Kun Run Biotechnology Inc., a leading bio-pharmaceutical company in China engaged in manufacturing and sales of peptide-based and small molecule drugs, today announced it has received the manufacturing approval for Entecavir from the China State Food and Drug Administration (SFDA).
Entecavir is an oral antiviral drug used in the treatment of Hepatitis-B infection. The drug received U.S. Food and Drug Administration (FDA) approval on March 30, 2005 for the treatment of chronic Hepatitis-B infection in adults.
The SFDA gave Hainan Zhonghe Pharmaceutical approval to produce Entecavir tablets under the brand names HeDing and HeEn on May 26, 2010, making it one of the first domestic pharmaceutical companies authorized to produce Entecavir in China.
Prior to 2010, Baraclude, the brand name of Entecavir from Bristol-Myers Squibb, was the only brand to be sold in the domestic market.
“We are very excited to have obtained the approval of Entecavir from SFDA,” Ye, CEO of Kun Run stated in the press release. “Entecavir is a very effective therapy for those patients affected by Hepatitis-B, and China has a big Hepatitis-B population. The approval is good news for Hepatitis-B patients, as domestically produced Entecavir could be offered at a low price compared to imported products.”
Ye also noted Kun Run’s position in the market as one of the first companies to bring Entecavir to the China’s pharmaceutical market.
“Kun Run has a leading brand in China and with our product is being brought to the market as one of the first-to-market generic products; we expect our product to penetrate the domestic market well. This is expected to be a strong growth driver for Kun Run’s financial performance,” Ye stated.