Hengrui Pharmaceutical (01276): SHR-1819 injectable drug marketing license application accepted

Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, the company's subsidiary Guangdong Hengrui Pharmaceutical Co., Ltd. received the “Notice of Acceptance” issued by the State Drug Administration, and the company's drug marketing license application for Zhuoqibizumab injection (SHR-1819 injection) was accepted by the State Drug Administration.

SHR-1819 injection is a recombinant humanized monoclonal antibody targeting human IL-4Rα independently developed by the company. It can block IL-4 and IL-13 signaling at the same time. The research indications cover various type 2 inflammatory diseases such as atopic dermatitis, nodular pruritus, and allergic rhinitis. Currently, only 2 drugs with the same target have been approved for marketing in the world. Dupilumab (trade name Dupixent) has been approved for listing in many countries and regions such as the US, the European Union, and Japan since 2017, and was approved for listing in China in 2020; Stapokibart (product name: Kang Yueda) was approved for listing in China in 2024. According to the EvaluatePharma database, total global sales of Dupilumab and Stapokibart in 2025 were approximately US$18.076 billion. Up to now, the total R&D investment for SHR 1819 injection-related projects is about 385.7 million yuan (unaudited).