Announcement • Sep 17

LongBio Pharma Biologics License Application For LP-003 Accepted By China NMPA

LongBio Pharma's Biologics License Application (BLA) for LP-003 was accepted by the National Medical Products Administration (NMPA) for the treatment of seasonal allergic rhinitis. This milestone marks LP-003 as the first anti-IgE biologic candidate in China to file a BLA for seasonal allergic rhinitis. Allergic rhinitis is one of the most prevalent chronic diseases in China, with over 200 million patients suffering from symptoms such as nasal pruritus, sneezing, rhinorrhea and nasal congestion, which severely impairs work efficiency, sleep quality and daily life. Despite the proven clinical value of targeted anti-IgE therapy, such regimens have not yet been officially approved in China, leaving a large number of patients without optimal treatment options and creating significant unmet clinical needs. LP-003, LongBio Pharma's flagship product, is a proprietary next-generation anti-IgE monoclonal antibody featuring an innovative sequence design. By binding to free IgE in the human body and blocking the interaction between IgE and the high-affinity IgE receptor (FceRI), LP-003 is designed to interrupt the downstream allergic cascade reaction at its source, offering a targeted mechanism of action. Altruist Biologics supported the program across the full CMC lifecycle, including process development, scale-up, GMP large-scale manufacturing and regulatory submission. Since the collaboration's onset, Altruist has leveraged its extensive biologics development and manufacturing expertise and internationally recognized quality systems to address key requirements spanning process robustness, production stability and data integrity. This integrated support enabled the program to progress efficiently through development and successfully reach BLA submission and acceptance. LP-003 is a next-generation anti-IgE monoclonal antibody with a novel sequence design. It targets and neutralizes free IgE to block IgE-mediated allergic pathways, covering a wide range of allergic disease indications. Multiple clinical trials of LP-003 are ongoing in China, and its IND application for peanut allergy has been approved by the U.S. FDA.

Announcement • Jul 14

LongBio Pharma (Suzhou) Co., Ltd. Receives FDA Approval For Clinical Trial Application On LP-003 For Peanut Allergy

LongBio Pharma (Suzhou) Co., Ltd. announced that the clinical trial application for LP-003 for the indication of peanut allergy has been approved by the United States Food and Drug Administration. Food allergy, including peanut allergy, is a condition caused by an abnormal immune response to dietary components, usually proteins, which can be triggered through IgE-driven, non-IgE-driven, or a combination of both mechanisms. Clinical manifestations are diverse, affecting the skin, gastrointestinal, respiratory, and cardiovascular systems, and it is one of the leading causes of allergic shock. There are a large number of food allergy patients around the world, and its prevalence has grown from 273.2 million in 2018 to 361.8 million in 2024, with a CAGR of 4.8%. With the increasing prevalence of food allergy, the number of food allergy patients around the world is expected to reach 456.7 million in 2030 at a CAGR of 4.0% from 2024 to 2030. LP-003 is an anti-IgE antibody with novel sequencing. LP-003 is targeted to treat allergic diseases, including seasonal AR, CSU, allergic asthma, CRSwNP and food allergy. The primary function of LP-003 is to block free IgE in blood and tissues, and thus inhibiting the occurrence of IgE-driven allergic reactions. LP-003 has the capability to bind free IgE and prohibit those free and excessive IgE from binding to the high-affinity IgE receptor, FceRI. IgE is the core mechanism driving Type I hypersensitivity. Type I hypersensitivity triggered by allergens in different organs causes seasonal AR, allergic asthma, CSU, food allergy and other allergic diseases. Anti-IgE antibody currently plays a pivotal role in the treatment of a variety of allergic diseases due to its capabilities of achieving cascade of allergic reactions. Anti-IgE therapy has been included in Chinese guidelines for the diagnosis and treatment of seasonal AR and CSU. Company has obtained IND approvals and/or initiated clinical trials for LP-003 in China for various indications, including seasonal AR, CSU, allergic asthma, CRSwNP and food allergy.

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