恒瑞医药:SHR-A2102获得药物临床试验批准通知书
2 1 Shi Ji Jing Ji Bao Dao·2025-12-24 10:04

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of its drug SHR-A2102, indicating progress in its oncology pipeline and potential market entry for a new targeted therapy [1] Group 1: Clinical Trials - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. have been authorized to conduct two clinical trials for SHR-A2102 [1] - The first trial will evaluate SHR-A2102 in combination with Vedolizumab for advanced solid tumors [1] - The second trial will assess SHR-A2102 in combination with Atezolizumab or other PD-(L)1 inhibitors for locally advanced or metastatic esophageal cancer in a multicenter, open-label Phase IB/II study [1] Group 2: Product Details - SHR-A2102 is a targeted antibody-drug conjugate (ADC) that targets Nectin-4, with an effective payload of topoisomerase I inhibitor (TOP1i) [1] - Currently, there is one similar product, Enfortumab vedotin (brand name: Padcev), which has been approved and is projected to generate global sales of approximately $1.949 billion in 2024 [1] Group 3: Investment and Development - The total investment in the SHR-A2102 development project has reached approximately 248.22 million yuan [1]