Domestic anti-HIV new drug, Addison Pharmaceutical's 'Inomitine Tablets' was approved for marketing!

On January 4, the State Food and Drug Administration (NMPA) announced that Addison Pharmaceutical's Class 1 innovative drug Enomiti tablets (trade name: Fubonde, R&D code: ACC008) was approved for marketing. It is used to treat adults who are newly treated with HIV-1 infection. Enomiti tablets also became the first new drug approved for marketing in 2023.

AIDS is an important public health issue, with a total of 1,053,000 people living with HIV and 351,000 reported deaths by the end of 2020, according to the Chinese Center for Disease Control and Prevention. At present, the size of China's anti-HIV drug market is about 1.5-2 billion yuan, and some institutions predict that with the increase of patient base, the improvement of diagnosis and treatment rates, the improvement of medical insurance payment capacity and the gradual increase of self-paying people, the scale of China's anti-HIV drug market will grow rapidly, and it is expected to exceed 11 billion yuan by 2027.

For HIV treatment, antiretroviral therapy is a key measure to achieve sustained suppression of the virus and reduce drug resistance, but it requires multiple drugs to be taken on time every day for life, and patients have poor compliance and are difficult to adhere to for a long time, which may lead to drug resistance problems and even treatment failure. A single combination preparation can significantly reduce the burden of medication on patients, increase compliance, and reduce the occurrence of drug resistance. It is the standard treatment plan recommended for HIV antiretroviral treatment in Europe and the United States, and a number of products have been marketed in the world, including Genvoya, Triumeq, Complera and other products approved in China, mainly imported drugs.

Enomiti tablets are anti-AIDS single-tablet compound preparations independently developed by Addi Pharmaceutical, including the three main components of inovirin (ACC007), tenofovir and lamivudine, and were listed in the national 13th Five-Year Plan "major new drug creation" major scientific and technological special project in December 2019. People with HIV only need to take 1 tablet a day and do not need to take other anti-AIDS drugs.

The core ingredient of inomimetine tablets is inovirin, a new generation of non-nucleoside reverse transcriptase inhibitors that prevent viral transcription and replication by non-competitive binding and inhibition of HIV reverse transcriptase activity. According to pharmacointelligence data, in June 2021, enoverine was approved for marketing in China for the treatment of adult HIV-1 infection naïve patients in combination with nucleoside antiretroviral drugs.

Based on the research and development of inoverine, the bioequivalence test of inovide was successfully completed in March 2021, and this time it was applied for marketing with the same indication as innovirin (for untreated HIV-1 patients).

In addition, the phase III clinical trial of enomittine tablets for treated patients is also progressing smoothly, and the enrollment of 762 clinical subjects has been completed at the end of March 2022, and the clinical trial work is progressing in an orderly manner as planned.

As the first compound monotablet independently developed in China, Enomiti tablets provide a new choice for domestic HIV-infected people to synchronize with the international and meet the growing medical needs of the domestic public.