CStone Pharmaceuticals-B (02616) has announced that the Investigational New Drug (IND) application for a Phase II clinical trial of its core asset CS2009, a PD-1/VEGF/CTLA-4 tri-specific antibody for advanced solid tumors, has been approved by the U.S. Food and Drug Administration (FDA). The FDA's approval of the Phase II IND application for CS2009 in advanced solid tumors marks a significant advancement in the global development of this innovative immunotherapy. The global multi-center Phase II clinical trial is currently actively enrolling patients in Australia and China, comprising a total of 15 monotherapy/combination therapy cohorts and 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 data. Further data from Phase I and Phase II clinical 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, Head of R&D, and Executive Director of CStone Pharmaceuticals, stated: "We are very pleased to see the efficient progression of the global multi-center Phase II clinical trial for CS2009 and its approval by the FDA to proceed. This IND approval is based on positive communications during meetings between CStone Pharmaceuticals and the U.S. FDA, as well as the FDA's full affirmation of the key results from the dose escalation and dose expansion phases of the Phase I trial, which demonstrated CS2009's favorable safety and anti-tumor activity. During these meetings, both parties further confirmed the Phase II clinical trial protocol, including dose optimization strategies, dose expansion design, and other core elements. We are now comprehensively advancing the global clinical development program for CS2009 and look forward to sharing more positive data and research progress in the near future."