Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of three drugs, indicating progress in its research and development pipeline [1] Group 1 - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has been granted approval for the clinical trial of SHR-A2102 [1] - Shanghai Heng Rui Medicine Co., Ltd. has received approval for the clinical trial of Adalimumab injection [1] - Shanghai Shengdi Medicine Co., Ltd. has been authorized to conduct clinical trials for SHR-1802 [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-163 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"）子公司广东恒瑞医 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 SHR-1905 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、药物的基本情况 药物名称：SHR-1905 注射液 剂 型：注射剂 受 理 号：CXSL2500602 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 7 月 17 日受理的 SHR-1905 注射液临床试验申请符合药品注册的有关要求，同 意本品开展特应性皮炎的临床试验。 二、药物的其他情况 SHR-1905 注射液是胸腺基质淋巴细胞生成素（TSLP）单克隆抗体，可以阻 断炎症细胞因子的释放，抑制下游炎症信号的传导，最终改善炎症状态并控制疾 病进展。目前,全球有同类产品 T ...

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、上海盛迪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、阿 得贝利单抗注射液、注射用 SHR-1802 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： 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 2025-161 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。 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过 特异性结合 PD-L1 分子从而阻断导致肿瘤免疫耐受的 PD-1/PD-L1 通路，重新激 活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。公司阿得贝利单抗注射液 已于 2023 年 2 月获批上市，获批的适应症为与卡铂和依托泊苷联合用于广泛期 小细胞肺癌患者的一线治疗。国外有同类产品 Atezolizumab ...

申请事项：临床试验 受 理 号：CXSL2500583 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 7 月 11 日受理的注射用 SHR-A2102 符合药品注册的有关要求，同意本次临床 试验申请，具体为：一项注射用 SHR-A2102 联合其他抗肿瘤治疗在晚期实体瘤受 试者中的安全性、耐受性及有效性的多中心、开放Ⅱ期临床研究。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-162 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 二、药物的其他情况 注射用 SHR-A2 ...

Core Viewpoint - Heng Rui Medicine has received approval for clinical trials of SHR-A2102, indicating progress in its drug development pipeline [1] Group 1: Company Developments - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. have obtained the clinical trial approval notice from the National Medical Products Administration for SHR-A2102 [1] - The company plans to commence clinical trials in the near future [1] Group 2: Financial Overview - For the year 2024, Heng Rui Medicine's revenue composition is projected to be 89.37% from the pharmaceutical manufacturing sector and 10.63% from other businesses [1] - As of the report date, Heng Rui Medicine's market capitalization stands at 444.6 billion yuan [1]

Core Viewpoint - Heng Rui Medicine announced the approval of clinical trials for SHR-1905 injection by the National Medical Products Administration, indicating a significant step in the development of a new therapeutic option targeting inflammation [1] Group 1: Company Developments - The subsidiary Guangdong Heng Rui Medicine Co., Ltd. received the clinical trial approval notice for SHR-1905 injection [1] - SHR-1905 is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which plays a role in blocking the release of inflammatory cytokines [1] Group 2: Product Information - SHR-1905 injection aims to inhibit downstream inflammatory signaling pathways, ultimately improving inflammatory conditions and controlling disease progression [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Guangdong Heng Rui Medicine Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1905 injection, which is expected to commence soon [1] Group 1: Company Developments - The SHR-1905 injection is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), designed to block the release of inflammatory cytokines [1] - The mechanism of SHR-1905 involves inhibiting downstream inflammatory signaling pathways, ultimately improving inflammatory conditions and controlling disease progression [1]

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: Product Development - SHR-A2102 is a self-developed antibody-drug conjugate (ADC) targeting Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i) [1] - Research indicates that high expression of Nectin-4 in tumors is closely related to tumor progression and poor prognosis [1]

Core Viewpoint - Heng Rui Medicine's subsidiary has received approval for clinical trials of SHR-1905 injection, a monoclonal antibody targeting TSLP, which aims to improve inflammation and control disease progression [1] Group 1: Company Developments - Heng Rui Medicine (600276.SH) announced that its subsidiary, Guangdong Heng Rui Medicine Co., Ltd., has received the clinical trial approval notice from the National Medical Products Administration for SHR-1905 injection [1] - The SHR-1905 injection is designed to block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] Group 2: Market Context - There is a similar product, Tezepelumab (AstraZeneca/Amgen, marketed as Tezspire), which has been approved and is projected to generate approximately $1.22 billion in global sales in 2024 according to EvaluatePharma database [1]

Core Viewpoint - Heng Rui Medicine has received clinical trial approval for three drug candidates, indicating progress in its research and development pipeline [1] Group 1: Clinical Trial Approvals - The company’s subsidiaries have received approval from the National Medical Products Administration for clinical trials of SHR-A2102, Adebeli monoclonal antibody injection, and SHR-1802 [1] - SHR-A2102 is an antibody-drug conjugate targeting Nectin-4, with only one similar product approved globally [1] - SHR-1802 is a humanized monoclonal antibody developed by the company, with no similar products approved in China [1] - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by the company [1]