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(Changshu, Jiangsu, China, 13 July 2026), LongBio Pharma (Suzhou) Co., Ltd. (hereinafter referred to as “LongBio Pharma” or the “Company”, Stock Code: 1779 on the Hong Kong Stock Exchange) issues this voluntary announcement to inform the market that the clinical trial application for LP-003, a novel sequence anti-IgE antibody independently developed by the Company, for the indication of peanut allergy has been approved by the U.S. Food and Drug Administration (FDA), authorizing the conduct of relevant clinical studies in the United States.

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. Peanut allergy represents a prevalent and high-risk subtype of food allergies that can easily trigger allergic shock, leaving a substantial unmet clinical need in overseas markets.

About LP-003

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, FcεRI. 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. We have 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.

About the Company

The Company is a clinical-stage biopharmaceutical company. Established in 2020 and located in Shanghai and Changshu, Suzhou, China, the Company primarily focuses on in-house discovery and development of biopharmaceuticals targeting allergic and autoimmune diseases. The Group has developed a comprehensive product pipeline for biologic treatments targeting rhinology, dermatology, respiratory, hematology, nephrology and other autoimmune diseases. The Company continues to advance the research, development and commercialization of high-quality innovative biologic drugs, aiming to deliver safer and more effective novel therapeutic options for patients worldwide.

Forward-Looking Statements Disclaimer

All forward-looking statements contained herein are formulated solely based on information and facts available as of the publication date of this article. Except as required by applicable laws and regulations, the Company shall bear no obligation to update or revise any forward-looking statements, nor to make public corrections for unforeseen subsequent events, regardless of new information, future developments or other circumstances arising thereafter. Readers are advised to review this article carefully and note that the Company’s actual future performance and operational results may differ materially from current expectations. All statements in this article are made as of the release date and are subject to changes driven by future industrial and corporate developments.