LongBio Pharma Announces Positive Phase III Results for LP-003 in Seasonal Allergic Rhinitis
Hong Kong, June 12, 2026 – LongBio Pharma (Suzhou) Co., Ltd. (HKEX: 1779), a clinical-stage biopharmaceutical company, has announced that its lead candidate, LP-003, has achieved highly statistically and clinically significant results in a Phase III clinical trial for the treatment of moderate-to-severe seasonal allergic rhinitis (AR) in China.
Key Highlights from the Announcement
- Primary Endpoints Met: The Phase III study met its pre-specified primary endpoints, demonstrating the clinical efficacy of LP-003 in patients with seasonal AR who were inadequately controlled by standard of care (SoC) treatment. Results were described as both highly statistically and clinically significant.
- Trial Design: The study was a multi-center, randomized, double-blind, placebo-controlled trial conducted in China. A total of 546 patients were enrolled and randomly assigned to receive either 100 mg LP-003 injection or placebo, administered once every four weeks.
- Patient Criteria: Enrollees were patients with moderate-to-severe seasonal AR who had not responded satisfactorily to standard treatments, per the “Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China (2022, revised edition).” Key exclusion: patients with other concurrent conditions.
- Endpoints:
- Primary Endpoint: Improvement in total nasal symptom scores (TNSS) during the peak pollen season (PPP).
- Secondary Endpoints: Safety, daily nasal and ocular symptom scores, rescue medication use, pharmacokinetics (PK), and pharmacodynamics (PD).
- About LP-003: LP-003 is a novel anti-IgE antibody designed to block free IgE in blood and tissues, preventing it from binding to the high-affinity IgE receptor (FcεRI). This mechanism is central to halting Type I hypersensitivity reactions, which underlie a range of allergic diseases including AR, chronic spontaneous urticaria (CSU), allergic asthma, CRSwNP (chronic rhinosinusitis with nasal polyps), and food allergies.
- Pipeline and Strategy: LP-003 is being developed for multiple indications. IND approvals and/or clinical trials have been initiated for seasonal AR, CSU, allergic asthma, CRSwNP, and food allergy. The company has a comprehensive pipeline focused on rhinology, dermatology, respiratory, hematology, nephrology, and other autoimmune diseases.
Potential Price Sensitive Information
- Significance of Results: The successful completion of a pivotal Phase III trial with strong efficacy results positions LP-003 as a potential new therapy for patients with seasonal AR who do not respond to SoC. This could drive future regulatory filings and commercialization, leading to significant revenue potential if successfully approved and launched.
- Market Impact: Seasonal AR affects 10-20% of the global population and is a major chronic respiratory disease. The market opportunity for a new, effective therapy is substantial, with potential to improve both patient quality of life and company valuation.
- Risks: The company explicitly cautions that there is no guarantee LP-003 will be successfully developed or marketed, highlighting regulatory, commercialization, and competitive risks.
Details for Shareholders
- The positive Phase III data represent a major milestone for LongBio Pharma and could be a significant catalyst for the company’s share price, subject to regulatory and commercial progress.
- Shareholders should monitor further announcements regarding regulatory submissions, potential approvals, and updates on LongBio’s broader pipeline.
- The company’s business model is heavily reliant on in-house discovery and development, with a focus on biologic drugs for allergic and autoimmune diseases.
- The Board is chaired by Dr. Liu Heng and includes a mix of executive, non-executive, and independent non-executive directors.
Company Overview
Established in 2020 with operations in Shanghai and Changshu (Suzhou), LongBio Pharma focuses on developing biopharmaceuticals for allergic and autoimmune diseases, leveraging its own R&D capabilities. The company’s pipeline covers a range of disease areas, aiming to address unmet medical needs.
Disclaimer
Disclaimer: The information provided in this article is for informational purposes only and does not constitute investment advice. Investors are advised to exercise due care and seek independent professional advice before making any investment decisions. The company has stated there is no guarantee LP-003 will achieve regulatory or commercial success.
