Frontier Biotechnologies' Aikening gains approval in China as first domestically developed HIV therapy

Frontier Biotechnologies announced the approval in China of the long-acting fusion inhibitor Aikening (albuvirtide) as the first domestically developed drug for the treatment of HIV. The once-weekly injectable agent is designed to be used with other antiretroviral medicines to treat people suffering from HIV who have received antiviral therapy.

In 2016, Frontier Biotech reported that the Phase III TALENT study of Aikening met its primary objective based on an interim analysis. In the trial, Aikening plus ritonavir-boosted lopinavir was shown to be non-inferior to a World Health Organization-recommended second-line three-drug regimen at week 48 in treatment experienced HIV-1 infected adults. The company noted at the time, that patients given Aikening showed statistically better renal safety than those taking the control regimen containing Gilead Sciences' Viread (tenofovir disoproxil fumarate).

Frontier Biotech indicated that Aikening has a novel mechanism of action that should make the therapy effective against common strains of HIV-1, including drug-resistant varieties. The drugmaker added that the treatments low frequency of use, high resistance barriers and safety should significantly improve patient compliance and quality of life.

Dong Xie, Frontier Biotech's chief scientific officer, remarked "as a long-acting injectable drug with new mechanism of action, [Aikening] has the potential to be a significant addition and improvement to currently all oral drug regimen." The executive called the approval "a major milestone" for the company, adding "we will continue...to develop a complete regimen with all-injectable long-acting new drug combination."

The company is also developing a combination of Aikening and the novel broad-spectrum HIV neutralising antibody 3BNC117 as part of an agreement signed last year with The Rockefeller University. At the time the deal was announced, Frontier Biotech indicated that clinical studies of the two-drug regimen would start in 2018.

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