On December 30, 2022, the National Medical Products Administration (NMPA) approved Ainuomiti (150 mg ainuovirine, 300 mg lamivudine and 300 mg tenofovir disoproxil fumarate) tablets which is the first innovative antiretroviral Fixed-dose Combination (FDC) Class 1 new drug developed in China. It is currently indicated for treatment-naïve HIV-1 infected adults, will significantly improve patients’ quality of life; and a phase III clinical trial (762 participants) for treatment-experienced patients is proceeding as planned.

Clinical Benefits of Ainuomiti Tablets

Ainuovirine (ANV), the core ingredient of Ainuomiti tablets, is a 3rd-generation non-nucleoside reverse transcriptase inhibitor (NNRTIs). According to the summary report of the phase III clinical trial of ANV, it showed excellent safety compared with Efavirenz (EFV) especially in the following aspects: significantly reduced adverse reactions of the central nervous system, improved blood lipids indexes, low hepatotoxicity and low incidence of rash. Also, its efficacy is not inferior to that of EFV.

In addition to the advantage of core ingredient (ANV), the 3 in 1 Ainuomiti tablets is a beneficial antiretroviral therapy (ART) to improve patients’ convenience and compliance while reducing drug resistance and economic burden.

R&D Pipelines of Anti-HIV/AIDS New Drugs

Aidea Pharma is committed to achieving a complete solution in the field of HIV/AIDS to increase patient access to comprehensive regimes. In addition to NNRTIs, the R&D pipelines also cover new therapeutic targets like the integrase inhibitor (ACC017) and long-acting therapeutic drug (ACC027).