智通财经网·2026-01-20 11:33Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9839 and HRS-4642, indicating progress in its oncology drug development pipeline [2] Group 1: Clinical Trial Approvals - The company and its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. have been granted a clinical trial approval notice for SHR-9839 and HRS-4642 [2] - SHR-9839 will undergo an open-label, multi-center Phase I/II clinical study to evaluate its safety, tolerability, and efficacy in patients with advanced colorectal cancer [2] Group 2: Drug Development Details - SHR-9839 is a humanized antibody drug developed by the company, aimed at treating advanced solid tumors by blocking two key signaling pathways related to tumor development [2] - The subcutaneous formulation of SHR-9839 has one competitor with the same target already approved globally [2] - The total R&D investment for SHR-9839 has reached approximately 93.9 million yuan (unaudited) [2] Group 3: HRS-4642 Injection - HRS-4642 injection specifically binds to KRASG12D and inhibits the phosphorylation of MEK and ERK proteins, demonstrating anti-tumor effects [2] - Currently, there are no similar drugs approved for HRS-4642 in both domestic and international markets [2] - The total R&D investment for HRS-4642 has reached approximately 254.2 million yuan (unaudited) [2]