IND Application Approved for Next-Generation Oral Long-Acting HIV Drug Candidate Independently Developed by Genuine Biotech

Henan Genuine Biotech Co., Ltd. (hereinafter referred to as "Genuine Biotech") announced that the IND clinical trial application for CL-197, a next-generation oral long-acting HIV drug candidate developed by Genuine Biotech, was formally approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on Oct. 8, 2022.

CL-197 is a novel nucleoside reverse transcriptase inhibitor (NRTI) that inhibits reverse transcription by mimicking (namely competing with) endogenous purine nucleotides. It has potential long-lasting effects in the treatment of HIV infection. A preclinical study completed in Dec. 2021 demonstrated that CL-197 is effective in inhibiting HIV replication and is expected to be a long-acting anti-HIV drug that requires only one oral dose per week.

To date, there are more than 41 million HIV patients worldwide, and current treatment options are troubling many HIV patients due to limitations such as "daily medication, drug toxicity, high treatment costs and drug resistance". In response, Dr. Du Jinfa, Executive Director, Chairman of the Board, CEO and CSO of Genuine Biotech, said that CL-197, as a next-generation oral long-acting anti-HIV candidate drug, has three highlighted features: (1) Effective inhibition of HIV replication; (2) Oral long-acting profile: Pharmacokinetic studies indicated that the active ingredient of CL-197 in PBMC has a half-life of approximately 168 hours; and (3) Weekly oral administration expectedly: A more convenient dosing regimen will improve medication compliance and clinical outcomes. In addition, the company's HIV solution Azvudine, which was approved for marketing in 2021, has the characteristics of dual-target and long-acting effects. The combination of CL-197 and Azvudine meets the requirements of HIV cocktail therapy, which is equivalent to having three drugs with different mechanisms of action acting simultaneously. The cocktail treatment can effectively prevent the occurrence of drug resistance and is expected to be developed into the first fully oral long-acting anti-HIV drug in the world.

Current HIV drug development focuses on improving drug safety, efficacy, drug resistance, and simplifying treatment to improve drug compliance. Nucleoside analog is the backbone of all first-line antiretroviral therapy recommended by WHO for patients infected with HIV and represents an important component of the anti-HIV drug market with significant growth potential. According to Frost & Sullivan analysis, the global HIV drug market has been growing steadily and will grow from $38 billion in 2021 to $57.5 billion by 2030.

Following this IND approval, Genuine Biotech will conduct a single-center, randomized, double-blind, placebo-controlled and single ascending-dose trial to evaluate the safety, tolerability and pharmacokinetic profile of CL-197 in healthy subjects. As part of its global expansion strategy, the company also plans to submit IND application in overseas jurisdictions following the IND application in China, aiming to improve R&D efficiency, so as to benefit patients worldwide as soon as possible.