Organon, Shanghai Henlius Biotech: FDA accepts BLA for HLX14
The Fly

Organon, Shanghai Henlius Biotech: FDA accepts BLA for HLX14

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.

Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App