Shenzhen Huada Gene Co., Ltd., a listed company for genetic sequencing in China (“Huada Gene,” 300676), announced on May 10 that its wholly-owned subsidiary, BGIEuropeA/S (European Medicine), has recently been included in the World Health Organization’s (WHO) Emergency Use List (“EmergencyUseListing”).
Huada gene said, “The company’s products were included in the WHO emergency use list, meaning that WHO product quality recognition and affirmation, for WHO member countries and the intention to purchase the procurement basis, is conducive to further enhance the international competitiveness of the company’s products, on a global basis to help the new coronavirus infection pneumonia outbreak prevention and control work.”
According to the WHO official website, a total of 5 domestic and foreign enterprises of the new coronavirus detection products in the WHO emergency use list, the above-mentioned test kit is the first to be shortlisted in the WHO emergency use list of Chinese enterprises products.
Huada gene was listed by WHO as a new coronavirus 2019-nCoV nucleic acid detection kit (fluorescent PCR method) number MFG030011, approved date of May 7, 2020. This product can be used in suspected patients of pneumonia with a new coronavirus infection or other persons who need to diagnose or identify a new coronavirus infection, by detecting nucleic acids extracted from samples of pharynx swabs or alveolar irrigation fluid taken by the subject to determine whether the subject has a new coronavirus infection. The purchase period of the product is 1 year.
Up to now, The approval of Huada gene testing products is as follows:
In the domestic market, has been issued by China’s State Drug Administration medical device registration certificate.
In the European market, the EU CE certification was completed and the EU certificate of free sale was obtained.
In the U.S. market, emergency use authorization (EUA) has been obtained from the U.S. Food and Drug Administration (FDA).
In the Japanese market, has passed the Japanese PMDA certification, in the Australian market, has been registered with the Australian TGA.
In the Singapore market, it has been provisionally authorized by the Singapore Health Science Stoa.
In the Canadian market, health Canada has been certified.
Huada Gene’s controlling shareholder is Shenzhen Huada Gene Technology Co., Ltd., with a shareholding of 37.18%; Headquartered in Shenzhen, China, in Beijing, Tianjin, Wuhan, Shanghai, Guangzhou and other major domestic cities with branches and medical laboratories, and in Europe, the Americas, Asia-Pacific and other regions with overseas centers and core laboratories, has formed a “national coverage, radiation global” network layout.
The company’s main business for genetic testing, mass spectrometry, bio-information analysis and other means, for medical institutions, scientific research institutions, enterprises and institutions to provide genomics testing and research services. The main products include NIFTY (noninvasive prenatal gene testing / fetal chromosomal non-integral detection) including reproductive health basic research and clinical application services, tumor prevention and control and translational medicine services, infection prevention and control basic research and clinical application services, multi-group big data services and synthesis services, precision medical testing integrated solutions.
It is worth mentioning that, under the global demand for new crown epidemic testing kits and other factors, Huada Gene’s operating income in the first quarter of this year was 791 million yuan, an increase of 35.78 percent year-on-year, and the net profit attributable to shareholders of listed companies was 140 million yuan, an increase of 42.59 percent year-on-year. In the first quarter of the results rose at the same time, Huada Gene share price in the first quarter ushered in a wave of sustained gains, the stock has risen nearly 60% so far this year.