Hengrui Pharma's Novel Drug SHR-1918 Injection Receives Marketing Application Acceptance and Priority Review Status

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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (600276.SH) announced that its subsidiary, Beijing Shengdi Pharmaceutical Co., Ltd., recently received a Notice of Acceptance from the National Medical Products Administration (NMPA). The Marketing Authorization Application (MAA) for the company's Class 1 innovative drug, SHR-1918 injection, has been accepted and included in the priority review program. SHR-1918 injection is a self-developed angiopoietin-like protein 3 (ANGPTL3) monoclonal antibody. It works by inhibiting the activity of ANGPTL3, thereby reducing serum levels of triglycerides (TG) and LDL-C. Currently, the only approved drug globally targeting the same pathway is Regeneron's EVKEEZA® (evinacumab-dgnb). According to the EvaluatePharma database, the global sales of this product in 2025 are projected to be approximately $216 million. To date, the cumulative research and development investment for the SHR-1918 injection project is about 242.2 million yuan (unaudited).

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