Hong Kong Stocks Movement | HENLIUS (02696) Surges Nearly 6% in Afternoon Trading Following FDA Approval of BILDYOS and BILPREVDA in the US

Stock News

Sep 03

HENLIUS (02696) jumped nearly 6% during afternoon trading. As of press time, the stock was up 5.78% to HK$81.45, with trading volume reaching HK$48.73 million.

On the news front, HENLIUS and Organon (OGN.US) jointly announced on September 2 that the U.S. Food and Drug Administration (FDA) has approved the marketing applications for denosumab injection (60mg/mL) BILDYOS (denosumab-nxxp) and denosumab injection (120mg/1.7mL) BILPREVDA (denosumab-nxxp). These two products are biosimilars of PROLIA (denosumab) and XGEVA (denosumab) respectively, with this approval covering all indications already approved for the reference products in the United States.

According to reports, in 2022, HENLIUS entered into a licensing and supply agreement with Organon, granting Organon exclusive global commercialization rights for multiple biosimilars including BILDYOS and BILPREVDA in all regions except China. The approval of BILDYOS and BILPREVDA further strengthens Organon's biosimilar product portfolio in the United States. This portfolio has been developed over more than eight years and covers five major therapeutic areas.

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