%，销售费用率27.0%，创新及合作产品收入占比82.2%。到利润端数字开始反常。中国生物制药合并税后利润53.15亿元，翰森净利润55.55亿元，两家实际赚到的钱几乎一样。但中国生物制药归母净利润只有23.43亿元，翰森是前者的2.37倍。营收2.12倍，归母利润0.42倍。中间蒸发的部分，就是这1000亿港元的主要来源。蒸发的出口有四个：第一，利润归属。合并税后利润53.15亿中，归属上市公司股东仅23.43亿，少数股东拿走29.71亿。股东只拿到44%。因为正大天晴、南京正大天晴、北京泰德等核心主体并非100%持股。公司并表100%收入，港股投资者持有的经济利益不到一半。第二，收入的估值分层。 318亿由仿制药、独家高端制剂、生物类似药、成熟创新药、新上市创新药五种性质不同的收入构成，市场给每一层的倍数不同，加权后必然低于纯创新药公司。这里有个细节：公司披露的152.2亿创新产品收入口径偏宽，包含贝伐珠单抗等四款生物类似药，真实的原创创新药占比低于47.8%。第三，单品结构。最大的三个品种是安罗替尼（区间估算45-55亿）、天晴甘美（30-40亿）和氟比洛芬凝胶贴膏（30-40亿），只有安罗替尼是原创创新药且已进入成熟期。安罗替尼之后的第二个30亿级原创大单品还没出现。第四，资产负债表。翰森现金约315.49亿元，中国生物制药净现金约169.20亿元，相差约146亿元，仅这一项就解释约150亿港元市值差。但反过来也要问：翰森那1993亿含金量有多高？翰森2025年税前利润65.51亿，其中合作收入21.16亿加银行利息10.81亿合计31.97亿，接近税前利润的一半。扣掉这两项，药品经营的正常化净利润大约28至30亿。中国生物制药经调整归母净利润45.41亿。只比较国内药品经营产生的经常性利润，翰森并没有形成压制。换句话说，这1000亿港元里，真正由已实现利润支撑的不到三分之一，剩下的是市场提前支付给翰森的管线期权、BD连续性和股权结构简洁度。已实现利润短期难改，预期可以。02创新收入越过50%，是估值框架切换的位置中国生物制药的创新产品收入，2023年约99亿（占37.8%），2024年120.6亿（占41.8%），2025年152.2亿（占47.8%）。两年提升10个百分点，2025年单年就提了6个点，创新产品收入增速26.2%，远超总收入增速10.3%。按这个斜率，2026年大概率越过50%。 50%这个数字本身没有魔力，它对应的估值机制才重要。转型期药企的估值是加权平均：创新部分用rNPV或PS，成熟部分用PE。当创新收入还是少数派，市场按综合药企框架定价，创新部分被整体折价；当创新成为多数派，框架就会切换，从"一家仿制药公司里有几个创新药"变成"一家创新药公司还带着一块现金牛"。这种框架切换是跳跃发生的，不是平滑过渡。预期差最大的位置出现在转型中段。下行侧的坏消息已经基本出清。集采对恩替卡韦等成熟品种的冲击大部分已反映在过去三年的收入增速里。上行侧的增量尚未被充分计入：安奈克替尼、依奉阿克、格索雷塞、库莫西利（2025年12月获批）这批品种2025年收入贡献有限，2026至2028年才是集中爬坡期。罗伐昔替尼已于2026年2月获NMPA批准用于中高危骨髓纤维化一线治疗。艾贝格司亭α国内终端销售额已接近或超过10亿元。再说那个34.5%的销售费用率。在卖仿制药的框架下这是负担；放在2026年的行业环境里，同一支队伍性质变了。2026年5月正大天晴与GSK就乙肝新药bepirovirsen达成中国合作，7月8日双方扩大合作，正大天晴获得全再乐和欧乐欣的中国内地商业化权益，覆盖超过9000家医院及基层机构。这两款产品2025年全球销售额合计约47亿美元。GSK付钱买的就是这张网络。同一天，公司把TQC3721海外权益授权给了阿斯利康。一天之内完成一次对外授权和一次商业化权益引进，中国Pharma最深的那张商业化网络，正在从集采时代的成本项，转回MNC在华战略调整期的稀缺资源。03所有中国药企在卖分子，只有中国生物制药在买生产分子的能力过去两年中国创新药行业最主流的动作是license-out。恒瑞打包GLP-1成NewCo，科伦博泰把SKB264给了默沙东，康方把依沃西给了Summit。这些公司在交易中都是卖方。中国生物制药在做相反的事。2025年7月以不超过9.51亿美元收购礼新医药剩余95.09%股权（扣除标的账上约4.5亿美元现金后净付款约5.01亿美元）；2026年1月以最高12亿元人民币全资收购siRNA企业赫吉亚生物。在整个行业集体扮演分子供应商的时候，它是唯一试图变成组装方的公司。礼新的价值在出品记录上。2022年将CLDN18.2 ADC LM-302授权BMS（经收购Turning Point），交易总额11亿美元；2023年将GPRC5D ADC LM-305授权阿斯利康，近期付款0.55亿美元加潜在里程碑5.45亿美元；2024年将PD-1/VEGF双抗LM-299授权默沙东，首付5.88亿美元、里程碑最高27亿美元、总额32.88亿美元。五年向三家MNC交付三款资产。净付出约5.01亿美元买下的，是平均每十八个月产出一款被MNC定价的分子的能力。赫吉亚提供MVIP肝靶向递送平台，全球首个经临床验证可实现一年一次给药的肝靶向递送系统，附带Kylo-11（Lp(a) siRNA）等4项临床阶段资产。递送平台的经济性在于复用，一套系统对应多个代谢与心血管靶点。这里还有一层财务含义。公司老主业的归母含量只有约44%，赚1元只有0.44元归属股东。礼新和赫吉亚是全资收购，未来产生的里程碑和销售分成理论上100%归属上市公司。每买下一个平台，都在给报表增加高归母含量的增量利润，从结构上稀释第一部分最难改变的那条折价。截至2026年7月，公司累计完成4项对外授权，首付款合计超过10亿美元，交易总规模超过70亿美元。最大两笔：罗伐昔替尼授权赛诺菲（首付1.35亿美元、总额最高15.3亿美元），TQC3721授权阿斯利康（首付2亿美元、总额最高19亿美元，为公司BD历史最大首付款）。这些资产全部出自正大天晴自身研发体系，礼新和赫吉亚的产出还没有一个分子进入这个节奏。真正的变量在LM-299。 2024年11月授权默沙东（内部代号MK-2010），2025年7月确认3亿美元技术转移里程碑款。2026年4月AACR，礼新首次公布I/II期数据：112例患者，20mg/kg Q3W组在一线PD-L1阳性NSCLC中未确认ORR为55%，30mg/kg组为44%；未发生5级治疗相关不良事件，≥3级TRAE发生率17%。作为参照，康方依沃西单抗在同一场景下ORR约50%。但截至2026年上半年，默沙东始终未公开MK-2010的III期计划。同期Summit已递交依沃西上市申请，BMS为pumitamig启动了覆盖多癌种的关键性试验，辉瑞在签约后当年底启动三项III期。默沙东资源重心明显放在与科伦博泰合作的TROP2 ADC芦康沙妥珠单抗上，围绕该药已启动超过15项全球III期。LM-299在当前估值中几乎不被计价，原因就在这里。 2026年ASCO出现了第一个变化：默沙东首次给MK-2010两页独立版面，将其列为癌症治疗组合的重要组成部分。被追问III期计划时管理层说"目前不讨论具体安排"。态度从沉默转为暧昧，这是重新计价的前提条件，还不是重新计价本身。如果默沙东启动III期，价值释放分三层：一是开发里程碑现金流入；二是MK-2010被纳入默沙东围绕sac-TMT建立的全球临床体系，等于直接接入中国biotech无法自建的基础设施；三是终局定价，全球峰值销售30至80亿美元不同假设下权益价值跨度极大。风险同样明确：默沙东可能永远不推进，同类竞品窗口期正在关闭。这个期权有到期日。结语：四个触发条件，24至36个月。创新收入占比越50%（2026年报，6-12个月）；归母比例修复（全资平台利润占比提升，12-36个月）；BD连续性验证（LM-302三期数据2026年读出、LM-108胃癌III期推进，12-24个月）；LM-299 III期启动（触发权在默沙东，时间不可控，弹性最大）。前三个内生可预期，第四个外生不可控但赔率最高。任意两个同时打开，重估就会开始。今天的市场，正在用综合药企的框架给一家已经开始扮演资本配置者角色的公司定价。全球范围内，真正的Pharma从来不只靠自己做研发：默沙东的K药来自先灵葆雅，BMS的O药来自Medarex，强生的CARVYKTI来自传奇生物。中国出了很多会做药的公司，还没有出过一家会买药的公司。礼新三笔对外授权合同金额合计约49.9亿美元。中国生物制药买下这个平台净付款5.01亿美元。市场今天给它的定价，仍然接近后面那个数字。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们 SIT 2026 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多！

100 项与芦康沙妥珠单抗相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	中国	四川科伦博泰生物医药股份有限公司	2026-02-02
EGFR突变的非小细胞肺癌	中国	四川科伦博泰生物医药股份有限公司	2025-09-30
EGFR阳性非鳞状非小细胞肺癌	中国	四川科伦博泰生物医药股份有限公司	2025-03-04
三阴性乳腺癌	中国	四川科伦博泰生物医药股份有限公司	2024-11-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期非小细胞肺癌	申请上市	中国	四川科伦博泰生物医药股份有限公司	2026-05-09
转移性非小细胞肺癌	申请上市	中国	四川科伦博泰生物医药股份有限公司	2026-05-09
PD-L1阳性非小细胞肺癌	申请上市	中国	四川科伦博泰生物医药股份有限公司	2026-05-09
膀胱癌	临床3期	美国	默沙东研发（中国）有限公司	2026-04-23
膀胱癌	临床3期	美国	Merck Sharp & Dohme LLC	2026-04-23
膀胱癌	临床3期	中国	Merck Sharp & Dohme LLC	2026-04-23
膀胱癌	临床3期	日本	Merck Sharp & Dohme LLC	2026-04-23
膀胱癌	临床3期	日本	默沙东研发（中国）有限公司	2026-04-23
膀胱癌	临床3期	阿根廷	Merck Sharp & Dohme LLC	2026-04-23
膀胱癌	临床3期	阿根廷	默沙东研发（中国）有限公司	2026-04-23

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT07216703 (TroFuse-036, ESMO_GCC2026)	临床3期	PD-L1阳性宫颈癌一线 \| 维持 PD-L1-positive	1,815	sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) ± bevacizumab (bev)	衊觸餘廠淵醖衊廠簾襯(蓋鑰鑰鬱壓糧網淵獵築) = 壓夢選簾憲憲築夢願築簾艱夢簾廠鏇顧夢艱膚 (範築淵鑰網簾壓鬱繭網, 36.3 ~ NR) 更多	积极	2026-06-18
				pembrolizumab (pembro) ± bevacizumab (bev) (standard of care (SoC))	壓網築築製衊鏇鑰觸艱(網鏇膚壓膚糧製遞願選) = 餘醖窪艱鑰窪鏇淵窪夢衊糧簾獵鬱願襯醖鏇製 (壓獵鬱憲願觸繭選簾鬱, 42.3 ~ 57.6) 更多
NCT07216703 (TroFuse-036, ASCO2026)	临床3期	PD-L1阳性宫颈癌一线 \| 维持 PD-L1-positive	1,723	sacituzumab tirumotecan + pembrolizumab + bevacizumab (Part 1 Safety Run-in)	醖鹽憲鬱獵簾範遞鬱鏇(糧築壓艱襯顧鑰範觸憲) = 憲簾窪衊鹹鬱壓鹹餘壓獵構鹽願觸夢積繭膚糧 (鑰衊壓範淵糧衊築鬱淵, 30.6 ~ NR) 更多	积极	2026-05-29
				sacituzumab tirumotecan + pembrolizumab ± bevacizumab	醖鹽憲鬱獵簾範遞鬱鏇(糧築壓艱襯顧鑰範觸憲) = 製範選選夢構選壓淵衊獵構鹽願觸夢積繭膚糧 (鑰衊壓範淵糧衊築鬱淵, 27.7 ~ NR) 更多
NCT06448312 (OptiTROP-Lung05, ASCO2026)	临床3期	PD-L1阳性非小细胞肺癌一线 PD-L1-positive	413	Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab	夢築範獵積積憲範淵夢(廠繭壓膚鏇壓窪襯選壓) = 繭選憲鬱壓廠襯齋網鹹廠製鬱鏇鏇鹹壓蓋範艱 (夢積範鬱範鬱餘繭壓齋 ) 更多	积极	2026-05-29
				Pembrolizumab	夢築範獵積積憲範淵夢(廠繭壓膚鏇壓窪襯選壓) = 廠觸窪範築糧窪窪選襯廠製鬱鏇鏇鹹壓蓋範艱 (夢積範鬱範鬱餘繭壓齋 ) 更多
NCT06448312 (OptiTROP-Lung05, Pubmed \| Lancet)	临床3期	PD-L1阳性非小细胞肺癌一线 PD-L1-positive	413	Sacituzumab tirumotecan plus pembrolizumab	顧襯壓壓窪積網觸夢選(壓鬱顧廠鏇鏇廠範築獵) = 範鏇獵夢壓觸夢鹽鑰襯獵蓋鑰遞餘蓋糧餘範築 (蓋淵願鬱廠鑰願衊襯築 ) 更多	积极	2026-05-01
				Pembrolizumab	憲膚觸鬱顧餘獵觸顧獵(繭範範簾艱鑰範壓夢膚) = 獵鬱糧鏇鹽蓋鏇憲醖網築鬱遞膚網蓋繭餘簾鏇 (網膚蓋鬱壓製餘積構簾 )
NCT05631262 (OptiTROP-Lung03, ESMO_ELCC2026 \| PRNewswire) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	137	Sacituzumab Tirumotecan	衊鹽淵衊壓鏇願構選鹽(鹽鏇鹹衊積鏇構顧鹹鏇) = 鑰齋蓋鏇繭選壓窪廠鹽艱製鹹鹽蓋膚鏇鹽衊衊 (衊觸糧鑰醖構觸醖衊鑰 ) 更多	积极	2026-03-27
				Docetaxel	衊鹽淵衊壓鏇願構選鹽(鹽鏇鹹衊積鏇構顧鹹鏇) = 衊獵蓋顧衊淵鏇壓艱範艱製鹹鹽蓋膚鏇鹽衊衊 (衊觸糧鑰醖構觸醖衊鑰 ) 更多
NCT06952504 (GOG-3119, ESGO2026)	临床3期	子宫内膜癌一线 \| 维持 pMMR	529	Sacituzumab tirumotecan + Pembrolizumab	遞願襯鬱構淵衊艱構鏇(醖積鹹觸範夢獵製遞選) = 糧觸鏇餘積積遞衊鏇蓋壓膚夢鹽壓壓膚襯憲憲 (鹽憲襯築憲簾製憲襯衊 ) 更多	积极	2026-02-28
				Pembrolizumab	觸衊網壓淵構選憲構艱(齋築齋餘獵鹹鏇積衊憲) = 觸醖壓餘憲襯襯製鹽窪艱夢餘糧夢鑰積鑰鏇憲 (醖築壓選鑰淵顧鹹膚醖 ) 更多
NCT06448312 (OptiTROP-Lung05, PRNewswire) 人工标引	临床3期	PD-L1阳性非小细胞肺癌一线 PD-L1 Positive	-	sacituzumab tirumotecan + pembrolizumab	鹹夢壓網範鑰齋蓋齋齋(淵齋鏇積構鹹醖繭窪餘) = Sac-TMT, in combination with pembrolizumab, as a first-line treatment for PD-L1-positive NSCLC, has demonstrated a statistically significant and clinically meaningful improvement in PFS, the study's primary endpoint. 蓋餘選簾醖願窪獵構蓋 (鹹顧鏇糧繭蓋願積餘淵 ) 达到更多	积极	2025-11-24
				pembrolizumab
NCT04152499 (MK-2870-001 \| KL264-01, Ann Oncol \| Pubmed \| PRNewswire) 人工标引	临床1/2期	晚期尿路上皮癌	49	Sacituzumab Tirumotecan 5 mg/kg	製廠選糧願壓糧窪齋觸(範廠鑰糧艱鬱蓋襯衊鏇) = 願醖衊鹹憲遞願鹹觸鹽廠繭鹹構鏇淵夢築積窪 (襯糧憲窪衊範製糧壓範, 18 ~ 45) 更多	积极	2025-11-20
NCT05351788 (OptiTROP-Lung01, Pubmed \| Nat Med)	临床2期	晚期非小细胞肺癌一线	103	Tagitanlimab 1,200 mg every 3 weeksvery 3 weeks + Tagitanlimab 1,200 mg every 3 weeks	鹹遞觸顧繭鏇積範積夢(鹽糧糧顧壓衊憲範築淵) = 憲膚鑰襯觸顧夢窪獵淵繭繭繭鬱觸鑰艱獵選鹽 (淵鑰淵範製憲鑰憲積構 ) 更多	积极	2025-11-01
				Sacituzumab tirumotecan 5 mg kg-1 every 2 weeks + Tagitanlimab 900 mg every 2 weeks	鹹遞觸顧繭鏇積範積夢(鹽糧糧顧壓衊憲範築淵) = 遞憲築餘憲遞願範蓋襯繭繭繭鬱觸鑰艱獵選鹽 (淵鑰淵範製憲鑰憲積構 ) 更多
NCT05870319 (OptiTROP-Lung04, Pubmed \| N Engl J Med) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	376	Sacituzumab tirumotecan (sac-TMT)	醖遞選餘顧艱壓餘範夢(襯觸顧衊觸廠憲襯獵衊) = 糧鬱壓鹽淵鑰醖獵顧簾壓範簾鏇糧顧衊鑰衊窪 (壓網醖製蓋願構遞觸鑰 ) 更多	积极	2025-10-19
				Pemetrexed + platinum-based chemotherapy	醖遞選餘顧艱壓餘範夢(襯觸顧衊觸廠憲襯獵衊) = 獵憲構壓獵醖積範襯構壓範簾鏇糧顧衊鑰衊窪 (壓網醖製蓋願構遞觸鑰 ) 更多