BOAN BIOTECH (06955.HK): Masked PD-1/IL-2 Prodrug BA1203 Approved for Clinical Trial in China for Multiple Solid Tumours

NewTimeSpace News: On 14 September 2026, Shandong Boan Biotechnology Co., Ltd. (stock code: 06955.HK) announced on a voluntary basis that the investigational new drug application for its PD-1/IL-2 antibody-cytokine prodrug BA1203 has been approved by the Centre for Drug Evaluation of the National Medical Products Administration of the PRC, and is intended to be developed for the treatment of multiple solid tumours. To the Company's knowledge, BA1203 is the world's only PD-1/IL-2 molecule that is IL-2 receptor alpha high-activity, masked and PD-1 blocking.

The announcement disclosed that BA1203 combines the dual mechanisms of a PD-1 antibody and an IL-2 cytokine, aiming to achieve both immune checkpoint blockade and local tumour immune activation; through its masked IL-2 prodrug design, IL-2 is selectively activated in the tumour microenvironment while remaining at low activity in peripheral tissues, and the molecule adopts a high-affinity bivalent PD-1 targeting design and a symmetric molecular structure. Preclinical studies showed that BA1203 demonstrated anti-tumour activity in multiple tumour models with low or no response to PD-1/PD-L1 inhibitors and was superior to existing PD-1/PD-L1 inhibitors; in tumour-bearing mouse models it showed better efficacy than comparable products and a safety advantage of tumour-dependent activation; and in cynomolgus monkey studies it had a good safety profile and excellent tolerability.

Following the approval to enter clinical trials, the Company intends to conduct a multicentre, open-label Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of BA1203 in patients with advanced solid tumours, to further verify its advantages in efficacy and safety and to explore monotherapy and combination development paths. The announcement also noted that a substantial proportion of patients still show primary non-response, relapse or resistance to immunotherapy represented by PD-1/PD-L1 inhibitors, and that a previous meta-analysis showed an overall objective response rate of about 20% for PD-1/PD-L1 inhibitor monotherapy.

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