China News Service, Beijing, February 6 (Reporter Du Yan) Kexing Holding Biotechnology Co., Ltd. announced on the 6th that the State Drug Administration had approved the company’s subsidiary Beijing Kexing Zhongwei Biotechnology on February 5 according to law. Co., Ltd. (hereinafter referred to as "Kexing Zhongwei") developed a new type of coronavirus inactivated vaccine, Kierlai Fu, which is conditionally listed in China.
The State Drug Administration website announced on the 6th that on February 5, the State Drug Administration approved the registration application for the new coronavirus inactivated vaccine (Vero cell) of Kexing Zhongwei with conditions.
The vaccine is suitable for preventing the disease caused by the new coronavirus infection (COVID-19).
On the 6th, Kexing Holding Biotechnology Co., Ltd. introduced that the new coronavirus inactivated vaccine developed by the company's subsidiary Kexing Zhongwei was approved for emergency use in China in June 2020 and started in July. Emergency use has been carried out for specific groups of people in China.
Since January 2021, countries such as Indonesia, Turkey, Brazil, Chile, Colombia, Uruguay and Laos have successively approved the emergency use of Clareford in the local area. At present, many countries have successively launched vaccines for high-risk groups such as medical staff and the elderly. Inoculation work.
It is reported that Kexing Zhongwei began rolling submission of registration materials to the Center for Drug Evaluation (CDE) of the State Drug Administration in September 2020.
According to the relevant provisions of the "Vaccine Administration Law" and "Drug Administration Law", the State Food and Drug Administration conducts emergency review and approval in accordance with the special drug approval procedures, and approves the listing application with conditions.
Yin Weidong, chairman, president and CEO of Kexing Holdings, said that Kexing Zhongwei will continue to actively promote the phase III clinical research and conditional post-marketing clinical research of Kellife, as well as the registration and application in relevant countries and regions. Contribute to the prevention and control of the global new crown pneumonia epidemic and the availability and affordability of the global new crown vaccine.
It is reported that on December 30, 2020, the National Medical Products Administration approved the registration application of the new coronavirus inactivated vaccine of Sinopharm China Bio-Beijing Company.