2025/05/21 / Aidea news
Three-Year "iStudy Program" Successfully Concluded! Chinese Data Paves the Way for National Innovation in HIV Prevention and Treatment
Three-Year "iStudy Program" Successfully Concluded! Chinese Data Paves the Way for National Innovation in HIV Prevention and Treatment
2025-05-21

During the 10th National AIDS Academic Conference, which was held from April 11th to 14th, the Real-World Clinical Diagnosis and Treatment Data Collection Program for AIDS (hereinafter referred to as the "iStudy Program"), jointly launched by Jiangsu Aidea Pharmaceutical Co., Ltd. (hereinafter referred to as "Aidea Pharma") and the Chinese Association for STD and AIDS Prevention and Control held a grand program summary conference.


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The iStudy Program was launched in April 2022, recruiting national-level HIV treatment centers nationwide and then extending its reach to nearly 300 provincial and community-level treatment facilities. As the first endeavor that systematically gathers real-world clinical data, it established a structured database for HIV in China and laid a solid foundation for real-world evidence and research on the Ainuovirine-based therapeutic regimen.

 

During its three-year implementation period, the program collected treatment and follow-up data of over 10,000 patients on Ainuovirine and Ainuomiti therapies, amassing more than 40,000 data records. This effort significantly enriched the clinical experience with Ainuovirine-based regimens in China. The efficacy and safety data gathered have provided invaluable research-grade evidence for real-world studies, resulting in the publication of 7 SCI-indexed papers to date. Notably, the Ainuovirine regimen has become the most extensively published national innovative drug therapy in international HIV research.


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Nearly 300 domestic experts in CDC, treatment specialists, and physicians from provincial and community-level treatment centers gathered for the iStudy Program Summary Conference.


During the conference, Dr. Fu Heliang, Chairman of Aidea Pharma, delivered a keynote report “National Innovation in Anti-HIV Drug Development”. He introduced the company’s R&D pipeline for HIV therapies, showcasing Aidea Pharma’s commitment to advancing homegrown innovations in the fight against HIV.


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Based on relevant clinical trial results, Dr. Fu shared the clinical value of the new-generation non-nucleoside reverse transcriptase inhibitor, Ainuomiti Tablets. He highlighted its proven efficacy, favorable immune-reconstruction profile, notable safety advantages, low drug resistance risk, and high medication adherence. Additionally, he introduced to the audience the novel HIV integrase strand transfer inhibitor (ACC017) and an ultra-long-acting targeted capsid protein inhibitor.

 

Professor Zhang Fujie, the principal investigator of the SPRINT study, first disclosed the long-term follow-up data on Ainuomiti. The data demonstrated high viral suppression rates exceeding 95% and low treatment discontinuation rates over three years. Both metrics significantly outperformed those of imported integrase inhibitors and non-nucleoside drugs, which had rates below 90% [1][2][3][4], underscoring its superior efficacy and safety profile. This provides critical therapeutic assurance for Chinese patients amid complex global dynamics.

 

[1] Brar, et al. Medicine (Baltimore), 2025.

[2] Osiyemi, et al. Clin Infect Dis, 2022.

[3] Kim YS, et al. HIV Res Clin Pract, 2019.

[4] Kumar P, et al; DRIVE-SHIFT Study Group. J Acquir Immune Defic Syndr, 2021.