CSTONE PHARMA-B(02616): The Phase II clinical trial application for CS2009 (PD-1/VEGF/CTLA-4 triple-specific antibody) has been approved by the US FDA.

CSTONE PHARMA-B (02616) announced that the company's core asset CS2009 (PD-1/VEGF/CTLA-4 triple-specific antibody) has obtained approval from the US Food and Drug Administration (FDA) for the Phase II clinical trial (IND) application for advanced solid tumors. The approval of the Phase II IND application for CS2009 for advanced solid tumors by the FDA marks a significant advancement in the global development of this innovative immunotherapy. The Phase II global multi-center clinical trial is actively enrolling in Australia and China, including 15 monotherapy/combination therapy arms and 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 was presented at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting, demonstrating good safety and tolerability, as well as positive anti-tumor activity data. More Phase I and Phase II clinical study data are expected to be presented at this year's American Society of Clinical Oncology (ASCO) and ESMO meetings. Dr. Frank Jiang, CEO, Head of R&D, and Executive Director of CStone Pharma, stated: "We are delighted to see the efficient progress of the global multi-center Phase II clinical trial of CS2009 and its approval for initiation by the FDA. This IND approval was based on proactive communications between CStone Pharma and the FDA, as well as the FDA's full recognition of the good safety profile and anti-tumor activity demonstrated by CS2009 in the Phase I clinical trial's dose escalation and dose expansion stages. During this meeting, both parties further confirmed the research plan for the Phase II clinical trial, including dose optimization strategies, dose expansion design, and other key elements. We are currently advancing the global clinical development of CS2009 and look forward to sharing more positive data and research progress in the near future."