Frontier Biotech announced today its IND of novel long-acting, all-injectable anti-HIV two drug combo (albuvirtide for injection, ABT and 3BNC117) was allowed by the US FDA on August 14th 2018, and the company will start a phase II clinical trial of the combo therapy in the US soon.

Frontier Biotechnologies Inc. (Frontier Biotech), a leading science-driven biopharmaceutical company in China, announced today 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 second long-acting HIV drug 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

Dr. Jing Bao was appointed to Vice President Clinical Development at Frontier Biotech. Dr. Bao has 16 years’ experience in global clinical trials oversight, scientific administration, pharmacovigilance, technology transfer, and 10 years’ experience as a practicing physician. Prior to joining Frontier Biotech, she was a Medical Officer at the Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH). She pioneered NIH-China clinical research collaboration and served as the China Liaison for Alliance for Clinical Research Excellence and Safety. She is also the Chair of Washington DC Chapter of American Women for International Understanding and a member of Asian American Government Executives Network. Dr. Bao holds a PhD from the Weizmann Institute of Science in Israel and a MD from Southeast University Medical School in Chi

Dr. Huyi (John) Zhang, was appointed as Vice President of Regulatory Affairs. Dr. Zhang is an expert in drug registration and regulatory science with rich experience in drug discovery and development. Prior to joining Frontier Biotech, he was Head of Regulatory Affairs at Simcere. Prior to that, Dr. Zhang worked at US FDA with a track record of increasing responsibilities as a reviewer, supervisor and associate director. He was at Wyeth (acquired by Pfizer) as senior scientist and project leader. Dr. Zhang is also an instructor for CFDA Institute of Executive Development and CDE, and a member of ICH Quality Guidance Expert Team at CDE. Dr. Zhang earned his PhD degree from Peking University School of Pharmaceutical Science and had post-doc training at Worcester Polytechnic Institute in the US.

The HIV Forum on “bNAbs and Functional Cure” was successfully held by Tsinghua University and Frontier Biotech on Nov 28, 2017 in Beijing. Coming with the 30th World AIDS Day, this event was focused on the latest research of broad neutralizing antibodies (bNAbs) and long-acting drug regimen for HIV treatment. Delegates from China CDC, Ministry of Science and Technology, National Health and Family Planning Commission, Office of National Science and Technology Major Project, CFDA CDE, The Rockefeller University, Beijing Ditan Hospital, China Association of STD & AIDS Prevention, Chinese Foundation for Prevention of STD and AIDS, NIH, Wuxi Biologics, Sunshine Guojian attended the forum.

Frontier Biotechnologies, Inc., a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing significant unmet medical needs, today announced it has signed an agreement with The Rockefeller University of the US for the worldwide license for combining 3BNC117, a novel broad-spectrum HIV neutralizing antibody, with albuvirtide for the treatment and prophylaxis of HIV infection and AIDS.

On December 31, 2016 in Nanjing, Jiangsu, FRONTIER BIOTECHNOLOGIES, INC.（“Frontier Biotech”） announced completion of 300 million yuan C financing. This investment was led by Huaxin Century Investment Group Co., Ltd. (abbreviated as “Huaxin Century”) and funded jointly by Shenzhen Capital Group Co., Ltd. (abbreviated as “SCG”) and Shenzhen Yifeng Ruiyi Investment (abbreviated as “Yifeng Investment”) etc.. China Renaissance acted as the financial consultant.

On November 23, 2016, the new generation of anti-HIV drug (HIV fusion inhibitor - Albuvirtide) debuted. Albuvirtide was independently researched and developed by Chinese scientists with the support of national major scientific and technological project.

2016 HIV Medicine Therapy Conference was held in Glasgow, UK from October 23 to 26. Dr. Dong Xie, founder of Frontier Biotech and Chief Scientist, was invited to address a TALENT research themed speech.