Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of HRS-6209 capsules and HRS-2189 tablets, targeting breast cancer treatment [1] Group 1: Product Development - HRS-6209 is a novel selective CDK4 inhibitor that effectively inhibits the CDK4/cyclinD complex and downstream signaling, inducing tumor cell arrest in the G1 phase, aimed at treating advanced malignant solid tumors [1] - HRS-6209 has improved selectivity for the CDK6/cyclinD3 signaling pathway compared to CDK4/6 inhibitors, potentially reducing blood toxicity associated with CDK4/6 inhibitors [1] - The total R&D investment for HRS-6209 has reached approximately 80.37 million yuan [1] Group 2: Market Position - There are currently no similar products approved for market in both domestic and international markets for HRS-6209 [1] - HRS-2189 is a new KAT6 inhibitor that regulates downstream oncogene expression by inhibiting histone lysine acetylation, also aimed at treating advanced malignant tumors [1] - The total R&D investment for HRS-2189 has reached approximately 49 million yuan [1] - There are currently no approved drugs targeting the same pathway as HRS-2189 in both domestic and international markets [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of Fumaric Acid Tegilide Injection, marking a significant step in the development of China's first independently developed class 1 opioid analgesic [1] Company Summary - Heng Rui Medicine's Fumaric Acid Tegilide Injection is a μ-opioid receptor (MOR) biased small molecule agonist, expected to be approved for domestic market launch in January 2024 [1] - The company has invested approximately 199.99 million yuan in the research and development of Fumaric Acid Tegilide Injection to date [1] Industry Summary - Fumaric Acid Tegilide Injection is positioned as a novel opioid analgesic in China, with a similar product, Oliceridine (brand name: Olinvyk), developed by Trevena, already approved in the U.S. in 2020 [1] - Jiangsu Enhua Pharmaceutical Co., Ltd. has obtained exclusive licensing from Trevena for Oliceridine, which was approved for sale in China in May 2023, although sales data is currently unavailable [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-6209 capsules and HRS-2189 tablets, targeting breast cancer treatment [1] Group 1: Product Development - HRS-6209 is a novel selective CDK4 inhibitor that effectively inhibits the CDK4/cyclinD complex and downstream signals, inducing tumor cell arrest in the G1 phase, aimed at treating advanced malignant solid tumors [1] - HRS-6209 has improved selectivity for the CDK6/cyclinD3 signaling pathway compared to CDK4/6 inhibitors, potentially reducing blood toxicity associated with CDK4/6 inhibitors [1] - The total R&D investment for HRS-6209 has reached approximately 80.37 million yuan [1] Group 2: Market Position - There are currently no similar products approved for market in both domestic and international markets for HRS-6209 [1] - HRS-2189 is a new KAT6 inhibitor that regulates downstream oncogene expression by inhibiting histone lysine acetylation, also aimed at treating advanced malignant tumors [1] - The total R&D investment for HRS-2189 has reached approximately 49 million yuan [1] - There are currently no approved drugs targeting the same pathway as HRS-2189 in both domestic and international markets [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for the clinical trial of Fumaric Acid Targinine Injection, marking a significant step in the development of innovative pain relief medications in China [1] Group 1: Company Developments - The company will soon initiate clinical trials for Fumaric Acid Targinine Injection, which is a μ-opioid receptor (MOR) biased small molecule agonist [1] - This product is set to be approved for market launch in China in January 2024, representing the first domestically developed Class 1 opioid analgesic innovation [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"）收到国家药品监督 管理局（以下简称"国家药监局"）核准签发关于富马酸泰吉利定注射液的《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：富马酸泰吉利定注射液 二、药品的其他情况 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-181 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 剂 型：注射剂 申请事项：临床试验 受 理 号：CXHL2500912、CXHL2500913 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 8 月 28 日受理的富马酸泰吉利定注射液临床试验申请符合药品注册的有关要 求，同意本品开展用于重症监护患者机械通气时的镇痛的临床试验。 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。药品 从研制、临床试验报批到投产的周期长、环节多，药品研发及至上市容易受到一 些不确定性因素的 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-180 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。 HRS-6209 是一种新型选择性 CDK4 抑制剂，能够强效抑制 CDK4/cyclinD 复 合物及下游信号，诱导肿瘤细胞阻滞在 G1 期，进而发挥抗肿瘤作用，临床拟用 于治疗晚期恶性实体瘤。与 CDK4/6 抑制剂相比，提高了对 CDK6/cyclinD3 信号 通路的选择性，可改善 CDK4/6 抑制剂相关的血液毒性。经查询，国内外尚无同 类产品获批上市。截至目前，HRS-6209 相关项目累计研发投入约 8,037 万元。 HRS-2189 是一种新型的 KAT6 抑制剂，通过抑制组蛋白赖氨酸乙酰化水平， 调控下游多种癌基因表达进而发挥抗肿瘤作用，拟用于治疗晚期恶性肿瘤。目前 国内外暂无同靶点药物获批上市。截至目前，HRS-2189 相关项目累计研发投入 约 4,900 万元。 三、风险提示 根据我国药品注册相关的法律法规要求，药物 ...

SHR-1701 注射液是公司自主研发并具有知识产权的抗 PD-L1/TGF-βRII 双 功能融合蛋白，可以促进效应性 T 细胞的活化，同时还可有效改善肿瘤微环境中 的免疫调节作用，最终有效促进免疫系统对于肿瘤细胞的杀伤。经查询，国内外 尚无同类产品获批上市。截至目前，SHR-1701 注射液相关项目累计研发投入约 68,570 万元。 SHR-7367 注射液为公司自主研发的靶向人 FAP 和 CD40 的 IgG1 亚型双特异 性抗体，可以通过与肿瘤相关抗原特异性结合，激活免疫共刺激分子，从而激活 肿瘤微环境中的多种免疫细胞发挥抗肿瘤作用。经查询,目前国内外暂无同类产 品获批上市。截至目前，SHR-7367 相关项目累计研发投入约 4,310 万元。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-179 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"）及子公司苏州盛迪 亚生物医药有限公司 ...

Core Viewpoint - 恒瑞医药 has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in its drug development pipeline [1][2]. Group 1: Company Developments - 恒瑞医药 and its subsidiaries have been granted clinical trial approval for several products, including HRS-4642 injection, SHR-1701 injection, and others, which will commence trials soon [1]. - The company's revenue composition for the year 2024 is projected to be 89.37% from pharmaceutical manufacturing and 10.63% from other businesses [1]. Group 2: Market Position - As of the latest report, 恒瑞医药's market capitalization stands at 410.2 billion yuan [2].

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of two new drugs, HRS-6209 and HRS-2189, which are aimed at treating advanced malignant tumors [2] Group 1: Drug Development - HRS-6209 is a novel selective CDK4 inhibitor intended for the treatment of advanced malignant solid tumors, with no similar products approved for market domestically or internationally [2] - HRS-2189 is a new KAT6 inhibitor also aimed at treating advanced malignant tumors, with no drugs targeting the same pathway approved for market domestically or internationally [2]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in its drug development pipeline [1] Group 1: Clinical Trials - The company and its subsidiaries, including Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have been granted clinical trial approval for several drugs [1] - The approved drugs include HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, Adebali monoclonal antibody injection, Bevacizumab injection, SHR-A2102 for injection, Appleseed Famitinib capsules, and Hydroxyethyl sulfonic acid Darsilil tablets [1] - A specific trial will focus on the safety, tolerability, and efficacy of HRS-4642 in combination with anti-tumor drugs in solid tumor subjects, categorized as a Phase I/II study [1]