智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，公司收到国家药品监督管理局(简称"国家药监 局")下发的《受理通知书》，公司SHR7280片的药品上市许可申请获国家药监局受理。 拟定适应症(或功能主治)：在辅助生殖技术中，用于控制性卵巢刺激治疗的患者，预防早发黄体生成素 (LH)峰。 ...

Group 1 - The cell immunotherapy sector experienced a decline of 2.75%, ranking among the top losers in the concept sector, with ST Zhongzhu hitting the daily limit down [1] - Major stocks within the cell immunotherapy sector that saw significant declines include Zhaoyan New Drug, Jimin Health, and Boteng Co., with respective drops of 6.04%, 5.45%, and 5.34% [1][2] - The sector faced a net outflow of 1.61 billion yuan from main funds, with 48 stocks experiencing outflows, and six stocks seeing outflows exceeding 100 million yuan, led by Hengrui Medicine with a net outflow of 293 million yuan [2] Group 2 - The top gainers in today's concept sectors included the SMIC concept with a rise of 1.22% and the National Big Fund holding with an increase of 1.08% [2] - The main inflows were observed in stocks such as Betta Pharmaceuticals, Chutian Technology, and Rongchang Bio, with net inflows of 35.97 million yuan, 21.30 million yuan, and 14.08 million yuan respectively [4] - The overall market sentiment reflected a mixed performance across various sectors, with notable declines in the Huawei Pangu and MLOps concepts, down 3.69% and 3.31% respectively [2]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-151 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：片剂 申请事项：临床试验 受 理 号：CXHL2500654、CXHL2500655 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 7 日受理的 HRS-3095 片临床试验申请符合药品注册的有关要求，同意本 品开展临床试验。申请的适应症为用于慢性自发性荨麻疹（CSU）患者。 二、药物的其他情况 HRS-3095 片是公司自主研发的靶向免疫细胞的小分子化合物，对过敏性疾 病起到良好的治疗效果。临床前数据显示，HRS-3095 可有效改善小鼠的皮肤过 敏症状。经查询，针对 CSU 适应症，目前国内外暂无同靶点药物获批上市。截至 目前，HRS-3095 片相关项目累计研发投入约 1,603 万元。 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"）子公司成都盛迪医 药有限公司收到国家药品监督管理局（以 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-150 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 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。 一、药品的基本情况 药品名称：SHR7280 片 剂型：片剂 受理号：CXHS2500118 申报阶段：上市 申请人：江苏恒瑞医药股份有限公司 拟定适应症（或功能主治）：在辅助生殖技术中，用于控制性卵巢刺激治疗 的患者，预防早发黄体生成素（LH）峰。 二、药品的临床试验情况 2024 年 11 月，SHR7280 片Ⅲ期临床试验（SHR7280-302）达到了方案预设的 主要研究终点。该研究是以醋酸加尼瑞克注射液为对照，在不孕症女性受试者中 开展的多中心、随机、双盲双模拟、非劣效性Ⅲ期临床研究，由北京大学第三医 院乔杰院士担任主要研究者，研究共入组 317 例不孕症女性受试者。研究结果表 明，在辅助生殖技术控制性卵巢刺激治疗中，口服 SHR7280 片与皮下注射醋酸加 尼瑞克注射液具有相当的临床疗效，SHR7280 可有效预防早发 LH 峰 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-152 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 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"）下发的《受理 通知书》，公司阿得贝利单抗注射液新适应症的药品上市许可申请获国家药监局 受理。现将相关情况公告如下： 一、药品的基本情况 药品名称：阿得贝利单抗注射液 剂型：注射剂 受理号：CXSS2500099 申报阶段：上市 最新发布的中国癌症疾病负担报告显示，肺癌是中国发病率及死亡率最高的 恶性肿瘤[1]，其中非小细胞肺癌（NSCLC）是肺癌的主要病理类型，约占所有肺 癌的 80%～85%。根治性手术切除是早期 NSCLC 治疗的主要手段，但是术后复发 仍是临床治疗的难题，尽管围手术期化疗（新辅助或辅助化疗）加入到临床实践 中，但仅能将 5 年生存率提高约 5%，临床迫切需要更优的系统治疗手段。近年 来，免疫治疗 ...

Market Overview - The Shanghai Composite Index fell by 0.18% on September 23, with five industries experiencing gains, led by the banking and coal sectors, which rose by 1.52% and 1.11% respectively [1] - The social services and retail trade sectors saw the largest declines, down by 3.11% and 2.90% respectively [1] - The pharmaceutical and biotechnology industry also declined by 1.93% [1] Capital Flow Analysis - The main capital outflow from the two markets totaled 996.85 billion yuan, with only three industries seeing net inflows: banking (14.00 billion yuan), construction and decoration (1.69 billion yuan), and coal (399.41 million yuan) [1] - The electronics industry experienced the largest net outflow, totaling 200.43 billion yuan, followed by the computer industry with a net outflow of 166.60 billion yuan [1] Pharmaceutical and Biotechnology Sector - The pharmaceutical and biotechnology sector saw a net outflow of 81.15 billion yuan, with 474 stocks in the sector; 32 stocks rose while 441 fell [2] - The top net inflow stocks in this sector included Amgen Pharmaceuticals-U with a net inflow of 114.11 million yuan, followed by China National Pharmaceutical and Guangsheng Tang with inflows of 74.18 million yuan and 73.03 million yuan respectively [2] - The sector's outflow leaderboard featured WuXi AppTec with a net outflow of 65.79 million yuan, followed by Bory Pharmaceutical and Sunflower with outflows of 56.65 million yuan and 49.46 million yuan respectively [4]

每经AI快讯，9月23日，恒瑞医药（600276）(600276.SH)公告称，公司收到国家药监局下发的《受理通 知书》，公司SHR7280片的药品上市许可申请获国家药监局受理。SHR7280片是一种口服小分子GnRH 受体拮抗剂，可以阻断内源性GnRH与GnRH受体的结合，抑制LH等促性腺激素的合成和释放，用于辅 助生殖技术的控制性超促排卵治疗。国内外辅助生殖领域尚无口服GnRH拮抗剂获批上市。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of HRS-3095 tablets, aimed at treating chronic spontaneous urticaria (CSU) [1] Group 1: Clinical Trial Approval - The clinical trial application for HRS-3095 tablets was accepted on July 7, 2025, and has met the requirements for drug registration [1] - The drug is designed for patients suffering from chronic spontaneous urticaria (CSU) [1] Group 2: Drug Development - HRS-3095 tablets are a self-developed small molecule compound targeting immune cells, showing promising therapeutic effects for allergic diseases [1] - Preclinical data indicates that HRS-3095 can effectively improve skin allergy symptoms in mice [1] - Currently, there are no approved drugs targeting the same mechanism for CSU in both domestic and international markets [1] Group 3: Research Investment - The total research and development investment for the HRS-3095 project has reached approximately 16.03 million yuan [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Shanghai Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the marketing authorization application of the new indication for Adebeli monoclonal antibody injection [1] Group 1: Product Information - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by the company, which can specifically bind to the PD-L1 molecule to block the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] - Similar products abroad include Atezolizumab (brand name: Tecentriq), Avelumab (brand name: Bavencio), and Durvalumab (brand name: Imfinzi), which have been approved for sale in the United States, with Atezolizumab and Durvalumab also approved in China [1] Group 2: Market Context - The global sales of Atezolizumab, Avelumab, and Durvalumab are projected to total approximately $9.648 billion in 2024 [1] - Domestic competitors include similar products such as Envolimab from CanSino Biologics, Sugilumab from CStone Pharmaceuticals, and Bemarituzumab from Zhenhua Tianqing Pharmaceutical, all of which have been approved for sale [1] Group 3: R&D Investment - The cumulative R&D investment related to Adebeli monoclonal antibody injection has reached approximately 939 million yuan [1]

Core Viewpoint - The company, Heng Rui Medicine, announced that its subsidiary, Shanghai Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the new indication application of its drug, Adebali monoclonal antibody injection [1] Group 1: Product Information - Adebali monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by the company, which can specifically bind to the PD-L1 molecule to block the PD-1/PD-L1 pathway that leads to tumor immune tolerance, thereby reactivating the immune system's anti-tumor activity [1] - Similar products available in the market include Atezolizumab (brand name: Tecentriq), Avelumab (brand name: Bavencio), and Durvalumab (brand name: Imfinzi), which have been approved for sale in the United States, with Atezolizumab and Durvalumab also approved in China [1] Group 2: Market Context - The combined global sales of Atezolizumab, Avelumab, and Durvalumab are approximately $9.648 billion for the year 2024 [1] - The cumulative research and development investment for the Adebali monoclonal antibody injection project has reached approximately 939 million yuan [1]