Tianchen Biologics' LP-003 Demonstrates Superior Efficacy Over Omalizumab in Phase II Interim Analysis for Chronic Spontaneous Urticaria, Poised to Reshape the Multi-Billion-Dollar Market
LongBio
Next-Generation Large Molecule Antibody Developer
On March 2, 2025 (local time), LongBio Pharma (Suzhou) Co., Ltd. (“LongBio”), an innovative Chinese biopharmaceutical company, presented interim Phase II clinical data for its independently developed next-generation anti-IgE antibody LP-003 in the treatment of chronic spontaneous urticaria (CSU) at the American Academy of Allergy, Asthma & Immunology Annual Meeting (AAAAI 2025). The results demonstrated that LP-003 outperformed the existing anti-IgE therapy omalizumab on key efficacy endpoints and exhibited long-acting advantages, positioning it as a potentially disruptive drug in the global anti-IgE therapeutic landscape.
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Standout Core Data: Dual Breakthroughs in Efficacy and Adherence
This multicenter, double-blind, omalizumab- and placebo-controlled Phase II study (Clinical Trial Registration No. CTR20233300 / NCT06228560) demonstrated that LP-003 exhibits:
● Faster onset of action:By Week 4 of treatment, the reduction from baseline in pruritus and wheal symptom scores (Urticaria Activity Score over 7 days, UAS7) and the proportion of patients achieving complete symptom resolution (UAS7=0) in the LP-003 group had surpassed those in the omalizumab group.
● Continuous Improvement:At Week 12 of treatment, the proportion of patients in the LP-003 group who achieved complete symptom resolution (UAS7=0) was higher than that in the omalizumab group, and the reduction from baseline in patient scores for itch and wheals (UAS7) was greater in the LP-003 group than in the omalizumab group.
● Long-acting advantages:An every-8-week dosing regimen maintains efficacy and significantly improves medication adherence.
● Excellent safety profile:The incidence of adverse events showed no statistically significant difference compared with the placebo group, and no new safety signals were identified.
02
Benchmarking Against International Giants: Significant Differentiated Competitive Advantages
Notably, LP-003 outperformed Roche’s first-generation anti-IgE antibody, omalizumab, in head-to-head comparisons. Furthermore, the absolute reduction in UAS7 achieved by LP-003 was comparable to that of Barzolvolimab (an anti-C-KIT monoclonal antibody), the flagship product of US-based Celldex Therapeutics (a Nasdaq-listed company with a market capitalization exceeding $1.3 billion), while no adverse events similar to those associated with Barzolvolimab were observed. With its faster clinical improvement, more durable clinical effects, and superior safety profile, LP-003 is well-positioned to secure a leading position in the global allergic disease treatment market, which is valued at over $10 billion.
03
Pipeline Depth Strategy: Tapping into the Multi-Billion Blue Ocean of Allergic Diseases
The breakthrough progress of LP-003 marks that LongBio’s strategic layout in the field of allergic immunotherapy has entered a harvest period:
● Advancement Across Multiple Indications:In addition to the imminent completion of Phase II clinical trials for chronic spontaneous urticaria (CSU), LongBio has initiated Phase III clinical trials for allergic rhinitis and Phase II clinical trials for asthma (with dosing every three months); furthermore, the Investigational New Drug (IND) application for food allergy has been approved by the National Medical Products Administration (NMPA).
● Tapping into a Multi-Billion Market:The number of patients with allergic diseases is substantial, with over 17 million individuals in the United States alone suffering from food allergies. Anti-IgE therapy is the only treatment mechanism for food allergies approved by the U.S. Food and Drug Administration (FDA), and the competitive landscape is favorable. LP-003 is poised to achieve a breakthrough first in this market, which exceeds $10 billion in value;
● Accelerated Commercialization:The clinical program for the allergic rhinitis indication, which is currently advancing most rapidly, is scheduled to complete its Phase III trials in China by the end of 2025, while negotiations regarding overseas rights collaboration are also underway.