AbbVie's Class 1 Anti-HIV Drug ABBV-382 Receives IND Approval in China

Intelligent Finance APP learned on July 29 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that AbbVie's (ABBV.US) Class 1 new drug, ABBV-382 injection, has been approved for clinical trials. It is intended to be developed for the sustained suppression of immune-mediated HIV (with HIV plasma viral load at undetectable levels) without combined antiretroviral therapy (ART). Public data shows that ABBV-382 is an α4β7 integrin monoclonal antibody currently in Phase 2 clinical trials globally. This marks the first time this investigational new drug has been approved for clinical trials in China.

According to the AbbVie official website, the company is developing a combination of ABBV-181 (budigalimab, anti-PD-1) and ABBV-382 (development code: ABBV-1882), which is being studied as an antiretroviral therapy (ART) regimen for HIV viral control and is currently in Phase 2 clinical trials.