Boan Biotech announced that the first patient in Phase III clinical trial of its Nivolumab Injection (BA1104) in China has been enrolled. BA1104 is the first biosimilar to Opdivo to undergo a Phase III study in China. Nivolumab is a monoclonal antibody that can enhance the immune response of T cells against tumors by preventing the programmed cell death 1 (PD-1) receptor from binding to its ligands PD-L1 and PD-L2.

As a broad-spectrum anticancer medication, Nivolumab has been approved for multiple indications both in China and abroad. These include its use as a neoadjuvant, an adjuvant, or a first-line or later-line therapy for advanced cancers. It can be used as a standalone treatment, in combination with chemotherapy, or alongside novel immune checkpoint inhibitors.

Nivolumab has become a product of basic therapy for a variety of solid tumors. The development of BA1104 follows the relevant guidelines for biosimilars. Pre-clinical studies show that BA1104 is highly similar to Opdivo in pharmaceutical and non-clinical activities.

The results of the completed Phase I clinical trial support a demonstration of biosimilarity to Opdivo in terms of pharmacokinetics(PK), safety, and immunogenicity, and all study endpoints were met. The Phase III clinical trial is a randomized, double-blind, multicenter study designed to compare the efficacy, safety, and immunogenicity of BA1104 and Opdivo combined respectively with chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma. According to the Guidelines on Similarity Evaluation and IndicationExtrapolation of Biosimilars issued by the Center for Drug Evaluation of the National Medical Products Administration, after the completion of the Phase III clinical trial, BA1104 can apply and be approved for all the same indications as Opdivo in China.

Immunotherapies such as PD-1 inhibitors have become one of the primary treatments for different types of cancer worldwide, and have consistently demonstrated clinical value and potential in the marketplace. Publicly available data shows that Opdivo, the first approved PD-1 in the world, achieved global sales of approximately USD 8.249 billion in 2022. Frost & Sullivan predicts that the market for anti-PD-1/L1 antibodies in China will reach RMB 29.8 billion by 2025, with a compound annual growth rate of 63.4% from 2018 to 2025.