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LongBio Announces Positive Results from LP-003 Phase II Trial

LongBio Pharma (Suzhou) Co., Ltd., a clinical-stage biotechnology firm, has recently reported clinically promising outcomes from a Phase II clinical trial evaluating its next-generation anti-IgE antibody, LP-003, particularly in comparison with the established therapy Xolair® (Omalizumab). Conducted as a multicenter, randomized, double-blind study, this trial aimed to assess the safety and efficacy of LP-003 in patients diagnosed with chronic spontaneous urticaria (CSU), a condition that still affects individuals despite treatment with antihistamines.

Overview of the Trial

The trial, registered under NCT06228560 and CTR20233300, involved 202 patients who were randomly assigned to receive one of several treatments: LP-003 at varying dosages (100 mg every 4 weeks, 200 mg every 4 weeks, 200 mg every 8 weeks), Omalizumab (300 mg every 4 weeks), or a placebo. Each participant was treated over a period of 24 weeks, and the results were presented at the prestigious AAAAI Annual Meeting in 2026.

Key Findings

The most striking results highlighted the superior performance of LP-003 against Omalizumab on multiple fronts. In particular, the primary endpoint measured the proportion of patients achieving a score of UAS7=0 by Week 12. The results displayed that 44.4%, 66.7%, 57.5% of patients in the 100 mg Q8W, 200 mg Q8W, and 200 mg Q4W groups, respectively, reached this benchmark compared to only 10.8% in the placebo group. The standout finding was that the group receiving 200 mg Q8W of LP-003 had statistically significant improvements over Omalizumab, with p=0.0405.

For the secondary endpoint, changes from baseline in UAS7 scores by Week 12 showed similarly impressive reductions for LP-003 groups when set against Omalizumab and control groups. Notably, the group receiving LP-003 at a dose of 200 mg every 8 weeks exhibited changes of -26.63, significantly outperforming the -21.85 observed in the Omalizumab cohort (p=0.0137).

By the fourth week of treatment, the remission rate for the LP-003 groups soared to between 35-35.9%, indicating a notably quick onset of action that represents a crucial benefit over the slower responses typically associated with Omalizumab.

Future Prospects for LP-003

LongBio aims to leverage these positive findings to submit a Biologics License Application (BLA) to the NMPA (the Chinese FDA) by the third quarter of 2026. If approved, LP-003 will also bring a breath of fresh air to the market—being the first major innovative anti-IgE medication approved globally in over 20 years after Omalizumab. This approval would not only signify a major advancement in treating allergic diseases but could reshape the landscape for patients suffering from conditions like seasonal allergic rhinitis (SAR), CSU, allergic asthma, CRSwNP, and food allergies.

LongBio’s commitment to the advancement of biologics that target allergic and autoimmune diseases strongly positions the company at the forefront of medical innovation. Established in 2020, and operating out of Shanghai and Suzhou, China, LongBio continues to refine and develop therapies aimed at improving lives through better disease management.

In summary, the results of the Phase II trial underscore the potential of LP-003 to be an effective and novel therapeutic option in the treatment of CSU and other allergic conditions, paving the way for future clinical studies and market introduction.