Sinopharm's Mpox Vaccine Candidate Approved for Clinical Trials in China
Key Insights
Sinopharm's mpox (search) vaccine candidate has been approved by China's drug regulator for clinical trials, joining other domestic candidates.
Preclinical studies suggest the Sinopharm vaccine is safe and effective, stimulating immune protection against mpox (search) in animal models.
China reported its first domestic mpox (search) case in June 2023 and has classified it as a Class B infectious disease.
China's National Medical Products Administration has approved clinical trials for a mpox (search) vaccine developed by Sinopharm, marking a significant step in the country's efforts to combat the disease. This development adds to the growing pipeline of domestically produced vaccine candidates.
The experimental vaccine is a collaborative effort between the Beijing Institute of Biological Products (search), a subsidiary of Sinopharm, and the National Institute for Viral Disease Control and Prevention, under the Chinese Center for Disease Control and Prevention (China CDC). The company stated that preclinical research has demonstrated the vaccine's safety and efficacy, showing its ability to stimulate immune protection against mpox (search) in various animal models, including non-human primates.
"This vaccine is independently developed by Chinese scientists and has complete proprietary intellectual property rights," the company stated, emphasizing its potential role in mpox (search) control and prevention within China.
Clinical Trial Pathway
In China, vaccine candidates typically undergo three phases of clinical trials before they can be considered for market approval. This process can span several years.
Other Vaccine Candidates
Another mpox (search) vaccine candidate, developed by the Shanghai Institute of Biological Products (search), another Sinopharm subsidiary, was approved to begin clinical trials in September. Furthermore, the Institute of Microbiology under the Chinese Academy of Sciences is exploring an mRNA (search)-based mpox vaccine, which has shown promising results in mice studies. The institute has reportedly signed agreements with drug manufacturers to further research and seek market registration for this experimental vaccine.
Mpox Situation in China and Globally
The World Health Organization (WHO) declared mpox (search) a global health emergency in August 2023, following its spread across Africa and other regions. The majority of cases were concentrated in Congo, Burundi, and Uganda, with over 120 countries reporting confirmed cases.
China reported its first domestic mpox (search) case in June 2023 and classified the disease as a Class B infectious disease, alongside COVID-19 (search) and HIV/AIDS (search), two months later. Recent data from the China CDC indicates 46 infections in September and 38 in October.