Ground glass hepatocytes high mag cropped

Taiwanese pharmaceutical firms Genovate Biotechnology and ScinoPharm Taiwan have jointly developed the highly potent oral generic drug, Livepro (Entecavir), for the treatment of hepatitis B.

In Taiwan, Livepro is expected to be commercially available by the end of 2013, accounting for more than TWD2bn ($70m) worth of market opportunity in the region.

Under the joint project, ScinoPharm was responsible for development and manufacturing of the active pharmaceutical ingredient for Livepro, while formulations were developed by Genovate in order to enter the markets in Taiwan and China.

ScinoPharm president and CEO Jo Shen said Livepro is the first commercially available product produced via the company’s branching out into the field of formulation, specifically its ‘double A’ strategy (API + ANDA) of combining API manufacturing with formulations required in abbreviated new drug applications (ANDA).

"The company’s strategy is to respond to customers’ demand for high-quality drugs through its one-stop shop services."

"The company’s strategy is to respond to customers’ demand for high-quality drugs through its one-stop shop services," Shen said.

Genovate CEO Jen Chen said: "The launch of Livepro is not for vying for existing market share but to extend the overall demands and save more untreated patients, because fewer than 20% of the estimated three million people with hepatitis B actually receive treatment."

Livepro reduces the amount of the hepatitis B virus to undetectable levels and also produces no drug resistance after intake by patients, according to the clinical data gathered over the past two years.

In addition, the therapeutic effect appears to be better compared to any other commercially available drug.

Taiwan has around three million hepatitis B carriers accounting for one-eighth of its population, while chronic hepatitis B is one of the major medical issues in the field of medicine in Chinese society.


Image: Ground glass hepatocytes as seen in a chronic hepatitis B liver biopsy. Photo: courtesy of Nephron.