Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., has announced that its injectable SHR-A1904 has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration (NMPA) of China [1] Group 1: Industry Context - Gastric cancer is a significant global health issue, ranking fifth in incidence and fourth in mortality worldwide, with approximately 60% of cases occurring in East Asia [1] - In China, gastric cancer is particularly prevalent, with 479,000 new cases and 374,000 deaths reported in 2020, accounting for 44.0% and 48.6% of global gastric cancer incidence and mortality, respectively [1] - The incidence and mortality rates of gastric cancer rank fourth and third among malignant tumors in China, posing a serious threat to public health [1] Group 2: Product Information - SHR-A1904 is a targeted antibody-drug conjugate (ADC) developed by the company, specifically targeting Claudin18.2, with its effective payload being a topoisomerase inhibitor (TOPOi) [2] - Claudin proteins are key components of tight junctions (TJ), maintaining various functions of TJs and stabilizing the intracellular environment [2] - Claudin18.2 is a highly specific cell surface molecule expressed only in differentiated gastric mucosal epithelial cells under normal conditions, but is highly expressed in gastric cancer, pancreatic cancer, and esophageal cancer [2] - Currently, there are no similar products approved for market globally, and the cumulative R&D investment for SHR-A1904 has reached approximately 174 million yuan [2]

Group 1 - The core announcement is that Jiangsu Hengrui Medicine Co., Ltd. and its subsidiary Shanghai Hengrui Medicine Co., Ltd. have had their injectable SHR-A1904 included in the list of breakthrough therapy products by the National Medical Products Administration [1] - Gastric cancer is a significant global health issue, ranking fifth in incidence and fourth in mortality worldwide, with approximately 60% of cases occurring in East Asia. In China, there were 479,000 new cases and 374,000 deaths from gastric cancer in 2020, accounting for 44.0% and 48.6% of global cases and deaths, respectively [1] Group 2 - SHR-A1904 is a targeted antibody-drug conjugate (ADC) developed by the company, specifically targeting Claudin18.2, with an effective payload of topoisomerase inhibitor (TOPOi). Claudin proteins are key components of tight junctions (TJ) that maintain various functions and stability of the intracellular environment [2] - Claudin18.2 is a highly specific cell surface molecule expressed only in differentiated gastric mucosal epithelial cells under normal conditions, but is highly expressed in gastric cancer, pancreatic cancer, and esophageal cancer. Currently, there are no similar products approved for market globally [2] - The cumulative R&D investment for SHR-A1904 has reached approximately 174 million yuan [2]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of its drug SHR-A2102, indicating progress in its oncology pipeline and potential market entry for a new targeted therapy [1] Group 1: Clinical Trials - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. have been authorized to conduct two clinical trials for SHR-A2102 [1] - The first trial will evaluate SHR-A2102 in combination with Vedolizumab for advanced solid tumors [1] - The second trial will assess SHR-A2102 in combination with Atezolizumab or other PD-(L)1 inhibitors for locally advanced or metastatic esophageal cancer in a multicenter, open-label Phase IB/II study [1] Group 2: Product Details - SHR-A2102 is a targeted antibody-drug conjugate (ADC) that targets Nectin-4, with an effective payload of topoisomerase I inhibitor (TOP1i) [1] - Currently, there is one similar product, Enfortumab vedotin (brand name: Padcev), which has been approved and is projected to generate global sales of approximately $1.949 billion in 2024 [1] Group 3: Investment and Development - The total investment in the SHR-A2102 development project has reached approximately 248.22 million yuan [1]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. and its subsidiary Shanghai Hengrui Medicine Co., Ltd. have announced that their injectable SHR-A1904 has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) of China [1] Group 1: Drug Information - Drug Name: Injectable SHR-A1904 [1] - Acceptance Number: CXSL2100034 [1] - Drug Type: Therapeutic biological product [1] - Registration Category: Class 1 [1] - Application Date: November 1, 2025 [1] - Proposed Indication: Locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma positive for CLDN18.2, previously treated with at least one line of systemic therapy [1] Group 2: Regulatory Approval - The application has been reviewed and meets the requirements of the "Drug Registration Management Measures" and the announcement regarding the "Breakthrough Therapy Drug Review Work Procedures (Trial)" issued by the NMPA [1] - The inclusion in the breakthrough therapy program has been approved [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, indicating progress in its drug development pipeline [1] Group 1: Drug Information - Drug Name: SHR-A2102 [1] - Dosage Form: Injectable [1] - Application Type: Clinical trial [1] Group 2: Approval Details - Acceptance Numbers: CXSL2500879, CXSL2500881 [1] - Approval Conclusion: The clinical trial applications for SHR-A2102, submitted on October 13 and 14, 2025, meet the requirements for drug registration and are approved for two clinical trials [1] Group 3: Clinical Trials - The first trial will investigate the combination of SHR-A2102 with Vedolizumab in patients with advanced solid tumors [1] - The second trial will assess the safety, tolerability, and efficacy of SHR-A2102 combined with Atezolizumab or other PD-(L)1 inhibitors, with or without other anti-tumor treatments, in patients with locally advanced or metastatic esophageal cancer [1]

Market Overview - The Shanghai Composite Index rose by 0.53% on December 24, with 26 out of the 28 sectors experiencing gains, led by the defense and electronics sectors, which increased by 2.88% and 2.12% respectively [1] - The pharmaceutical and biological sector saw a modest increase of 0.24% [1] - The agriculture, forestry, animal husbandry, and fishery sectors, along with coal, were the worst performers, declining by 0.85% and 0.70% respectively [1] Capital Flow Analysis - The net inflow of capital in the two markets reached 10.37 billion yuan, with 17 sectors experiencing net inflows [1] - The electronics sector had the highest net inflow, totaling 8.68 billion yuan, coinciding with its 2.12% increase [1] - The power equipment sector also performed well, with a 1.03% increase and a net inflow of 3.76 billion yuan [1] - Conversely, 14 sectors experienced net outflows, with the non-ferrous metals sector leading with a net outflow of 1.635 billion yuan, followed by the basic chemicals sector with 1.212 billion yuan [1] Pharmaceutical and Biological Sector - The pharmaceutical and biological sector increased by 0.24%, but faced a net outflow of 1.141 billion yuan [2] - Out of 479 stocks in this sector, 320 rose while 134 fell, with one stock hitting the daily limit down [2] - The top three stocks with significant net inflows included C Jianxin with 690 million yuan, followed by Hanyu Pharmaceutical and Innovation Medical with 134 million yuan and 68.69 million yuan respectively [2] - The sector's outflow leaders included Hainan Haiyao with a net outflow of 280 million yuan, followed by Heng Rui Pharmaceutical and Luyan Pharmaceutical with 180 million yuan and 136.53 million yuan respectively [4]

证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-206 江苏恒瑞医药股份有限公司 拟定适应症（或功能主治）：既往接受至少一线系统治疗的CLDN18.2阳性的 局部晚期或转移性胃或胃食管交界处腺癌。 理由及依据：经审核，本申请符合《药品注册管理办法》和《国家药监局关 于发布＜突破性治疗药物审评工作程序（试行）＞等三个文件的公告》（2020年 第82号）有关要求，同意纳入突破性治疗药物程序。 关于药物纳入突破性治疗品种名单的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日,江苏恒瑞医药股份有限公司（以下简称"公司"）及子公司上海恒瑞医 药有限公司注射用SHR-A1904被国家药品监督管理局药品审评中心（以下简称"药 审中心"）纳入突破性治疗品种名单。现将相关情况公告如下： 一、药物的基本情况 药物名称：注射用SHR-A1904 受理号：CXSL2100034 药物类型：治疗用生物制品 注册分类：1类 申请日期：2025年11月1日 二、药物的其他相关情况 胃癌在全球范围内是一种重要的癌症，在全球范围内的 ...

审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 10 月 13 日和 14 日受理的注射用 SHR-A2102 临床试验申请符合药品注册的有 关要求，同意本品开展两项临床试验。分别为：本品联合注射用维迪西妥单抗在 晚期实体瘤中开展临床试验；本品联合阿得贝利单抗或其他 PD-(L)1 药物联合或 不联合其他抗肿瘤治疗在局部晚期或转移性食管癌受试者中的安全性、耐受性及 有效性的多中心、开放ⅠB/Ⅱ期临床研究。 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司苏州盛迪亚 生物医药有限公司、上海恒瑞医药有限公司收到国家药品监督管理局（以下简称 "国家药监局"）核准签发关于注射用 SHR-A2102 的《药物临床试验批准通知书》， 将于近期开展临床试验。现将相关情况公告如下： 一、药物的基本情况 药物名称：注射用 SHR-A2102 剂 型：注射剂 申请事项：临床试验 受 理 号：CXSL2 ...

格隆汇12月24日丨恒瑞医药(600276.SH)公布，公司及子公司上海恒瑞医药有限公司注射用SHR-A1904 被国家药品监督管理局药品审评中心（称"药审中心"）纳入突破性治疗品种名单。拟定适应症（或功能 主治）：既往接受至少一线系统治疗的CLDN18.2阳性的局部晚期或转移性胃或胃食管交界处腺癌。 ...

恒瑞医药(600276.SH)发布公告，近日,公司及子公司上海恒瑞医药有限公司注射用SHR-A1904被国家药 品监督管理局药品审评中心纳入突破性治疗品种名单。该药品拟定适应症(或功能主治)：既往接受至少 一线系统治疗的CLDN18.2阳性的局部晚期或转移性胃或胃食管交界处腺癌。 ...