Shenzhen Huada Gene Co., Ltd. (hereinafter referred to as “Huada Gene”, 300676), a domestic gene sequencing listed company, announced on May 10 that its wholly-owned subsidiary BGIEuropeA / S (European Medicine) detects new coronavirus nucleic acids The product was recently included in the World Health Organization (WHO) Emergency Use List (“EmergencyUseListing”).
BGI said, “This time the company ’s products are included in the WHOEUL, which means that WHO ’s recognition and affirmation of the company ’s product quality can be used by WHO member countries and various The intention to provide purchasers with a basis for procurement is conducive to further enhancing the international competitiveness of the company ’s products and to help prevent and control pneumonia outbreaks of new coronavirus infections worldwide.
WHO official website, a total of 5 domestic and foreign companies’ new coronavirus detection products are listed in the WHO emergency use list, of which the company’s above test kit is the first Chinese enterprise product to be included in the WHO emergency use list.
BGI was included in the emergency use product new coronavirus 2019-nCoV nucleic acid detection kit (fluorescent PCR method) number MFG030011, the approval date is May 7, 2020. The product can be applied to Patients with suspected pneumonia of new coronavirus infection or other persons who need diagnosis or differential diagnosis of new coronavirus infection, by detecting nucleic acid extracted from pharyngeal swab or alveolar lavage fluid sample collected from the subject To determine whether the subject has a new coronavirus infection. The purchase period of the product is 1 year.
As of now, the approval status of BGI ’s test products is as follows:
In the domestic market, it has obtained a medical device registration certificate issued by the State Drug Administration of China.
In the European market, completed the EU CE certification and obtained the EU free sales certificate.
In the US market, it has obtained the US Food and Drug Administration (hereinafter referred to as ” FDA ”) issued an Emergency Use Authorization (EUA).
In the Japanese market, it has passed the Japanese PMDA certification; in the Australian market, it has obtained the Australian TGA registration. < br>
In the Singapore market, it has been granted a temporaryAuthorization.
In the Canadian market, it has passed the certification of Health Canada.
The controlling shareholder of Huada Gene is Shenzhen Huada Gene Technology Co., Ltd., with a shareholding ratio of 37.18%; the actual controller of the company is Wang Jian. Headquartered in Shenzhen, China, with branches and medical laboratories in major domestic cities such as Beijing, Tianjin, Wuhan, Shanghai, and Guangzhou, and overseas centers and core laboratories in Europe, America, Asia-Pacific, etc. “Nationwide, Radiation Global” network layout.
The company ’s main business is to provide genomics for medical institutions, scientific research institutions, enterprises and institutions through genetic testing, mass spectrometry testing, biological information analysis, etc. Testing and research services. The main products include NIFTY (non-invasive prenatal genetic testing / fetal chromosomal aneuploidy testing), basic research on fertility health and clinical application services, tumor prevention and control and translational medicine services, infection prevention and control basic research and clinical application services Multi-group learning big data services and synthesis services, comprehensive solutions for precision medical testing, etc.
It is worth mentioning that, due to the global demand for new crown epidemic detection kits and other factors, BGI ’s operating income in the first quarter of this year was 791 million yuan. A year-on-year increase of 35.78%; net profit attributable to shareholders of listed companies was 140 million yuan, an increase of 42.59% year-on-year. While the performance in the first quarter rose, BGI’s stock price ushered in a continuous rise in the first quarter. This year, the stock price has risen by nearly 60%.