Phase III Clinical Trial of BIOKANGTAI COVID-19 Vaccine Initiated in Malaysia

On June 21, local time, phase III clinical fieldwork of the Inactivated COVID-19 Vaccine (Vero cells) independently developed and manufactured by Shenzhen Kangtai Biological Products Co., Ltd. was officially initiated in Malaysia, and the first batch of enrolled subjects was vaccinated on-site.

In February this year, BIOKANGTAI and Malaysia's Yong Tai Berhad signed an Agreement on Phase III Clinical Trial of Inactivated COVID-19 Vaccine and Product Procurement, reaching a consensus to further carry out the phase III clinical trials and commercialization of the agreed products in Malaysia. On May 31, the National Pharmaceutical Regulatory Agency (NPRA), Malaysia, approves the clinical trial of the vaccine. Subsequently, on June 11, clinical samples of the vaccine were delivered from Shenzhen, China to Malaysia.

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. Since the company was listed on the A-shares market in 2017, its market value has continuously increased, ranking among the top 50 biopharmaceutical companies in the world.

In May this year, the BIOKANGTAI Inactivated COVID-19 Vaccine was granted the Emergency Use Authorization (EUA) in China, making it the sixth COVID-19 vaccine variety approved in China and also the first COVID-19 vaccine variety approved in Guangdong province. Since the commencement of the large-scale vaccination of the vaccine on June 1, the cumulative dose of vaccination has reached millions, according to the statistics of local regulatory authorities, its adverse reaction rate is much lower than the average level, showing its excellent safety. 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, the 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%.

Regarding this collaborative clinical trial, Miao Xiang, executive vice chairman of BIOKANGTAI, said, "In the face of the pandemic, BIOKANGTAI, together with our Malaysian partner, will provide Malaysians with COVID-19 vaccines which have been proven to be safe on a large scale, to help Malaysia overcome the epidemic as soon as possible with our responsibility and duty as a Chinese vaccine enterprise. At the same time, both companies will actively promote the roll-out of the phase III clinical trial, to accelerate the fair supply of COVID-19 vaccines as a public product in the world, especially in developing countries, by verifying the effectiveness and safety of the vaccine on a larger scale."

Datuk Wira Boo Kuang Loon, CEO of Yong Tai Berhad said, " The COVID-19 Vaccine will become a long-term demand, and we currently lack the technology to produce vaccines on our own, we hope to introduce the advanced technology of BIOKANGTAI and to promote local R&D and manufacturing."