Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received clinical trial approval for two drugs, SHR-A2102 and SHR-1905, from the National Medical Products Administration, indicating progress in its drug development pipeline [1][6]. Group 1: Drug Information - SHR-A2102 is a targeted antibody-drug conjugate (ADC) that targets Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i). It is undergoing a Phase II clinical trial for safety, tolerability, and efficacy in advanced solid tumors [1][2]. - SHR-1905 is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), aimed at treating atopic dermatitis. It has also received approval for clinical trials [6][7]. Group 2: Market Context - The global sales of a similar product to SHR-A2102, Enfortumab vedotin (brand name: Padcev), are projected to be approximately $1.949 billion in 2024 [2]. - The global sales of a comparable product to SHR-1905, Tezepelumab (brand name: Tezspire), are estimated to be around $1.22 billion in 2024 [7]. Group 3: R&D Investment - The cumulative R&D investment for SHR-A2102 is approximately 224.84 million yuan [2]. - The cumulative R&D investment for SHR-1905 is about 209.62 million yuan [7]. - The cumulative R&D investment for SHR-1802, another drug in development, is around 62.09 million yuan [12]. - The cumulative R&D investment for the anti-PD-L1 monoclonal antibody, Abedilizumab, is approximately 939.08 million yuan [13].
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