AikeningTM (AlfusidTM) Marketing Authorization Granted by the Ministry of Health of Ecuador

  • 2021-03-18  19:58:20

Frontier Biotech (688221.SH) recently received the Certificate of Registration of Foreign Medicines issued by the Ministry of Health of Ecuador for company's innovative anti-HIV drug AikeningTM (Albuvirtide for injection 160 mg) to be marketed in Ecuador.AlfusidTM is the registered trade mark of AikeningTM in South American countries.

Ecuador is the first country outside of China where the marketing authorization for AikeningTM has been granted.This is a major milestone achieved for company's international commercialization effort.The company is working closely with its local partner on AlfusidTM launch plan in Ecuador and will make the drug available for patients soon. 

Frontier Biotech is actively working with international partners on AikeningTM marketing authorization in over 20 countries in South Eastern Asia, Africa, South America and Central Europe.

About AikeningTM

AikeningTM is a novel drug (new chemical entity, NCE) protected by global IP with patents granted in the US,China,EU,Japan and other countries/regions.It is world's 1st long-acting HIV-1 fusion inhibitor(once-a-week injection). China NMPA approved its marketing authorization in 2018. It's indicated for treatment-experienced HIV-1 patients who still have viral replication, combining with any ARVs. AikeningTM is a chemically modified synthetic peptide that conjugates with human serum albumin (HSA) through a covalent linkage quickly upon intravenous injection. Its serum half-life is about 12 days, enabling weekly injection. AikeningTM is effective against most HIV-1 strains including drug-resistant strains with a superior safety profile and minimal drug-drug interactions (DDI). In clinical trials and clinical practices no predictable and observed drug-drug interactions between ABT and ARVs, and antibacterial, antifungal, anti-tuberculosis, anti-cancer drugs commonly used by AIDS patients. AikeningTM was listed in Liverpool DDI Database (

In October 2018 AikeningTM was included in "AIDS Diagnosis and Treatment Guidelines of China (2018 Edition)" promulgated by the Infectious Diseases Branch of the Chinese Medical Association and Chinese Center for Disease Control and Prevention, as one of the new antiretroviral drugs in China. In December 2020 AikeningTM was included in China's National Reimbursement Drug List.

Develop Innovative Therapies to Better Human Lives