The company receives a conditional approval from DCA for its Convidicea vaccines
by NUR HAZIQAH A MALEK
SOLUTION Group Bhd has a deal to supply 3.5 million of one-dose CanSino vaccines to the Ministry of Health (MoH) and is currently setting up a fill-and-finish (F&F) facility.
Its deputy MD Datuk Dr Mohd Nazlee Kamal said the company received a conditional approval from Drug Control Authority (DCA) for its Convidicea vaccines and hopes to deliver its first dose by the end of the third quarter (3Q).
“We are glad that the DCA has granted us conditional registration approval for the Covid-19 vaccine. We are in the process of setting up an F&F facility to produce the vaccine in Malaysia.”
The 20,000 sq ft F&F facility located at the Technology Park Malaysia (in Bukit Jalil, Kuala Lumpur,) is expected to be fully operational by August this year after receiving the good manufacturing practices certification by the National Pharmaceutical Regulatory Agency.
The F&F hub is expected to produce three million doses of the CanSino vaccine per month. The vaccine is the only single-dose vaccine among the few available in Malaysia.
Following this development, Solution joined Pharmaniaga Bhd and Duopharma Biotech Bhd in doing F&F of various Covid-19 vaccines in the country as the country’s infection numbers cross the 700,000 mark and casualty figures rise above the 4,000 level.
According to the company, CanSino uses adenovirus much like the AstraZeneca vaccine. Two aspects setting the two apart are the CanSino vaccine does not use adenovirus derived from chimpanzees and has zero case adverse reaction so far.
The CanSino vaccine is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARSCoV-2 spike protein, by using a weakened common cold virus to deliver genetic material that codes for the SARS-CoV-2 spike protein to the cells.
These cells then produce the spike protein and travel to the lymph nodes where the immune system creates antibodies that will recognise the spike protein and fight off the coronavirus infection.
Based on preliminary information, CanSino has released Convidicea interim phase three trial results with 65.7% efficacy in preventing moderate symptoms and 100% in severe disease prevention.
The agreement that was signed on Feb 5 has Solution group planning to go regional with its vaccine supply plans.
Mohd Nazlee admitted it was a risk the group took by constructing the F&F plant before receiving the green light for the vaccine use, but it was done in order to ensure the country secures its vaccine supply without delay.
Since June 14, Solution’s share price has declined steadily from its peak of RM2 last December to close at RM1.22 yesterday, which is a far cry from its price of nine sen a year ago.
Its subsidiary, Solution Biologics Sdn Bhd, will head the venture and is expected to contribute positively to Solution’s earnings, which posted a net loss of RM1.66 million in 1Q ended March 31, 2021, after the company accounted the unrealised loss on the fair value of the short-term investment during the quarter.
Revenue for the quarter stood at RM5.48 million, higher than the previous year’s RM3.45 million on more project progress during the quarter.