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恒瑞医药(600276.SH):注射用SHR-A2102联合阿得贝利单抗联合SHR-1802开展临床试验获批
智通财经网· 2025-10-13 11:03
Core Viewpoint - 恒瑞医药's subsidiaries have received approval from the National Medical Products Administration for clinical trials of three new drug candidates, indicating progress in their oncology pipeline [1][2][3] Group 1: Drug Candidates - SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed by the company, targeting Nectin-4, with a total R&D investment of approximately 224.84 million yuan. It is noted that Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis. A similar product, Enfortumab vedotin, is projected to have global sales of about 1.949 billion USD in 2024 [1] - SHR-1802 is a humanized monoclonal antibody that activates and promotes anti-tumor T cell responses, with no similar products approved in China to date. The cumulative R&D investment for SHR-1802 is approximately 62.09 million yuan [2] - 阿得贝利单抗注射液 is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity. It was approved for use in first-line treatment of extensive-stage small cell lung cancer in February 2023. The total R&D investment for this product is approximately 939.08 million yuan. Similar products in the market, such as Atezolizumab, Avelumab, and Durvalumab, are expected to generate combined global sales of about 9.648 billion USD in 2024 [3]
恒瑞医药(01276)子公司获药物临床试验批准通知书
智通财经网· 2025-10-13 09:45
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]
恒瑞医药:注射用SHR-A2102、阿得贝利单抗注射液获得药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-08-13 09:21
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of two drugs, SHR-A2102 and Adebali monoclonal antibody injection, indicating progress in its oncology pipeline [1] Group 1: Drug Development - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has been authorized to conduct clinical trials for SHR-A2102, a targeted antibody-drug conjugate (ADC) that specifically targets Nectin-4, which is associated with tumor progression and poor prognosis [1] - SHR-A2102 contains a topoisomerase I inhibitor as its effective payload, highlighting its potential in cancer treatment [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody developed by the company, has already been approved for use in combination with carboplatin and etoposide for first-line treatment of extensive-stage small cell lung cancer [1] Group 2: Market Position - The approval of Adebali monoclonal antibody injection in March 2023 marks a significant milestone for the company, enhancing its position in the oncology market [1] - The company is actively expanding its oncology portfolio, which may lead to increased market share and revenue growth in the future [1]