Henlius' proprietary Denosumab Injection, marketed as BILDYOS® and BILPREVDA®, has secured US FDA approval as biosimilars to the originator drugs PROLIA® and XGEVA®. This milestone encompasses all indications approved in the United States. Notably, in 2022, Henlius licensed the overseas rights of this product to Organon, entrusting the latter with sales responsibilities in the US market. Pursuant to the agreement, Henlius anticipates earning potential revenue of approximately $540 million from this deal. Furthermore, marketing authorization applications for this biosimilar have been favorably received in the European Union and Canada, with approval anticipated in the latter half of 2025. To date, Henlius boasts three products approved in the United States, a feat that has not only expedited its international expansion but also propelled the company to achieve full-year profitability for the very first time. Currently, Henlius is vigorously progressing with multiple clinical trials in the United States, leveraging the FDA's revised biosimilar registration policy to its advantage.