Unibest

Pipeline Database

UB637

Tenofovir alafenamide Fumarate tablets

UB637

ProductTenofovir alafenamide Fumarate tablets
IndicationsChronic hepatitis B virus infection
TherapeuticsGastroenterology & Hepatology
GMPCN - NMPA
RegistrationChina
ModalitiesSmall Molecule

Exclusive Summary

  • The originator's core patents have expired or are expiring in numerous countries, providing a clear market entry window for generics.
  • As a first-line therapy recommended by the WHO and major global guidelines, TAF targets a massive and growing patient pool of nearly 300 million people with Hepatitis B and tens of millions with HIV.
  • It offers clear clinical value with significant renal and bone safety advantages over the older generation TDF, making it the preferred choice for treatment upgrades.
  • The generic version offers the same therapeutic efficacy as the originator at a significantly lower cost, possessing strong price competitiveness and helping to expand patient access, especially for public health programs and in emerging markets.

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