LONGBIO-B: FDA Clears LP-003 Clinical Trial Application for Peanut Allergy

Bulletin Express07-13

LongBio Pharma (Suzhou) Co., Ltd. announced that the U.S. Food and Drug Administration has approved the company’s Investigational New Drug application for LP-003 to treat peanut allergy.

Food allergies affect a growing global population, rising from 273.20 million patients in 2018 to 361.80 million in 2024, reflecting a 4.8% CAGR. The prevalence is projected to reach 456.70 million by 2030 at a 4.0% CAGR from 2024.

LP-003 is a novel anti-IgE monoclonal antibody designed to bind and neutralize free IgE, preventing its interaction with the high-affinity IgE receptor (FcεRI) and thereby suppressing Type I hypersensitivity reactions. Beyond peanut allergy, the candidate is being developed for seasonal allergic rhinitis, chronic spontaneous urticaria, allergic asthma and chronic rhinosinusitis with nasal polyps, with related IND approvals or clinical trials already initiated in China.

Founded in 2020 and headquartered in Shanghai and Changshu, Suzhou, LongBio Pharma is a clinical-stage biopharmaceutical company specializing in biologics for allergic and autoimmune diseases. Management cautions that successful development and commercialization of LP-003 remain uncertain, and advises shareholders and potential investors to exercise due care when dealing in company shares.

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