Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate BA1104. This marks a significant milestone as BA1104 becomes the first biosimilar to Opdivo (nivolumab) to reach the Phase III stage in China. Opdivo, developed by Bristol-Myers Squibb (BMS, NYSE: BMY), was the first programmed death-1 (PD-1) inhibitor to gain global approval in July 2014 and has since been approved for a wide range of cancer indications.
Development and Pre-Clinical Studies of BA1104
Boan’s development of BA1104 adheres to the guidelines for biosimilars in China. Pre-clinical studies have demonstrated that BA1104 is highly similar to Opdivo in pharmaceutical and non-clinical activities. The results from the completed Phase I clinical trial support the demonstration of biosimilarity to Opdivo in terms of pharmacokinetics (PK), safety, and immunogenicity, with all study endpoints met.
Phase III Clinical Trial Design
The Phase III clinical trial is a randomized, double-blind, multicenter study designed to compare the efficacy, safety, and immunogenicity of BA1104 and Opdivo when combined with chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma. Following the completion of the Phase III clinical trial, BA1104 can apply for and be approved for all of Opdivo’s China-approved indications, according to the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars issued by the Center for Drug Evaluation of the National Medical Products Administration.-Fineline Info & Tech
