Boan Biotech (HKG:6955) is making significant strides as it forges ahead with the first Phase III clinical trial of BA1104, a Nivolumab biosimilar, in China. This groundbreaking trial signifies a landmark development in the nation’s clinical research landscape.
BA1104, developed by Boan Biotech, mirrors the therapeutic properties of Opdivo, enhancing the T-cell immune response against a spectrum of solid tumors by inhibiting the binding of the PD-1 receptor to its ligands. This novel drug exhibits versatility, finding applications in neoadjuvant, adjuvant, first-line, and later-line therapies for advanced cancers. Furthermore, it can be employed in combination with chemotherapy or immune checkpoint inhibitors, such as PD-1 inhibitors.
The ongoing Phase III trial is dedicated to evaluating the comparative efficacy of BA1104 and Opdivo in patients suffering from advanced esophageal squamous cell carcinoma. Notably, pre-clinical studies and Phase I results have underscored BA1104’s high level of similarity to Opdivo, both in terms of pharmaceutical activities and its safety profile. This positive likeness extends to the critical aspect of immunogenicity.
Upon the successful conclusion of the Phase III trial, BA1104 will be poised to seek regulatory approval for all Opdivo indications in accordance with the protocols established by China’s drug evaluation center. This development is of particular significance as PD-1 inhibitors continue to play a pivotal role in the landscape of global cancer treatment. In 2022, Opdivo achieved global sales totaling an impressive $8.249 billion, highlighting the demand for such therapies.
Looking forward, the outlook for the Chinese market in anti-PD-1/L1 antibodies is exceedingly promising. Industry projections indicate that this market is anticipated to burgeon, with an estimated value of RMB 29.8 billion by the year 2025, reflecting a remarkable compound annual growth rate of 63.4%. These forecasts have been furnished by industry experts at Frost & Sullivan.
