恒瑞医药(01276):9款药物获批开展临床试验
智通财经网·2025-11-21 11:20

Core Viewpoint - 恒瑞医药 has received approval from the National Medical Products Administration for multiple clinical trial applications for new drug candidates, indicating a significant advancement in its oncology pipeline [1][2][3][4][5] Group 1: New Drug Approvals - The company has received clinical trial approval for SHR-9839, a humanized antibody drug targeting advanced solid tumors, with a cumulative R&D investment of approximately 72.31 million [1] - SHR-A2009, an antibody-drug conjugate targeting HER3, has a cumulative R&D investment of about 227 million [2] - SHR-1826, targeting c-MET, has a cumulative R&D investment of around 101 million [2] - HRS-4642, a KRAS G12D inhibitor, has a cumulative R&D investment of approximately 191 million [2] - 阿得贝利单抗, a humanized anti-PD-L1 monoclonal antibody, has been approved for use in extensive-stage small cell lung cancer, with a cumulative R&D investment of about 969 million [3] - 注射用瑞康曲妥珠单抗, targeting HER2, has been approved for use in non-small cell lung cancer, with a cumulative R&D investment of around 1.415 billion [4] - SHR-A2102, an ADC targeting Nectin-4, has a cumulative R&D investment of approximately 248 million [5] - HRS-7058, a selective small molecule inhibitor for KRAS G12C mutations, has a cumulative R&D investment of about 69.57 million [5] Group 2: Market Context and Competitors - SHR-9839 is the only drug in its class currently in development, with one similar drug already approved globally [1] - SHR-A2009 is the first of its kind, with no similar drugs approved globally [2] - SHR-1826 has a competitor, ABBV399, which received accelerated approval in the U.S. for specific lung cancer patients [2] - 阿得贝利单抗 has several competitors, including Atezolizumab and Durvalumab, which collectively generated approximately 9.648 billion in global sales in 2024 [3] - 注射用瑞康曲妥珠单抗 has competitors like Ado-trastuzumab emtansine and Fam-trastuzumab deruxtecan, with a combined global sales forecast of about 6.557 billion in 2024 [4] - SHR-A2102 has one competitor, Enfortumab vedotin, with a projected global sales of approximately 1.949 billion in 2024 [5] - HRS-7058 faces competition from Sotorasib and Adagrasib, which are expected to generate around 485 million in global sales in 2024 [5]