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Home News NCLD2014 Release Data of a 48-week Clinical Trial Using Enganding Indicating Clinical Equivalence to Imported Entecavir

NCLD2014 Release Data of a 48-week Clinical Trial Using Enganding Indicating Clinical Equivalence to Imported Entecavir

Published:2014-08-19 | Source: | Visited:128

On “The 9th National Conference of Liver Disease & The 3rd European Association for the Study of the Liver (EASL) Day”, Professor Ren Hong, Deputy Chairman of the Committee of the Chinese Society of Hepatology, CMA and President of the Second Affiliated Hospital of Chongqing Medical University initially announced the data from a 48-week phase-4 clinical trial using entecavir, showing the clinical equivalence of Cosunter Enganding - Entecavir Capsules to the imported entecavir.

“The 9th National Clinical Academic Conference of Liver Disease & The 3rd European Association for the Study of the Liver (EASL) Day” organized by the Chinese Society of Hepatology, CMA and the Editorial Committee of the Chinese Journal of Hepatology was held at the Jiaozi International Conference Center in Chengdu, China from August 14 to 17, 2014. Some renowned Chinese and foreign academics were invited to give speeches on the conference, and workshop was carried out in respect of the current progress and hot topics of hetatological research, thereby presenting the latest achievements and development trend of the hepatological field in an all-around way. The chairman of the conference Professor Ren Hong presided over the opening ceremony.

On August 15, Academician Zhuang Hui and Professor Hou Jinlin presided over the Cosunter Symposium, on which Professor Ren Hong shared with the present doctors the clinical data from treatment for HBeAg positive chronic hepatitis B patients using the Entecavir Capsules, which was the initial release of trial data from the first multi-center using the Entecavir Capsules.


On the conference, Professor Ren as the leader of the research group announced the data from the 48-week phase-4 clinical trial using the Entecavir Capsules indicating a significant decrease of HBV DNA after using said capsules: proportion of patients with HBV DNA less than 400 copies/ml of 71.9%, an HBeAg negative conversion rate of 18.3%, an HBeAg seroconversion rate of 15.69%, an ALT normalization rate of 84.2% and a drug-resistance mutation rate of 0. The 48-week data evidence the clinical equivalence of the Entecavir Capsules manufactured by Cosunter to the imported entecavir. The Entecavir Capsules can effectively inhibit the replication of hepatitis B virus and promote the recovery of liver functions with extremely less occurrence of drug resistance.


Professor Hou Jinlin, Chairman of the Committee of the Chinese Society of Infectious Diseases, CMA remarked that this Cosunter clinical trial study led by Professor Ren Hong was the first head-to-head double-blind test for tenofovir and entecavir around the world, and the release of clinical data results was expected for a long term. In his conclusion, Academician Zhuang Hui indicated Cosunter’s emphasis on and participation in many national research projects and proactive promotion for the progress of localizing the imported drugs, which should be highly praised. This study is of great significance since domestic entecavir has been put on the market for years but lacks of random double-blind comparative trials and researches. The Entecavir Capsules (Enganding) are clinically equivalent to the imported drugs with a lower price, which allows more hepatitis B patients to accept antivirus treatment, increases the accessibility of treatment to hepatitis B patients and contributes to hepatitis B patients in China.