YONG Tai Bhd is all set to roll out its Phase III clinical trial in Malaysia after the National Pharmaceutical Regulatory Agency (NPRA) granted its approval for the Clinical Trial Import License (CTIL).
This follows the earlier approval received from the Medical Review Ethics Committee (MREC).
The roll-out makes Yong Tai’s the first private company to conduct Phase III clinical trial for COVID-19 vaccine in Malaysia.
This coincides with the Emergency Use Authorisation (EUA) granted by the Chinese Government recently for the inactivated COVID-19 vaccine (KCONVAC) developed by the group’s strategic partner, Shenzhen Kangtai Biological Products Co Ltd.
Shenzhen Kangtai has also commenced its KCONVAC vaccination programme in China, with its first batch of vaccination programme of more than 500,000 doses on June 1.
“Shenzhen Kangtai has already undergone the Phase I and II clinical trials in China since last year with encouraging results – and with the approval now granted for emergency use in China – we’re cautiously optimistic that the results of our Phase III clinical trial in Malaysia will show promising results,” commented Yong Tai’s CEO and executive director Datuk Wira Boo Kuang Loon.
The roll-out of the Phase III clinical trial comes as Malaysia is facing a huge battle against the COVID-19 pandemic.
The Government has warned of dire consequences if the nation’s healthcare system collapses under the strain of increasing COVID-19 cases, while the country has started a two-week national full lockdown from June 1 to 14, following a spike in COVID-19 cases.
Given the sharp increase in COVID-19 cases that have put the country’s healthcare system at breaking point, Boo said the group would proceed with the application for the EUA in Malaysia following the roll-out of its Phase III clinical trial.
“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,” he projected.
“We hope that the faster approval for emergency use in Malaysia will help to bridge the supply gap of the vaccine in the country as we are committed to provide 10 million doses plus another option of 10 million doses yearly by our partner.”
Boo added the approval would also add another vaccine supply for the country, on top of the currently available vaccines – Pfizer, AstraZeneca and Sinovac.
At the close of today’s trading, Yong Tai was up 2.5 sen or 10.42% to 26.5 sen with 48.91 million shares traded, thus valuing the company at RM357 mil – June 3, 2021
