China’s national drug authority on Wednesday examined clinical research results on adomestically produced anti- HIV/Aids drug in its final phase prior to officially approving the drug.Once approved, the new-generation drug, named Albuvirtide for Injection.expected to be the world’s first long-acting injection for HIV treatment.
Developed by the Nanjing-based Frontier Biotechnologies Inc, the medicine can blockfusion of the viral and host cell membranes, interrupting the HIV life cycle in its earlieststage. It has been put into phase-3 clinical trials in 12 clinical centers across the countrysince February 2014, the Xinhua News Agency reported.The drug is a fusion inhibitor that should be used with antiretroviral drugs to treat peoplesuffering from HIV who have received antiviral therapy, the company’s website said.
The China Food and Drug Administration on Wednesday verified medium-termexperimental data of the drug’s phase-3 clinical trials in the Beijing Youan Hospital (BYH), which took charge of conducting national clinical trials of the drug.”Medium-term experimental data shows that one primary and three secondary endpointsof the trial have all achieved expectations, with the HIV concentration of 80.4 percent ofpatients in the experimental groups being reduced to less than 50 copies per milliliter, thedetection sensitivity of HIV,” BYH infectious diseases center dean Wu Hao was quoted assaying by Xinhua.
Wu said that the drug, which is applied once a week, is much more effective and safer thancurrent drugs in that it does less harm to the kidneys.The data was collected between the 24th and 48th weeks of the trials that include 83 experimental groups and 92 control groups, read a company document sent to the GlobalTimes.
There has been no report about the drug’s side effects. Li Dun, a professor at the TsinghuaUniversity Center for the Study of Contemporary China, noted that the side effects, if thereare any, should be made publicAccording to the company’s government affairs manager, Zhang Xuelin, the drug is likelyto be promoted in the market at the end of the year, and will be included in the free HIVtreatment directory of the Chinese Center for Disease Control and Prevention (CDC) within two years.