Zhifei Bio's ZFA01 zoster vaccine accepted for clinical trials

Chongqing Zhifei Biological Products Co., Ltd. (Zhifei Bio) announced its wholly-owned subsidiary, Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., has received acceptance for its clinical trial application for the recombinant herpes zoster ZFA01 adjuvant vaccine (CHO cell). The National Medical Products Administration issued the acceptance notice, initiating a 60-day period during which Zhifei Longcom can proceed with the clinical trial if no objections are raised.

The ZFA01 vaccine, developed using a novel adjuvant, aims to elicit both cellular and humoral immune responses for enhanced protection against herpes zoster. This development marks a key achievement in Zhifei Bio’s innovation strategy and is expected to enrich its adult vaccine portfolio, strengthening its market position. The company states that the acceptance of this application will not have a significant impact on its near-term financial performance.

Currently, two herpes zoster vaccines are approved for use in China. Zhifei Bio is also exploring multiple technological pathways, including recombinant protein technology and mRNA, to develop herpes zoster vaccines. The company cautions investors about the inherent risks associated with drug development, including lengthy timelines and uncertain outcomes regarding clinical trials and product launch.