LongBio Pharma (Suzhou) Co., Ltd. (1779.HK) today announced that the Biologics License Application (BLA) for LP-003, the Company’s independently developed novel anti-IgE antibody, has been officially accepted by the National Medical Products Administration (NMPA) for the treatment of seasonal allergic rhinitis.
The BLA acceptance marks a pivotal milestone in the clinical development of LP-003 and represents a critical step forward toward the commercialization of this next-generation anti-IgE antibody. As a core pipeline product of the Company, LP-003 has completed key registrational clinical trials. The current BLA submission is supported by positive Phase III clinical data in seasonal allergic rhinitis, which fully validates the product’s efficacy and safety profile.
Next-Generation Anti-IgE Antibody with Novel Sequence Design
Immunoglobulin E (IgE) is the core mediator of type I hypersensitivity and allergic reactions. Anti-IgE therapy is a clinically proven and well-established treatment modality that has been incorporated into multiple clinical guidelines and manuals for the diagnosis and management of allergic diseases.
LP-003, the Company’s flagship product, is a proprietary next-generation anti-IgE monoclonal antibody featuring an innovative sequence design. It functions by binding to free IgE in the human body and blocking the interaction between IgE and the high-affinity IgE receptor (FcεRI) expressed on the surface of mast cells and basophils, thereby interrupting the downstream allergic cascade reaction.
Beyond the currently submitted indication for seasonal allergic rhinitis (SAR), LP-003 is being developed for a broad spectrum of allergic diseases, including chronic spontaneous urticaria (CSU), allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and food allergy. Multiple indications have obtained clinical trial approvals and are currently undergoing clinical development in China. In addition, the Investigational New Drug (IND) application of LP-003 for peanut allergy has been approved by the U.S. Food and Drug Administration (FDA).
Substantial Unmet Medical Need in Allergic Rhinitis Treatment
Seasonal allergic rhinitis affects a large patient population. During pollen seasons, patients suffer from typical symptoms including nasal pruritus, sneezing, rhinorrhea and nasal congestion, which severely impair 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.
As the first anti-IgE biologic candidate in China to file a BLA for seasonal allergic rhinitis, LP-003 is expected to provide a novel therapeutic option for vast numbers of patients with seasonal allergic rhinitis upon approval.
Advancing Regulatory Review Actively to Benefit Patients at an Early Date
“The acceptance of LP-003’s BLA represents a major phased achievement of LongBio Pharma in the research and development of innovative therapies for allergic diseases, embodying the joint efforts of clinical researchers and the entire project team. Moving forward, the Company will fully cooperate with the Center for Drug Evaluation (CDE) in the regulatory review process, promptly respond to review inquiries, efficiently complete supplementary data submission and technical communication, and steadily advance the review progress. We look forward to this independently developed next-generation anti-IgE antibody benefiting domestic patients with allergic diseases at an early date,”
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.
LongBio Pharma (Suzhou) Co., Ltd. is a clinical-stage innovative biopharmaceutical enterprise. The Company focuses on the independent research and development of novel biologics for allergic and autoimmune diseases, and has built a diversified product pipeline covering rhinology, dermatology, respiratory medicine, nephrology and other therapeutic areas. Committed to developing high-quality innovative biologic drugs, the Company strives to address unmet clinical medical needs in China.
Certain statements contained in this announcement are forward-looking statements, which are based on available information and known facts as of the release date of this announcement. Save as required by applicable laws, the Company undertakes no obligation to update or revise any forward-looking statements, nor will it make further public corrections in respect of any emergent or unforeseen events, even if new information, future events or other objective changes arise subsequently. Readers are advised to exercise caution in referring to such statements. The actual future operating performance and development of the Company may differ materially from the forward-looking statements set out herein. All views and statements contained in this announcement are valid only as of the release date and may be adjusted in accordance with subsequent industry trends and corporate development.
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