China-based Luye Pharma Group (HKG: 2186) announced that its controlling subsidiary Shandong Boan Biotechnology Co., Ltd has received clinical trial approval from the Center for Drug Evaluation (CDE) for its in-house developed long-acting monoclonal antibody (mAb) BA2101.
BA2101: Drug Profile and Mechanism
BA2101 is an innovative long-acting human monoclonal IgG4 antibody targeting the interleukin-4 receptor subunit α (IL-4Rα). Administered subcutaneously, the drug is designed to be given once every four weeks. It can inhibit both IL-4 and IL-13 signaling pathways, regulate Th2-type inflammation, reduce eosinophil content and IgE levels, and treat allergic diseases caused by Th2-type inflammation. Intended indications include atopic dermatitis, asthma, chronic sinusitis with nasal polyps, prurigo nodosum, chronic spontaneous urticaria, and others.
Market Context and Comparative Advantages
Sanofi’s Dupixent (dupilumab), the world’s first IL-4Rα mAb, is widely used to treat prurigo nodosa, eosinophilic esophagitis, atopic dermatitis, asthma, chronic sinusitis with nasal polyps, and other conditions caused by Th2 inflammation. Dupixent was approved in China in 2020 for moderate to severe atopic dermatitis and was included on the National Reimbursement Drug List (NRDL) via price negotiations. Preclinical studies have shown that BA2101 has a longer half-life and higher drug exposure compared with similar products on the market, while maintaining similar efficacy and a good safety profile. BA2101 is expected to be administered once every four weeks, in contrast to Dupixent’s two-week administration cycle.
Future Outlook
With the CDE’s approval, Luye Pharma is poised to advance BA2101 into clinical trials, marking a significant step in the development of long-acting treatments for allergic diseases. The company aims to leverage the drug’s extended dosing interval and favorable pharmacokinetic profile to offer a more convenient treatment option for patients.-Fineline Info & Tech
