A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

开始日期2025-12-01

申办/合作机构

基石药业

NCT06741644

/ Recruiting临床1期

A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS2009, a Tri-specific Antibody Targeting PD-1/VEGFA/CTLA-4, in Participants With Advanced Solid Tumors

This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.

开始日期2025-02-24

申办/合作机构

基石药业

CTR20232998

/ CompletedN/A

评估受试制剂普拉替尼胶囊（规格：100 mg）与参比制剂普吉华®（规格：100 mg）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两制剂、两序列、四周期、完全重复生物等效性研究

主要试验目的：研究空腹状态下单次口服受试制剂普拉替尼胶囊（规格：100 mg，凯莱英生命科学技术（天津）有限公司生产）与参比制剂普拉替尼胶囊（普吉华®，规格：100 mg；Catalent CTS, LLC生产）在健康受试者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂普拉替尼胶囊（规格：100 mg）和参比制剂普拉替尼胶囊（普吉华®）（规格：100 mg）在健康受试者中的安全性。

开始日期2023-10-30

申办/合作机构

基石药业（苏州）有限公司

100 项与基石药业相关的临床结果

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0 项与基石药业相关的专利（医药）

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项与基石药业相关的文献（医药）

2025-04-15·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

First-Line Sugemalimab Plus Chemotherapy for Advanced Gastric Cancer

Article

作者: Shi, Qingmei ; Shen, Zhenwei ; Liang, Xinjun ; Liao, Wangjun ; Pan, Hongming ; Zhang, Tao ; Sun, Meili ; Shen, Lin ; Gao, Yanrong ; Hou, Anji ; Li, Qi ; Deng, Yanhong ; Zhao, Yunbo ; Xiao, Li ; Wang, Jufeng ; Wang, Qi ; Chen, Yanhua ; Wan, Yiye ; Xie, Zhong ; Liu, Yunpeng ; Luo, Zhanxiong ; Zhang, Li ; Xie, Yanru ; Wang, Gang ; Zhu, Dan ; Yang, Xinhui ; Lu, Chuangxin ; Yang, Jason ; Hu, Changlu ; Lin, Xiaoyan ; Lin, Yan ; Sun, Yinping ; Ji, Yanxia ; Luo, Jie ; Yan, Dong ; Wang, Junye ; Wang, Zishu ; Mou, Yiping ; Yao, Sheng ; Li, Hongxia ; Zhang, Xiaotian ; Zhang, Yanqiao ; Fan, Qingxia ; Zhang, Ruixing ; Shi, Yongquan ; Sun, Sanyuan ; Xiong, Jianping ; Li, Jiayi ; Shu, Yongqian ; Fu, Ting ; Chen, Ping ; Yao, Juntao

Importance:

Gastric cancer, including gastroesophageal junction cancer, is one of the most commonly diagnosed cancers worldwide, with high mortality. Sugemalimab is a fully human anti–programmed death-ligand 1 (PD-L1) antibody. The combination of sugemalimab and chemotherapy showed promising antitumor activity and safety in a phase 1b study among patients with treatment-naive, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. This combination was further evaluated in the GEMSTONE-303 phase 3 trial.

Objective:

To evaluate the efficacy of sugemalimab in combination with capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX as first-line treatment for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 combined positive score (CPS) of 5 or greater.

Design, Setting, and Participants:

GEMSTONE 303 is a phase 3, randomized, double-blind, placebo-controlled study conducted at 54 sites in China that enrolled patients from April 9, 2019, through December 29, 2021, with follow-up to July 9, 2023. A total of 479 eligible patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS of 5 or greater who did not receive any prior systemic therapy were randomized.

Intervention:

Patients received sugemalimab (1200 mg intravenously) (n = 241) or placebo (n = 238) every 3 weeks for up to 24 months, plus CAPOX every 3 weeks for up to 6 cycles.

Main outcomes and Measures:

Primary outcomes were overall survival and investigator-assessed progression-free survival.

Results:

Baseline characteristics were well balanced between the 2 groups. Most patients were male (71.4% in sugemalimab group, 74.8% in placebo group). Median follow-up was 25.1 months in the sugemalimab group and 26.3 months in the placebo group. The sugemalimab group demonstrated significant improvements in overall survival (median, 15.6 months [95% CI, 13.3-17.8] vs 12.6 months [95% CI, 10.6-14.1]; hazard ratio, 0.75 [95% CI, 0.61-0.92]; P = .006) and progression-free survival (median, 7.6 months [95% CI, 6.4-7.9] vs 6.1 months [95% CI, 5.1-6.4]; hazard ratio, 0.66 [95% CI, 0.54-0.81]; P &lt; .001). Grade 3 or higher treatment-related adverse events occurred in 53.9% of patients in the sugemalimab group and 50.6% in the placebo group.

Conclusions and Relevance:

Sugemalimab plus chemotherapy significantly prolonged overall survival and progression-free survival with a manageable safety profile in previously untreated patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03802591

2024-09-01·Targeted Oncology

A Phase 1a/1b Dose Escalation/Expansion Study of the Anti-PD-1 Monoclonal Antibody Nofazinlimab in Chinese Patients with Solid Tumors or Lymphoma

Article

作者: Huang, Gang ; Tse, Archie N ; Zhou, Caicun ; Guo, Ye ; Wang, Ziping ; Li, Wei ; Zhang, Wei ; Zhang, Yanqiao ; Ba, Yi ; Wu, Rachel ; Chen, Tong ; Yang, Haiyan ; Zhou, Yuhong ; Gong, Jifang ; Shen, Lin ; Wang, Mengzhao ; Li, Peiqi ; Dou, Jinzhou ; Cai, Qiqing ; Yue, Zenglian ; Tse, Archie N. ; Cai, Zhongheng ; Su, Rila

BACKGROUND:

Immune checkpoint blockade with anti-programmed cell death 1 (PD-1) antibodies has demonstrated efficacy in multiple tumor types. Nofazinlimab is a humanized rat antibody targeting PD-1. A first-in-human study of nofazinlimab conducted in Australia found no dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) was not reached in the range of 1-10 mg/kg.

OBJECTIVE:

We evaluated nofazinlimab for multiple advanced malignancies in Chinese patients.

PATIENTS AND METHODS:

This was a phase 1a/1b, open-label, multicenter, dose-escalation/expansion trial. In phase 1a, patients received an abbreviated dose escalation of nofazinlimab at 60 mg and 200 mg every 3 weeks (Q3W) to determine DLTs and the recommended phase 2 dose (RP2D). In phase 1b, patients received the RP2D (monotherapy/combination) in six arms by tumor type; DLTs were evaluated for nofazinlimab plus lenvatinib in the unresectable hepatocellular carcinoma (uHCC) arm. Safety (continuously monitored in patients who received nofazinlimab) and efficacy (patients with measurable baseline disease) were assessed.

RESULTS:

Overall, 107 patients were eligible and received nofazinlimab. In phase 1a, no DLTs were observed; the RP2D was 200mg Q3W. In phase 1b, no DLTs were observed with nofazinlimab plus lenvatinib. The safety profile was consistent with that observed in the first-in-human study (NCT03475251). In phase 1b, 21/88 (23.9%) patients achieved confirmed objective responses, 26 (29.5%) had stable disease, and 9/20 (45.0%) patients with uHCC achieved confirmed objective responses to nofazinlimab plus lenvatinib.

CONCLUSIONS:

Nofazinlimab was well tolerated in Chinese patients. Preliminary efficacy was encouraging, particularly for nofazinlimab plus lenvatinib in uHCC, which is being studied in an ongoing phase 3 trial.

CLINICAL TRIAL REGISTRATION:

NCT03809767; registered 18 January 2019.

2024-03-01·CPT: pharmacometrics & systems pharmacology

Tumor growth inhibition‐overall survival modeling in non‐small cell lung cancer: A case study from GEMSTONE‐302

Article

作者: Wang, Hao ; Wang, Jingru ; Tse, Archie N ; Teng, Shu-Wen ; Sheng, Yucheng

Abstract:

Overall survival is vital for approving new anticancer drugs but is often impractical for early‐phase studies. The tumor growth inhibition‐overall survival (TGI‐OS) model could bridge the gap between early‐ and late‐stage development. This study aimed to identify an appropriate TGI‐OS model for patients with non‐small cell lung cancer from the GEMSTONE‐302 study of sugemalimab. We used three TGI models to delineate tumor trajectories and investigated three OS model for linking TGI metric to OS. All three TGI models accurately captured tumor profiles at the individual level. The published atezolizumab‐based TGI‐OS model predicted survival time satisfactorily through simulation‐based evaluation, whereas the other published model built from multi‐treatment underestimated OS. Our study‐specific TGI‐OS model identified time‐to‐growth as the most significant metric with the number of metastatic sites and neutrophil‐to‐lymphocyte ratio at baseline as covariates and exhibited robust OS predictability. Our findings demonstrated the effectiveness of the TGI‐OS models in predicting phase III outcomes, which underpins their value as a powerful tool for antitumor drug development.

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项与基石药业相关的新闻（医药）

2025-07-30

·医药笔记

20.75亿美元：石药集团小分子GLP-1授权给Madrigal Pharmaceuticals

▎Armstrong2025年7月30日，石药集团宣布将小分子GLP-1受体激动剂SYH2086的中国外全球权益授权给Madrigal Pharmaceuticals，后者支付1.2亿美元预付款，19.55亿美元里程碑付款，以及双位数百分比的销售分成。SYH2086目前处于临床前阶段，Madrigal Pharmaceuticals的THR-β激动剂已经获批上市，用于治疗MASH。Madrigal Pharmaceuticals认为GLP-1+THR-β联合治疗进一步巩固其在MASH领域的地位。总结翰森药业的临床前小分子GLP-1授权给默沙东，石药集团的小分子GLP-1授权给Madrigal Pharmaceuticals，中国药企的小分子创新药日益受到国际认可，在临床前阶段即完成高额授权出海合作。石药集团的小分子Lpa同样是在临床前阶段授权给阿斯利康，并在后续与其达成53亿美元AI制药合作。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

2025-07-30

·BioBAY

一日内两款！康宁杰瑞、血霁生物获得FDA孤儿药认定

7月29日，BioBAY园内企业康宁杰瑞JSKN003用于治疗胃癌及胃食管结合部癌、血霁生物XJ-PLT-001用于先天无巨核细胞性血小板减少症获美国食品药品监督管理局（FDA）授予孤儿药资格认定。“孤儿药资格认定”源自《孤儿药法案》（Orphan Drug Act，ODA），是FDA鼓励开发用于治疗在美国患病人数低于20万的疾病的创新药措施。企业获得该认定后将有利于后续在美国的研发、注册与商业化等方面获得相关政策支持，包括研发费用资助、临床研究费用税收减免、处方药用户费用豁免、加速上市审评审批等，以及药物获批后有望获得美国市场的7年独占权。康宁杰瑞：JSKN003JSKN003是康宁杰瑞利用特有的糖基定点偶联平台自主研发的HER2双抗ADC，将抗体分子KN026重链糖基经过酶催化和点击化学反应获得DAR值约为4的定点修饰抗体偶联物，能够结合肿瘤细胞表面的HER2，通过细胞内吞释放拓扑异构酶Ⅰ抑制剂，进而发挥抗肿瘤作用。JSKN003较同类ADC药物具有更好的血清稳定性、更强的旁观者杀伤效应，有效地扩大了治疗窗。往期研发数据显示，JSKN003耐受性和安全性良好，在既往接受过多线系统性抗肿瘤治疗后的多种晚期实体瘤患者中疗效明显，尤其在HER2高表达的胃肠道肿瘤患者中具有良好的抗肿瘤活性。2024年9月，康宁杰瑞与石药集团（股票代码：1093.HK）全资子公司上海津曼特生物科技有限公司（以下简称“津曼特生物”）达成授权合作，根据协议条款，津曼特生物科技将获得在中国内地（不包括香港、澳门及台湾地区）开发、销售、许诺销售及商业化JSKN003用于治疗肿瘤相关适应症的独家许可及再许可权，并成为JSKN003肿瘤相关适应症在中国内地的唯一上市许可持有人（MAH）。康宁杰瑞将有权收取最高共计30.8亿元人民币的首付款和里程碑付款，以及根据监管审批进展收取的监管里程碑付款和销售里程碑付款。（相关阅读：30.8亿元！康宁杰瑞与石药集团就HER2双抗ADC药物JSKN003达成中国内地授权合作）血霁生物：XJ-PLT-001XJ-PLT-001是血霁生物以造血干细胞作为源头细胞，未经任何基因编辑，通过无血清、无饲养层细胞、无永生化操作、无杂细胞残留的定向诱导分化体系产生高质量、大规模、稳定可控的血小板细胞。该血小板细胞安全稳定、成熟度高、无传染病风险、无致瘤风险，符合血液输注用于不同年龄段、用于不同疾病的诉求，不需要多年随访畸胎瘤，是全球首个获得FDA的ODD认定的血小板注射液产品。一直以来，BioBAY始终坚持创新发展理念，紧跟国际生物医药技术前沿开展产业培育。聚焦创新药物、高端医疗器械、大健康等重点领域，前瞻布局细胞和基因技术、核酸药物、ITBT、合成生物等未来产业方向，建设运营全国生物医药领域首个国家技术创新中心（国家生物药技术创新中心，简称NCTIB），全力打造世界级生物医药产业地标。在新药研发领域，BioBAY园内已有包括信达生物、百济神州、基石药业在内的多家企业获孤儿药认证。与此同时，生物医药产业园入驻企业已累计获得临床试验批件765张，累计批准生产上市药品52件，16款创新药产品已相继进入国家医保目录。未来，BioBAY将紧扣创新药驱动战略，紧密对接国家医药创新布局，勇担使命。在汇聚优质资源、培育战略科技力量、提高原始创新能力、攻克关键核心技术、加速科技成果转化等方面不断取得新突破，推动新质生产力加快发展，助力建设开放创新的世界一流高科技园区。▌文章来源：康宁杰瑞、血霁生物责编：于嘉敏审核：任旭推荐阅读上半年利润同比增长超47倍！和铂医药发布2025年度上半年正面盈利预告百赛飞完成新一轮融资，全面驶入医用涂层应用全球化快车道引航生物再获超亿元融资，加速全球新品商业化

抗体药物偶联物孤儿药引进/卖出

2025-07-29

·医药笔记

MCE出海里程碑：泽安生物医药与礼来合作开发自免新药

▎Armstrong2025年7月29日，泽安生物医药宣布与礼来达成重大战略合作，针对特定靶点开发髓系细胞衔接器（MCE）新药，用于治疗自身免疫性疾病。根据合作协议，礼来支付数千万美元预付款，并得到礼来的股权投资，泽安生物医药还有资格获得潜在里程碑付款和一定比例的销售分成。不同于TCE，MCE通过募集髓系细胞来杀伤靶细胞，髓系细胞在肿瘤组织中占比更多，在细胞因子释放profile相比于TCE也具有更好的安全性，因此有很大的潜力拓展至自免领域。泽安生物医药研发管线如下，包括用于血液瘤/自免的CD79 MCE、实体瘤的多EpCAM MCE等新药。总结MNC已经纷纷意识到MCE对于肿瘤和自免领域的巨大潜力，诺华与Dren Bio合作开发治疗肿瘤的MCE药物，合作总金额高达30亿美元，赛诺菲引进Dren Bio的CD20靶向MCE，预付款高达6亿美元，合作总金额高达19亿美元。泽安生物医药的MCE新药已经处于临床阶段，此次其技术平台获得礼来的认可，开发自免领域的MCE新药，标志着MCE出海的里程碑。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

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