LONGBIO-B (01779) has announced that the Biologics License Application (BLA) for LP-003, targeting the indication of seasonal allergic rhinitis, has been formally accepted for review by China's National Medical Products Administration.

LP-003 is an anti-IgE antibody featuring a novel sequence design. It is being developed to address a range of allergic conditions, including seasonal allergic rhinitis, chronic spontaneous urticaria, allergic asthma, chronic rhinosinusitis with nasal polyps, and food allergies. The primary mechanism of LP-003 involves blocking free IgE in the blood and tissues, thereby suppressing the onset of IgE-mediated allergic reactions.

The drug functions by binding to free IgE, preventing these excessive unbound IgE molecules from attaching to the high-affinity receptor FcεRI. IgE serves as the central mediator of type I hypersensitivity reactions, which, when triggered by allergens in various organs, lead to conditions such as seasonal allergic rhinitis, allergic asthma, chronic spontaneous urticaria, and food allergies. Anti-IgE antibodies play a pivotal role in treating multiple allergic diseases by interrupting the cascade of the allergic response, and this therapeutic approach has been incorporated into Chinese clinical guidelines for managing seasonal allergic rhinitis and chronic spontaneous urticaria.

The company has already obtained Investigational New Drug approvals and/or initiated clinical trials in China for LP-003 across several indications, encompassing seasonal allergic rhinitis, chronic spontaneous urticaria, allergic asthma, chronic rhinosinusitis with nasal polyps, and food allergies. Additionally, an IND application for LP-003 targeting peanut allergy has received approval from the U.S. Food and Drug Administration.