Sinovac Biotech, a Chinese provider of biopharmaceutical products, has signed an agreement with Boryung Pharmaceutical Company, a Korean manufacturer of pharmaceuticals, to collaborate on marketing efforts and possible H1N1 vaccine supply to the South Korean government.
The agreement follows meetings between Sinovac and the Korean Food and Drug Administration and the Korean Center for Disease Control where Sinovac presented the scientific data of Sinovac's H1N1 vaccine. The deal gives Boryung exclusive rights to represent Sinovac in discussions with the KFDA and KCDC for the development of business opportunities in South Korea surrounding Sinovac's H1N1 vaccine. The price, volume, delivery schedule and other specific details about how Sinovac's H1N1 vaccine might be marketed and supplied to the government of South Korea have not been determined.
Weidong Yin, the chairman, president, and CEO of Sinovac, commented that they chose Boryung as their potential partner in South Korea because of their well-respected position in that country and familiarity with the regulatory bodies there.
On August 30 and 31, 2009, China's State Food and Drug Administration organized and held an experts' evaluation conference focused on A/H1N1 vaccines to evaluate Sinovac's H1N1 vaccine, which had recently completed a clinical trial. Top-line results from the trial demonstrated Sinovac's H1N1 vaccine to have a good safety profile and immunogenicity factors that meet EU criterion after a single shot. No severe adverse effects were reported after inoculation. Based on the results of the evaluation, the experts unanimously agreed that Sinovac's H1N1 vaccine is suitable for all people from three to 60 years old and the vaccination schedule is a single shot. The result of the experts' evaluation conference was submitted to SFDA on September 1st, 2009 and will be the primary basis for the SFDA to issue a production license.