Jiangsu Hengrui Pharmaceuticals (600276.SH): Clinical trials of injection SHR-9839(sc) and HRS-4642 injection solution drugs approved.

Jiangsu Hengrui Pharmaceuticals (600276.SH) announced that recently, the company and its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Jiangsu Hengrui Pharmaceuticals Co., Ltd., have received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration (hereinafter referred to as "NMPA") regarding the injection SHR-9839(sc), HRS-4642 injection solution, and will soon begin clinical trials. Specifically, an open-label, multicenter phase IIB/II clinical study on the safety, tolerability, and efficacy of SHR-9839 in combination with anti-tumor therapy in patients with advanced colorectal cancer will be conducted. SHR-9839 is a humanized antibody drug independently developed by the company, intended for the treatment of advanced solid tumors by simultaneously blocking two key signaling pathways related to tumor occurrence and development to exert its anti-tumor effects. The subcutaneous injection formulation of SHR-9839(sc) is currently the only drug targeting the same target that has been approved for marketing worldwide. As of now, the accumulated research and development investment in the SHR-9839 related project is approximately 93.9 million yuan (unaudited). HRS-4642 injection solution specifically binds to KRASG12D, inhibits the phosphorylation of MEK and ERK proteins, and exerts anti-tumor effects. According to the search, there are currently no similar drugs approved for marketing domestically or internationally. As of now, the accumulated research and development investment in the HRS-4642 injection solution related project is approximately 254.2 million yuan (unaudited).