PHILADELPHIA, March 2, 2026 /PRNewswire/ — LongBio Pharma (Suzhou) Co., Ltd. (“LongBio”), a clinical-stage biotech company focused on discovery and development of biologics targeting allergic and autoimmune diseases, proudly announced positive topline results from a Phase II clinical trial of its next-generation anti-IgE antibody, LP-003, with a head-to-head comparison with Xolair® (Omalizumab). The data was presented as a late-breaking poster at the 2026 AAAAI Annual Meeting. The results demonstrated that LP-003 achieved comprehensive clinical advantages over omalizumab, with statistically superior outcomes in the key efficacy endpoints.
The trial (NCT06228560, CTR20233300) is a multicenter, randomized, double-blind, placebo and active drug (Omalizumab) controlled Phase II study, designed to evaluate the efficacy and safety of LP-003 in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. A total of 202 patients were enrolled and randomly assigned to one of three LP-003 treatment groups (100 mg Q4W, 200 mg Q4W, 200 mg Q8W), the Omalizumab group (300 mg Q4W), or the placebo group, with a total treatment duration of 24 weeks.
In this head-to-head trial against Omalizumab, LP-003 exhibited comprehensive superiority in efficacy, a fast onset of action, and a favorable safety profile, further confirming its potential as a best-in-class anti-IgE therapy.
LP-003 Demonstrates Comprehensive Efficacy Superiority and Fast onset Over Omalizumab
For the primary endpoint, at Week 12, the proportions of patients achieving UAS7=0 were 44.4%, 66.7%, 57.5%, 43.6% and 10.8% in the LP-003 100 mg Q8W, 200 mg Q8W, 200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W vs. Omalizumab, p=0.0405).
For the second key efficacy endpoint, LS mean changes from baseline in UAS7 at Week 12 were -23.15, -26.63, -24.74, -21.85 and -13.98 in the LP-003 100 mg Q8W, 200mg Q8W, 200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W vs. Omalizumab, p=0.0137).
By Week 4, the complete remission rate across LP-003 groups reached 35%-35.9%. Compared to Omalizumab, LP-003 showed fast onset efficacy.
LP-003 demonstrated statistically significant and clinically meaningful superiority compared to Omalizumab in two key efficacy endpoints, along with a favorable safety profile.
The leading indication of LP-003 is seasonal allergic rhinitis (SAR), which is expected to submit Biologics License Application (BLA) to NMPA (China FDA) in or before the third quarter of 2026. Once approved, LP-003 would become the first and only innovative anti-IgE drug to be launched globally in over 20 years since the approval of Omalizumab.
About LongBio
LongBio is a clinical-stage biotech company. Established in 2020 and located in Shanghai and Suzhou, China, LongBio primarily focuses on the in-house discovery and development of biologics targeting on allergic and autoimmune diseases.
LP-003 is an novel anti-IgE antibody developed by LongBio for the treatment of allergic diseases, including seasonal AR, CSU, allergic asthma, CRSwNP and food allergy. Compared with Xolair (Omalizumab), LP-003 has a 860-fold greater IgE binding affinity and 30-fold higher blocking activity. In addition to its potent bioactivity, LP-003 has a much longer half-life over Omalizumab.
The Phase III clinical trial in China for seasonal AR indication has completed patient enrollment, with BLA submission to NMPA planned in or before Q3 2026. A Phase III trial for CSU in China is expected to start in H1 2026.
For more information, please visit www.longbio.com or contact [email protected].
