Jiangsu Hengrui Pharmaceuticals (01276): The application for the marketing license of SHR-1819 injection has been accepted.

Jiangsu Hengrui Pharmaceuticals (01276) announced that its subsidiary, Guangdong Jiangsu Hengrui Pharmaceuticals Co., Ltd., has received an "Acceptance Notification" issued by the National Medical Products Administration (NMPA). The application for the marketing authorization of the company's Trokeptin (SHR-1819 Injection) has been accepted by the NMPA. SHR-1819 Injection is a recombinant humanized monoclonal antibody independently developed by the company, targeting human IL-4R. It can simultaneously block the signaling of IL-4 and IL-13, with indications currently under research including atopic dermatitis, nodular prurigo, allergic rhinitis, and various other type 2 inflammatory diseases. Currently, there are only two drugs targeting the same receptor that have been approved globally. Dupilumab (brand name: Dupixent) has been approved in several countries and regions, including the United States, EU, and Japan since 2017, and was approved for market launch in China in 2020; Stapokibart (brand name: ) was approved for launch in China in 2024. According to the EvaluatePharma database, the global sales of Dupilumab and Stapokibart are projected to reach approximately $18.076 billion in 2025. As of now, the cumulative research and development investment related to SHR-1819 Injection is approximately 385.7 million yuan (unaudited).