China’s NMPA Approves Recombinant Protein COVID-19 Vaccine for Human Clinical Trials

China’s NMPA Approves Recombinant Protein COVID-19 Vaccine for Human Clinical Trials

China’s National Medical Products Administration (NMPA) recently approved clinical trials for a new COVID-19 recombinant protein vaccine candidate developed by the West China Hospital of Sichuan University. This represents China’s first COVID-19 vaccine candidate grown in insect cells on humans. This investigational vaccine was designed to trigger antibodies against specific areas on the spike protein of SARS-CoV-2, the virus behind the COVID-19 pandemic.  Developed in the State Key Laboratory of Biotherapy, the Chengdu-based research center has inked a deal with a local biotech company to design a vaccine production line to produce products for human clinical trials.

Basis for Greenlight to Human Trials

The NMPA based its decision on the results of preclinical animal testing studies, the result of which were published in the journal Nature on July 29, 2020. They reveal that the vaccine can induce immune response against SARS-CoV-2 infection in mice, rabbits and non-human primates as early as seven or 14 days post the administration of single dose injections. The researchers observed no apparent side effects on the animals.

Genetic Engineering

The virus was actually created by modifying and inserting genes of the SARS-CoV-2 virus into insect cell cultures, which can grow viral proteins. This approach, according to Wei Yuquan, study co-author and senior researcher at the West China Hospital of Sichuan University, State Key Laboratory of Biotherapy, is suitable for large-scale manufacturing of vaccines.

This approach, according to the NPMA press release, has been used to develop recombinant vaccines against cervical cancer and influenza in Western countries, reported Dr. Wei who added the approach can be safely applied to humans.

West China Hospital of Sichuan University

Based in Chengdu, the West China Hospital of Sichuan University actually got its start back in 1892. Known as the West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH), or the Huaxi Hospital is a prestigious and well-known medical center in this western Chinese city of 16.5 million people.

It includes a sizable medical center with 4,300 beds, over 10,000 employees with 46 clinical departments and 5.73 million outpatient visits in 2019.

Research Center

The State Key Laboratory of Biotherapy, a comprehensive and multidisciplinary research center, was established to improve the treatment of major diseases such as cancer, cardiovascular diseases, obesity, diabetes and others.  It was selected as one of the National Research and Development (R&D) Platforms for Novel Drugs in 2008 and became a site for the Chinese National Collaborative Innovation Center for Therapy in 2013. 

This center employs 100 plus researchers studying gene and cell therapy, vaccines, monoclonal antibodies, recombinant proteins and synthetic small molecules and natural products for drug discovery.

The group capitalizes on access to clinical resources at West China Hospital and has, to date, licensed over 50 patents in China and transferred 45 potential drug candidates for commercial development.

Lead Research/Investigator

Wei Yu-quan, Senior Researcher, Director, State Key Laboratory of Biotherapy

Educated at West China University of Medical Sciences (undergrad) and master’s and Doctoral at Kyoto University, Japan, he has published over 300 papers in international journals. He is now president of the China Medicinal Biotech Association.