Gilead Sciences Submits New Indication Application in China for HIV Therapy Emtricitabine and Tenofovir Alafenamide Tablets (II)

Intelligent Finance APP learned on July 6 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that Gilead Sciences (GILD.US) submitted a new indication marketing application for the Class 5.1 new drug Emtricitabine and Tenofovir Alafenamide Tablets (II). Public information shows that this drug is a fixed-dose combination formulation, which has been approved by the U.S. FDA for the treatment of AIDS and pre-exposure prophylaxis. In China, this drug was approved for marketing in 2018 for the treatment of HIV-1 infection in adults and adolescents.

Public information shows that Emtricitabine and Tenofovir Alafenamide Tablets (Ⅱ) is a fixed-dose combination drug containing 200mg of emtricitabine and 25mg of tenofovir alafenamide. Among these, emtricitabine is a novel nucleoside reverse transcriptase inhibitor, and tenofovir is an acyclic nucleotide reverse transcriptase inhibitor. The features of Emtricitabine and Tenofovir Alafenamide Tablets lie in improved renal and bone safety, which can help meet the long-term treatment needs of HIV-infected individuals suitable for this therapy.

Emtricitabine and Tenofovir Alafenamide Tablets were first approved by the FDA in 2016 (English trade name: Descovy) for use in combination with other antiviral drugs to treat HIV-infected patients. In December 2018, the drug was approved in China (Chinese trade name: 达可挥), indicated for use in combination with other antiretroviral drugs to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and above and weighing at least 35kg).