Henlius' EU Marketing Application for Denosumab Biosimilar Accepted and Validated by Regulator

MT Newswires Live05-24

Shanghai Henlius Biotech (HKG:2696) said its marketing authorization applications for HLX14 as a biosimilar of Prolia and Xgeva have been validated by the European Medicines Agency, according to a Friday filing with the Hong Kong Exchange.

Independently developed by the company, HLX14 is a proposed biosimilar to Prolia and Xgeva. It is intended for the treatment of osteoporosis in postmenopausal women and for other indications consistent with the label of the reference biologic.

Denosumab, HLX14's reference biologic, has been approved in different countries and regions under different trade names for a range of indications, including

The validation means all essential regulatory elements required for scientific assessment are included in the application.

The stock finished nearly 5% higher on Friday.

Price (HKD): $18.84, Change: $+0.84, Percent Change: +4.67%

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