Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant step forward in its drug development pipeline [1] Group 1: Company Developments - 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 products [1] - The approved products include HRS-7058 capsules, HRS-7058 tablets, SHR-9839(sc), Adebali monoclonal antibody injection, Bevacizumab injection, and SHR-A2102 injection [1] Group 2: Industry Implications - The approval of these clinical trials reflects ongoing advancements in the biopharmaceutical sector, showcasing the company's commitment to expanding its therapeutic offerings [1] - The initiation of these trials may enhance the company's competitive position in the market, potentially leading to new revenue streams upon successful development and commercialization of the drugs [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, aimed at treating vitiligo [1] Group 1: Company Developments - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have been granted the Clinical Trial Approval Notice for the mentioned drugs [1] - The clinical trial applications for Sulfate Emamectin Benzoate Tablets and SHR0302 Gel were accepted on August 29, 2025, and have met the requirements for drug registration [1] Group 2: Product Information - The intended use for Sulfate Emamectin Benzoate Tablets is as a monotherapy or in combination with SHR0302 Gel for the treatment of vitiligo [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, indicating progress in its drug development pipeline [1] Group 1: Drug Approvals and Clinical Trials - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have been granted a clinical trial approval notice for Sulfate Emamectin Benzoate Tablets and SHR0302 Gel [1] - Sulfate Emamectin Benzoate Tablets have already been approved for four indications in China, including treatment for adult patients with active ankylosing spondylitis and moderate to severe rheumatoid arthritis who have had inadequate response to TNF inhibitors [1] Group 2: Drug Mechanism and Market Context - Sulfate Emamectin Benzoate is a highly selective JAK1 inhibitor that exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [1] - Currently, there are no oral drugs of the same class approved globally for the treatment of vitiligo, although a topical drug, Ruxolitinib cream (OPZELURA®), has been approved, with no sales data available [1] Group 3: Research and Development Investment - The cumulative R&D investment for Sulfate Emamectin Benzoate projects has reached approximately 1.091 billion yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin and SHR0302 gel, indicating a significant advancement in its product pipeline [1] Group 1: Clinical Trial Approvals - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have been granted the Clinical Trial Approval Notice for Sulfate Emamectin Tablets and SHR0302 gel [1] - Sulfate Emamectin Tablets have already been approved for four indications in China, including active ankylosing spondylitis and moderate to severe active rheumatoid arthritis [1] Group 2: Product Details - Sulfate Emamectin is a highly selective JAK1 inhibitor that exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [1] - Currently, there are no oral counterparts approved globally for the treatment of vitiligo, although a topical drug, Ruxolitinib cream (OPZELURA), has been approved [1] Group 3: Research and Development Investment - The cumulative R&D investment related to Sulfate Emamectin has reached approximately 1.091 billion yuan [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant step forward in its drug development pipeline [1] Group 1: Company Developments - 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 products [1] - The approved products include HRS-7058 capsules, HRS-7058 tablets, SHR-9839(sc), Adebali monoclonal antibody injection, Bevacizumab injection, and SHR-A2102 injection [1] Group 2: Industry Implications - The approval of these clinical trials reflects ongoing advancements in the biopharmaceutical sector, showcasing the company's commitment to expanding its therapeutic offerings [1] - The initiation of these clinical trials may enhance the company's competitive position in the market, potentially leading to new revenue streams upon successful development and commercialization of the drugs [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-189 一、药品的基本情况 药品名称：硫酸艾玛昔替尼片、SHR0302 碱凝胶 剂 型：片剂、凝胶剂 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"）及子公司瑞石生物 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 于硫酸艾玛昔替尼片、SHR0302 碱凝胶的《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： 硫酸艾玛昔替尼片已在国内获批上市四个适应症，分别为：用于对一种或多 种 TNF 抑制剂疗效不佳或不耐受的活动性强直性脊柱炎成人患者；用于对一种或 多种 TNF 抑制剂疗效不佳或不耐受的中重度活动性类风湿关节炎成人患者；用于 对局部外用治疗或其他系统性治疗应答不充分或不耐受的中重度特应性皮炎成 人患者；用于成人重度斑秃患者。 三、药品的其他情况 硫酸艾玛昔替尼是一种高选择性的 JAK1 抑制剂，可 ...

上市。截至目前，SHR-9839 相关项目累计研发投入约为 7,231 万元。 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（商品名： Tecentriq）、Avelumab(商品名：Bavencio)和 Durvalumab(商品名：Imfinzi) 于美国获批上市销售，其中 Atezolizumab 和 Durvalumab 已在中国获批上市。国 内有多款同类产品获批上市。经查询，2024 年 Atezolizumab、Avelumab 和 Durvalumab 全球销售额合计约为 96.48 亿美元。截至目前，阿得贝利单抗注射 液相关项目累计研发投入约 96,898 万元。 贝伐珠单抗是一种人源化抗 VEGF 单克隆抗体，由中外制药和罗氏的子公司 基因泰克合作开发， ...

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, indicating progress in its drug development pipeline [1] Group 1: Company Developments - Heng Rui Medicine and its subsidiary, Ruishi Bio, have been granted the Clinical Trial Approval Notice for Sulfate Emamectin Benzoate Tablets and SHR0302 Gel [1] - Sulfate Emamectin Benzoate Tablets have already been approved for four indications in China, showcasing the company's existing market presence [1] - Sulfate Emamectin Benzoate is identified as a highly selective JAK1 inhibitor, which may position the company favorably in the competitive pharmaceutical landscape [1] Group 2: Regulatory Environment - The approval for clinical trials is a prerequisite for conducting further clinical studies and obtaining production and marketing approval from the National Medical Products Administration [1] - The company must adhere to the relevant laws and regulations regarding drug registration in China, which emphasizes the importance of regulatory compliance in the pharmaceutical industry [1]

Core Viewpoint - Heng Rui Medicine (600276) 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 Trial Approvals - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have received approval for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, which will commence shortly [1] - Additionally, the company and its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have been granted approval for clinical trials of several products, including HRS-7058 Capsules, HRS-7058 Tablets, SHR-9839(sc), Adebali Injection, Bevacizumab Injection, and SHR-A2102 Injection, with trials set to begin soon [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of multiple drug candidates, indicating a significant step forward in its research and development efforts [1] Group 1: Clinical Trial Approvals - 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 HRS-7058 capsules, HRS-7058 tablets, SHR-9839(sc), Adebali monoclonal antibody injection, Bevacizumab injection, and SHR-A2102 injection [1] - The approved clinical trials will focus on the safety, tolerability, and efficacy of HRS-7058 in combination with anti-tumor drugs in subjects with solid tumors, specifically a Phase II clinical study [1] Group 2: Regulatory Compliance - The approved drug candidates were reviewed and found to meet the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] - The approval was based on the submission received on August 18, 2025, confirming compliance with relevant regulations [1]