Jiangsu Hengrui Pharmaceuticals (01276): SHR-1819 injection, SHR-1905 injection receive drug clinical trial approval notice.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, its subsidiary Guangdong Jiangsu Hengrui Pharmaceuticals Co., Ltd. has received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration for SHR-1819 injection and SHR-1905 injection, and will soon conduct clinical trials. SHR-1819 injection is a recombinant humanized monoclonal antibody targeting human IL-4R developed independently by the company, which can simultaneously block the signal transduction of IL-4 and IL-13, and is intended for the treatment of type 2 inflammation-related diseases. Currently, there are only 2 drugs with the same target approved for the market globally. Since 2017, Dupilumab (brand name Dupixent) has been approved for the market in multiple countries and regions such as the United States, the European Union, and Japan, and was approved for the market in China in June 2020; Stapokibart (brand name: Kangyueda) was approved for the market in China in September 2024. According to the EvaluatePharma database, Dupilumab's global sales in 2025 were approximately USD 17.761 billion. As of now, the cumulative research and development investment in the SHR-1819 injection project is approximately RMB 345.6 million (unaudited). SHR-1905 injection is a monoclonal antibody against thymic stromal lymphopoietin (TSLP), which can block the release of inflammatory cytokines, inhibit the downstream inflammatory signal transmission, ultimately improve the inflammatory state, and control disease progression. Currently, a similar product Tezepelumab (AstraZeneca, brand name TEZSPIRE) has been approved for the market globally. According to the EvaluatePharma database, Tezepelumab's global sales in 2025 were approximately USD 1.936 billion. As of now, the cumulative research and development investment in the SHR-1905 injection project is approximately RMB 257.1 million (unaudited).