CSTONE PHARMA-B Receives FDA Clearance for Phase II Trial of CS2009

CSTONE PHARMA-B (02616) has announced that the Investigational New Drug (IND) application for a Phase II clinical trial of its core asset, CS2009, for the treatment of advanced solid tumors has been approved by the U.S. Food and Drug Administration (FDA). The approval of the IND for CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, marks a significant milestone in the global development of this innovative immunotherapy. The global multi-center Phase II trial is currently actively enrolling patients in Australia and China. The trial comprises 15 monotherapy and combination therapy cohorts targeting 9 solid tumor indications, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC), triple-negative breast cancer (TNBC), extensive-stage small cell lung cancer (ES-SCLC), and platinum-resistant ovarian cancer (PROC). Preliminary data from the Phase I clinical study of CS2009 were presented at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting, demonstrating a favorable safety and tolerability profile along with positive anti-tumor activity. Additional data from the Phase I and Phase II studies are expected to be presented at the upcoming American Society of Clinical Oncology (ASCO) and ESMO meetings this year. Dr. Yang Jianxin, Chief Executive Officer, President of R&D, and Executive Director of CSTONE PHARMA-B, expressed great satisfaction with the efficient progress of the global multi-center Phase II trial and the FDA's approval. The IND approval was based on positive communications with the FDA and the agency's full recognition of the key results from the dose-escalation and dose-expansion phases of the Phase I trial, which showed promising safety and anti-tumor activity. During these discussions, the Phase II clinical study protocol, including dose optimization strategies, expansion design, and other core elements, was further confirmed. The company is now comprehensively advancing the global clinical development program for CS2009 and looks forward to sharing more positive data and research progress in the near future.