Zhifei Bio-Products advances varicella, zoster mRNA vaccines to clinical trials

Chongqing Zhifei Biological Products announced today that its wholly-owned subsidiary, Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., has received acceptance for clinical trial applications from the National Medical Products Administration for both its lyophilized inactivated varicella vaccine and its zoster mRNA vaccine. This signifies that, barring any objections within 60 days, Zhifei Longcom can proceed with clinical trials for both products.

The varicella vaccine targets the prevention of diseases caused by varicella-zoster virus and is developed using an innovative inactivated technology pathway. It is intended for individuals aged 12 months and older. Currently, eight varicella live attenuated vaccines are on the market, but no inactivated varicella vaccines have been approved.

The zoster mRNA vaccine is designed to prevent diseases caused by herpes zoster infection. Zhifei Longcom's zoster mRNA vaccine is an independently developed mRNA technology product, boasting high production efficiency and good safety. While two zoster vaccines are approved in China, no mRNA zoster vaccines have yet received approval. The company is employing multiple technical routes, including recombinant protein technology and mRNA, to develop its zoster vaccine pipeline.

The acceptance of these clinical trial applications underscores Zhifei Bio-Products' focus on innovative technologies and strengthens its core R&D capabilities. This move is expected to enrich the company's upgraded vaccine portfolio, optimize its product layout, and reinforce its market position. The company emphasized that drug development involves substantial investment and long cycles, and the progress and outcomes of subsequent clinical trials, as well as market launch, remain uncertain. Investors are advised to exercise caution and be aware of investment risks.