China’s mpox vaccine ready for clinical trial

December 16, 2024

BEIJING – China’s top drug regulator has recently approved clinical trials of a mpox vaccine developed by the domestic drugmaker Sinopharm, adding to a growing number of homegrown candidates in the pipeline, according to the company.

The experimental vaccine is jointly created by the Beijing Institute of Biological Products administered by Sinopharm as well as the National Institute for Viral Disease Control and Prevention under the Chinese Center for Disease Control and Prevention, the company said in a statement released on Thursday.

There is currently no approved mpox vaccine in China. The vaccine candidate from Sinopharm has proved safe and effective during preclinical research and it can stimulate immune protection against mpox in various animal models including nonhuman primates.

“This vaccine is independently developed by Chinese scientists and has complete proprietary intellectual property rights,” said the company. “The dose is expected to play an important role in the control and prevention of mpox in China.”

In China, a vaccine candidate typically goes through three phases of clinical trials before gaining market approval. The process can take years and even decades.

Another mpox vaccine candidate under research is developed by the Shanghai Institute of Biological Products, another subsidiary of Sinopharm. This vaccine gained the green light for carrying out clinical trials in September.

The Institute of Microbiology under the Chinese Academy of Sciences said last month that its scientists are researching a potential mpox vaccine based on the novel messenger RNA technology and achieved positive results in mice studies.

The institute said that it has signed agreements with drug manufacturers to advance research into and market registration of the experimental dose.

The World Health Organization declared mpox as global health emergency in August after the disease spread across Africa. The majority of cases were concentrated in Congo, Burundi and Uganda and more than 120 countries and regions across the world have registered confirmed cases.

The Chinese mainland reported its first domestic case in June last year and classified mpox as a Class B infectious disease — on par with COVID-19 and HIV/AIDS — two months later.

The latest data from the China CDC shows that the nation reported 46 infections in September and another 38 cases in October.