KUALA LUMPUR: Yong Tai Bhd (YTB) and Shenzhen Kangtai Biological Products Co Ltd (SZKT) have entered into Phase 3 clinical and product procurement agreement for Phase 3 clinical trials and exclusive commercialisation of the latter’s Covid-19 vaccine.
YTB’s subsidiary YTB Healthcare Sdn Bhd signed the agreement with SZKT to formalise the collaboration between the two companies on the clinical trials and commercialisation of the vaccine under the head of agreement (HoA) framework signed in December last year.
“The signing of the definitive agreement marks another milestone for the group in our venture towards the pharmaceutical business.
“We are confident this collaboration will show results in the near-term given the track record of SKZT in the pharmaceutical industry,” said YTB chief executive officer Datuk Wira Boo Kuang Loon.
This virtual signing ceremony was witnessed by senator Tuan Jaziri Alkaf Abdillah Suffian.
Also present at the ceremony is the Clinical Research Malaysia chief executive officer Dr Akhmal Yusof.
At the same event, YTB has also signed a service agreement with BCA International Sdn Bhd, which was represented by its managing director Mazliza Mahdzar.
Boo said the company had obtained approval for clinical trial in China last year as it would sponsor the cost for Phase 3 clinical trials in Malaysia that can be recovered from the commercialisation of the vaccine, if successful.
The clinical trials will enroll 2,880 participants from Malaysia which will receive the vaccine in two doses 28 days apart.
While YTB will bear the cost for the clinical trials in Malaysia, SZKT will bear all costs for the supply of vaccine samples for the trials, which includes the cost of transporting the vaccine from China to Malaysia.
Under the agreement, YTB has to obtain the approval of Phase 3 study protocol from Ethics Committee of Ministry of Health and National Pharmaceutical Regulatory Authority (NPRA) of Malaysia prior to the commencement of the clinical trials here.
Boo said more work needs to be done to ensure that the clinical trials could start as soon as possible.
“We know that there are a lot more works for us to do from here onwards. We just need to stay focus with the next course of action in compiling the Phase 1 and Phase 2 clinical trials data and prepare the Phase 3 trial protocol to be submitted to the relevant authorities.
“We are willing to contribute ourselves to be the first private company to initiate and sponsor the trials to be done in Malaysia with the guidance and assistance from the experts,” he added.
Upon the conclusion of the clinical trials or emergency usage approval, both YTB and SZKT will cooperate on a vaccine procurement programme of no less than 10 million doses of the vaccine with another option of 10 million doses per year for five years.
SZKT has a track record in the pharmaceutical industry and operates the biological product manufacturing business.
The company produces biological vaccines and other vaccine products.
Aside from Malaysia, SZKT will also be doing Phase 3 clinical trials in Columbia, Argentina, which will help to provide a larger set of data for its efficacy and safety level.
It recently completed a facility designed to be able to produce 400 million doses of AstraZeneca’s Covid-19 vaccine per year, doubling its capacity target promised in 2020.