Shanghai Henlius Biotech, Inc. Class H (HK:2696) has released an update.
Shanghai Henlius Biotech, Inc. has announced the validation of two marketing authorization applications by the European Medicines Agency for their biosimilar HLX14, targeting the same indications as the reference drugs Prolia and Xgeva. The applications’ success is backed by data from analytical similarity and clinical comparative studies. This could be a significant step for the company, given the global sales value of denosumab injections reached US$6.83 billion in 2023.
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