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Time: Aug 21, 2018

Frontier Biotech receives marketing authorization from China FDA for Aikening® (albuvi-
tide for injection), China's first new drug for the treatment of HIV

Frontier Biotechnologies Inc. (Frontier Biotech), a leading science-driven biopharmaceutical company in China, announced that China Food and Drug Administration (CFDA) has granted marketing authorization for Aikening® (albuvirtide for injection, ABT), China's first new drug for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.  

ABT is a new chemical entity (NCE) with novel molecular mechanism of action and long-acting activity against HIV-1. ABT is approved for use in treatment-experienced adults who still have virus replication, in combination with other antiretroviral agents.  ABT is the first new HIV medicine discovered and developed in China and the first long-acting HIV fusion inhibitor in the world. 

Data from interim analysis of an on-going phase 3 clinical trial showed that ABT was safe and effective against major strains of HIV including resistant viruses, and the efficacy was long-acting (once weekly dosing). ABT combining with LPV/r suppressed HIV replication in adults who failed the standard first-line antiretroviral drug regimen.  The primary efficacy end-point of HIV-1 RNA <50 copies/ml at week 24 and 48 was non-inferior or superior to that of the standard second-line therapy.  ABT showed a favorable safety profile, no injection site reactions were observed.  Frontier Biotech owns global IP rights of ABT.
HIV/AIDS is a serious chronic infectious disease and continues to be a major global public health issue. There is no cure for HIV so once someone is infected by HIV they will carry the virus for life. With improved access to antiretroviral treatment HIV has largely become a chronic treatable disease. But a lot more can be done for the estimated 36.7 million people living with HIV in the world. 

"The approval of ABT is a very positive news for the estimated ~700,000 HIV infected people in China. When the selection of antiretroviral drugs is limited, we are delighted to be able to provide a new treatment option. As a long-acting injectable drug with new mechanism of action, ABT has the potential to be a significant addition and improvement to currently all oral drug regimen”, said Dr. Dong Xie, Chairman and CSO of Frontier Biotech, “we are committed to the discovery, development, and commercialization of innovative drug products addressing significant unmet medical needs. This approval is a major milestone achieved and we will continue making best efforts to develop a complete regimen with all-injectable long-acting new drug combination and provide preferred solutions to patients globally”. 
Frontier Biotech:
Frontier Biotech is a research-based, clinical stage pharmaceutical company founded in 2002. The management team have extensive business and development experiences in the US and China pharma/biotech industry. Frontier Biotech leverages China's large patient population, and rapid growing economy and pharmaceutical market, develops innovative pharmaceutical products with worldwide IP protection and to be marketed in the near future. We are dedicated in the discovery, development and commercialization of innovative products for unmet medical needs and under-served patients. We actively seek strategic partnerships to complement and enhance our original research and product portfolio. Please contact us to learn more about our partnering interests and how we can work together to create a win-win collaboration. Let's combine our strengths to bring the best of medicine to patients worldwide.