BOAN BIOTECH (06955): The China Phase III clinical trial of Navulizumab has completed the enrollment of all patients.

BOAN BIOTECH (06955) announced that the company's independently developed BA1104 (nivolumab injection) has completed all patient enrollment in the Phase III clinical trial in China. BA1104 is progressing ahead and is the first domestically developed biosimilar to conduct Phase III clinical trials of Opdivo (nivolumab). Nivolumab is a humanized monoclonal antibody (IgG4 subtype) targeting the programmed cell death protein 1 (PD-1) receptor. By blocking the binding of PD-1 receptor to its ligands PD-L1 and PD-L2, it enhances the anti-tumor response of T cells, making it a broad-spectrum anti-tumor drug. Since becoming the world's first PD-1 inhibitor in 2014, Opdivo has been approved for multiple indications in dozens of countries and regions globally, covering various cancer types and stages of treatment including neoadjuvant therapy, adjuvant therapy, first-line and second-line therapy for advanced cancer, and its use in monotherapy, combination with chemotherapy, and combination with new immune checkpoint inhibitors. BA1104 follows the guidelines for biosimilar drug development and the Phase III clinical trial conducted in China is a randomized, double-blind, multicenter trial comparing the efficacy, safety, and immunogenicity of BA1104 and Opdivo in combination with chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma. According to the "Guiding Principles for the Evaluation of Biosimilarity and Extrapolation of Indications", after completing the Phase III clinical trial, BA1104 can apply for approval for all indications approved for Opdivo in China. The results of the Phase I clinical trial have shown that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, meeting all study endpoints, with the results published in the international journal "BioDrugs". Immunotherapy for cancer treatment, especially with PD-1 inhibitors, has become a major approach in cancer therapy. With the continuous breakthroughs in combination therapy and the synergistic development of multiple immunotherapies, the clinical application boundaries of PD-1 inhibitors are expanding, demonstrating broad clinical value and market potential. According to publicly available data, Opdivo had global sales of approximately $9.3 billion in 2024. According to a Frost & Sullivan report, the Chinese antibody market based on PD-1/L1 is expected to reach 59.9 billion RMB by 2030.