The Dutch biopharma Crucell N.V. (NSDQ: CRXL) said the SFDA released its hepatitis B vaccine Hepavax-Gene® for registration and quality control in China. Crucell pointed out that Hepavax-Gene offers two advantages over competing products: its production is based on Crucell's hansenula polymorpha patented technology, a protein expression platform, and the vaccine is completely free of the mercury-based compound thiomersal. In many countries, thiomersal is being phased out from vaccines given to children because of potentially adverse effects.

Crucell said that Hepavax-Gene “will contribute significantly to the sustainability of our Chinese operations.” The company put the market in China for hepatitis B vaccines at 100 million doses annually. Crucell will aim the vaccine for the high-end private market sector, especially young adults.

Hepavax-Gene, a recombinant hepatitis B vaccine, occupies the number three spot world in sales for hepatitis B vaccines. The company has sold almost 600 million doses since its introduction in 1996.

Hepatitis B virus (HBV) can cause acute hepatitis lasting several weeks, but it can also result in chronic hepatitis, cirrhosis of the liver and liver cancer. A highly infectious disease, there are more than 350 million chronic carriers world wide, and the incidence of the disease is particularly high in China. HBV claims about one million lives each year.