Watson Bio-Recombinant Novel Coronavirus Vaccine (Chimpanzee Adenovirus Vector) Obtained Clinical Approval

On May 28th, Watson Bio announced that the company has recently received the "Drug Clinical Trial Approval Document" approved by the National Medical Products Administration for the recombinant new coronavirus vaccine (chimpanzee adenovirus vector) (hereinafter referred to as "the vaccine").

The main contents of the approval document are as follows:

Drug name: Recombinant new coronavirus vaccine (chimpanzee adenovirus vector)

Application matter: clinical trial

Batch number: 2021L90009

Specification: 0.

Dosage form: injection

Registration Classification: Biological Products for Preventive Use

Applicants for registration: Tsinghua University, Tianjin Medical University, Yunnan Watson Biotechnology Co.

Approval conclusion: In order to respond to the pneumonia epidemic caused by the new coronavirus infection, in accordance with the "Drug Administration Law of the People's Republic of China", "The People's Republic of China Vaccine Administration Law", "Drug Registration Management Measures" and "Special Drug Approval Procedures of the State Food and Drug Administration" 》, after review and review by a special expert group, this product was approved for clinical trials in an emergency.

At present, five new coronavirus vaccines based on the adenovirus vector technology route have been approved for emergency use licenses or conditional marketing licenses in the world