BOAN BIOTECH (06955.HK): First Patient Dosed in China Phase I Trial of BA1203

NewTimeSpace News: On 22 October 2026, Shandong Boan Biotechnology Co., Ltd. (the "Company") voluntarily announced that the first subject has been enrolled in the Phase I clinical trial in China of BA1203, its investigational PD-1/IL-2 antibody-cytokine prodrug. To the Company's knowledge, the investigational drug is the world's only IL-2 alpha receptor highly active, masked and PD-1 blocking PD-1/IL-2 molecule.

The announcement disclosed that the trial is a multicentre, open-label Phase I study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BA1203 in patients with advanced solid tumours. The Company noted that immunotherapy represented by PD-1/PD-L1 inhibitors has become a core treatment modality for malignant tumours, but benefits vary across cancer types and patient populations, and a significant proportion of patients still face challenges such as primary non-response, relapse or drug resistance, leaving unmet clinical needs; IL-2 is an important cytokine for promoting T cell proliferation and functional recovery, but conventional IL-2 therapies are limited by a narrow therapeutic window, non-selective activation of peripheral immune cells and the risk of systemic toxicity, so achieving precise delivery and selective activation of IL-2 in the tumour microenvironment has become an important direction for next-generation cancer immunotherapy.

The Company stated that BA1203, a next-generation immuno-oncology candidate independently developed by the Company, combines the dual mechanisms of action of a PD-1 antibody and an IL-2 cytokine, aiming to achieve both immune checkpoint blockade and local tumour immune activation. Its masked prodrug design enables IL-2 to be selectively activated in the tumour microenvironment while maintaining low activity in peripheral tissues, thereby enhancing local tumour immune responses and reducing the risk of systemic toxicity; the molecule also adopts a high-affinity bivalent PD-1 targeting design, which helps strengthen PD-1 pathway blockade and deliver IL-2 more precisely to PD-1-positive tumour-infiltrating T cells; in addition, BA1203 adopts a symmetric molecular structure design, which helps improve molecular stability and manufacturing process controllability. Preclinical studies showed that, in multiple tumour models with low or no response to PD-1/PD-L1 inhibitors, BA1203 demonstrated excellent anti-tumour activity significantly superior to existing PD-1/PD-L1 inhibitors; in tumour-bearing mouse models, BA1203 showed better efficacy than comparable competitors and a safety advantage of tumour-dependent activation; in terms of safety, BA1203 showed low peripheral toxicity while enhancing local tumour immune activation, with a favourable safety profile and excellent tolerability in cynomolgus monkey studies. The Company said it will accelerate the clinical development of BA1203 and fully explore its potential as monotherapy and in combination therapies across multiple solid tumours.