China-based Qilu Pharmaceutical has commenced the first Phase III clinical trial for its biosimilar candidate QL2302, making it the first tezepelumab biosimilar to enter late-stage development. The trial is a multicentre, randomised, double-blind, parallel-group, active-controlled study designed to enrol 538 adult patients with uncontrolled severe asthma. The primary endpoint is the annualised rate of asthma exacerbations over 52 weeks, comparing the efficacy and safety of QL2302 against Amgen and AstraZeneca's originator Tezspire.

The reference product, is a monoclonal antibody (mAb) that blocks TSLP, a key upstream regulator of inflammatory pathways involved in asthma and other conditions. It was first approved in the US in December 2021 for severe asthma and gained an additional indication for chronic rhinosinusitis with nasal polyps (CRSwNP) in October 2025, generating USD 1.219 billion in revenue for AstraZeneca in 2024. While tezepelumab remains the only marketed TSLP inhibitor globally, other Chinese firms, including Chia Tai Tianqing and Hengrui Pharmaceuticals, have novel TSLP-targeting candidates in Phase III development.

PharmCube's NextBiopharm® database shows that QL2302 is currently the only tezepelumab biosimilar in human trials. Click here to request a free trial for NextBiopharm®.