Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injectable Rikan Trastuzumab, marking a significant step in the development of new cancer therapies [1][2]. Group 1: Clinical Trial Approval - The clinical trial application for injectable Rikan Trastuzumab (SHR-A1811) was approved, allowing for a Phase III study comparing it to a combination of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab for the treatment of early or locally advanced HER2-positive breast cancer [1][2]. - The approval was based on compliance with the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1]. Group 2: Product Mechanism and Market Context - Injectable Rikan Trastuzumab works by binding to HER2-expressing tumor cells, inducing apoptosis through the release of toxins within the cells [2]. - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which have been approved in China [2]. - The global sales of similar products are projected to reach approximately $6.557 billion in 2024, indicating a robust market for HER2-targeted therapies [2]. - The cumulative R&D investment for injectable Rikan Trastuzumab has reached approximately 141.475 million yuan [2].

Core Viewpoint - The Medical Health Index (980016) closed at 6646.6 points, down 0.3%, with a trading volume of 19.922 billion yuan and a turnover rate of 0.75% on October 23 [1] Group 1: Index Performance - Among the constituent stocks of the Medical Health Index, 16 stocks rose while 31 stocks fell, with Kanglong Chemical leading the gainers at 1.55% and Te Bao Biological leading the decliners at 6.07% [1] - The top ten constituent stocks of the Medical Health Index include: - WuXi AppTec (14.37% weight, latest price 101.90, market cap 304.045 billion yuan) - Hengrui Medicine (11.45% weight, latest price 65.14, market cap 432.347 billion yuan) - Mindray Medical (8.07% weight, latest price 221.80, market cap 268.920 billion yuan) [1] Group 2: Capital Flow - The net outflow of main funds from the constituent stocks of the Medical Health Index totaled 1.072 billion yuan, while retail investors saw a net inflow of 955 million yuan [3] - Detailed capital flow for key stocks includes: - Mindray Medical: Main net inflow of 66.9479 million yuan, retail net inflow of 3.6088 million yuan - Te Bao Biological: Main net inflow of 29.0966 million yuan, retail net outflow of 41.3737 million yuan [3]

Core Viewpoint - The company has received approval for clinical trials of its injectable drug, Rukangquzhu Single Antibody, which is aimed at treating advanced non-small cell lung cancer (NSCLC) patients with HER2 mutations [1] Group 1: Company Developments - The subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has been granted a clinical trial approval notice by the National Medical Products Administration [1] - The injectable Rukangquzhu Single Antibody is expected to be launched in China by May 2025 [1] - The drug is indicated for adult patients with unresectable locally advanced or metastatic NSCLC who have previously received at least one systemic therapy [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injection Rituximab, which will commence soon [1] Group 1: Product Development - The injection Rituximab is set to be launched in China by May 2025 [1] - It is indicated for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy [1]

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 发关于注射用瑞康曲妥珠单抗的《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、药品的基本情况 药品名称：注射用瑞康曲妥珠单抗 剂 型：注射剂 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-164 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 细胞溶酶体内通过蛋白酶剪切释放毒素，诱导细胞周期阻滞从而诱导肿瘤细胞凋 亡。其释放的毒素具有高透膜性，可发挥旁观者杀伤效应，进一步提高抗肿瘤疗 效。经查询，目前国外已上市的同类产品有罗氏公司研发的 Ado-trastuzumab emtansine 及阿斯利康与第一三共合作研发的 Fam-trastuzumab deruxtecan，且 均已在国内上市。除此之外，荣昌生物研发的维迪西妥单抗于 2021 年在国内获 批上市，科伦博泰研发的 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 江蘇恒瑞醫藥股份有限公司 呈交日期： 2025年10月23日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | A | | 於香港聯交所上市 | 否 | | | | 證券代號 (如上市) | 600276 | 說明 | A股（於上海證券交易所上市） | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | ...

Core Insights - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of injection-use Ruikang Trastuzumab [1] Group 1: Clinical Trial Details - The clinical trial will focus on Ruikang Trastuzumab as a monotherapy compared to Docetaxel + Carboplatin + Trastuzumab + Pertuzumab for neoadjuvant treatment of early-stage or locally advanced HER2-positive breast cancer [1] - This study is a randomized, open-label, multi-center Phase III clinical trial [1] Group 2: Product Approval and Indications - Injection-use Ruikang Trastuzumab has already been approved for use in China, specifically for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 activation mutations and have previously received at least one systemic treatment [1]

Core Insights - The report from Guojin Securities highlights the significant advancements in China's innovative drug research presented at the ESMO conference, indicating a potential boost for the international expansion of these drugs [1] Group 1: Innovative Drug Research - The number of significant research publications from Chinese pharmaceutical companies at ESMO has reached a historical high, making it a focal point of the conference [1] - A total of 35 Chinese studies were included in the regular oral abstracts for the 2025 ESMO conference, with 14 formal oral presentations, a significant increase from 5 in 2024 [1] - The inclusion of 23 Chinese studies in the Late-Breaking Abstracts (LBA) category also set a new record, showcasing the research strength and academic influence of Chinese companies on the international stage [1] Group 2: ADC Developments - Domestic ADCs are demonstrating the potential to redefine existing clinical treatment standards, with notable products like Kelun's SKB264 showing promising Phase III clinical data for NSCLC and HR+/HER2- breast cancer [2] - The mOS data for SKB264 in the second-line EGFRm NSCLC treatment is particularly impressive, with a hazard ratio of 0.60, indicating a significant survival benefit [2] - Bai Li Tian Heng's ADC, iza-bren, has achieved breakthroughs in treating nasopharyngeal carcinoma, marking a critical milestone from concept validation to efficacy verification [2] Group 3: Bispecific and Multi-specific Antibodies - Bispecific and multi-specific antibodies are poised to upgrade existing immunotherapy and targeted therapy, with significant data from Kangfang Biotech's PD-1/VEGF bispecific antibody showing superior results compared to traditional treatments for advanced squamous NSCLC [3] - The mPFS for the combination of the bispecific antibody and chemotherapy was reported at 11.14 months versus 6.90 months for the comparator, with a hazard ratio of 0.60, indicating a strong potential to reshape first-line treatment standards [3] - The HER2 bispecific antibody KN026 from Shiyao Group/Kangning Jierei has shown promising results in III phase trials for gastric cancer, indicating its potential as a global leader in this category [3]

FF305 公司名稱： 江蘇恒瑞醫藥股份有限公司 呈交日期： 2025年10月22日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | A | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) | 600276 | 說明 | A股（於上海證券交易所上市） | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | 事件 | | 已發行股份（不包括庫存股份）變動 | 庫存股份變動 | 每股發行/出售價 (註4) | 已發行股份總數 | | | | 已發行股份（不包括庫存股份）數 目 | 佔有關事件前的現有已發 行股份（不包括庫存股 份）數目百分比 (註3) | 庫存股份數目 | ...

Core Viewpoint - Heng Rui Pharmaceutical (01276.HK) announced a share buyback plan, indicating confidence in its stock value and commitment to returning capital to shareholders [1] Group 1 - The company plans to repurchase 10,000 A-shares at a total cost of RMB 650,000 [1] - The buyback price is set at RMB 65 per share [1] - The transaction is scheduled for October 22, 2025 [1]