A Multicenter, Prospective, Open-label, Randomized Controlled, Phase II Clinical Trial Comparing the Efficacy of Sintilimab Plus Nab-POF Regimen, Sintilimab Plus XELOX Chemotherapy, and Lenvatinib, Sintilimab Plus XELOX Chemotherapy in the Treatment of HER2-negative, Metastatic Gastric Cancer

This trial is a prospective, open, randomized, phase II clinical study. It compares the current first-line treatment for advanced gastric cancer in phase II clinical trials, with the best efficacy being the combination of orient-16 study with sintilimab and XELOX regimen. The purpose of this study is to evaluate whether adding anti-angiogenic drugs or chemotherapy drugs on the basis of two-drug chemotherapy regimen (XELOX regimen) and PD-1 monoclonal antibody can improve efficacy for advanced gastric cancer.

开始日期2024-12-25

申办/合作机构

复旦大学

CTR20242613

/ Recruiting临床1/2期

评价抗PD-1和LAG-3双特异性抗体AK129联合化疗联合或不联合卡度尼利单抗在不可手术切除的局部晚期或转移性HER2阴性胃癌或胃食管结合部腺癌患者中的安全性、耐受性和初步抗肿瘤疗效的Ib/II 期，开放性，剂量递增和剂量扩展研究

主要目的：评估AK129联合化疗联合或不联合卡度尼利单抗在不可手术切除的局部晚期或转移性HER2阴性胃癌或胃食管结合部腺癌患者中的安全性、耐受性。评估AK129联合化疗联合或不联合卡度尼利单抗在不可手术切除的局部晚期或转移性HER2阴性胃癌或胃食管结合部腺癌患者中的初步抗肿瘤疗效。次要目的：评估AK129联合化疗联合或不联合卡度尼利单抗在不可手术切除的局部晚期或转移性 HER2 阴性胃癌或胃食管结合部腺癌患者中的初步抗肿瘤疗效。评价AK129联合化疗/联合或不联合卡度尼利单抗时的药代动力学（PK）特征。评价AK129联合化疗/联合或不联合联合卡度尼利单抗时的免疫原性。探索性目的：探索AK129在联合化疗/联合或不联合卡度尼利单抗时的药效动力学特征。探索受试者肿瘤组织中与抗肿瘤疗效相关的潜在生物标志物。

开始日期2024-09-26

申办/合作机构

中山康方生物医药有限公司

[+2]

ChiCTR2400089076

/ Suspended临床2期IIT

The role of low-dose radiotherapy in maintenance therapy after first-line treatment of HER2-negative advanced gastric cancer

开始日期2024-09-01

申办/合作机构-

100 项与 HER2阴性胃癌相关的临床结果

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100 项与 HER2阴性胃癌相关的转化医学

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0 项与 HER2阴性胃癌相关的专利（医药）

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项与 HER2阴性胃癌相关的文献（医药）

2025-05-01·Advances in Therapy

First-Line Tislelizumab Plus Chemotherapy for Advanced Gastric Cancer with Programmed Death-Ligand 1 Expression ≥ 1%: A Retrospective Analysis of RATIONALE-305

Article

作者: Kato, Ken ; Wyrwicz, Lucjan ; Kadva, Alysha ; Tabernero, Josep ; Xu, Yaling ; Oh, Do-Youn ; Arkenau, Tobias ; Lee, Keun-Wook ; Hirano, Hidekazu ; Cruz-Correa, Marcia ; Yamaguchi, Kensei ; Sheng, Tao ; Yang, Silu ; Xu, Rui-Hua ; Moehler, Markus ; Spigel, David ; Pazo-Cid, Roberto A ; Fornaro, Lorenzo ; Disel, Umut ; Rha, Sun Young

INTRODUCTIONTislelizumab plus investigator-chosen chemotherapy (ICC) demonstrated a statistically significant improvement in overall survival (OS) versus placebo plus ICC in RATIONALE-305 in patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric cancer/gastroesophageal junction cancer (GC/GEJC) in the intent-to-treat population and in patients with programmed death-ligand 1 (PD-L1) Tumor Area Positivity (TAP) score ≥ 5%. The United States Food and Drug Administration Oncologic Drugs Advisory Committee voted (September 2024) against first-line treatment with programmed cell death protein-1 inhibitors in this setting in patients with a PD-L1 combined positive score < 1 or TAP score < 1%, due to an unfavorable benefit-risk profile. Thus, we retrospectively analyzed data from RATIONALE-305 in patients with a PD-L1 TAP score ≥ 1%.METHODSAdult patients with locally advanced unresectable or metastatic HER2-negative GC/GEJC were randomized to tislelizumab 200 mg or placebo with ICC every 3 weeks. Efficacy and safety outcomes of tislelizumab plus ICC versus placebo plus ICC were retrospectively assessed in those with a PD-L1 TAP score ≥ 1%.RESULTSAt the final analysis cutoff (February 28, 2023), 432 patients received tislelizumab plus ICC and 453 received placebo plus ICC, and had a PD-L1 TAP score ≥ 1%. Clinically meaningful improvements to OS were observed with tislelizumab plus ICC compared with placebo plus ICC [15.0 months (95% confidence interval [CI] 13.3-16.7) vs. 12.8 months (95% CI 12.1-14.1), respectively; stratified hazard ratio 0.77 (95% CI 0.67-0.90)]. Progression-free survival, overall response rate, duration of response, and disease control rate, were also improved. OS improvements were maintained at a 3-year data cutoff (February 28, 2024). Tislelizumab plus ICC had an acceptable safety profile with no new safety signals.CONCLUSIONSTislelizumab plus ICC is an effective and tolerable first-line treatment for patients with locally advanced unresectable or metastatic HER2-negative GC/GEJC with a PD-L1 TAP score ≥ 1%.TRIAL REGISTRATION NUMBERNCT03777657.

2025-04-01·Nature Medicine

First-line cadonilimab plus chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma: a randomized, double-blind, phase 3 trial

Article

作者: Wan, Lixin ; Ba, Yi ; Liu, Zhenyang ; Pan, Hongming ; Yao, Zhifang ; Guo, Zengqing ; Li, Baiyong ; Chen, Ye ; Wang, Meiqing ; Liu, Bo ; Li, Changzheng ; Xu, Nong ; Hu, Mingxiu ; Zhang, Tao ; Zhang, Futong ; Zhang, Jinghua ; Zhang, Xiaotian ; Zhou, Yongjian ; Wang, Zejun ; Li, Wei ; Xia, Michelle ; Liu, Ming ; Zhang, Jingdong ; Yu, Guohua ; Qu, Xiujuan ; Wang, Ying ; Jin, Jianying ; Sheng, Lili ; Li, Ning ; Gu, Kangsheng ; Zhang, Ruixing ; Bai, Yuansong ; Li, Wenxin ; Liu, Wei ; Xu, Jiye ; Xu, Huiting ; Xu, Hongyan ; Chen, Hao ; Zhuang, Zhixiang ; Pardoll, Drew M ; Nie, Peng ; Gao, Xiangyu ; Guo, Jun ; Zhao, Xuehong ; Huang, Mingwei ; Xie, Ming ; Yuan, Yuan ; Qiu, Wensheng ; Wang, Yusheng ; Zhang, Jiajia ; Zhao, Jun ; Zeng, Shan ; Wu, Guowu ; Wang, Zhongmin Maxwell ; Lu, Dongmei ; Tang, Yong ; Liu, Haiyan ; Wang, Weibo ; Zang, Aimin ; He, Yifu ; Liu, Zheng ; Ying, Xiangji ; Wei, Jia ; Wang, Zhenghua ; Huang, Mingzhu ; Zhang, Yanqiao ; Lin, Lizhu ; Zhang, Xizhi ; Sun, Shujuan ; Li, Xiaoqin ; Gao, Yong ; Zheng, Zhendong ; Wang, Daqing ; Fang, Xuefeng ; Ji, Jiafu ; Xie, Lin ; Li, Ziyu ; Liu, Lian ; Li, Qingshan ; Dai, Wenxiang ; Shen, Lin ; Ying, Jieer ; Zhang, Minghui ; Kang, Mafei ; Cao, Bangwei ; Chen, Jian ; Liu, Mulin ; Liu, Hao ; Fu, Yang ; Zhong, Diansheng

Programmed cell death protein-1 (PD-1) inhibitors plus chemotherapy have been the standard of care in the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma; however, the survival benefits are modest in patients with low programmed death ligand 1 (PD-L1) expression. Here we investigated the efficacy and safety of cadonilimab (PD-1/cytotoxic T lymphocyte antigen-4 (CTLA-4) bispecific antibody) plus chemotherapy as first-line treatment in G/GEJ adenocarcinoma. The prespecified interim analysis is reported here. This was a randomized, double-blind, placebo-controlled phase 3 study. Eligible patients were adults with untreated, unresectable, locally advanced or metastatic G/GEJ adenocarcinoma. Patients were randomized 1:1 to receive cadonilimab (10 mg kg^-1 every 3 weeks) or placebo plus chemotherapy (every 3 weeks). The primary endpoint was overall survival (OS) in the intention-to-treat population (one-sided significance level, P = 0.025). Secondary endpoints included OS in patients with a PD-L1 combined positive score ≥5, progression-free survival, objective response rate, duration of response and safety. As of 18 August 2023, 610 patients from 75 study centers were randomized to cadonilimab (n = 305) or placebo (n = 305). With a median follow-up of 18.7 months, the cadonilimab group had a significantly longer median OS (14.1 versus 11.1 months; hazard ratio (HR) 0.66; 95% confidence interval (CI) 0.54-0.81; P < 0.001) than the placebo group. The primary endpoint was met. The median progression-free survival was 7.0 months versus 5.3 months (HR 0.53, 95% CI 0.44-0.65). The median OS in patients with a PD-L1 combined positive score ≥5 was 15.3 months versus 10.9 months (HR 0.58, 95% CI 0.41-0.82). The objective response rate was 65.2% versus 48.9% with a median duration of response of 8.8 months versus 4.4 months. Grade ≥3 treatment-related adverse events occurred in 65.9% of the cadonilimab group and 53.6% of the placebo group, and the most common were decreased platelet count, decreased neutrophil count and anemia. Most of the immune-related adverse events were grade 1 or 2. No new safety signals were observed. Cadonilimab plus chemotherapy significantly improved OS with a manageable safety profile in patients with advanced G/GEJ adenocarcinoma. ClinicalTrials.gov registration: NCT05008783 .

2025-04-01·Advances in Therapy

First-Line Pembrolizumab Plus Chemotherapy for HER2-Negative Advanced Gastric Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-859 Study

Article

作者: Bai, Yuxian ; Ye, Feng ; Ying, Jieer ; Zuo, Yi ; Yang, Lin ; Liang, Xinjun ; Yang, Jianwei ; Li, Wei ; Chen, Xi ; Bordia, Sonal ; Luo, Suxia ; Lin, Xiaoyan ; Qu, Yanli ; Mao, Yixiang ; Pan, Hongming ; Li, Shouguo ; Liu, Tianshu ; Zhao, Lin ; Guo, Run ; Qin, Shukui ; Li, Jin

INTRODUCTIONResults of the global, randomized, phase 3 KEYNOTE-859 study (N = 1579) showed that first-line pembrolizumab plus chemotherapy produced a statistically significant and clinically meaningful improvement in overall survival (OS) with manageable toxicity versus placebo plus chemotherapy in patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction cancer. This subgroup analysis was conducted to investigate outcomes in patients enrolled in mainland China.METHODSAdults with previously untreated advanced or metastatic HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma were randomly assigned (1:1) to receive pembrolizumab or placebo with fluoropyrimidine- and platinum-containing chemotherapy. The primary outcome was OS. Secondary outcomes included progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR), all assessed per RECIST v1.1 by blinded independent central review, and safety.RESULTSOverall, 236 patients were enrolled in mainland China (126 pembrolizumab plus chemotherapy; 110 placebo plus chemotherapy). Median time from randomization to database cutoff (October 3, 2022) was 24.7 months (range 15.3-38.9). Median OS was 15.9 months (95% confidence interval [CI] 13.2-19.2) for pembrolizumab plus chemotherapy versus 12.2 months (95% CI 10.6-14.1) for placebo plus chemotherapy (hazard ratio [HR], 0.68; 95% CI 0.50-0.91). Median PFS was 8.1 months (95% CI 6.9-9.6) for pembrolizumab plus chemotherapy versus 5.7 months (95% CI 4.5-6.5) for placebo plus chemotherapy (HR, 0.65; 95% CI 0.48-0.88). ORR was 69.0% for pembrolizumab plus chemotherapy versus 45.5% for placebo plus chemotherapy; median DOR was 8.2 months (range 1.2+ to 34.6+) versus 5.5 months (range 1.3+ to 31.2+), respectively. Grade 3-5 treatment-related adverse events occurred in 82 patients (65.6%) treated with pembrolizumab plus chemotherapy and 54 patients (49.1%) treated with placebo plus chemotherapy.CONCLUSIONConsistent with efficacy in the overall population from KEYNOTE-859, first-line pembrolizumab plus chemotherapy showed improved efficacy, versus placebo plus chemotherapy, and manageable safety in patients enrolled in mainland China.TRIAL REGISTRATIONClinicaltrials.gov: NCT03675737.

项与 HER2阴性胃癌相关的新闻（医药）

2025-04-22

·摩熵医药

人福出手了！从麻醉龙头到抗癌新贵，抢攻1200亿市场

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近日，人福医药集团旗下武汉人福创新药物研发中心申报的1类新药HWS116注射液获批临床，拟用于治疗晚期实体瘤。据透露，其在HWS116项目中的研发投入现约为3800万元。此次临床试验申请获批，将有力推动其在肿瘤领域创新产品管线的进一步拓展。HWS116是一款靶向FGFR2b的人源化单克隆抗体，通过阻断成纤维细胞生长因子受体介导的信号通路抑制肿瘤生长，并通过其Fc介导的抗体依赖性细胞介导的细胞毒性作用（ADCC）和吞噬作用（ADCP）杀伤肿瘤细胞。FGFR2b的过表达与胃癌、乳腺癌、肝内胆管癌等高侵袭性肿瘤密切相关，约30%的HER2阴性晚期胃癌患者中存在FGFR2b过表达。开发靶向FGFR2b的疗法，有助于实现FGFR2b过表达癌症患者的精准治疗。人福医药集团医药研究院已完成HWS116注射液的药学、药理毒理研究、临床设计及注册申报等工作，并于2025年2月向国家药品监督管理局药品审评中心提交临床试验申请并获得受理。HWS116注射液审评时间轴截图来源：摩熵医药中国药品审评数据库临床前数据显示，HWS116能显著抑制FGFR2b高表达的多种小鼠皮下移植瘤生长，抑瘤效果优于同靶点药物Bemarituzumab，毒理学研究表明本品安全性良好。摩熵医药数据显示，近年来中国医院全终端市场抗肿瘤药（化药+生物药）销售额均达千亿规模，2023年超过1200亿元，同比增长5.60%；2024年Q1~Q2以7.67%的增速增长至近650亿元。截图来源：摩熵医药全国医院销售（全终端）数据库在抗肿瘤药领域，人福医药拥有5个生产批文（在使用），涉及塞来昔布胶囊、卡莫氟、乙磺酸尼达尼布软胶囊、注射用盐酸尼莫司汀等4个品种。据不完全统计，目前人福医药有4款抗肿瘤1类新药在国内处于I期临床及以上阶段，涵盖乳腺肿瘤、肺癌、前列腺癌等适应症。人福医药抗肿瘤药领域生产批文信息截图来源：摩熵医药中国药品批文数据库近年来，人福医药坚持研发创新和国际化拓展，加快核心领域的创新药项目研发。摩熵医药数据库显示，今年以来，人福医药已有1类新药CXJM-66注射液、2类改良型新药RFUS-301注射剂获批临床，均为神经系统药物。CXJM-66注射液为宜昌人福自主研发的新分子实体，临床拟用于手术麻醉术后镇痛。RFUS-301注射剂是一款改良型术后镇痛药物，国内目前尚无同类型产品上市。自1997年上市以来，人福医药在国内麻醉、镇痛的神经系统用药领域一直盘踞在行业龙头的位置，且不断地深挖护城河。其芬太尼系列、氢吗啡酮等神经系统药物核心产品，市占率可谓一骑绝尘。2023年注射盐酸瑞芬太尼全国医院终端市场销售额超42亿元，人福医药核心子公司宜昌人福医药市场占比超过八成。截图来源：摩熵医药全国医院销售（全终端）数据库截至目前，人福医药及其子公司拥有649个药品生产批文（在使用），其中59个独家品规产品，158个品规产品被纳入国家基药目录，254个品种被纳入国家医保目录，同时还拥有230多个FDA批准的ANDA（简化新药申请）文号。END本文为原创文章，转载请留言获取授权近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

申请上市抗体药物偶联物临床1期临床申请

2025-04-21

·同写意

人福医药生物制品1类创新药HWS116注射液获批临床丨会员动态

抗体药物偶联物申请上市临床申请临床1期

2025-04-10

·药事纵横

精准打击实体瘤！！先声药业FGFR2b靶向ADC药物SIM0686获批临床

2025年4月9日，国家药品监督管理局药品审评中心（CDE）官网公示的信息显示，先声药业集团旗下先祥医药申报的1类新药注射用SIM0686获批临床，拟用于治疗FGFR2b阳性的局部晚期或转移性实体瘤。图源：CDE官网作为一款靶向FGFR2b的ADC药物，SIM0686的临床开发方向聚焦于胃癌、肺癌等晚期恶性肿瘤的治疗，这也是该药物在中国首次获得临床试验批准（IND），距离其前代产品SIM0505（靶向CDH6的ADC）于2025年1月获批IND仅过去三个月，凸显了公司在ADC赛道的加速布局。FGFR2b作为FGFR家族的重要亚型，其异常表达与多种实体瘤的发生发展密切相关。研究表明，FGFR2b在胃癌、非小细胞肺癌和乳腺癌中存在过表达或基因扩增，这种异常激活通过促进细胞增殖、抑制凋亡、诱导血管生成等多重机制驱动肿瘤进展。与FGFR家族其他成员（如FGFR1、FGFR3）相比，FGFR2b在组织分布上更具特异性，主要表达于上皮细胞，这为开发靶向治疗提供了潜在的治疗窗口。既往针对FGFR通路的抑制剂多为小分子酪氨酸激酶抑制剂（TKI），如厄达替尼（Erdafitinib）和培米替尼（Pemigatinib），这类药物虽在胆管癌等适应症中展现出疗效，但受限于对FGFR亚型的选择性不足，易引发高磷血症、视网膜病变等靶点相关毒性，且耐药机制复杂。相较之下，SIM0686采用的ADC技术路径具有双重优势：其一，通过抗体部分特异性识别FGFR2b抗原，可精准区分肿瘤与正常组织，降低脱靶毒性；其二，借助连接子-载荷系统实现细胞毒药物的定点递送，理论上可突破传统化疗的系统毒性瓶颈，并克服TKI类药物因旁路激活导致的耐药问题。SIM0686的首个适应症锁定FGFR2b阳性局部晚期/转移性实体瘤，这一设计体现了"篮子试验"（Basket Trial）的先进理念，即基于生物标志物而非传统解剖学类筛选患者，可加速药物在多个瘤种中的疗效验证。根据中国国家癌症中心2023年统计数据，胃癌和肺癌年新发病例分别达48.3万和87.6万，其中约60%的胃癌患者确诊时已处于晚期，五年生存率不足30%。尽管PD-1/PD-L1抑制剂联合化疗已成为一线治疗标准，但总体应答率徘徊在40%-60%，且获得性耐药问题突出。针对HER2阴性胃癌（占全部胃癌的80%），现有治疗手段更为有限。SIM0686若能在FGFR2b阳性人群中验证疗效，有望填补这一空白。在肺癌领域，虽然EGFR、ALK等驱动基因靶向治疗已取得长足进步，但仍有大量患者缺乏有效治疗靶点。临床前研究显示，FGFR2b过表达与EGFR-TKI耐药相关，提示SIM0686可能具备逆转耐药或联合用药的潜力。此外，考虑到ADC药物在晚期线治疗中的突破性表现（如DS-8201在HER2低表达乳腺癌中的获批），SIM0686的临床开发可能采取"后线单药探索→前线联合拓展"的双路径策略，初期聚焦经治患者，后续逐步向一线治疗、辅助治疗等场景延伸。全球范围内，FGFR2b靶向药物研发尚处早期阶段。Boehringer Ingelheim的FGFR2b单抗Bemarituzumab是当前进展最快的竞品，其II期FIGHT试验显示，在FGFR2b过表达（免疫组化≥10%）、HER2阴性胃癌患者中，联合化疗组中位总生存期（OS）达19.2个月，较对照组延长6.9个月（HR=0.60）。2024年3月，该药物已获FDA突破性疗法认定。与此相比，SIM0686作为ADC药物，在作用机制上具有显著差异：Bemarituzumab通过阻断FGF7/10配体与FGFR2b结合抑制下游信号通路，属于"单纯抑制型"疗法；而SIM0686则通过抗体介导的内吞作用将细胞毒药物定向递送至肿瘤细胞，实现"靶向杀伤"。这种机制差异可能带来疗效优势，尤其是在肿瘤微环境复杂、旁路信号活跃的患者中。从市场维度看，先声药业在本土化开发方面具备战略先机。中国胃癌患者中FGFR2b阳性比例（约25%-30%）相对较高，且目前国内尚无靶向FGFR2b药物获批，SIM0686有望依托快速临床推进抢占市场窗口期。另一方面，跨国药企如阿斯利康、第一三共等虽在ADC领域领先，但其管线多集中于HER2、TROP2等成熟靶点，FGFR2b作为新兴靶点的竞争压力相对较小，这为SIM0686创造了差异化发展空间。根据证券之星数据，先声药业港股当前市值约188亿港元，位列化学制药行业第七，且近90天内6家投行给予“买入”评级，目标均价9.83港元，反映资本市场对其研发管线的认可。ADC赛道近年来持续升温，2024年全球ADC市场规模已突破200亿美元，年复合增长率超过20%，而FGFR靶向药物作为细分领域，预计到2030年将占据抗肿瘤药物市场的显著份额。先声药业通过SIM0505与SIM0686的双线布局，不仅覆盖了CDH6（在卵巢癌、肾癌中高表达）与FGFR2b两大靶点，同时与国内外生物技术公司、科研院校建立合作，加速管线推进。近年来，国家药监局通过优先审评、附条件批准等政策工具，显著缩短了创新药的审评周期。例如，SIM0686从IND提交至获批仅用时数月，与全球监管机构的高效审评体系接轨。此外，国内药企在ADC领域的集体发力（如荣昌生物的维迪西妥单抗、科伦博泰的SKB264）已形成集群效应，推动中国从“仿制大国”向“创新高地”转型。然而，挑战依然存在：一方面，全球ADC研发同质化竞争加剧，靶点扎堆（如HER2、TROP2）可能导致市场饱和；另一方面，生产工艺复杂性和质量控制要求高，对企业的CMC（化学、制造与控制）能力提出严峻考验。SIM0686的临床开发仅是万里长征的第一步。若其能顺利通过I期安全性验证，并在II期试验中展现出优于现有疗法的生存获益，有望成为晚期胃癌二线治疗或肺癌靶向治疗的新选择。从更宏观的视角看，先声药业的案例印证了中国药企从“Fast Follow”到“First-in-Class”的转型潜力，但其成功仍需依赖持续的高研发投入、临床试验设计的科学性，以及国际化布局的能力。信息来源：［1］先声药业集团自愿公告 – SIM0686（FGFR2b抗体偶联药物）获国家药品监督管理局签发药物临床试验批准通知书[公告]. 中财网. http://www.cfi.cn/newspage.aspx?id=20250410000544［2］证券之星.先声药业FGFR2b抗体偶联药物拟开展晚期实体瘤临床试验.证券之星股票频道. http://stock.stockstar.com/IG2025041000005246.shtml药事纵横投稿须知：稿费已上调，欢迎投稿

抗体药物偶联物临床申请