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Home News CMACSI Data Indicate Clinical Equivalence of Lamivudine Tablets (Heganding) Manufactured by Cosunter to Imported Drugs

CMACSI Data Indicate Clinical Equivalence of Lamivudine Tablets (Heganding) Manufactured by Cosunter to Imported Drugs

Published:2014-06-23 | Source: | Visited:130

The 13th National Academic Conference for Infectious Diseases organized by the Chinese Society of Infectious Diseases, CMA was held successfully at Guangzhou Baiyun International Convention Center from June 13 to 16, 2014. In the conference, extensive academic exchanges were carried out with respect to epidemiology, etiology, pathogenesis, prevention, diagnosis and treatment and other issues closely related to clinical works. Some renowned Chinese experts and professors were also invited to give special academic lectures. Professor Hou Jinlin, Chairman of Society of Infectious Diseases, CMA presided over the opening ceremony.

In the special symposium held at 17:45 to 18:00 on June 14, Academician Zhuang Hui and Professor Weng Xinhua were invited to preside over the symposium, and Professor Meng Qinghua as the guest speaker shared with the present doctors the clinical data from the optimized treatment for HBeAg positive chronic hepatitis B patients using domestic lamivudine, which was the first official release of 48-week data from the first clinical trial for optimized treatment using domestic lamivudine.

The 48-week clinical trial of the multi-center clinical trial organized by the Peking University Health Science Center and co-organized by Fujian Cosunter Pharmaceutical Co., Ltd., led by Academician Zhuang Hui and participated in by four clinical centers including the Beijing YouAn Hospital, Shanghai Public Health Clinical Center, No.302 Hospital of People’s Liberation Army and No.88 Hospital of People’s Liberation Army (hereinafter referred to as the Advance Project) was completed. The nucleoside antivirus drugs involved in the research project are the “Heganding - Lamivudine Tablets” and “Aganding - Adefovir Dipivoxil Tablets” provided by Cosunter.

During the test cycle of 96 weeks of this research project, observation is made for the efficacies and occurrence of drug resistance and effects on histologic improvements of optimized treatment for chronic hepatitis B patients using domestic lamivudine (Heganding) and adefovir dipivoxil (Aganding), to provide a basis for clinical medication. Supervised by a professional contract research organization (CRO) throughout the project, this research project applies the international standards for clinical trials, and takes the lead to observe the clinical efficacy and drug resistance of optimized treatment using domestic lamivudine and its effects on histologic improvements through pretreatment and posttreatment liver biopsies.

The 48-week data show a significant decrease of HBV DNA with the optimized treatment program using domestic lamivudine, proportions of patients with HBV DNA less than 1,000 copies/ml and 300 copies/ml of 62.1% and 48.3% respectively, an HBeAg negative conversion rate of 23%, an HBeAg seroconversion rate of 19.5%, an ALT normalization rate of 80.2% and a drug-resistance mutation rate of 4.6%. In terms of efficacy presented at Week 48, the Heganding and Aganding manufactured by Cosunter are equivalent to the imported products of the same category, with a one-third above reduction in cost compared to optimized treatment regimen using imported products.

The chairmen of the conference Academician Zhuang Hui and Professor Weng Xinhua made a conclusion for the conference, Zhuang indicated that the localization of antivirus drugs was to provide affordable anti-HBV drugs for more hepatitis B patients in China. At present, exact clinical data of optimized treatment using domestic lamivudine and adefovir dipivoxil have not been obtained yet those using imported drugs have. This research project evidences not only the biological equivalence but also the clinical equivalence of the Lamivudine (Heganding) and Adefovir Dipivoxil (Aganding) manufactured by Cosunter to the imported drugs. Supervised by a professional contract research organization (CRO) throughout the project, this research project applies the international standards and implements normal clinical observation, ensuring the test results authentic and reliable. The clinical trial indicates the good antivirus effects and lower occurrence of drug resistance of the said Heganding and Aganding in the 24-week optimized treatment. In the conference, Zhuang affirmed the proactive engagement of Cosunter in the national research project under the “11th Five-year Plan”, promoting the clinical evidence-based medical researches and making contribution to hepatitis B patients.