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Entecavir is an oral antiviral drug used in the treatment of Hepatitis-Binfection. It works by inhibiting reverse transcription, DNA replication andtranscription in the viral replication process. The US Food and DrugAdministration (FDA) approved Entecavir on March 30, 2005 for the treatment ofchronic Hepatitis-B infection in adults.
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In China, when treating both HBeAg-positive and HBeAg-negative CHBpopulations, Entecavir is the most cost-effective option when compared withLamivudine and Adefovir(1). It is also reported that Entecavir has fewer sideeffects and lower risk of triggering emergence of drug-resistant Hepatitis-Bvirus than the earlier generation of leading drugs used to treat Hepatitis-Bsuch as Lamivudine and Adefovir.
On 26th May, 2010, Hainan Zhonghe Pharmaceutical limited obtained theapproval from SFDA to produce Entecavir tablets and capsules with brand name"HeDing" and "HeEn". This is one of the first domestic pharmaceuticalcompanies authorized to produce Entecavir in China. Before 2010, onlyBaraclude, the brand name of Entecavir from Bristol-Myers Squibb has been soldin the domestic market. Baraclude has been the no.1 and best in classnucleoside analogue drug since it was launched to market in 2006 among theother nucleoside analogue drugs.
"We are very excited to have obtained the approval of Entecavir fromSFDA," Mr. Ye, CEO of Kun Run said. "Entecavir is a very effective therapy forthose patients affected by Hepatitis-B, and China has a big Hepatitis-Bpopulation. The approval is good news for Hepatitis-B patients, asdomestically produced Entecavir could be offered at a low price compared toimported products." Mr. Ye stressed, "Kun Run has a leading brand in China andwith our product is being brought to the market as one of the first-to-marketgeneric products; we expect our product to penetrate the domestic market well.This is expected to be a strong growth driver for Kun Run's financialperformance."
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 cancerworldwide is caused by chronic HBV infection. HBV is found in highestconcentrations in blood (as high as 10 billion viruses per mL); concentrations10 to 100 times lower are found in semen and vaginal fluid.
China has a high Hepatitis-B carrier rate. According to the World HealthOrganization's 2009 report, Hepatitis-B is endemic in China with 130 millioncarriers and 30 million chronically infected. In another words, of the 350million individuals worldwide infected with the Hepatitis-B virus (HBV),one-third reside in China. Infection with Hepatitis-B virus can cause majorhealth problems. According to medical research, during a 5-year period, 10.0%of patients with chronic Hepatitis developed cirrhosis, and 20.3% of the caseswith compensated cirrhosis progressed to decompensate cirrhosis. 6.5% of thepeople with cirrhosis and chronic Hepatitis progressed to hepatocellularcarcinoma.
Nucleoside analogue drugs are the best treatment method recognized bydoctors and hospitals worldwide. Currently Lamivudine, Adefovir Dipivoxil,Entecavir, Telbivudine, and Tenofovir etc are the most popular nucleosideanalogue products to treat the Hepatitis-B virus worldwide. Except forTenofovir, 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 thebrand name "Baraclude" in China's domestic market.
Lamivudine and Adefovir (nucleoside and interferon drugs) are historicallythe two main therapies in China. Interferon drugs may have a high level oflasting effectiveness, but are dogged by significant toxicity as well as sideeffects. Lamivudine, a potent DNA replication inhibitor, is the firstnucleoside analog approved for the treatment of chronic Hepatitis-B. However,long term use of Lamivudine unfortunately leads to the emergence ofdrug-resistant Hepatitis-B virus mutants. As for Adefovir, it can block viralreplication and reduce Hepatitis-B virus load in patients, but takes a muchlonger period of time before taking effect and may induce renal dysfunctionand other kidney and liver problems.
About Kun Run Biotechnology, Inc.
Kun Run Biotechnology, Inc., together with its subsidiaries, engages inthe manufacture and sale of polypeptide medicines and small molecule drugs. Ituses solid phase peptide synthesis (SPPS) and advanced purifying technology toproduce various therapeutic polypeptide drugs, of which "TP-5" is the mostknown for efficiently regulating humans' immune systems in order to defend andcure malignant diseases. The company maintains two state-of-the-artmanufacturing plants and possesses one of the largest peptide synthesizingcapacities across Asia.(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".
SOURCE Kun Run Biotechnology, Inc.
