China Set to Approve First Long-active Anti-HIV Injection

| Nov 27, 2016 09:21 PM EST

A worker performs a CD4 HIV test at a lab of Shanghai Xuhui District Central Hospital on Dec. 6, 2006, in Shanghai, China.

China's national drug watchdog announced on Wednesday that it has examined clinical research results on a domestically produced anti-HIV drug in its final phase prior to being officially approved for use by the public.

Once approved, the new-generation drug, named Albuvirtide for injection, is expected to be the world's first long-acting intravenous treatment for HIV, according to a report from the state-owned Global Times newspaper.

Developed by the Nanjing-based Frontier Biotechnologies Inc, the medicine can interrupt the HIV life cycle in its earliest state. It has been put into clinical trials in 12 clinical centers across the country since February 2014, the report said.

According to a statement on the company's website, Albuvirtide is the world's first long-acting anti-HIV drug to enter phase-3 clinical trials that is effective on both the HIV-1 virus and other similar viruses.

The drug contains a fusion inhibitor that should be used alongside antiretroviral drugs to treat people suffering from HIV who have received antiviral therapy, the statement said.

The China Food and Drug Administration said it has verified medium-term experimental 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 endpoints of the trial have all achieved expectations," Wu Hao, dean of the BYH infectious diseases center, told Xinhua.

Wu said the drug, which is taken once a week, is much more effective and safer than current drugs as it does less damage to the kidneys.

The data was collected between the 24th and the 48th weeks of the trials that include 83 experimental drugs and 92 control groups, the Frontier Biotechnologies said in a statement to the Global Times.

"Current HIV treatments used in China are either generic or imported, and were developed one or two decades ago and are comparatively ineffective under current conditions," said the company's government affairs manager, surnamed Zhang.

Zhang said once approved, the company is willing to promote the drug as soon as possible.

Six in every 10,000 people in China are affected with HIV/AIDS. Over 570,000 people in China had been found to be HIV positive by the end of 2015, and an estimated 32 percent of those infected remain undiscovered, said Liang Xiaofeng, deputy director of the CDC at a forum in October.

Liang said the Chinese government has taken measures, including the expansion of the scope of medical examinations, to deal with the disease.

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