Hengrui Medicine receives clinical trial approval for SHR-1316

Jiangsu Hengrui Medicine (SSE:600276) announced that its subsidiary, Suzhou Shengdiya Biomedical, has received approval from the National Medical Products Administration for clinical trials of its SHR-1316(sc) injection, a subcutaneous formulation of the anti-PD-L1 monoclonal antibody. The trial will evaluate the drug's pharmacokinetics, safety, tolerability, and efficacy in combination with carboplatin and etoposide as a first-line treatment for extensive-stage small cell lung cancer. Hengrui Medicine already markets an intravenous version of an anti-PD-L1 antibody, Aidelibeili, approved in March 2023 for the same indication. The company notes that development of SHR-1316 has incurred accumulated research and development expenses of approximately CNY 81.491 million. The company cautioned investors regarding the risks and uncertainties inherent in the drug development and approval process.