BOAN BIOTECH: The Phase III clinical trial of Navulizumab in China has completed the enrollment of all patients

According to the Zhitong Finance APP, BOAN BIOTECH (06955) announced that the Phase III clinical trial of its self-developed BA1104 (Nivolumab Injection) in China has completed the enrollment of all patients. The development progress of BA1104 is leading, making it the first biosimilar of Opdivo® to conduct Phase III clinical trials in China. Nivolumab is a humanized monoclonal antibody (IgG4 subtype) targeting the programmed cell death protein 1 (PD-1) receptor, which enhances T cell anti-tumor responses by blocking the binding of the PD-1 receptor to its ligands PD-L1 and PD-L2. It is a broad-spectrum anti-tumor drug. Since its approval in 2014 as the world's first PD-1 inhibitor, Opdivo® has been approved for multiple indications in dozens of countries and regions worldwide, covering various tumor types, and its clinical applications span all stages of cancer treatment, including preoperative neoadjuvant therapy, postoperative adjuvant therapy, first-line and subsequent-line treatment for advanced tumors, with usage including monotherapy, combination chemotherapy, and use in conjunction with new immune checkpoint inhibitors. BA1104 is developed in accordance with the research guidelines for biosimilars, and its Phase III clinical trial conducted in China is a randomized, double-blind, multi-center trial aimed at comparing the efficacy, safety, and immunogenicity of BA1104 combined with chemotherapy versus Opdivo® combined with chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma. According to the "Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilars," BA1104 can apply for simultaneous approval for all indications for which Opdivo® has been approved in China after completing the Phase III clinical trial. The results of the completed Phase I clinical trial show that BA1104 is highly comparable to Opdivo® in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints, and the relevant research results have been published in the international journal "BioDrugs." Tumor immunotherapy represented by PD-1 inhibitors has become one of the main methods for cancer treatment. With continuous breakthroughs in combination therapy and the synergistic development of diverse immunotherapies, the clinical application boundaries of PD-1 inhibitors are constantly expanding, showing broad clinical application value and market potential. Public information shows that the global sales of Opdivo® are expected to be approximately USD 9.3 billion in 2024. According to a Frost & Sullivan report, the market size of PD-1/L1-based antibodies in China is expected to reach RMB 59.9 billion by 2030