The world's first long-acting injection of anti-AIDS, is expected to be born in China

Release date: 2016-11-28

On the 23rd, the Expert Group of the Food and Drug Inspection and Inspection Center of the State Food and Drug Administration came to Beijing You'an Hospital, affiliated to Capital Medical University, to conduct a clinical trial data verification of a new generation of anti-AIDS drugs independently developed by Chinese scientists, marking China's leading global The anti-AIDS drug developed into the final sprint before the market, the drug is expected to become the world's first long-acting injection of anti-AIDS.

The HIV fusion inhibitor Aiboweitai, developed by a team led by Dr. Xie Dong, a national thousand-person plan scientist, blocks the virus from entering the target cells by blocking the fusion of the virus with the target cell membrane, and blocks the viral replication cycle at the initial stage of infection. In February 2014, Phase III clinical trials were initiated in 12 clinical centers nationwide.

"Long-acting injections can bring AIDS patients the clinical benefits that oral drugs can't provide. It is an important trend in the development of international anti-AIDS drugs. As a major project of 863 plan and 12th Five-Year New Drug Creation Technology, in the National Health Planning Commission, food and medicine. With the support of the General Administration of Science and Technology, the Ministry of Science and Technology and other relevant departments, after 14 years of hard work, we have finally taken the lead in the world. This is the world's first long-acting anti-AIDS injection that declares new drugs and originals." Xie Dong said.

Professor Wu Wei, director of the Beijing You'an Hospital Infection Center and member of the National AIDS Expert Advisory Committee, who is responsible for all the clinical trials of the drug, introduced that 208 cases of HIV-infected patients with failed first-line drug therapy were divided into two groups for multicenter randomized clinical trial. In the trial, the control group was treated with the World Health Organization standard second-line treatment program for 48 weeks. The interim data summary showed that one primary and three secondary trial endpoints all met expectations ahead of schedule, with 80.4% of the trial group's blood virus suppressed below the detection sensitivity (50 copies/ml), compared with 66.0% of the control group. Achieve this major efficacy goal. The other three efficacy indicators in the trial group, including the percentage of effective treatment, the absolute decline in viral concentration, and the improvement in immunity were all achieved.

The AIDS treatment drugs currently widely used in China are generic drugs, and most of them are anti-AIDS drugs developed in the 1980s and 1990s in foreign countries. "In terms of effectiveness and safety, Aiboweitai is better than the second-line drugs commonly used in developed countries. The side effects are small, especially the damage to the kidneys is greatly reduced, and the patient's daily medication is changed to weekly. One injection, this achievement is a major breakthrough in the field of anti-AIDS drug research and development in the world," Wu said.

It is understood that the State Food and Drug Administration officially accepted the drug review for the drug on July 18, and then initiated the priority review process.

“Currently, any national drug regulatory agency, including the US Food and Drug Administration (FDA), has not yet approved a long-lasting anti-AIDS drug. If Abbott is successfully approved, it is likely to become a global The first anti-A long-acting drug," said Zhang Fujie, head of the AIDS Clinical Working Group of the National Health and Family Planning Commission.

Source: Xinhua News Agency New Media Line

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