CSTONE PHARMA-B(02616) announces that the IND for the Phase II clinical trial of CS2009 (PD-1/VEGF/CTLA-4 triple-specific antibody) combination therapy has been approved in China, further exploring the potential of triple antibody treatment.

CSTONE PHARMA-B (02616) announced today that the company has received approval from the China National Medical Products Administration (NMPA) for the Investigational New Drug (IND) application of CS2009 (PD-1/VEGF/CTLA-4 triple-specific antibody) combination therapy for late-stage solid tumors. Dr. Frank Yang, CEO, Chief Scientific Officer, and Executive Director of CStone Pharma, stated: "The preliminary data from the Phase I study of CS2009 has given us great confidence to accelerate the Phase II study of CS2009. Therefore, the Phase II clinical trial of CS2009 adopts a multi-cohort parallel expansion design, covering a total of 15 monotherapy/combination therapy cohorts, including 9 solid tumor indications such as non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). Currently, the Phase II clinical trial is actively enrolling patients in Australia. The approval of the IND in China will further accelerate the clinical development progress and explore and validate the broad therapeutic potential of CS2009."