ZZU Listing Application for New Anti-HIV 1.1 Drug Enters Priority Review Process
Publisher: Yang Ming   From: ZZU   Publish Date: 2020.11.03   Read Count: 47 
Recently, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the listing application of the new anti-AIDS 1.1 drug “Azivudine (FNC) ”, developed by Prof. Chang Junbiao from ZZU School of Chemistry and licensed by Henan Sincere Biotechnology Co., Ltd. ) has entered the priority review procedure.

Azivudine is the world’s first HIV reverse tranase and accessory protein Vif dual-target inhibitor drug, the first domestic anti-HIV oral drug with independent intellectual property rights, and has won the national major scientific and technological project of “Major New Drug Creation” Project support. Clinical research results show that the oral dose of FNC is small, only 1% of the positive control drug lamivudine, while the effect is significant. It can still inhibit HIV-1 replication by 100% after 4 days of single administration. It has the advantage of long-term effect. And with that, it stands a great chance of being the first choice for HIV-1 prevention drugs before exposure in the future.

Azvudine obtained a compound patent in 2009, ZZU was the first patentee, and Henan Analysis and Testing Research Center was the joint patentee. The drug realized the transfer of patented technology at a price of RMB 40 million in 2011. It obtained Phase I clinical approval in April 2013, and was approved by the State Food and Drug Administration in November 2015 to enter Phase 2/3 clinical trials. 2019 completed all the phase II clinical trials, ranging from multi-center, randomized, double-blind, double-dummy, to positive control and dose exploration. After listed on the market, Azivudine will become the first oral anti-HIV 1.1 new drug with independent intellectual property rights in China, whereby making a major contribution to the treatment and prevention of AIDS in our country.郑州大学版权所有,禁止非法转载!2020-11-24 23:15:39
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