Merck & Co., Inc. (MRK.US) has submitted its oral drug for the treatment of AIDS for market approval in China.

On August 5, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that the market application submitted by Merck & Co., Inc. (MRK.US) for doravirine/islatravir (DOR/ISL) has been accepted. According to the CDE website, the product has previously been included in priority review, with the intended indication being: as a complete dual-drug treatment regimen for adults with HIV-1 infection, suitable for patients who are currently receiving a stable antiretroviral therapy regimen achieving virological suppression (HIV-1 RNA < 50 copies/ml), have no history of antiretroviral treatment failure, and have no known mutations related to doravirine resistance, replacing their current antiretroviral therapy regimen. Public information indicates that doravirine is an oral non-nucleoside reverse transcriptase inhibitor. It prevents the HIV-1 virus from converting RNA into DNA by binding to the reverse transcriptase of the HIV-1 virus, thereby blocking HIV-1 replication. It has been approved for the treatment of adult HIV-1 infection patients in the United States and China. Islatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI), which has both transcriptase and translocation inhibitory effects (preventing nucleotide binding and incorporation into the DNA chain, leading to immediate termination of the chain) and delayed chain termination effects (preventing nucleotide incorporation even in the presence of translocation).