BEIJING – China’s National Medical Products Administration has approved clinical trials for an experimental mpox vaccine developed by the state-owned pharmaceutical giant Sinopharm, marking a major step toward a home-grown solution for the disease.
The vaccine, created jointly by the Beijing Institute of Biological Products under Sinopharm and the National Institute for Viral Disease Control and Prevention of the China CDC, is the nation’s first mpox vaccine candidate to enter clinical trials. Sinopharm announced the approval on December 12, emphasizing the vaccine’s safety, efficacy, and ability to stimulate immune protection against mpox in pre-clinical animal studies, including tests on non-human primates.
“This vaccine is independently developed by Chinese scientists and holds full proprietary intellectual property rights,” Sinopharm said in its statement, highlighting its potential role in controlling and preventing the disease in China.
Although no mpox vaccine is currently approved for use in China, the country has been ramping up efforts to develop domestic vaccines. A separate mpox vaccine candidate, also by Sinopharm subsidiary Shanghai Institute of Biological Products, began clinical trials in September. The Institute of Microbiology under the Chinese Academy of Sciences is additionally advancing an mRNA-based mpox vaccine, which has shown promising results in animal models, according to a November update.
Mpox, declared a global health emergency by the World Health Organization (WHO) in August 2023, has primarily affected countries in Africa, with cases also being reported across more than 120 countries and regions worldwide. In China, the first domestic case was reported in June 2023. Two months later, the disease was classified as a Class B infectious disease, grouping it alongside HIV and Covid-19.
According to the China CDC, the country reported 46 mpox infections in September and another 38 cases in October, underscoring the need for effective preventive measures. Sinopharm’s vaccine and other candidates under development represent critical components of China’s strategy to combat mpox outbreaks domestically.
China’s vaccine development process traditionally involves three phases of clinical trials, which can take years to achieve final market approval. With growing momentum in the development pipeline, the efforts are expected to position China as a global player in mpox prevention in the coming years.