Shanghai Henlius Biotech and Organon (OGN) announced that the U.S. FDA has accepted the Biologic License Application for HLX14, an investigational biosimilar of PROLIA/XGEVA. In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China.
Don't Miss Our Christmas Offers:
- Discover the latest stocks recommended by top Wall Street analysts, all in one place with Analyst Top Stocks
- Make smarter investments with weekly expert stock picks from the Smart Investor Newsletter
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on OGN:
- Organon completes acquisition of Dermavant
- Organon, Henlius announce Phase 3 study of HLX11 met primary endpoint
- Eyes on Fed ahead of expected interest rate cut: Morning Buzz
- Organon likely won’t lose money on deal with Roivant, says Evercore ISI
- Roivant divestment of Dermavant ‘great decision,’ says JPMorgan