Qilu Pharmaceutical Secures China's First Generic Approval for $1.35B HIV-1 Triple Combination Therapy Emtricitabine/Rilpivirine/Tenofovir Alafenamide Tablets
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On July 16, according to the official website of NMPA,Qilu PharmaceuticalTreatment of HIV-1(HIV-1)InfectedEntrectinib TabletsApproved for marketing, this variety is the first generic drug combining Emtricitabine, Rilpivirine Hydrochloride, and Tenofovir Alafenamide Fumarate in a triple-combination to be approved for marketing in China.
Entrectinib TabletsThe original drug is Odefsey from Gilead Sciences. It is indicated for the treatment of HIV-1 infection in adults and pediatric patients weighing ≥35kg. This product is composed of emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide fumarate. According to the PharmaOcean database, global sales of Odefsey in 2023 were $1.35 billion.
Entrectinib TabletsIt was first approved for marketing in the United States in March 2016 for the treatment of HIV infection, and subsequently approved in Europe and Japan.Emtricitabine, a leading nucleoside reverse transcriptase inhibitor, can precisely intercept and block the synthesis of viral DNA chains, effectively curbing viral replication. Meanwhile, Rilpivirine, as a non-nucleoside reverse transcriptase inhibitor, firmly locks onto HIV-1 reverse transcriptase through a non-competitive mechanism, powerfully inhibiting viral replication and demonstrating broad and deep antiviral effects against various subtypes of HIV-1.Tenofovir alafenamide undergoes highly efficient biotransformation in the body, first being activated to tenofovir and then further phosphorylated to tenofovir diphosphate, the active form that ingeniously intervenes and terminates the replication process of the viral DNA chain, further strengthening the antiviral defense.The combination regimen of three drugs has proven efficacy and is a guideline-recommended antiviral treatment for adult and adolescent patients who are treatment-naive. The single-tablet formulation is more convenient to take, requiring only one tablet per day, which helps reduce the medication burden on patients and improve adherence.
Currently, the original researchEntrectinib TabletsNot yet marketed in China.Qilu PharmaceuticalIn January 2023, Qilu Pharmaceutical was the first to submit a generic Class 3 marketing application for this variety.Is the first company in China to receive approval for the generic drug combining Emtricitabine, Rilpivirine Hydrochloride, and Tenofovir Alafenamide Fumarate in a single three-in-one compound.Secured the first domestic generic + first to pass the evaluation in China.
Qilu Pharmaceutical has been deeply engaged in the anti-AIDS field for many years, and has alreadyTenofovir Disoproxil Fumarate Tablets, Emtricitabine Tenofovir Tablets, Emtricitabine CapsulesMultiple products have been launched. From 2024 to date, Qilu Pharmaceutical has had 27 varieties pass the evaluation, among which...Eltrombopag Ethanolamine Tablets, Bendamustine Hydrochloride Injection Concentrate, Clomipramine Maleate Soft Capsules, Metformin Empagliflozin Tablets (Ⅵ), Entrectinib Pinostilbene TabletsFive varieties are the first domestic generics in China.
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