CSTONE PHARMA-B (02616) saw its shares surge more than 12%. At the time of writing, the stock was up 12.71%, trading at HK$6.65 with a turnover of HK$36.9543 million.

The movement follows a previous announcement from the company stating that the Investigational New Drug (IND) application for its core asset, CS2009 (a PD-1/VEGF/CTLA-4 tri-specific antibody) for the treatment of advanced solid tumors, has been approved by the US Food and Drug Administration (FDA). Dr. Yang Jianxin, Chief Executive Officer, President of R&D, and Executive Director of CStone Pharmaceuticals, stated that the company is comprehensively advancing the global clinical development program for CS2009 and looks forward to sharing more positive data and research progress in the near future.

A research report from Guoyuan Securities noted that clinical data for CStone's core product CS2009 is excellent, with a safety profile significantly superior to similar therapies. In IO-treated NSCLC patients, the Objective Response Rate (ORR) reached 17.6%, and the Disease Control Rate (DCR) reached 82.4%. The report indicated that CS2009 is currently undergoing a global multi-center Phase II clinical study, with sites in Australia and China. Patient enrollment has reached 200 subjects. The US Phase II clinical trial has already received FDA approval, with a data update expected in March, which is anticipated to advance Business Development (BD) collaboration efforts.