KUALA LUMPUR (Aug 28): The United States Food and Drug Administration (FDA) has responded to the second communication to Ho Wah Genting Bhd’s (HWGB) joint-venture, E-Mo Biology Inc (EBI), based in the US.
In a statement today, HWGB said EBI has been requested to provide further information on the Investigational New Drug application which proposes the use of existing poliomyelitis virus vaccines for prevention of COVID-19.
The company had, on Aug 14, 2020, through wholly-owned subsidiary HWGB Biotech Sdn Bhd, signed a joint-venture (JV) agreement with EBI for the research and development (R&D) of vaccines, immunological treatment and diagnostic product development in relation to the COVID-19 virus, following the Memorandum of Agreement signed on Aug 6, 2020.
Following the JV, EBI was approved by the FDA to conduct phase IV clinical trials for a proposed COVID-19 vaccine based on the polio vaccines.
“The FDA approval to conduct the clinical trials is really a step closer for us in our goal of producing a COVID-19 vaccine.
“Upon completion of the clinic trials, HWGB Biotech will enjoy the exclusive rights to start the production and distribution of the vaccines to assist in limiting the pandemic’s impact,” HWGB said.
To recap, under the JV, EBI is also responsible for R&D, testing, registration and commercialisation of five provisional patent applications and other applications related to the patents, which EBI owns.