Nanjing-based Frontier Biotechnologies Inc. (SHA: 688221) has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for its version of albuvirtide, marking a significant step forward for China’s first domestically developed innovative HIV therapy. The study will evaluate albuvirtide as a maintenance treatment in combination with other antiretroviral drugs for HIV-1 infected patients who have previously been treated with multiple antiretroviral drugs but continue to experience HIV-1 virus replication.
Albuvirtide’s Mechanism and Characteristics
Albuvirtide is recognized as the world’s first long-acting HIV drug, functioning as a cell fusion inhibitor that prevents the HIV virus from fusing with healthy cells. The drug is known for its low medication frequency, rapid onset, high resistance barrier, high safety profile, and minimal side effects, making it a promising treatment option for HIV patients.
Reimbursement Status and Clinical Progress
Albuvirtide was included in the National Reimbursement Drug List (NRDL) in China in 2020, a status that was renewed in January 2023 with the same price and payment scope. This reimbursement status, coupled with the drug’s advancement to Phase II clinical trials, underscores its potential impact on the standard of care for HIV patients in China and globally.- Flcube.com
