Gelonghui, October 30th – Boan Bio (06955.HK) announced that the company's self-developed BA1104 (Nivolumab Injection) has completed patient enrollment for its Phase III clinical trial in the People's Republic of China ("China"). BA1104 is at the forefront of development and represents the first Opdivo biosimilar to enter Phase III clinical trials domestically.
Nivolumab is a humanized monoclonal antibody (IgG4 subtype) targeting the programmed cell death 1 ("PD-1") receptor. By blocking the binding of the PD-1 receptor with its ligands PD-L1 and PD-L2, it enhances T-cell anti-tumor responses and is considered 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 across dozens of countries and regions globally, covering various types of cancers. Its clinical applications span all stages of cancer treatment, including neoadjuvant therapy before surgery, adjuvant therapy after surgery, first-line and subsequent treatments for advanced tumors. Usage methods include monotherapy, combination with chemotherapy, and combination with new immune checkpoint inhibitors.
BA1104 has been developed in accordance with relevant research guidelines for biosimilars. The Phase III clinical trial conducted in China is a randomized, double-blind, multi-center study aimed at comparing the efficacy, safety, and immunogenicity of BA1104 versus Opdivo when combined with chemotherapy for treating patients with advanced or metastatic esophageal squamous cell carcinoma. According to the 'Technical Guidelines for Biosimilar Similarity Evaluation and Extrapolation of Indications,' upon completion of the Phase III clinical trial, BA1104 can apply for simultaneous approval of all indications currently authorized for Opdivo in China. Results from the completed Phase I clinical trial indicate that BA1104 demonstrates high comparability with Opdivo in terms of pharmacokinetics (PK), safety, and immunogenicity, meeting all study endpoints. Relevant findings have been published in the international journal BioDrugs.
Cancer immunotherapy represented by PD-1 inhibitors has become one of the main approaches in cancer treatment. With continuous breakthroughs in combination therapies and the coordinated development of diverse immunotherapies, the clinical application boundaries of PD-1 inhibitors are constantly expanding, presenting significant clinical value and market potential. Public data shows that Opdivo’s global sales in 2024 are approximately USD 9.3 billion. Additionally, according to a Frost & Sullivan report, the market size of China-based PD-1/L1 antibodies is expected to reach RMB 59.9 billion by 2030.
