The first long-acting anti-Ai original drug in China will be listed soon

The first long-acting anti-Ai original drug in China will be listed soon

June 16, 2016 Source: South News Network

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The “Thousand Talents” enterprise and the Frontier Biopharmaceutical (Nanjing) Co., Ltd., located in Jiangning High-tech Park, announced last week that their self-developed national first-class drug Aibo Weitai’s confirmatory clinical phase III trial has reached all pre-advanced in advance. The clinical endpoints will be submitted to the State Food and Drug Administration for notification of new drug listings in the near future. This is the first anti-AIDS drug developed in China and the world's first long-acting drug for the treatment of AIDS.

The reporter learned that there are currently nearly 30 anti-AIDS original drugs in the world, but none of them is produced in China. To this end, John Hopkins University Dr. Xie Dong, Harvard Medical School postdoctoral Lu Rongjian, and the University of Kentucky School of Pharmacy Dr. Wang Changjin and other three US elites resolutely returned to China to participate in the development of anti-AIDS original drugs. Their team has withstood tremendous research and development, financial pressure, and has been gnashing for 13 years in the harsh environment of domestically developed original innovative drugs.

HIV can develop resistance to a single drug. If three or more different drugs are put together, the fight against HIV will not produce resistance. Therefore, the current treatment of AIDS is the use of "cocktail" therapy, patients with several drugs mixed together to eat, eat a lot, one to three times a day. The cutting-edge organisms are developing long-acting drugs, which will change the frequency of drugs to one-a-day, and the price will be 60% lower than the existing anti-AIDS drugs in Europe and America.

Since February 2014, cutting-edge organisms have launched China's first clinical phase III trial of new AIDS drugs in 12 clinical centers across the country. Approved by the State Food and Drug Administration, Phase III clinical trials are used to treat HIV-infected patients who fail standard first-line treatment. Based on an interim data analysis of 208 patients who had completed 24-48 weeks of treatment, weekly efficacy of Aiboweitai combined with lopinavir/ritonavir in the treatment of “HIV-infected patients with failed first-line formula” It is equivalent or better than the second-line formula recommended by the World Health Organization (combination of three drugs).

Dr. Xie Dong, Chairman and Chief Scientist of Frontier Biology, said: "Aboweitai is the world's first long-acting anti-Ai Ai drug to enter Phase III clinical trials. Its new molecular mechanism of action makes it a major epidemic of HIV-1 and its The drug-resistant virus is effective. At present, there is a shortage of AIDS drugs in China, and there is no independent innovation drug. Aiboweitai is expected to provide a new treatment option for the majority of patients. In developed countries, AIDS has become a drug-controllable chronic disease, Aibowei Taike has changed all of the current treatment strategies for oral medicine, providing a new treatment for HIV-infected people to get rid of their daily life."

According to reports, Abbott's Phase III clinical trial was designed according to international standards. The primary endpoint was the percentage of patients with a viral viral load of less than 50 copies/ml in 48 weeks of treatment. Interim data showed that 80.4% of patients in the Aboweitai group achieved the primary endpoint.

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