Jiangsu Hengrui Pharmaceuticals (01276)'s independently developed Class 1 new drug, Ruipeximab Injection, has been approved for marketing.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, its subsidiary Beijing Shengdi Pharmaceutical Co., Ltd. received a notice from the National Medical Products Administration approving the marketing of Ruipeximab Injection, a Class 1 new drug independently developed by the company. Ruipeximab Injection is an angiopoietin-like protein 3 (ANGPTL3) monoclonal antibody independently developed by the company, which reduces serum triglyceride (TG) and LDL-C levels by inhibiting the activity of ANGPTL3. This approval is based on a randomized, double-blind, placebo-controlled Phase III clinical study (SHR-1918-301) conducted in HoFH patients aged 12 years, the results of which were presented at the LBA (Late-Breaking Science) session of the 2026 European Society of Cardiology (ESC) Congress. Currently, a same-target drug from Regeneron, EVKEEZA (evinacumab-dgnb), has been approved for marketing overseas. According to the EvaluatePharma database, the product's global sales in 2025 were approximately US$216 million. As of now, cumulative R&D investment in the Ruipeximab Injection-related project is approximately RMB302.90 million (unaudited).