BOAN BIOTECH (06955) announced that patient enrollment has been completed for the Phase III clinical trial of its self-developed BA1104 (nivolumab injection) in China. BA1104 is the first biosimilar of Opdivo® (nivolumab) to enter Phase III clinical trials in China, demonstrating leading progress in development.
Nivolumab is a humanized monoclonal antibody (IgG4 subtype) targeting the programmed cell death-1 (PD-1) receptor. By blocking the interaction between PD-1 and its ligands PD-L1/PD-L2, it enhances T-cell-mediated antitumor responses and is a broad-spectrum anticancer drug. Since its approval in 2014 as the world's first PD-1 inhibitor, Opdivo® has been authorized for multiple indications across dozens of countries and regions, covering various cancer types and clinical applications spanning different stages of cancer treatment—including neoadjuvant therapy, adjuvant therapy, and first- or later-line treatment for advanced cancers. It can be administered as monotherapy, in combination with chemotherapy, or alongside other immune checkpoint inhibitors.
BA1104 is being developed in accordance with biosimilar research guidelines. The Phase III trial in China is a randomized, double-blind, multicenter study designed to compare the efficacy, safety, and immunogenicity of BA1104 versus Opdivo®, both combined with chemotherapy, in patients with advanced or metastatic esophageal squamous cell carcinoma.
Under China’s Technical Guidelines for Biosimilarity Evaluation and Indication Extrapolation, BA1104 may apply for approval for all Opdivo®-authorized indications in China upon successful completion of Phase III trials. Results from the completed Phase I trial showed that BA1104 exhibited highly comparable pharmacokinetics, safety, and immunogenicity to Opdivo®, meeting all study endpoints. These findings have been published in the international journal *BioDrugs*.
PD-1 inhibitors, as a cornerstone of cancer immunotherapy, have become a major treatment approach. With continuous breakthroughs in combination therapies and the synergistic development of diverse immunotherapies, the clinical applications of PD-1 inhibitors continue to expand, demonstrating significant clinical value and market potential.
Public data indicates that Opdivo® generated approximately $9.3 billion in global sales in 2024. According to Frost & Sullivan, China’s PD-1/L1 antibody market is projected to reach RMB 59.9 billion by 2030.
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