Boan Biotech's (HKG:6955) BA1104, a Nivolumab biosimilar to Opdivo, is currently undergoing a Phase III trial in China, marking the first time such a trial has been conducted in the country. The drug, which enhances T cell immune response against various solid tumors by inhibiting PD-1 receptor binding to its ligands, can be used as a neoadjuvant, adjuvant, first-line, or later-line therapy for advanced cancers and can be combined with chemotherapy or immune checkpoint inhibitors like PD-1 inhibitors.
The ongoing Phase III trial is comparing BA1104 and Opdivo in patients with advanced esophageal squamous cell carcinoma. Pre-clinical studies and Phase I results have shown BA1104's high similarity to Opdivo in terms of pharmaceutical activities, safety, and immunogenicity.
Once the trial concludes, BA1104 can seek approval for all Opdivo indications according to guidelines set by China's drug evaluation center. This development comes as PD-1 inhibitors continue to play a crucial role in global cancer treatments. In 2022, Opdivo recorded $8.249 billion in global sales.
Looking ahead, the Chinese market for anti-PD-1/L1 antibodies is projected to reach RMB 29.8 billion by 2025. This represents a compound annual growth rate of 63.4%, according to projections from Frost & Sullivan.
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