Pharmaceutical Business review

Kun Run Biotechnology Entecavir Gets SFDA Manufacturing Approval

Entecavir is an oral antiviral drug used in the treatment of Hepatitis-B infection. It works by inhibiting reverse transcription, DNA replication and transcription in the viral replication process. The FDA approved Entecavir on March 30, 2005 for the treatment of chronic Hepatitis-B infection in adults.

Kun Run claimed that in China, when treating both HBeAg-positive and HBeAg-negative CHB populations, Entecavir is the most cost-effective option when compared with Lamivudine and Adefovir.

Kun Run also reported that Entecavir has fewer side effects and lower risk of triggering emergence of drug-resistant Hepatitis-B virus than the earlier generation of leading drugs used to treat Hepatitis-B such as Lamivudine and Adefovir.

Earlier, on May 26, 2010, Hainan Zhonghe Pharmaceutical had obtained the approval from SFDA to produce Entecavir tablets and capsules with brand name ‘HeDing’ and ‘HeEn’.

Ye stressed, CEO of Kun Run, said: “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. This is expected to be a strong growth driver for Kun Run’s financial performance.”