Kuala Lumpur, 28 September 2020 – Solution Group Berhad’s subsidiary Solution Biologics Sdn. Bhd. (“SOLBIO”) has forged a partnership with CanSino Biologics Inc. (“CanSinoBIO”) to market and distribute in Malaysia CanSinoBIO’s Recombinant Novel Coronavirus Vaccine.
Solution Group board of directors said the vaccine called Adenovirus Type 5 Vector (Ad5-nCoV) will be registered after the completion of phase three trial with the Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) and complies with the cGMP (current Good Manufacturing Practice of the US Food and Drugs Administration) standards.
Upon obtaining the Market Authorization Certificate from NPRA, the Agreement will enable SOLBIO to commence the marketing and distribution of the vaccine.
Investors also warmed up to the collaboration as Solution Group shares rose 4 sen or 5.8 percent to 73 sen on Bursa Malaysia as soon as this announcement was made garnering a market capitalisation of RM223.5 million.
“Investors like the long term prospect of this company as the Covid-19 threat is far from over and there will be high demands for this vaccine,” said an analyst at Maybank Investment.
In a statement, the company said under their alliance, SOLBIO had on 23 September 2020 signed a Registration, Manufacturing and Commercialisation Agreement with CanSinoBIO.
According to Solution’s Group Managing Director, Mr Barry Lim, this agreement is an important milestone, not only to Solution Group but for our nation as a whole.
“We are working very hard on this project and hope to secure the vaccine as soon as our partner successfully completes the Phase three clinical trial and commercialise the said vaccine”.
SOLBIO and CanSinoBIO has formed a Joint Working Committee and started to communicate with all the relevant parties, including but not limited to our Ministry of Health, to ensure the smooth implementation of the project.
According to SOLBIO chief executive officer Dato’ Mohd Nazlee Kamal, under the agreement, SOLBIO will establish a “state-of-the-art” fill and finish facility while CanSinoBio will provide the technology transfer and relevant technical know-how for the operation of the facility.
This facility will be established at SOLBIO current premises located at PT13796, Jalan Tekno Usahawan 2, Technology Park Malaysia , Bukit Jalil, 57000 , Kuala Lumpur.CanSinoBIO is a China-based biotech company, listed on both Hong Kong Stock Exchange and Shanghai Stock Exchange.
CanSinoBIO is one of the 9 COVID 19 vaccine research groups that entered international Phase three clinical trial, which they are dedicated towards developing novel vaccines and therapeutics for unmet medical needs.
CanSinoBIO is developing the novel recombinant Ad5-nCoV vaccine which is composed of an adenovirus type 5 vector (liquid for injection).
CanSinoBIO will collaborate with SOLBIO in obtaining the necessary approvals (including the Marketing Authorization) for the purposes of the registration and commercialization of the Product in Malaysia.
Upon the Product’s registration, CanSinoBIO will supply to SOLBIO the bulk product for further manufacturing (fill and finish), its final quality control release and its commercialisation by SOLBIO in Malaysia.
SOLBIO and CanSionBIO hereby agree to combine their efforts in the co-development of the Product, including, in particular, performance of the studies, registration and commercialisation of the Product in Malaysia, as well as manufacturing and supply of the Bulk Product for the purposes of the manufacturing of the finished Product for Malaysia.
The Product will be registered in Malaysia after completion of the Part of Global Phase 3 Study and after the conditions for registration in Malaysia have been fulfilled.
In principal, both parties agree that CanSinoBIO is the actual beneficial owner of the Products and SOLBIO will be the Market Authorisation holder in Malaysia.
Solution Group Directors said upon the successful implementation of the terms, interests and the intention of the Parties as set out in the Agreement, the firm expects the collaboration will contribute positively to its earnings in the future.
The Board, having taken into consideration all aspects of the Agreement, is of the opinion that the Agreement is in the best interest of the Solution Group. The execution of the Agreement has no effect on the issued and paid-up share capital and the substantial shareholders’ shareholdings of SGB.