Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2026-01-20 23:33Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received clinical trial approval from the National Medical Products Administration for two drugs, SHR-9839 and HRS-4642, indicating progress in its oncology pipeline [1][2]. Group 1: Drug Information - SHR-9839 is a humanized antibody drug developed by the company, intended for the treatment of advanced solid tumors by blocking two key signaling pathways related to tumor development. The total R&D investment for SHR-9839 has reached approximately 93.9 million yuan (about 13.5 million USD) [1]. - HRS-4642 is a KRAS G12D inhibitor in a liposome formulation, specifically designed to bind to KRAS G12D and inhibit the phosphorylation of MEK and ERK proteins, with no similar drugs approved in the market. The cumulative R&D investment for HRS-4642 is approximately 254.2 million yuan (about 36.5 million USD) [2]. - HRS-2141 tablets (I) and (II) have also received clinical trial approval for type 2 diabetes treatment, with a cumulative R&D investment of about 5.4 million yuan (about 0.8 million USD) [6]. Group 2: Regulatory Approval - The company has received the clinical trial approval notice for SHR-9839 and HRS-4642, allowing it to proceed with clinical trials [1][2]. - The approval for HRS-2141 tablets was granted based on compliance with the relevant drug registration requirements, allowing the company to initiate clinical trials for the diabetes indication [6].