Nanjing-based Frontier Biotechnologies Inc. has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its version of albuvirtide, China’s first domestically developed innovative HIV therapy. The study will assess the drug’s efficacy in addressing immune reconstitution insufficiency in HIV-1 infected patients who are receiving stable antiretroviral therapy and have achieved virological suppression (HIV-1 RNA < 50 copies/mL).
Albuvirtide: World’s First Long-Acting HIV Drug
Albuvirtide is described as the world’s first long-acting HIV drug. It is a cell fusion inhibitor that prevents the HIV virus from fusing with healthy cells. The drug is characterized by low medication frequency, fast onset, high resistance barrier, high safety, and minimal side effects. Albuvirtide was included in China’s National Reimbursement Drug List (NRDL) in 2020, with its status renewed in January 2023 at the same price and payment scope.
HIV Infections and Immune Dysfunction
As of June 30, 2024, over 1.32 million individuals with HIV infections have been reported across 31 provinces in China. Despite long-term antiretroviral therapy achieving virological suppression, about 20% to 30% of HIV-infected patients still experience poor CD4+ T cell count recovery, a condition known as immune dysfunction. Individuals with immune dysfunction face a significantly increased risk of developing opportunistic infections, malignant tumors, other complications, and even death. The Phase II study of albuvirtide aims to address this critical unmet need in HIV treatment.-Fineline Info & Tech
