Recently, Jiangsu Aidea Pharmaceutical Co., Ltd. (hereinafter referred to as the "Aidea Pharma") received the "Drug Registration Certificate" issued by the National Medical Products Administration (NMPA), marking the approval of the registration for the new indication of Ainuovirine, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets, the anti-HIV new drug, Aitribond®, which was developed by Aidea Pharma independently. After that, Aitribond® can be used for both treatment-naïve and virologically-suppressed people with HIV-1 (PWH).
Aitribond® was approved for marketing in December 2022. It is a fixed-dose combination based on the oral anti-HIV new drug, Ainuovirine, combined with lamivudine and tenofovir disoproxil fumarate. As the first oral anti-HIV new single-tablet regimen in China, it has been included in the National Medical Insurance Catalogue (2023 Edition) and the Chinese Guidelines for the Diagnosis and Treatment of AIDS (2024 Edition).
The results of a head-to-head Phase III clinical study of Aitribond® (SPRINT study) and the imported original drug, Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets (EVG/Cobi/FTC/TAF), an INSTI-based regimen, showed that Aitribond® can maintain viral suppression in virologically-suppressed (PWH) non-inferior to that to EVG/Cobi/FTC/TAF, and had comparable liver and kidney safety, as well as superior benefits in cardiovascular metabolic safety indicators such as blood lipids, weight and uric acid.
In July 2024, phase Ⅲ SPRINT study was published in full online by The Lancet Regional Health - Western Pacific, an authoritative international medical journal. This is also the first domestic oral anti-HIV new drug to be published in the top international clinical medicine journal, indicating that China's evidence-based medicine in anti-HIV has been recognized by international industry once again.
According to data reported at the 9th National AIDS Academic Conference: As of the end of 2023, China had reported a total of 1.29 million PWH, with 110,500 new cases in 2023. With the newly approved indication, Aitribond® can benefit more population.
PWH only need to take one tablet of Aitribond® every day without taking other anti-HIV drugs, which can significantly reduce the burden of taking medication, enhance medication adherence, improve efficacy, reduce the occurrence of drug resistance, and provide PWH with a new choice of smooth switching treatment that are in sync with international standards.