China-based Henan Genuine Biotech Co., Ltd’s investigational new drug (IND) filing for its oral long-acting HIV drug candidate CL-197 has been approved by the National Medical Products Administration (NMPA). CL-197 is a novel nucleoside reverse transcriptase inhibitor (NRTI) that inhibits reverse transcription by simulating endogenous purine nucleotides, thus having potential long-term effects on HIV infection. The preclinical study completed in December 2021 demonstrated that CL-197 can effectively inhibit the replication of HIV and is expected to become a long-term HIV/AIDS treatment drug that only needs to be taken orally once a week.
Advantages of CL-197
CL-197 offers several key advantages:
- Effective HIV Replication Inhibition: CL-197 has been shown to effectively inhibit the replication of HIV.
- Oral Long-Acting Characteristics: Pharmacokinetic studies revealed that the half-life of the active ingredient CL-197 in peripheral blood mononuclear cells (PBMC) is approximately 168 hours.
- Weekly Oral Administration: The drug is expected to be administered orally once a week, offering a more convenient dosing regimen that can improve drug compliance and clinical outcomes.
Combination Therapy Potential
In addition to its standalone potential, CL-197 can be combined with azvudine, the company’s dual-targeting and long-acting HIV therapy that was approved in 2021. This combination is expected to act as a cocktail therapy, enhancing the overall efficacy and convenience of HIV treatment.
Future Outlook
The approval of the IND filing for CL-197 by the NMPA underscores Henan Genuine Biotech’s commitment to advancing innovative HIV treatments. By developing a long-acting oral therapy, the company aims to improve patient outcomes and address significant unmet medical needs in the management of HIV/AIDS.-Fineline Info & Tech
