Shandong Boan Biotechnology Co., Ltd. (BOAN BIOTECH) announced that China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted the investigational new drug (IND) application for BA1203, an antibody-cytokine prodrug designed to target PD-1 and IL-2 pathways in multiple solid tumors.

BA1203 is positioned as a next-generation immuno-oncology (IO) therapy. According to the company, it is expected to be the first masked PD-1/IL-2 antibody-cytokine fusion protein with retained IL-2 α-subunit binding activity to advance into clinical trials in China.

Current PD-1/PD-L1 inhibitors deliver an average objective response rate of roughly 20%, underscoring significant unmet needs for patients who exhibit non-response, relapse, or resistance. BA1203 seeks to address these gaps through a dual mechanism: high-affinity, bivalent PD-1 blockade combined with a masked IL-2 prodrug that is selectively activated within the tumor microenvironment. This design aims to enhance intratumoral immune activation while limiting systemic toxicity.

Preclinical evaluations demonstrated that BA1203 achieved superior anti-tumor activity versus existing PD-1/PD-L1 antibodies in models where conventional checkpoint inhibitors showed limited efficacy. In cynomolgus monkey studies, the candidate maintained low peripheral toxicity and exhibited favorable safety and tolerability, attributes the company links to its tumor-dependent activation profile and symmetric molecular architecture.

BOAN BIOTECH views BA1203 as a core component of its strategy to expand its next-generation IO portfolio. The company plans to expedite clinical development of the candidate, assessing its potential both as a monotherapy and in combination regimens.