Shandong Boan Biotechnology Receives CDE IND Clearance for BA1203
核心洞察
China's NMPA Center for Drug Evaluation (搜索) approved the IND application for Boan Biotech's investigational PD-1 (搜索)/IL-2 antibody cytokine prodrug BA1203 (搜索) in solid tumors (搜索).
Boan Biotech describes BA1203 (搜索) as the world's only IL-2 alpha receptor high-activity, masked, PD-1 (搜索) blocking PD-1/IL-2 molecule.
The company plans a multicenter, open-label Phase I study assessing safety, tolerability, pharmacokinetics and preliminary efficacy in advanced solid tumors (搜索).
Boan Biotech (06955) announced on September 14 that its investigational PD-1 (搜索)/IL-2 antibody cytokine prodrug BA1203 (搜索) has received approval from the Center for Drug Evaluation (搜索) (CDE) of China's National Medical Products Administration (搜索) (NMPA) for a new drug clinical trial application (IND), intended for the treatment of various solid tumors (搜索). According to the company, BA1203 is the only IL-2 alpha receptor high-activity, masked, and PD-1 blocking PD-1/IL-2 molecule in the world.
BA1203 (搜索) is a next-generation immuno-oncology candidate independently developed by Boan Biotech that integrates the dual mechanisms of a PD-1 (搜索) antibody and an IL-2 cytokine, aiming to achieve immune checkpoint blockade and local immune activation of tumors simultaneously. Following the IND clearance, the company plans to run a multicenter, open-label Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of BA1203 in patients with advanced solid tumors (搜索).
The trial is designed to further validate the candidate's efficacy and safety advantages and to explore development pathways for both monotherapy and combination therapy, with the company citing differentiated therapeutic potential in PD-1 (搜索) target binding, immune pathway blockade and tumor microenvironment immune activation. Shares of Boan Biotech rose nearly 4% on the news, up 3.75% at HKD 2.625 with trading volume of HKD 2.2693 million.
Source: longbridge.com