Boan Holds BPD Type 2b Meeting with FDA on BA1104

Boan Biotech announced that regarding its self-developed BA1104 (Nivolumab Injection), the company has held a Biological Product Development (BPD) type 2b meeting with the U.S. Food and Drug Administration (FDA). The FDA has agreed on a "streamlined" clinical approach for BA1104, which means only one pharmacokinetics(PK) similarity study (Phase 1) is sufficient to support the submission of Biologic License Application (BLA) in the U.S., and the comparative clinical study (CCS, Phase 3) is not needed. In addition, the FDA has agreed on the design of this study, including the subject population, the sample size, the dose, the treatment duration, and the clinical endpoints. In comparison to a traditional approach with separate Phase 1 and Phase 3 trials, this "streamlined" single clinical trial approach is projected to significantly reduce clinical development costs and shorten the clinical development timeline.

BA1104 is a proposed biosimilar to Opdivo® (Nivolumab Injection). 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 comparative analytical and non-clinical studies. The results of the completed Phase 1 clinical trial support a demonstration of biosimilarity to Opdivo® in terms of PK, safety, and immunogenicity, and all study endpoints were met, and were published in BioDrugs1. The Phase 3 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.

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 10.206 billion in 2024. Frost & Sullivan predicts that the market for anti-PD-1/L1 antibodies in China will reach RMB 50 billion by 2030.