ACC008 Phase III clinical trial completed the enrolment of clinical subjects

Recently, Aidi Pharmaceuticals (stock code: SH.
688488) announced in its annual report that its ainovirine-based anti-AIDS three-in-one compound single-tablet preparation ACC008 (ANV 150mg + TDF 300mg + 3TC 300mg) targets HIV.
The phase III clinical trial of infected patients has completed the enrollment of 762 clinical subjects
.
The trial adopted a multi-center, randomized, double-blind, double-dummy, positive parallel-controlled, non-inferiority trial, and included 762 clinical subjects who had been diagnosed with HIV infection and were carried out in 10 well-known AIDS clinical trial institutions across the country.
A head-to-head test with the imported original research drug Icogen Bacterial Tablets (trade name: Jie Fu Kang?)
.
The phase III clinical study of ACC008 tablets is the first phase III clinical study of the first-line treatment regimen for HIV-experienced patients in China.
The core drug in the ACC008 formula, ainovirine, can significantly reduce central nervous system adverse reactions compared with existing similar drugs
.
At the same time, ACC008 completed the bioequivalence trial in March 2021, and the new drug marketing application for HIV-infected patients was accepted by NMPA in May 2021 and is currently under review
.
The combination regimen and drug selection of ACC008 are in line with the international trend.
Patients only need to take 1 tablet per day and do not need to take other anti-AIDS drugs, which helps to reduce the burden of patients taking medication, increase compliance, and reduce the occurrence of drug resistance
.
If the product successfully completes the clinical research and is approved for marketing, it will help provide a new choice for domestic HIV-infected patients to keep pace with the international community and meet the growing medical needs of the domestic public
.