Business

YTB Healthcare gets nod to carry out Covid-19 vaccine’s Phase 3 clinical trials

It is first private firm in M’sia to get approval to do so

Updated 5 years ago · Published on 26 Apr 2021 6:47PM

YTB Healthcare gets nod to carry out Covid-19 vaccine’s Phase 3 clinical trials
YTB Healthcare’s Phase 3 clinical trials will be carried out in Malaysia and involve 3,000 volunteers. – File pic, April 26, 2021

KUALA LUMPUR – Yong Tai Bhd’s (YTB) subsidiary YTB Healthcare (YTBH) Sdn Bhd has been given the green light to carry out Phase 3 clinical trials of its inactivated Covid-19 trial vaccines in Malaysia.

YTB CEO and executive director Datuk Boo Kuang Loon said: “With this approval, we will be the first private company to initiate and sponsor the Phase 3 clinical trial of vaccines in Malaysia.”

YTBH has already formalised the Phase 3 clinical trial and product procurement with its partner, Shenzhen Kangtai Biological Products Co Ltd (SZKT), since last December. SZKT is one of the largest vaccine manufacturers in China.

He said the group has set an internal target to roll out the distribution of SZKT’s inactivated vaccine by the third quarter this year, subject to approval by National Pharmaceutical Regulatory Authority (NPRA) for emergency usage.

“We have an ambition to roll out the distribution of the vaccine by third quarter this year, subject to the approval by NPRA for emergency usage. So far, the Covid-19 vaccines are procured by the government and administered for free to the public. The regulators have already approved the Pfizer-BioNTech vaccine, China’s Sinovac and Britain’s AstraZeneca.

“So far, we have only seen around 2.4% of the population obtaining at least one dose of the vaccine. It is still a long way and we believe that involvement of the local private sector in the distribution of vaccines will help escalate the country’s goal to achieve herd immunity against Covid-19.”

The group will now focus on its Phase 3 clinical trials, which will be carried out in Malaysia and involve 3,000 volunteers.

Under the collaboration with SZKT, YTBH will be granted exclusive distributorship rights in Malaysia on a vaccine procurement programme of no less than 10 million doses per annum with an option to purchase for additional 10 million doses per annum for a five-year period. In the event of unsold doses, the surplus shall be allowed to be sold with permission in other Asean and Indian subcontinent countries.

With both the domestic and export markets, YTB will start to see contributions coming from the distribution of vaccines once approval for conditional marketing authorisation is obtained. – The Vibes, April 26, 2021

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