China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has approved an additional indication filing for its HIV treatment Fubangde (ainuovirine, lamivudine, tenofovir disoproxil). The new indication targets two groups of adults infected with human immunodeficiency virus type 1 (HIV-1) weighing over 35 kilograms: (1) patients without prior antiretroviral therapy history, and (2) those seeking an alternative treatment option after achieving stable virological suppression (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without treatment failure.
Fubangde, classified as a Category 1 chemical drug for HIV infection, was initially approved in December 2022 for treatment-naïve HIV-1 patients in China.
In a Phase III study, Fubangde was compared head-to-head with Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide), a single-tablet regimen developed by Gilead Sciences and included in China’s National Reimbursement Drug List (NRDL). The results indicated that after 48 weeks of treatment, Fubangde achieved comparable efficacy and safety to Genvoya, while demonstrating superior cardiovascular metabolic safety profiles, including improvements in blood lipids, weight, and uric acid levels.
The subsequent 48-96 week open expansion study yielded positive results, with a virological inhibition rate of 96.6% (368/381) after 96 weeks of Fubangde treatment, surpassing the efficacy of imported competitors. Additionally, the control group that switched from Genvoya to Fubangde maintained a virological inhibition rate of 96.6% (364/377), indicating that the transition from the integrase inhibitor Genvoya to Fubangde effectively sustained high levels of virological control. Notably, patients switching to Fubangde also experienced positive changes in body weight and low-density lipoprotein cholesterol levels. – Flcube.com
