During the special period in which novel coronavirus pandemic continues to spread, in order to more effectively support the international community in coping with such a global public crisis, on April 25, 2020, the Ministry of Commerce, the General Administration of Customs, and the State Administration for Market Regulation issued an announcement No. 12 of 2020 Announcement on further strengthening the quality control on exported epidemic prevention materials. Hybribio’s COVID-19 diagnostic reagent has been white listed by the Ministry of Commerce.

The announcement pointed out that since April 26, export enterprises of novel coronavirus diagnostic reagents whose products have obtained certification or registration of foreign standards must submit electronic or written declarations at the time of customs declaration, promising that the products meet the quality standards and safety requirements of the importing country (region). The Customs shall inspect and release the exported anti-epidemic products on the basis of the list of production enterprises that have obtained certification or registration of foreign standards provided by the Ministry of Commerce (The website of China Chamber of Commerce for Import and Export of Medicines and Health Products www.cccmhpie.org.cn is updated dynamically).

From March to April, Hybribio's COVID-19 diagnostic kit (fluorescence PCR method) has successively obtained EU CE certification and Brazil ANVISA certification. At the same time, it entered the WHO EUL (Emergency Use List) for acceptance and passed the preliminary screening. Hybribio is the first COVID-19 diagnostic reagent company in China that has passed the WHO EUL product registration information review (Product Dossier). Obtaining product access qualifications in many countries and regions with excellent product performance enables Hybribio to continuously expand the coverage of area for epidemic prevention and control.

In response to the large-scale outbreak of the COVID-19, Hybribio has leveraged the advantages of the entire industrial chain to rapidly increase its production capacity, and at the same time launched integrated novel coronavirus detection solution, released a COVID-19 diagnostic kit basing on the fluorescent PCR platform and with supporting nucleic acid extraction kits, sample preservation solutions, and fully automated nucleic acid extraction instrument, forming a complete set of diagnostic solutions to facilitate rapid testing of large-scale samples both domestically and overseas.

It has been affirmed by the government that Hybribio COVID-19 diagnostic kit has been selected as one of the export companies approved by the Ministry of Commerce. Hybribio feels a great responsibility. We will try our best to enhance production capacity, strictly guarantee product quality, make every product that goes into the international market a Chinese-made identity, help the prevention and control of the pandemic, and shoulder the social responsibility of national enterprises.