China Pioneer Pharma Holdings Limited announced that the Food and Drug Administration of the United States (FDA) has recently commenced with the Pre-Emergency Use Authorization (the Pre-EUA) process on the Novel Coronavirus (SARS-CoV-2) IgG/IgM Combined Antibody Test Kit (Fluorescence Immunochromatography Method) (the Test Kits). The Test Kits are the products of Shenzhen Microprofit Biotech Co. Ltd. (Shenzhen Microprofit), a company incorporated in the People's Republic of China and a third party which is and whose shareholders are independent of the Company and of its connected persons (with the meanings ascribed thereto by the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited). The Group acts as the exclusive agent in the United States for a term of 10 years from 2020 of various Novel Coronavirus (SARS-CoV-2) test kits of Shenzhen Microprofit currently in development. The Pre-EUA process allows FDA scientific and technical subject matter experts to begin a review of information and assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an Emergency Use Authorization (EUA) in advance of an emergency and helps to facilitate complete EUA requests during a current emergency declaration. An EUA allows FDA to authorize the use of an unapproved medical countermeasures, in anticipation of a potential emergency or during an actual emergency.