CStone Pharmaceuticals-B(02616)CS2009(PD-1/VEGF/CTLA-4 Tri-specific Antibody) Phase II Clinical Trial Application Approved by the US FDA

CITIC Securities Finance APP has learned that CStone Pharmaceuticals-B (02616) announced that the IND application for its core asset CS2009 for Phase II clinical trials in advanced solid tumors has been approved by the FDA. The IND application for a Phase II clinical trial of CS2009 (a tri-specific antibody targeting PD-1/VEGF/CTLA-4) for advanced solid tumors has received approval from the U.S. Food and Drug Administration (FDA), marking a significant progress in the global development of this innovative immunotherapy.

The Phase II global multicenter clinical trial is actively recruiting in Australia and China, including 15 monotherapy/combination therapy cohorts 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).

Initial data from the Phase I clinical study of CS2009 was presented at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting, showing good safety and tolerability, with positive anti-tumor activity data. More Phase I and Phase II clinical data are expected to be announced at the upcoming American Society of Clinical Oncology (ASCO) and ESMO conferences this year.

Dr. Jianxin Yang, CEO, Chief R&D Officer, and Executive Director of CStone Pharmaceuticals, stated, “We are very pleased to see the efficient progress of the global multicenter Phase II clinical trial of CS2009 and its approval by the U.S. FDA. This IND approval is based on active communication with the FDA and full recognition of the favorable safety profile and anti-tumor activity demonstrated by CS2009 in Phase I clinical trials, including key results from dose escalation and expansion phases. During this meeting, both parties further confirmed the study design for the Phase II trial, including dose optimization strategies, dose expansion plans, and other core 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.”