Yong Tai wins NPRA approval to conduct Phase 3 vaccine trial

A picture taken on October 9, 2020 shows a dose of Sinovac Biotech potential vaccine against the COVID-19 during the 3rd phase trials at the Acibadem Hospital in Istanbul. (Photo by Yasin AKGUL / AFP) (Photo by YASIN AKGUL/AFP via Getty Images)

by NUR HAZIQAH A MALEK / pic by AFP

YONG Tai Bhd’s subsidiary, YTB Healthcare Sdn Bhd (YTBH), has secured approval for the clinical trial import licence from the National Pharmaceutical Regulatory Agency (NPRA), allowing it to conduct Phase 3 clinical trials for Covid-19 vaccine in Malaysia.

In a statement issued yesterday, Yong Tai stated its strategic partner Shenzhen Kangtai Biological Products Co Ltd (SZKT) has been granted the emergency use authorisation (EUA) by the government of China recently for developing the inactivated Covid-19 vaccine (KCONVAC).

SZKT has started its first batch of KCONVAC vaccination programme in China with more than 500,000 doses on June 1, 2021.

Yong Tai CEO and ED Datuk Boo Kuang Loon said SZKT has already undergone the Phases 1 and 2 clinical trials in China since last year with encouraging results.

“With the approval now granted for emergency use in China, we’re cautiously optimistic the results of our Phase 3 clinical trial in Malaysia will show promising results,” he added.

Following the rollout of Phase 3 clinical trial, YTBH will proceed to apply for the EUA in Malaysia.

“As our strategic partner has already managed to obtain approval for emergency use in China, we think this will pave the way for us to obtain similar approval in Malaysia.

“We hope the faster approval for emergency use in Malaysia will help bridge the supply gap of the vaccine in the country as we are committed to providing 10 million doses, plus another option of 10 million doses yearly by our partner,” said Boo.