Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, a targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - SHR-A2102 is a self-developed ADC targeting Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i) [1] - Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis [1] Group 2: Market Context - Currently, there is one similar product approved globally, Enfortumab vedotin (brand name: Padcev), with projected global sales of approximately $1.949 billion in 2024 [1] - The cumulative R&D investment for SHR-A2102 has reached approximately 225 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, a targeted antibody-drug conjugate aimed at Nectin-4, indicating progress in its oncology pipeline [1][2] Group 1: Clinical Trial Approval - The company’s subsidiaries have been granted a clinical trial approval notice for SHR-A2102, which will soon commence trials [1] - The clinical trial is a multi-center, open-label Phase II study focusing on the safety, tolerability, and efficacy of SHR-A2102 in combination with other anti-tumor treatments for patients with advanced solid tumors [1] Group 2: Product Details - SHR-A2102 is a self-developed antibody-drug conjugate targeting Nectin-4, with a payload of topoisomerase I inhibitor [2] - Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis [2] - Currently, there is one similar product approved globally, Enfortumab vedotin, projected to have global sales of approximately $1.949 billion in 2024 [2] - The cumulative R&D investment for SHR-A2102 has reached approximately 224.84 million yuan [2]

Group 1 - Company subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd. received approval from the National Medical Products Administration for clinical trials of SHR-A2102 and Adebeli monoclonal antibody injection [1] - SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed by the company, targeting Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i) [1] - Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis; currently, there is one similar product approved globally, Enfortumab vedotin, with projected global sales of approximately $1.949 billion in 2024 [1] Group 2 - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [2] - Adebeli monoclonal antibody injection (brand name: Ailili) was approved for use in first-line treatment of extensive-stage small cell lung cancer in March 2023; similar products include Atezolizumab, Avelumab, and Durvalumab, with combined projected global sales of approximately $9.648 billion in 2024 [2] - The cumulative R&D investment for Adebeli monoclonal antibody injection is approximately 901.3 million yuan [2]