Hansoh Pharma's Class 1 New Drug Hengmu (Tenofovir Amibufenamide Fumarate Tablets) Approved for Chronic Hepatitis B Treatment

China Economic Net, June 23 — On June 22, public information from the National Medical Products Administration (NMPA) indicated that Hengmu (tenofovir amibufenamide fumarate tablets), a Class 1 new drug independently developed by Hansoh Pharmaceutical Group Company Limited (hereinafter referred to as "Hansoh Pharma"), has been approved for marketing for the treatment of adult patients with chronic hepatitis B. This is the fifth Class 1 innovative drug independently developed by Hansoh Pharma.

Hengmu is a novel second-generation tenofovir independently developed by Hansoh Pharma, and the first Chinese-developed oral anti-hepatitis B virus (HBV) drug. Tenofovir Amibufenamide Fumarate Tablets are a novel nucleotide reverse transcriptase inhibitor. Through structural optimization, the drug exhibits enhanced cell membrane permeability, facilitating more efficient hepatocyte entry to achieve liver targeting, while effectively improving plasma stability and reducing systemic TFV exposure, thereby ensuring a safer profile for long-term treatment.

Clinical study results indicate that: compared with tenofovir disoproxil fumarate (Viread, TDF), Hengmu requires less than one-tenth of the dose to achieve similar antiviral efficacy; its antiviral efficacy is comparable to first-line drugs; it has a minimal impact on bone mineral density and renal function, demonstrating a superior bone and renal safety profile.

Data indicate that China remains a "major country for hepatitis B," with approximately 70 million individuals chronically infected with the hepatitis B virus (HBV), including 20 to 30 million patients with chronic hepatitis B. Prevention and control efforts remain a formidable and long-term challenge. The approval and market launch of Hengmu will provide clinicians with a new, low-dose, highly efficacious, and safe therapeutic option, offering adult patients with chronic hepatitis B a new treatment regimen for long-term use with improved medication adherence, thereby enhancing patients' quality of life and overall well-being.