Written by DengyueMed

Chronic hepatitis B (CHB) is a major global public health challenge caused by persistent infection with the hepatitis B virus (HBV). If not effectively controlled, it may progress to severe complications such as liver cirrhosis and hepatocellular carcinoma, posing a serious threat to patients’ health and survival. In the ongoing development of anti-HBV therapies, Tenofovir Amibufenamide (Brand name: Hengmu®), a novel nucleotide reverse transcriptase inhibitor independently developed in China, has brought new hope to patients with chronic hepatitis B through its unique structural advantages and outstanding clinical performance.

I. Basic Characteristics and Development Background

Tenofovir Amibufenamide is a phosphonamidate prodrug of tenofovir and is classified as a prescription medication. It was independently developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd., with full proprietary intellectual property rights. The development process spanned eight years, from project initiation to clinical research, demonstrating the technical capabilities of China’s innovative drug R&D ecosystem.

In June 2021, Tenofovir Amibufenamide was approved for marketing by the National Medical Products Administration (NMPA). In December of the same year, it was included in the National Reimbursement Drug List (NRDL), significantly improving accessibility and enabling more patients with chronic hepatitis B to benefit from this innovative therapy.

From a chemical perspective, the main active ingredient is Tenofovir Amibufenamide Fumarate, with the chemical name
9-((R)-2-(((S)-(((1-(isopropoxycarbonyl)-1-methyl)ethyl)amino)phenoxyphosphinyl)-methoxy)propyl)adenine fumarate.
Its molecular formula is C₂₂H₃₁N₆O₅P·C₄H₄O₄, with a molecular weight of 606.56. The drug is formulated as white film-coated tablets; after removal of the coating, the tablets appear white or off-white. The commonly used clinical strength is 25 mg (calculated as C₂₂H₃₁N₆O₅P).