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. Live News • Jun 13
LongBio Pharma’s LP-003 Achieves Key Phase III Success in China for Allergic Rhinitis LongBio Pharma’s lead allergy biologic candidate LP-003 met primary endpoints in a Phase III trial for moderate-to-severe seasonal allergic rhinitis in China.
The multicenter, randomized, double-blind, placebo-controlled study enrolled 546 patients and showed highly statistically and clinically significant results versus placebo.
Management highlighted that while the Phase III data reinforce LP-003’s potential in allergy biologics, commercialization is not yet assured.
Successful Phase III efficacy and safety data often mark a key inflection point for a biotech, as they can move a drug closer to potential regulatory submission and, if approved, eventual revenue contribution.
Investors still need to factor in regulatory review, potential commercialization timelines, competitive allergy treatments and funding needs before LP-003 can translate into cash flows for the company. Announcement • Jun 10
LongBio Pharma (Suzhou) Co., Ltd., Annual General Meeting, Jun 30, 2026 LongBio Pharma (Suzhou) Co., Ltd., Annual General Meeting, Jun 30, 2026, at 16:00 China Standard Time. Location: 5th floor, building f, area a, no. 128 yinhe road, dongnan subdistrict, changshu city, jiangsu province, suzhou China 
