Shanghai Henlius says China regulator accepts NDA for 120 mg denosumab biosimilar HLX14

PUBT · 2d ago
Shanghai Henlius says China regulator accepts NDA for 120 mg denosumab biosimilar HLX14
  • Shanghai Henlius Biotech received NMPA acceptance for an NDA covering a 120 mg (1.7 mL) vial of denosumab biosimilar HLX14.
  • Filing targets cancer-related bone disease indications, including prevention of skeletal-related events in bone metastases or multiple myeloma.
  • Application also covers unresectable giant cell tumor of bone, or cases where surgery would cause severe functional impairment.


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