Core Viewpoint - 恒瑞医药's subsidiary received approval for clinical trials of SHR-1905 injection, targeting atopic dermatitis, which may present a significant market opportunity given the success of similar products like Tezepelumab [1] Group 1: Clinical Trial Approval - The company announced that its subsidiary, Guangdong Heng Rui Pharmaceutical Co., Ltd., received the clinical trial approval notice from the National Medical Products Administration for SHR-1905 injection [1] - The clinical trial application for SHR-1905 was accepted on July 17, 2025, and meets the requirements for drug registration [1] Group 2: Product Information - SHR-1905 injection is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which can block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] - The product aims to improve inflammatory conditions and control disease progression [1] Group 3: Market Context - Tezepelumab, a similar product developed by AstraZeneca/Amgen, has been approved and is projected to generate approximately $1.22 billion in global sales in 2024 [1] - The cumulative R&D investment for SHR-1905 injection has reached approximately 209.62 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for multiple clinical trial applications for new drugs, indicating progress in its research and development pipeline [1] Group 1: Clinical Trial Approvals - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. received approval for the clinical trial of SHR-A2102 [1] - The same subsidiaries also received approval for clinical trials of SHR-A2102, Adebeli monoclonal antibody injection, and SHR-1802 [1] - Guangdong Heng Rui Medicine Co., Ltd. received approval for the clinical trial of SHR-1905 injection [1]

Core Viewpoint - 恒瑞医药's subsidiary, Guangdong Heng Rui Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1905 injection, targeting atopic dermatitis [1] Group 1: Clinical Trial Approval - The clinical trial application for SHR-1905 injection was accepted on July 17, 2025, and meets the requirements for drug registration [1] - The approval allows the company to conduct clinical trials for atopic dermatitis [1] Group 2: Product Information - SHR-1905 injection is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which can block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] - The product aims to improve inflammatory conditions and control disease progression [1] Group 3: Market Context - A similar product, Tezepelumab (AstraZeneca/Amgen, marketed as Tezspire), has been approved and is projected to generate global sales of approximately $1.22 billion in 2024 [1] - The cumulative R&D investment for SHR-1905 injection has reached approximately 209.62 million yuan [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of three new drug candidates, indicating a significant advancement in its oncology pipeline [1][2][3] Group 1: Drug Candidates - SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed by the company, which targets Nectin-4 and has shown a strong correlation with tumor progression and poor prognosis. The global sales of a similar product, Enfortumab vedotin, are projected to be approximately $1.949 billion in 2024. The cumulative R&D investment for SHR-A2102 is about 225 million yuan [1] - SHR-1802 is a humanized monoclonal antibody that activates and promotes anti-tumor T cell responses. Currently, there are no similar products approved in the domestic market. The cumulative R&D investment for SHR-1802 is approximately 62.09 million yuan [2] - Adebali monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity. It was approved for use in combination with carboplatin and etoposide for first-line treatment of extensive-stage small cell lung cancer in February 2023. Similar products like Atezolizumab and Durvalumab have combined global sales projected to be around $9.648 billion in 2024. The cumulative R&D investment for Adebali is about 939 million yuan [3]

Core Viewpoint - Company subsidiary Guangdong Hengrui Medicine Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of SHR-1905 injection, targeting atopic dermatitis [1] Group 1: Clinical Trial Approval - The clinical trial application for SHR-1905 injection was accepted on July 17, 2025, and meets the requirements for drug registration [1] - The approval allows the company to conduct clinical trials for atopic dermatitis [1] Group 2: Product Information - SHR-1905 injection is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which can block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] - The product aims to improve inflammatory conditions and control disease progression [1] Group 3: Market Context - A similar product, Tezepelumab (AstraZeneca/Amgen, marketed as Tezspire), has been approved and is projected to generate global sales of approximately $1.22 billion in 2024 [1] - The cumulative R&D investment for SHR-1905 injection has reached approximately 209.62 million yuan [1]

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) FF305 確認 根據《主板上市規則》第13.25C條 / 《GEM上市規則》第17.27C條，我們在此確認，據我們所知所信，第一章節所述的每項股份發行或庫存股份出售或轉讓已獲發行人董事會正式授權批准，並遵 照所有適用上市規則、法律及其他監管規定進行，並在適用的情況下： 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13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 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 董事會會議通告 江蘇恒瑞醫藥股份有限公司（「本公司」）董事會（「董事會」）謹此宣佈，董事會會 議將於2025年10月27日（星期一）舉行，藉以（其中包括）考慮及批准本公司及其 附屬公司截至2025年9月30日止九個月的季度業績及其發佈。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年10月13日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 ...

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 ...