BAT2606 (mepolizumab biosimilar) / Bio-Thera Solutions - LARVOL DELTA

Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial. (PubMed, Front Pharmacol) - P1 | "BAT2606 had a numerically lower ADA incidence than Nucala-US and Nucala-EU. https://www.clinicaltrials.gov/study/NCT05576454?term=BAT2606&rank=1."

Clinical • Journal • P1 data • PK/PD data

Clinical Remission Outcome in Chinese Patients With Severe Asthma With an Eosinophilic Phenotype Receiving Mepolizumab: A Post-hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial. (PubMed, Allergy Asthma Immunol Res) - P3 | "A higher proportion of Chinese SA-EP patients treated with mepolizumab achieved CR compared to those receiving placebo. Certain baseline characteristics are potentially predictive of CR."

Clinical • Journal • P3 data • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=207 | Completed | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=207 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Trial primary completion date: Feb 2023 ➔ Jun 2023

Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=207 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=207 | Recruiting | Sponsor: Bio-Thera Solutions

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases