Shandong Boan Gains CDE Nod for Phase II Combo Trial in NSCLC

Shandong Boan Biotechnology Company., Limited. Class H ( (HK:6955) ) just unveiled an update.

Shandong Boan Biotechnology announced that China’s Center for Drug Evaluation has accepted its application for a Phase II clinical trial of its anti-CD25 antibody BA1106 combined with PD-1 inhibitor BA1104 as first- or second-line therapy for driver gene-negative non-small cell lung cancer. The multicenter, single-arm, open-label study will assess efficacy, safety, and pharmacokinetics in a patient population with limited options after developing resistance to existing immune checkpoint inhibitors.

BA1106 is described as China’s first investigational non-IL-2-blocking anti-CD25 antibody in clinical trials for solid tumors, designed to selectively deplete regulatory T cells while preserving IL-2 signaling and enhancing anti-tumor responses. Phase I data indicated encouraging efficacy signals across several tumor types and a favorable safety profile, prompting the company to accelerate Phase II development in NSCLC and to explore further combinations with BA1104 in other high-incidence solid tumors such as gastric cancer, potentially strengthening its position in next-generation cancer immunotherapy.

More about Shandong Boan Biotechnology Company., Limited. Class H

Shandong Boan Biotechnology Co., Ltd. is a China-based biopharmaceutical company focused on developing innovative antibody therapies, particularly in oncology. The company’s pipeline includes proprietary candidates such as the anti-CD25 antibody BA1106 and the PD-1 inhibitor BA1104, targeting unmet medical needs in solid tumors including non-small cell lung cancer.

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Technical Sentiment Signal: Sell

Current Market Cap: HK$4.09B

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