Shandong Boan Biotechnology Co. Ltd. has announced the completion of patient enrollment for a Phase III clinical trial of its nivolumab injection, code-named BA1104, in China. BA1104 is the first biosimilar of Opdivo® in China to advance to a Phase III clinical trial. According to the company, Phase I trial results demonstrated that BA1104 is highly comparable to Opdivo® in pharmacokinetics, safety, and immunogenicity, and these results have been published in the journal BioDrugs. The Phase III trial results have not yet been presented. Upon completion of the Phase III trial, the company may apply for approval of BA1104 for all indications that Opdivo® has obtained in China, in accordance with national regulatory guidelines.
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