Nation's first mpox virus test product approved for market entry

China's National Medical Products Administration has given market entry approval to a monkeypox virus nucleic acid test kit developed by a medical diagnostics company in South China's Guangdong Province, marking the first approval of its kind in China, according to a statement published by medical products administration in Guangdong on Thursday.

The approved monkeypox test kit, developed by Daan Gene, will be mainly used in vitro qualitative detection of the monkeypox F3L gene in suspected cases, skin lesion samples of other individuals requiring monkeypox virus infection diagnosis or differential diagnosis, and throat swab samples, said the statement.

According to the statement, many listed companies are actively preparing for monkeypox test kits and other related products. To respond to the needs of overseas markets, many products developed by these companies have received the European Union's certification, exported to a number of overseas countries.

The World Health Organization (WHO) on August 14 declared the monkeypox surge a public health emergency of international concern -its highest alert level and urged manufacturers to ramp up vaccine production to rein in the spread of a more dangerous strain of the virus.

China's General Administration of Customs also announced that it would begin screening people and goods entering the country for monkeypox over the next six months. People arriving from countries where outbreaks have occurred, who have been in contact with monkeypox cases, or display symptoms will be required to declare this information to customs authorities when entering the country, adding that vehicles, containers, and items from areas with monkeypox cases should be sanitized.

As of July, a total of 99,176 laboratory-confirmed cases of monkeypox, including 208 deaths, have been reported to the United Nations health agency from 116 countries in all WHO regions, according to the UN News.

WHO spokeswoman Margaret Harris urged manufacturers to scale up monkeypox vaccine production, according to a report from Agence France-Presse (AFP) on August 17. 

The WHO also called for countries with monkeypox vaccine stockpiles to donate them to countries with ongoing outbreaks, according to the AFP.

Meanwhile, the replication-deficient monkeypox vaccine developed by the China National Pharmaceutical Group Corporation and Chinese Center for Disease Control and Prevention passed the clinical trial application phase in July of 2023, making it the earliest domestically developed monkeypox vaccine to enter the clinical research stage in China.