According to the Zhitong Finance App, Tianchen Bio-B (01779) announced that LP-003's clinical trial application for peanut allergy indications has been approved by the US Food and Drug Administration (FDA).
Food allergies (including peanut allergies) are diseases caused by abnormal immune responses to dietary components (usually proteins), and can be triggered by IgE-mediated, non-IgE-mediated, or a combination of the two. The clinical presentation is diverse and can affect the skin, gastrointestinal tract, respiratory tract, and cardiovascular system, and is one of the main causes of anaphylactic shock. There are a large number of people with food allergies worldwide. The number of cases has increased from 273 million in 2018 to 362 million in 2024, with a compound annual growth rate of 4.8%. As the prevalence of food allergies continues to rise, the number of global food allergy sufferers is expected to reach 456.7 million in 2030, with a compound annual growth rate of 4.0% from 2024 to 2030.
LP-003 is an anti-IgE antibody with a novel sequence design. LP-003 targets allergic diseases, including seasonal allergic rhinitis, CSU, allergic asthma, crSwnP, and food allergies. The main function of LP-003 is to block free IgE in blood and tissue, thereby inhibiting the occurrence of IgE-mediated allergic reactions. LP-003 can bind to free IgE and prevent such free and excessive IgE from binding to the high-affinity IgE receptor FcepsilRI. IgE is the core mechanism that mediates type I hypersensitivity reactions. Type I hypersensitivity reactions triggered by allergens in different organs cause seasonal allergic rhinitis, allergic asthma, CSU, food allergies, and other allergic diseases. Since anti-IgE antibodies can block the cascading process of allergic reactions, they currently play a key role in the treatment of various allergic diseases. Anti-IgE therapy has been included in the diagnosis and treatment guidelines for seasonal allergic rhinitis and CSU in China. The company has obtained LP-003's IND approval and/or initiated relevant clinical trials in China for various indications, including seasonal allergic rhinitis, CSU, allergic asthma, crSWnP, and food allergies.