Hong Kong–listed biopharmaceutical firm LongBio Pharma (LONGBIO-B) announced that the National Medical Products Administration (NMPA) has formally accepted its biologics license application (BLA) for LP-003 in the treatment of seasonal allergic rhinitis (SAR).

LP-003 is a novel anti-IgE monoclonal antibody designed to neutralize free immunoglobulin E and prevent its binding to the high-affinity FcεRI receptor, thereby interrupting the cascade of type I hypersensitivity reactions. Beyond SAR, the candidate is being clinically investigated for chronic spontaneous urticaria (CSU), allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and food allergies, including peanut allergy. Investigational new drug (IND) approvals for these indications have been secured in China, and the U.S. Food and Drug Administration has cleared an IND for the peanut-allergy program.

Founded in 2020 and headquartered in Shanghai and Changshu, Suzhou, LongBio Pharma focuses on in-house discovery and development of biologics targeting allergic and autoimmune diseases. The company’s pipeline spans therapeutic areas such as rhinology, dermatology, respiratory, hematology and nephrology.

Management highlighted that BLA acceptance represents a significant regulatory milestone for LP-003; however, successful commercialization is not guaranteed. Shareholders and potential investors are advised to exercise caution when dealing in the company’s shares.