Kun Run Biotechnology obtains China SFDA manufacturing approval for Entecavir

Kun Run Biotechnology, Inc. (the "Company" or "Kun Run") (OTC Bulletin Board: KURU), a leading bio-pharmaceutical company in China focusing on manufacturing and sales of peptide-based and small molecule drugs, today announced that they have obtained 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. It works by inhibiting reverse transcription, DNA replication and transcription in the viral replication process. The US Food and Drug Administration (FDA) approved Entecavir on March 30, 2005 for the treatment of chronic Hepatitis-B infection in adults.

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. It is 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.

On 26th May, 2010, Hainan Zhonghe Pharmaceutical limited obtained the approval from SFDA to produce Entecavir tablets and capsules with brand name "HeDing" and "HeEn". This is one of the first domestic pharmaceutical companies authorized to produce Entecavir in China. Before 2010, only Baraclude, the brand name of Entecavir from Bristol-Myers Squibb has been sold in the domestic market. Baraclude has been the no.1 and best in class nucleoside analogue drug since it was launched to market in 2006 among the other nucleoside analogue drugs.

"We are very excited to have obtained the approval of Entecavir from SFDA," Mr. Ye, 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." Mr. Ye stressed, "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."

Source:

Kun Run Biotechnology, Inc.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post
You might also like...
Monon Bioventures receives SBIR grant to develop glioblastoma therapeutic created at Purdue