BIOKANGTAI COVID-19 Vaccine Approved for Phase III Clinical Trial in the Philippines

SHENZHEN,China,Aug. 2,2021 --On July 30,Shenzhen Kangtai Biological Products Co.,Ltd. (BIOKANGTAI) was approved by the Philippine Food and Drug Administration (PFDA) to launch the phase III clinical trial of its independently developed Inactivated COVID-19 Vaccine (Vero cells) in the local area. Earlier,BIOKANGTAI has already been approved by the Vaccine Expert Panel (VEP) of the Philippine Department of Science and Technology (DOST) on June 14,and by the Single Joint Research Ethics Board (SJREB) of the Philippine Department of Health on June 21.

BIOKANGTAI is China's leading biopharmaceutical enterprise. Over the past 30 years since its establishment,it has accumulated rich experience in vaccine research and development,and it also has a notable scale of vaccine industrialization in China. In May 2021,BIOKANGTAI's Inactivated COVID-19 Vaccine was approved for emergency use and inoculated on a large-scale within China. In addition,according to the data of phase I/II clinical trials published on the medRxiv platform and in the National Medical Journal of China,in the phase II clinical trial of the vaccine another geometric mean titer of neutralizing antibody against the vaccine virus in the vaccine group on day 0-28 of the immunization program is 2.65 times of that of the serum neutralizing antibody of the convalescents,with an expected protection rate of more than 90%.

In June this year,BIOKANGTAI's Inactivated COVID-19 Vaccine first entered Southeast Asia and launched the phase III clinical trial in Malaysia. Meanwhile,BIOKANGTAI is proactively seeking to launch clinical trials in more countries and regions in South America,Europe,etc. It has already obtained clinical approval in Ukraine and is expected to launch trials in early August. The large-scale data will provide a stronger guarantee for vaccine safety and efficacy.

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