R-Pharm Group and Frontier Biotechnologies, a biopharmaceutical company headquartered in China, have signed a licensing agreement to commercialize Albuvirtide (Aikening™) in the Russian Federation. The cooperation envisages registration, licensing, supply and distribution of Aikening™, an HIV fusion inhibitor for the treatment of patients with HIV.
Aikening™ is a new fusion inhibitor. It is the first and only long-acting injectable (as IV infusion QW) available as a dual therapy for treatment-experienced patients with HIV-1 replication. The drug demonstrated efficacy against major strains of HIV, including resistant viral strains.
Resistant strains of HIV are a serious threat to public safety as their treatment with classic methods is difficult or impossible. That’s why, with the help of our partners from Frontier Biotechnologies, we decided to bring to the market a fundamentally new drug that allows to treat patients who suffer from resistant types of the human immunodeficiency virus. The medicine is already actively used in China. The combination of Albuvirtide with 3BNC117 (a recombinant antibody ) is currently undergoing clinical trial in the United States and China, said Anastasia Batrak, Vice President for Strategic Marketing and Product Portfolio Development of R-Pharm.
Aikening™ is a long acting injectable fusion inhibitor developed by Frontier Biotechnologies for the treatment of HIV-1 infections, in treatment-experienced patients with HIV-1 replication despite undergoing therapies and can be used in combination with other antiretroviral agent(s). It is effective against most HIV-1 strains including the drug-resistant ones. It also provides an ideal alternative to the existing regimens for patients who are either intolerant to oral medications, require antiretrovirals with little /no drug-drug interaction, or cannot take medications through gastrointestinal route before and after surgical procedures, said Cheryl Tan, Global Head, International Markets, Frontier Biotechnologies.
Aikening™ is the first novel long-acting anti-retroviral drug discovered and developed in China. Since its launch, it has benefited many patients in the country providing a life-saving treatment option to critically ill hospitalized patients as well as those having limited treatment options. There are also accumulating real-world data from China that show the potential benefits of using Aikening™, in combination with other potent ARTs, such as dolutegravir, in patients with liver failure or end stage renal disease, as well as hospitalized patients who are unable to take oral drugs. We are pleased to collaborate with R-Pharm to bring this innovative therapy to patients living with HIV in Russia, said Dr. CJ Wang, CEO, Frontier Biotechnologies.
In June 2018, Aikening™ was approved for marketing in China by China NMPA. In June 2019, R-Pharm has supplied Aikening™ to Russia for a specific patient in a life-threatening condition. The special import permission was granted by the Ministry of Health of the Russian Federation. Aikening™ has been listed in the National Drug Reimbursement Scheme in China. In 2020, R-Pharm JSC and Frontier Biotech entered into a licensing agreement to promote and commercialize Aikening™ in Belarus, Kazakhstan, Uzbekistan and Azerbaijan.