Study Objectives and Design

This Phase 2 dose‑finding study evaluates whether the inhaled single‑domain antibody LQ036 improves lung function (FEV1) in patients with uncontrolled asthma. Change in FEV1 at Week 12 versus placebo is the primary endpoint, with long‑term efficacy and safety assessed through Week 24. The study commenced on September 30, 2025, is currently enrolling, and will also assess exacerbation frequency and reduction in rescue inhaler use in addition to lung function.

Current Treatment Landscape and Unmet Need

Patients with severe asthma currently receive combination therapy such as inhaled corticosteroids and long‑acting β2‑agonists, yet a subset remains uncontrolled and at high risk for acute exacerbations. Existing therapies primarily target inflammation, while agents that directly address airway hyperresponsiveness and immune responses are limited. Consequently, introducing a therapy with a novel mechanism holds significant potential for personalized asthma management.

Differentiation Highlights of LQ036

LQ036 is a single‑domain antibody with a smaller molecular weight than conventional full‑size antibodies, facilitating direct pulmonary delivery. The nebulizer administration enables uniform distribution throughout the airways, potentially maximizing therapeutic effect. Simultaneous assessment of immunogenicity and pharmacokinetic properties will clarify its safety profile.

Market and Investment Impact

If the Phase 2 trial demonstrates meaningful lung‑function improvement and a favorable safety signal, LQ036 could secure a differentiated position relative to existing asthma biosimilars. The Asia‑Pacific region, including China, is experiencing rapid growth in asthma prevalence, creating opportunities for regional partnerships or expanded global licensing upon early success. Nonetheless, as the program remains in Phase 2, investment risk remains highly contingent on clinical outcomes.