Walvax varicella vaccine clinical trial application accepted

Yunnan Walvax Biotechnology Co., Ltd. and its subsidiaries, including Yunnan Vaccine Laboratory Co., Ltd., Beijing Walvax Innovation Biotechnology Co., Ltd., and Yuxi Walvax Biotechnology Co., Ltd., jointly announced the National Medical Products Administration's acceptance of their clinical trial application for a live attenuated varicella vaccine. The vaccine is classified as a preventive biological product for domestic production.

The vaccine uses an attenuated strain of the Varicella-zoster virus (VZV), propagated in human diploid cells and formulated as a freeze-dried live attenuated vaccine. It is designed to stimulate immunity against VZV, which causes both chickenpox and shingles. VZV is a highly contagious herpesvirus, primarily affecting children with chickenpox and adults with shingles.

While the clinical trial application has been accepted, the process will undergo technical review by the National Medical Products Administration's Center for Drug Evaluation. Walvax Biotechnology noted that the timeline and outcome of the review and approval are uncertain. The company also clarified that this acceptance is not expected to materially impact its operating performance for the current year.