Jiangsu Hengrui Pharmaceuticals (01276): SHR-4610 Injection and other drugs receive drug clinical trial approval notices

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (hereinafter referred to as the "Company") and its subsidiaries Suzhou Suncadia Biopharmaceuticals Co., Ltd., Shanghai Suncadia Pharmaceuticals Co., Ltd., and Shanghai Hengrui Pharmaceuticals Co., Ltd. received the Drug Clinical Trial Approval Notices approved and issued by the National Medical Products Administration (hereinafter referred to as the "NMPA") for SHR-4610 Injection, SHR-9839 (sc) for Injection, SHR-A2102 for Injection, SHR-4849 Injection, SHR-7787 Injection, and HRS-4508 Tablets, and will commence clinical trials in the near future. SHR-4610 Injection is an innovative anti-tumor drug independently developed by the Company, which has demonstrated good anti-tumor activity in preclinical animal models and is intended for the treatment of advanced solid tumors. As of now, the cumulative R&D investment in SHR-4610 Injection-related projects is approximately RMB16.8 million (unaudited). SHR-9839 is a humanized antibody drug independently developed by the Company, intended for the treatment of advanced solid tumors, which exerts anti-tumor effects by simultaneously blocking two key signaling pathways related to tumorigenesis and development. SHR-9839 (sc) for Injection is a subcutaneous injection formulation of SHR-9839. Currently, one drug targeting the same target has been approved for marketing globally. As of now, the cumulative R&D investment in SHR-9839-related projects is approximately RMB127.8 million (unaudited). SHR-A2102 for Injection is an antibody-drug conjugate targeting Nectin-4 independently developed by the Company with intellectual property rights. Currently, one similar product has been approved for marketing globally, namely Enfortumab vedotin (trade name: Padcev). According to the EvaluatePharma database, the global sales of this product in 2025 were approximately US$2.473 billion. As of now, the cumulative R&D investment in SHR-A2102 for Injection-related projects is approximately RMB455.1 million (unaudited). SHR-4849 Injection is an antibody-drug conjugate targeting DLL3 independently developed by the Company, which can specifically bind to DLL3 antigens on the surface of tumor cells, then be internalized into cells and transported to lysosomes, where free toxins are released through hydrolysis to kill tumor cells. It is intended for the treatment of advanced malignant solid tumors. According to inquiries, no similar drugs have been approved for marketing domestically or internationally. As of now, the cumulative R&D investment in SHR-4849 Injection-related projects is approximately RMB100.9 million (unaudited). SHR-7787 Injection is a Class 1 therapeutic biological product that exerts targeted killing of tumor cells by inducing and activating T cells. As of now, the cumulative R&D investment in SHR-7787 Injection-related projects is approximately RMB72.6 million (unaudited). HRS-4508 Tablets is a novel, highly potent, and selective tyrosine kinase inhibitor that exerts anti-tumor effects by inhibiting tumor cell proliferation. According to inquiries, similar products already marketed abroad include Zongertinib (trade name: Hernexeos) and Tucatinib (trade name: Tukysa), among which Zongertinib has been approved for marketing in China. According to the EvaluatePharma database, the global sales of Tucatinib in 2025 were approximately US$463 million. As of now, the cumulative R&D investment in HRS-4508 Tablets-related projects is approximately RMB110.1 million (unaudited).