2026-01-13 Written by DengyueMed

Tenofovir Amibufenamide (Hengmu®) is a next-generation tenofovir prodrug independently developed in China for the treatment of chronic hepatitis B (CHB). Designed with optimized molecular structure and enhanced liver targeting, Tenofovir Amibufenamide delivers potent antiviral efficacy at a significantly lower dose, while offering a favorable long-term safety profile—particularly in bone and renal outcomes.

As the first China-originated oral innovative anti-HBV therapy, Tenofovir Amibufenamide represents a major milestone in domestic antiviral drug development and provides clinicians and patients with a new, effective, and accessible treatment option.

Innovation Built on Targeted Design

Tenofovir Amibufenamide is a phosphonamidate prodrug of tenofovir, engineered to improve hepatocyte delivery and intracellular activation. Compared with conventional tenofovir formulations, its optimized design enables:

• Enhanced cellular membrane permeability

• Preferential activation within hepatocytes

• Reduced systemic exposure to tenofovir

This targeted pharmacokinetic profile translates into efficient viral suppression while minimizing off-target systemic effects.

Proven Mechanism, Efficient Viral Suppression

After oral administration, Tenofovir Amibufenamide is selectively converted within liver cells to tenofovir, which is subsequently phosphorylated to the active metabolite tenofovir diphosphate (TFV-DP). TFV-DP inhibits HBV reverse transcriptase by incorporating into viral DNA and terminating chain elongation, thereby effectively suppressing HBV replication.

Importantly, in vitro data demonstrate minimal inhibition of mammalian DNA polymerases, including mitochondrial DNA polymerase γ, supporting its suitability for long-term antiviral therapy.

Strong Efficacy at a Lower Dose

Clinical studies and real-world evidence have consistently demonstrated that Tenofovir Amibufenamide delivers antiviral efficacy comparable to established first-line therapies:

• Comparable virological response to tenofovir disoproxil fumarate (TDF)

• Achieves similar antiviral outcomes at less than one-tenth of the dose

• Maintains viral suppression in both treatment-naïve and treatment-experienced patients

• High rates of ALT normalization, reflecting improvement in liver inflammation

These results position Tenofovir Amibufenamide as an effective and reliable option across a broad CHB patient population.

Designed for Long-Term Safety

Long-term antiviral therapy requires sustained safety. By lowering systemic tenofovir exposure, Tenofovir Amibufenamide demonstrates a differentiated safety profile:

• Renal safety: Stable or improved serum creatinine and eGFR in long-term use

• Bone safety: No clinically significant bone mineral density loss observed

• Metabolic profile: Lipid parameters remain generally stable during extended treatment

This safety advantage makes Tenofovir Amibufenamide particularly suitable for patients requiring lifelong antiviral therapy or those at risk of renal or bone complications.

Simple, Patient-Friendly Dosing

• Indication: Adult patients with chronic hepatitis B

• Dosage: 25 mg once daily

• Administration: Oral, taken with food to optimize absorption

The convenient once-daily regimen supports adherence and long-term treatment continuity.

Advancing Access Through Innovation

Approved by the National Medical Products Administration (NMPA) in 2021 and included in China’s National Reimbursement Drug List the same year, Tenofovir Amibufenamide significantly improves treatment accessibility and affordability. Its availability reflects both clinical value and health-system recognition.

Global Evidence, Growing Recognition

An expanding body of real-world studies continues to validate the efficacy and safety of Tenofovir Amibufenamide across diverse patient populations. Data presented at major international congresses, including the European Association for the Study of the Liver (EASL), further support its role as a competitive long-term antiviral option with favorable renal outcomes.

A New Standard from China

Tenofovir Amibufenamide exemplifies China’s transition from generic manufacturing to original pharmaceutical innovation. By combining low-dose efficiency, durable viral suppression, and long-term safety, it offers a differentiated solution for chronic hepatitis B management and contributes to global efforts toward HBV control.