HIV Drug Pipeline

▶ Azvudine

Azvudine was conditionally approved by the NMPA in July 2021 as a national Class 1 innovative drug for treating HIV-1 infected adults with high viral load. As the world’s first pyrimidine nucleoside antiviral drug targeting both RT and Vif for the treatment of HIV infection, it has a number of advantages, including good efficacy, lower risk of drug resistance and potential to be an oral long-acting treatment. It has been listed as one of the National Science and Technology Major Projects (Major New Drug Innovation) in China. The company was granted a first prize of the Henan Province Technological Invention Award for azvudine as a dual-target HIV treatment. Azvudine was included in the 2021 and 2024 China AIDS Treatment Guidelines after it was approved by the NMPA, solidifying its position as a recommended drug for HIV treatment.

▶ CL-197 

CL-197 is a novel oral HIV drug candidate under development with potential long-acting mechanism, as demonstrated in pharmacokinetic studies in animal models under oral gavage administration with a half-life period of over 168 hours. CL-197 will be administered orally and has the potential of being administered only once per week. Such relatively convenient drug regimen may also improve medication compliance and thus improve clinical outcomes. The company submitted an IND application for CL-197 in China in July 2022 and received the IND approval in October 2022. The company commenced the Phase I clinical trial for CL-197 in August 2023. As of February, 2025, the clinical trials on all the 44 patients enrolled had been completed, and the company is analyzing the data collected. It is expected to complete this Phase I trial in 2025. As part of the global expansion strategy, the company also plans to apply for IND for CL-197 in jurisdictions overseas.

▶ Azvudine/CL-197 All-Oral Long-Acting Composite Tablet

Given the dual target mechanism of action and long-acting effect of azvudine, the combination of CL-197 and Azvudine meets the requirements of HIV cocktail therapy, treatment in which a patient is given two or more drugs (or other therapeutic agents) for a single disease, equivalent to a composite tablet that achieves the simultaneous effect of three drugs with different mechanisms of action. Pharmacokinetic studies have shown that CL-197 has a half-life of approximately 168 hours in PBMC. It suggests the potential of being administered only once per week.Such relatively convenient drug regimen may also improve medication compliance and thus improve clinical outcomes.