BS-104
(Generic/IMD of Nexavar®, Oral)

BS-104 is a targeted anticancer drug and an orally administered, multi-targeted small-molecule tyrosine kinase inhibitor. It can be developed as a generic or an incrementally modified drug (IMD) of Nexavar®. By using NUFS™ technology, BS-104 can be launched earlier without the patent infringements of the original drug’s patents related to both crystal form and formulation. In addition, BS-104 can reduce adverse effects due to unabsorbed sorafenib particles present in the gut by increasing bioavailability and reducing the dose of BS-104 compared to Nexavar®.
Active Pharmaceutical Ingredient : Sorafenib tosylate
Indication : Unresectable hepatocellular carcinoma, Advanced renal cell carcinoma
Global Nexavar® Sales : ‎‎€ 712 million in 2018
Development Objective : Increase in bioavailability (BA) & Maintenance of polymorphism
R&D status : Confirmation of possibility of the bioequivalence of BS-104 with Nexavar®
  • Increased BA in humans

    → Showing the possibility of achieving bioequivalence of BS-104 with approximately half of the dose of Nexavar®