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。 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd., have received approval from the National Medical Products Administration for the clinical trial of SHR-A2102, which will commence shortly [1] Group 1: Clinical Trial Approval - The clinical trial application for SHR-A2102 was accepted on October 13 and 14, 2025, and meets the requirements for drug registration [1] - Two clinical trials will be conducted: one involving SHR-A2102 in combination with Vedolizumab for advanced solid tumors, and the other involving SHR-A2102 in combination with Atezolizumab or other PD-(L)1 inhibitors for locally advanced or metastatic esophageal cancer [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has announced that its injectable SHR-A1904 has been included in the list of breakthrough therapies by the National Medical Products Administration's Drug Evaluation Center, targeting CLDN18.2 positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after at least one line of systemic therapy [1] Group 1 - The company and its subsidiary, Shanghai Heng Rui Medicine Co., Ltd., are advancing their drug development with SHR-A1904 being recognized as a breakthrough therapy [1] - The targeted indication for SHR-A1904 is for patients with CLDN18.2 positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma [1] - The inclusion in the breakthrough therapy list may expedite the development and approval process for SHR-A1904, potentially enhancing the company's market position [1]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. received approval from the National Medical Products Administration for the clinical trial of SHR-A2102, a targeted antibody-drug conjugate [1] Group 1 - SHR-A2102 is a self-developed drug targeting Nectin-4, with an effective payload of topoisomerase I inhibitor (TOP1i) [1] - Currently, there is only one similar product approved globally, Enfortumab vedotin (brand name: Padcev) [1]

Group 1: Industry Overview - In October, the total sales of pharmaceutical products in mainland China decreased by 3% year-on-year, a significant drop from the 6.8% growth in September [1] - Hospital channel sales fell by 3.3% year-on-year, compared to a 7.1% increase in the previous month [1] - Retail channel sales remained flat year-on-year, a slowdown from the 2.4% growth in September [1] Group 2: Company Performance - Hansoh Pharmaceutical (03692) recorded the highest year-on-year growth among peers in October at 8.6%, with most key products showing double-digit month-on-month growth, except for PEG-loxenatide [1] - The report maintains a "Buy" rating for Hansoh Pharmaceutical with a target price of HKD 45 [1] - Hengrui Medicine (01276) faced pressure on multiple key products, with total sample sales growing by only 2% year-on-year in October, and specific products like butorphanol, ioversol, and sevoflurane seeing declines of 49.1%, 0.5%, and 10.8% respectively [1] - Hengrui's A-share target price is set at RMB 57.7, with a "Underperform" rating [1] Group 3: Additional Company Insights - China Biologic Products (01177) showed a mixed performance in October, with core products anlotinib and glycyrrhizic acid growing by 6.5% and 4.4% year-on-year, while budesonide and esomeprazole saw declines of 28.5% and 39.4% respectively [2] - The revenue forecasts for 2026 and 2027 were lowered by 0.2% and 0.4% respectively due to the sales performance, with the target price adjusted from HKD 9.4 to HKD 8.3, while maintaining a "Buy" rating based on pipeline potential [2] - CSPC Pharmaceutical Group (01093) continued to experience low sales for several key drugs, maintaining an "Underperform" rating with a target price of HKD 7.2 [2]

Core Insights - In 2025, China's innovative drug sector is experiencing a significant surge, with 43 innovative drugs approved in the first half of the year, nearing the total approvals for 2024 [1] - China now accounts for approximately one-fourth of the global innovative drug R&D pipeline, conducting around 3,000 clinical trials annually, placing it among the world's leaders [1] - The total amount for external licensing of Chinese innovative drugs has surpassed $100 billion in the first three quarters of 2025, indicating a strong market potential and heightened interest from capital markets [1] Industry Overview - The Chinese innovative drug industry is reshaping the global biopharmaceutical landscape, transitioning from a "Fast-follower" role to a "First-in-class" and "Best-in-class" approach, led by companies like Hengrui [2] - The approval speed and innovation quality of Chinese drugs have significantly improved, with a nearly 60% year-on-year increase in new drug approvals in the first half of 2025 [3] - China has become a major source of global pharmaceutical innovation, with the number of new drug molecules designed in China surpassing those from the US and Europe for the first time in 2024 [3] Hengrui Pharmaceutical's Strategy - Hengrui's innovation strategy focuses on unmet clinical needs, utilizing new technologies to enhance patient care while maintaining a commitment to both domestic and international growth [1][4] - The company has established a comprehensive R&D strategy that includes targeting high-prevalence diseases, utilizing modular technology platforms, and creating a multi-layered chronic disease management system [4] - Hengrui's R&D efforts cover various advanced technology platforms, including ADCs, bispecific/multispecific antibodies, and small nucleic acid drugs, with a focus on continuous innovation and collaboration [4] Key Developments - Hengrui has achieved significant milestones in the oncology sector, developing a comprehensive therapeutic ecosystem that includes precision therapy, immunotherapy, and targeted chemotherapy [5] - The company has also made strides in non-oncology areas, such as obesity treatment, by addressing existing therapy limitations with innovative dual-mode solutions [5] - In 2025, Hengrui's external licensing transactions exceeded $28 billion, reflecting the growing recognition of Chinese drug design capabilities and clinical data quality [6][10] Notable Collaborations - Hengrui's collaboration with GlaxoSmithKline (GSK) involved a record-breaking deal covering 12 innovative projects, with an upfront payment of $500 million and potential total payments of approximately $12 billion [7] - This partnership highlights the increasing value of Chinese innovation and Hengrui's strong R&D capabilities, with the company investing over $50 billion in R&D to date [7][10] Market Position and Future Outlook - Hengrui's market position has strengthened, with its innovative drug revenue surpassing half of its total income, and it ranks first in China for the number of projects under development [9] - The company is expected to continue its international expansion, with plans for over 10 innovative drugs and around 20 new indications to be approved domestically in the next two years [8] - The overall trend indicates a shift towards building a sustainable innovation ecosystem that enhances global competitiveness for Chinese pharmaceutical companies [10][11]