KUALA LUMPUR: Yong Tai Bhd's (YTB) subsidiary YTB Healthcare Sdn Bhd (YHSB), has obtained approval from the Ministry of Health (MoH) for its Phase III clinical trial of the inactivated Covid-19 trial vaccines in Malaysia.
YTB chief executive officer and executive director Datuk Wira Boo Kuang Loon said the recent surge in Covid-19 cases is a concern for the country as the recent virus outbreaks also involve different variants of the virus.
"This makes it even more important for us as private sectors, to do our part in helping the country to achieve herd immunity.
"We are excited with the latest approval to start the Phase III clinical trial in Malaysia.
"With this approval, we will be the first private company to initiate and sponsor the Phase III clinical trial of vaccines in Malaysia. It is indeed a timely approval for us as well as for the country given the importance of vaccine in our fight against the Covid-19 pandemic," Boo said in a statement today.
YHSB has already formalised the Phase III clinical trial and product procurement with its strategic partner, Shenzhen Kangtai Biological Products Co Ltd (SZKT) since December last year.
SZKT is one of the largest vaccine manufacturers in China.
"If you look at our development over the past four months, we have been proactive in our efforts to ensure all regulatory and safety requirements are met for us to obtain this approval.
"This includes but not limited to the compilation and analytics of Phase I and Phase II clinical trials for the submission with the MoH," Boo said.
He said the company has set an internal target to roll out the distribution of SZKT's inactivated vaccine by the third quarter this year, subject to the 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," he said.
Boo said so far, the company have only seen around 2.4 per cent of the population that has obtained at least one dose of the vaccine.
"It is still a long way and we believe that involvement of a local private sector in the distribution of vaccine will help to escalate the country's goal to achieve herd immunity against Covid-19," Boo said.
YHSB will now focus on its Phase III clinical trial, which will be carried out in Malaysia, involving total 3,000 volunteers.
"With our collaboration, we are looking to help escalate the country's target to achieve herd immunity against Covid-19 and potentially bring in SZKT to set up their production centre in Malaysia.
"This will also help to attract huge investment into Malaysia, as well as transfer technical know-how to local workers and create job opportunities in the pharmaceutical sector," Boo said.
Under the collaboration with SZKT, YHSB will be granted exclusive distributorship rights in Malaysia on a vaccine procurement program 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 contribution coming from the distribution of vaccine once approval for conditional marketing authorisation is obtained.
"We are optimistic about the potential earnings contribution that will come from the development and distribution of vaccine business.
"However, our priority remains at helping the country achieve herd immunity as soon as possible in order to help a gradual return to normal as well as the recovery of the overall economy," Boo said.
