Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary approval filing for albuvirtide, China’s first domestically developed innovative HIV therapy, has been fully approved by regulators. The approval upgrades the drug’s status from “conditionally” approved to fully approved for marketing.
Albuvirtide: A First-of-Its-Kind HIV Therapy
Albuvirtide is described as the world’s first long-acting HIV drug and functions as a cell fusion inhibitor. It prevents the HIV virus from fusing with healthy cells by binding strongly to human blood protein albumin, which extends its half-life. This unique mechanism allows for once-weekly or biweekly dosing via intravenous infusion. The drug initially received market approval in May 2018 for use in HIV-1 infected individuals who still have virus replication after antiviral treatment, in combination with other antiretroviral drugs.
Market and Regulatory Milestones
Albuvirtide was included in China’s National Reimbursement Drug List (NRDL) in 2020, significantly enhancing its accessibility for patients. In February of last year, Ecuador became the first Latin American country to approve the drug, marking its entry into international markets. The recent full approval in China further solidifies albuvirtide’s position as a key treatment option in the global fight against HIV.-Fineline Info & Tech
