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]

格隆汇9月23日丨恒瑞医药(01276.HK)发布公告，近日，公司子公司上海盛迪医药有限公司收到国家药 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。 根据披露，本品联合含铂化疗作为新辅助治疗，术后继续以本品作为单药辅助治疗，用于治疗可手术切 除的Ⅱ、ⅢA和ⅢB期且无已知表皮生长因子受体(EGFR)突变或间变性淋巴瘤激酶(ALK)重排的成人非 小细胞肺癌(NSCLC)患者。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。 ...

Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of HRS-3095 tablets, aimed at treating Chronic Spontaneous Urticaria (CSU) [1] Group 1: Clinical Trial Approval - The clinical trial approval notice for HRS-3095 was issued based on compliance with the Drug Administration Law of the People's Republic of China [1] - The application for HRS-3095 was accepted on July 7, 2025, and has met the requirements for drug registration [1] Group 2: Drug Development - HRS-3095 is a small molecule compound developed by the company that targets immune cells and shows 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]

根据披露，本品联合含铂化疗作为新辅助治疗，术后继续以本品作为单药辅助治疗，用于治疗可手术切 除的Ⅱ、ⅢA和ⅢB期且无已知表皮生长因子受体(EGFR)突变或间变性淋巴瘤激酶(ALK)重排的成人非 小细胞肺癌(NSCLC)患者。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。 格隆汇9月23日丨恒瑞医药(01276.HK)发布公告，近日，公司子公司上海盛迪医药有限公司收到国家药 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。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of HRS-3095 tablets, a self-developed small molecule compound targeting immune cells for the treatment of allergic diseases [1] Group 1 - HRS-3095 tablets have shown promising preclinical results, effectively improving skin allergy symptoms in mice [1] - There are currently no approved drugs targeting the same indication (CSU) in both domestic and international markets [1] - The total research and development investment for the HRS-3095 project has reached approximately 16.03 million yuan [1]

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，防止提前排卵，且整体安全性良好。 智通财经APP讯，恒瑞医药(01276)发布公告，近日，公司收到国家药品监督管理局下发的《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。 ...