LONGBIO-B(01779): The Biologics License Application (BLA) for LP-003 targeting seasonal allergic rhinitis has been accepted by the National Medical Products Administration.

LONGBIO-B (01779) announced that the Biologics License Application (BLA) for LP-003, aimed at the indication of seasonal allergic rhinitis, has been accepted by the National Medical Products Administration of China. LP-003 is an anti-IgE antibody with a novel sequence design. It is targeted for the treatment of allergic diseases, including seasonal allergic rhinitis, chronic spontaneous urticaria (CSU), allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and food allergies. The primary function of LP-003 is to block free IgE in the blood and tissues, thereby inhibiting the occurrence of IgE-mediated allergic reactions. LP-003 can bind to free IgE, preventing these excessive free IgE molecules from binding to the high-affinity IgE receptor FcRI. IgE is the central mechanism mediating type I hypersensitivity reactions. Type I hypersensitivity reactions triggered by allergens in different organs lead to seasonal allergic rhinitis, allergic asthma, CSU, food allergies, and other allergic diseases. Because anti-IgE antibodies can block the cascade process of allergic reactions, they currently play a key role in the treatment of various allergic diseases. Anti-IgE therapy has been incorporated into the diagnosis and treatment guidelines for seasonal allergic rhinitis and CSU in China. The company has received authorization for clinical trials (IND) for LP-003 for multiple indications in China, including seasonal allergic rhinitis, CSU, allergic asthma, CRSwNP, and food allergies. The IND application for LP-003 targeting peanut allergy has also been approved by the U.S. Food and Drug Administration (FDA).