LongBio's LP-003 Outshines Xolair in Hives Trial, Poised to Disrupt Allergy Market

PHILADELPHIA, PA – March 02, 2026

A new challenger has emerged to potentially unseat a two-decade-long king in allergy treatment. LongBio, a clinical-stage biotechnology company, today announced compelling results from a head-to-head clinical trial showing its next-generation therapy, LP-003, is significantly more effective than the blockbuster drug Xolair (omalizumab) for treating chronic spontaneous urticaria (CSU), a severe and debilitating form of hives. The data, presented at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, signals a potential paradigm shift for patients and a major milestone for the rapidly innovating Chinese biotech firm.

A New Benchmark in Efficacy and Speed

The Phase II study (NCT06228560) directly compared LP-003 against both placebo and omalizumab in 202 patients with CSU who were not responding to standard antihistamine treatments. The results were striking.

At the 12-week mark, the primary goal was to see how many patients achieved complete symptom resolution, defined as a Urticaria Activity Score (UAS7) of zero. In the group receiving LP-003 at a 200 mg dose every eight weeks, a remarkable 66.7% of patients were completely free of itch and hives. This was statistically superior to the 43.6% of patients who achieved the same result with the current standard-of-care dose of omalizumab. The placebo group saw only a 10.8% response.

The superiority of LP-003 was also confirmed on a key secondary endpoint measuring the overall reduction in symptom severity. Patients on the 200 mg eight-week dose of LP-003 experienced an average reduction of 26.63 points on the UAS7 scale, significantly better than the 21.85-point reduction seen in the omalizumab group.

Beyond its superior peak efficacy, LP-003 demonstrated a faster onset of action. By just week four, between 35% and 35.9% of patients across the different LP-003 dosing groups had already achieved complete remission, offering the promise of quicker relief for those suffering from the relentless condition. The drug was also reported to have a favorable safety profile.

Underpinning these clinical advantages is the drug's molecular design. LP-003 is a novel monoclonal antibody engineered to bind to Immunoglobulin E (IgE), the key antibody that triggers allergic reactions. According to LongBio, it possesses an 860-fold greater binding affinity for IgE and 30-fold higher blocking activity than omalizumab. Crucially, it also has a much longer half-life, which enables a more convenient eight-week dosing schedule, compared to the four-week interval required for omalizumab.

Challenging a Decades-Old Standard of Care

For more than 20 years, omalizumab has been the only approved anti-IgE biologic and the primary advanced therapy for patients whose CSU is not controlled by antihistamines. Its arrival was a breakthrough, but significant unmet needs have persisted.

"While omalizumab has been an invaluable tool, the reality is that a complete response is not achieved in over half of our patients," commented an independent immunologist not involved with the study. "We see patients who get partial relief, and some who don't respond at all. There is a clear and urgent need for more effective options."

CSU is characterized by the sudden appearance of itchy welts, or hives, with no discernible trigger, lasting for six weeks or more. The condition can have a devastating impact on quality of life, leading to severe discomfort, sleep deprivation, anxiety, and depression. Patient advocacy groups have long highlighted the need for treatments that can deliver complete freedom from symptoms and reduce the treatment burden.

The prospect of a more effective therapy that also requires fewer injections—once every two months instead of monthly—directly addresses these long-standing patient desires for both better outcomes and greater convenience.

The Competitive Landscape Heats Up

LP-003's impressive data arrives at a time when the therapeutic landscape for CSU is undergoing a dramatic transformation. While omalizumab has long dominated the biologic space, a new wave of competitors with different mechanisms of action is entering the market.

Drugs like Dupixent (dupilumab), which targets the IL-4/IL-13 pathway, and the recently approved Bruton's tyrosine kinase (BTK) inhibitor Rhapsido™ (remibrutinib) are offering new avenues for treatment. Furthermore, other pipeline candidates, such as the promising mast cell-targeting drug barzolvolimab, are showing high rates of efficacy in their own clinical trials.

In this increasingly crowded field, LP-003's strategy appears to be one of perfecting a proven mechanism. Rather than targeting a new pathway, LongBio has created a potentially 'best-in-class' anti-IgE antibody. Its reported efficacy, particularly the high rate of complete responders, positions it competitively not just against omalizumab and its biosimilars, but also against the newest generation of CSU therapies. The combination of superior efficacy and a long-acting profile could make it a formidable player in the market.

A Chinese Biotech's Global Ambition

The success of the LP-003 trial is also a significant validation for its developer, LongBio. Established just in 2020 and headquartered in Shanghai and Suzhou, the company is part of a new generation of Chinese biotechs moving from imitation to innovation. Backed by prominent venture capital firms like Qiming Venture Partners, LongBio has rapidly advanced its pipeline of biologics for allergic and autoimmune diseases.

The company's ambitions are clearly global. While this Phase II CSU data makes waves, LongBio is already further ahead with LP-003 for another indication, seasonal allergic rhinitis (SAR). A Biologics License Application (BLA) for SAR is expected to be submitted to China's National Medical Products Administration (NMPA) by the third quarter of 2026.

If approved, LP-003 could become the first new anti-IgE drug to be launched anywhere in the world in over two decades, a landmark achievement. The company has also stated its intention to file for Investigational New Drug (IND) status with the U.S. FDA for CSU and food allergy, signaling a clear strategy to enter Western markets. The positive head-to-head data against a globally recognized standard of care will be a crucial asset in that endeavor, potentially paving the way for a new global leader in allergy treatment.