BOAN BIOTECH(06955.HK): IND Application for BA1203 (Masked PD-1/IL-2 Antibody-Cytokine Prodrug) Accepted by CDE
NewTimeSpace News: Shandong Boan Biotechnology Co., Ltd. (06955.HK) announced on 8 July that the Investigational New Drug (IND) application for BA1203, a masked PD-1/IL-2 antibody-cytokine prodrug under development, has been accepted by the Center for Drug Evaluation (CDE) of NMPA for the treatment of solid tumours. The candidate integrates PD-1 blockade and local IL-2 immune activation, with preclinical data demonstrating superior anti-tumour potency and favourable safety profiles versus existing PD-1 inhibitors. To the Company’s knowledge, BA1203 will be the first masked PD-1/IL-2 antibody-cytokine retaining IL-2Rα binding activity to enter clinical development in China. The Company reminds investors of uncertainties in drug R&D progress.
NewTimeSpace News: Shandong Boan Biotechnology Co., Ltd. released a voluntary announcement dated 8 July 2026. The Investigational New Drug (IND) application for BA1203, an in-house developed masked PD-1/IL-2 antibody-cytokine prodrug, has been accepted by the Center for Drug Evaluation (CDE) under the National Medical Products Administration.
This asset represents a new-generation tumour immunotherapy candidate independently developed by the Company, intended for the treatment of multiple solid tumours. To the Company’s best knowledge, BA1203 will become the first masked PD-1/IL-2 antibody-cytokine with preserved IL-2 receptor alpha subunit binding activity to advance into clinical trials in China.
BA1203 combines dual mechanisms of action from anti-PD-1 antibody and IL-2 cytokine. It adopts a high-affinity bivalent PD-1 targeting design, masked IL-2 prodrug architecture and symmetric molecular configuration. The design enables concurrent immune checkpoint blockade and selective immune activation within the tumour microenvironment, amplifying local anti-tumour immune responses while lowering systemic toxicity risks.
Preclinical studies revealed robust anti-tumour efficacy of BA1203 in tumour models with low or no response to PD-1/PD-L1 inhibitors, markedly outperforming current checkpoint inhibitors. It also exhibits tumour-dependent activation with superior safety advantages. Non-human primate studies in cynomolgus monkeys demonstrated a favourable safety profile and excellent tolerability.
NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.
Tags：
