CStone Pharmaceuticals-B (02616) announced today that the Investigational New Drug (IND) application for the Phase II clinical trial of CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) combination therapy in advanced solid tumors has been approved by China's National Medical Products Administration (NMPA).

Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, stated: "The preliminary data from the Phase I study of CS2009 has given us strong confidence, supporting the accelerated advancement of its Phase II research. Accordingly, the Phase II clinical trial adopts a multi-cohort parallel expansion design, encompassing 15 monotherapy/combination therapy cohorts across nine solid tumor indications, including non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). Currently, the Phase II trial is actively enrolling patients in Australia. The IND approval in China will further expedite clinical development, allowing deeper exploration and validation of CS2009's broad therapeutic potential."