Boan Reports Positive PK Similarity Study Results of BA1104

The Results of Phase I Pharmacokinetic Similarity Study of Boan Biotech’s Nivolumab Published in Journal of BioDrugs

The phase I clinical study aimed to establish the pharmacokinetic (PK) similarity between Boan Biotech’s Nivolumab injection BA1104（previously code-named LY01015）and Opdivo^® was recently published online in BioDrugs.  BA1104 is the first biosimilar to Opdivo^® in the world to have Phase I PK similarity results reported.

https://doi.org/10.1007/s40259-024-00679-w

BA1104 is a biosimilar to the reference product Opdivo^® (nivolumab). Nivolumab is a fully human immunoglobulin G4 (IgG4) antibody targeting the programmed cell death receptor-1 (PD-1). By relieving the tumor-induced immunosuppression, nivolumab restores  T-cell functions, thereby enabling immune-mediated tumor clearance and prolonging patient's life. Immunotherapies such as PD-1 inhibitors have become one of the primary treatments for cancer worldwide, and have consistently shown promise in the clinic.

This phase I study was a randomized, double-blind, single-dose, parallel-controlled design study to compare the PK profiles, safety, and immunogenicity of BA1104 and Opdivo^® in healthy Chinese male subjects. A total of 176 subjects were randomized to receive a single 0.3mg/kg intravenous dose of BA1104 or Opdivo^®at a 1:1 ratio. The primary PK endpoint was AUC_0-∞, and the secondary PK endpoints included AUC_0-t and C_max. Safety and immunogenicity were also evaluated in this study.

The results showed the 90% CI for the rations of geometric means for AUC_inf, AUC_last and C_max of BA1104 and Opdivo^® were all contained entirely within the prespedified equivalence limits[0.80; 1.25], suggesting PK similarity between BA1104 and Opdivo was demonstrated. Safety and immunogenicity were also highly similar between the two groups.