Navigation Links
Kun Run Biotechnology Announces That They Have Obtained the Manufacturing Approval for Entecavir from the China State Food and Drug Administration
Date:6/17/2010

HAIKOU, China, June 17 /PRNewswire-Asia/ -- 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(1). 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."

Additional Hepatitis-B background information

Hepatitis-B is a disease caused by infection with the Hepatitis-B virus (HBV). Chronic (lifelong) infection with HBV can lead to liver cirrhosis, liver failure, and liver cancer. About 60-80% of primary liver cancer worldwide is caused by chronic HBV infection. HBV is found in highest concentrations in blood (as high as 10 billion viruses per mL); concentrations 10 to 100 times lower are found in semen and vaginal fluid.

China has a high Hepatitis-B carrier rate. According to the World Health Organization's 2009 report, Hepatitis-B is endemic in China with 130 million carriers and 30 million chronically infected. In another words, of the 350 million individuals worldwide infected with the Hepatitis-B virus (HBV), one-third reside in China. Infection with Hepatitis-B virus can cause major health problems. According to medical research, during a 5-year period, 10.0% of patients with chronic Hepatitis developed cirrhosis, and 20.3% of the cases with compensated cirrhosis progressed to decompensate cirrhosis. 6.5% of the people with cirrhosis and chronic Hepatitis progressed to hepatocellular carcinoma.

Nucleoside analogue drugs are the best treatment method recognized by doctors and hospitals worldwide. Currently Lamivudine, Adefovir Dipivoxil, Entecavir, Telbivudine, and Tenofovir etc are the most popular nucleoside analogue products to treat the Hepatitis-B virus worldwide. Except for Tenofovir, the other drugs have been used in China for 2 years. Before 2010, only US Bristol-Myers Squibb company was authorized to sell Entecavir with the brand name "Baraclude" in China's domestic market.

Lamivudine and Adefovir (nucleoside and interferon drugs) are historically the two main therapies in China. Interferon drugs may have a high level of lasting effectiveness, but are dogged by significant toxicity as well as side effects. Lamivudine, a potent DNA replication inhibitor, is the first nucleoside analog approved for the treatment of chronic Hepatitis-B. However, long term use of Lamivudine unfortunately leads to the emergence of drug-resistant Hepatitis-B virus mutants. As for Adefovir, it can block viral replication and reduce Hepatitis-B virus load in patients, but takes a much longer period of time before taking effect and may induce renal dysfunction and other kidney and liver problems.

    (1) According to a research article "Cost-Effectiveness of Nucleoside
        Analog Therapy for Hepatitis B in China: A Markov Analysis" published
        in "2010 International Society for Pharmacoeconomics and Outcomes
        Research".

About Kun Run Biotechnology, Inc.

Kun Run Biotechnology, Inc., together with its subsidiaries, engages in the manufacture and sale of polypeptide medicines and small molecule drugs. It uses solid phase peptide synthesis (SPPS) and advanced purifying technology to produce various therapeutic polypeptide drugs, of which "TP-5" is the most known for efficiently regulating humans' immune systems in order to defend and cure malignant diseases. The company maintains two state-of-the-art manufacturing plants and possesses one of the largest peptide synthesizing capacities across Asia.


'/>"/>
SOURCE Kun Run Biotechnology, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Groundbreaking Study Published in Nature Biotechnology Demonstrates Sensitivity of Single Molecule Test for Detection of Prostate Cancer
2. Spectros Corp. Enters Into Optical Biotechnology Patent Sale Agreement With Philips Electronics N.V.
3. Kun Run Biotechnology, Inc. Executes Purchase Agreements for Approximately $8 Million Private Placement
4. Derycz Scientific Featured in Pharmaceutical Manufacturing and Genetic Engineering & Biotechnology News
5. Americas Pharmaceutical Research and Biotechnology Companies Lead the Charge Toward Longer, Healthier Lives for Americans
6. PDS Biotechnology Corporation Awarded $1.28M National Cancer Institute Contract
7. Champions Biotechnology Reports Fiscal 2010 Second Quarter Financial Results
8. TaiGen Biotechnology Reports Phase I and Preclinical Data for TG-0054 at the 2009 American Society of Hematology (ASH) Annual Meeting
9. Kun Run Biotechnology, Inc. Announces Third Quarter 2009 Results
10. Biotechnology Salutes Americas Veterans; Innovations Continue to Offer Improved Treatment and Care of Combat Troops
11. NeoStem, Inc. Names Edward Geehr, M.D. to Board of Directors; Biotechnology Executive Brings Scientific and Business Experience in Global Operations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/7/2017)... , Oct. 6, 2017   Provista, a ... than $100 billion in purchasing power, today announced a ... information. The Newsroom is the online home ... trends, infographics, expert bios, news releases, slideshows and events. ... to a wealth of resources at their fingertips, viewers ...
(Date:10/4/2017)... LAWRENCE, Mass. , Oct. 4, 2017 /PRNewswire/ ... developer of single-use, self-contained, illuminating medical devices, today ... National Health Surveillance Agency (or Agência Nacional ... ®. The first single-use, cordless surgical retractor with ... ONETRAC provides optimal access, illumination and exposure of ...
(Date:10/2/2017)... , Oct. 2, 2017 Halo Labs announces the European ... system called the HORIZON at MIBio 2017 in Cambridge, ... and visible particulate matter in biopharmaceutical samples with unprecedented speed and ... the novel technique Backgrounded Membrane Imaging. ... The HORIZON subvisible particle analysis system ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... While it’s often important to take certain medications during ... Austin, Texas, has identified a solution. , She developed a prototype for MOTION LIGHT-UP ... such, it eliminates the need to turn on a light when taking medication during ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a ... utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the ... a CBD form that can be easily incorporated into liquid products, while reducing costs ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Apple Rehab ... services, staged a mock evacuation of the facility as part of a disaster drill ... Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor ... on sciatica in a new episode of "Success Files," which is an award-winning ... innovation and investigates each subject in-depth with passion and integrity. , Sciatica occurs ...
Breaking Medicine News(10 mins):