BA1104 Phase III Trial in China Completes Patient Enrollment

Boan Biotech today announced that all the patients have been enrolled in a Phase III clinical trial of its nivolumab injection code-named BA1104 in China. This is China’s first biosimilar of Opdivo® to undergo a Phase III clinical trial.

Nivolumab is a humanized monoclonal antibody of the IgG4 subtype targeting the programmed death-1 (PD-1) receptor. By blocking the interaction between the PD-1 receptor and its two ligands PD-L1 and PD-L2, this antibody enhances T-cell-medicated anti-tumor responses and thereby acts as a broad-spectrum anti-cancer therapy. Since it was approved in 2014 as the world’s first PD-1 inhibitor, Opdivo has been approved for multiple indications in dozens of countries and regions involving different types of cancer. In clinical practice, it has been used for cancer treatment across different stages as a neoadjuvant therapy or an adjuvant therapy, or as a first-line treatment or subsequent treatments for advanced tumors. The drug can be administered as a monotherapy or in combination with chemotherapy or other immune checkpoint inhibitors.

BA1104 is developed in accordance with guidelines for biosimilars. The Phase III clinical trial conducted in China is a randomized, double-blind, multicenter study designed to compare the efficacy, safety, and immunogenicity of BA1104 plus chemotherapy versus Opdivo plus chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In accordance with the Guidelines on Similarity Evaluations and Indication Extrapolation of Biosimilars issued by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA), Boan Biotech may submit an application to the NMPA for the approval of BA1104 for all indications that Opdivo has obtained in China after completing its Phase III clinical trial. The results of a Phase I clinical trial show that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, and all the predefined endpoints have been met. Those results have been published in the international journal BioDrugs.¹

Immunotherapies represented by PD-1 inhibitors have become one of the mainstays in cancer treatment. Driven by continuous breakthroughs in combination therapy regimens and the synergistic development of diverse immunotherapies, the clinical applications of PD-1 inhibitors are constantly expanding, demonstrating broad clinical value and market potential. Publicly available data shows that the worldwide sales of Opdivo were approximately USD 9.3 billion in 2024. According to a Frost & Sullivan report, the size of the Chinese market for PD-1 inhibitors and PD-L1 inhibitors is expected to reach RMB 59.9 billion by 2030.

Dr. Changlin Dou, President of R&D and Chief Operating Officer at Boan Biotech, said:“PD-1 inhibitors are cornerstones for cancer immunotherapy covering many different indications. We will actively explore the combination of BA1104 with our innovative biologics, and the potential synergy between them will further increase the value of our pipeline.”

Boan Biotech is actively developing novel IO 2.0 therapies as well as the next-generation dual-target ADCs and dual-payload ADCs based on its own PD-1 inhibitors and VEGF-α inhibitors following an “immuno-oncology + antibody-drug conjugate” (“IO+ADC”) development strategy. The company has built a differentiated pipeline of investigational drugs, which include an anti-CD228 ADC code-named BA1302, an anti-CD25 antibody (non-IL-2-blocking) code-named BA1106, an anti-Claudin18.2 ADC code-named BA1301, a PD-1/IL-2 antibody-cytokine fusion protein code-named PR201, and a bispecific ADC targeting EGFR and B7-H3 code-named BA1304.

Reference：
1.Wang W, Zhang S, Dou C, Hu B, Song H, Qi F, Zhao Y, Li X, Zhou M, Xie J, Deng K, Wu Q, Ye L, Cui C, Liu L, Huang J, Yang G. Pharmacokinetics, Safety, and Immunogenicity of a Biosimilar of Nivolumab (LY01015): A Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Trial in Healthy Chinese Male Subjects. BioDrugs. 2024 Nov;38(6):855-865. doi: 10.1007/s40259-024-00679-w. Epub 2024 Sep 24. PMID: 39317850.