No Data
Express News | US FDA Accepts Biologics License Application (Bla) for Hlx14, Biosimilar Candidate of Prolia/Xgeva (Denosumab)
US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (Denosumab)
Henlius (02696.HK): The biological product license application (BLA) for HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection) similar to denosumab was accepted by the Food and Drug Administration (FDA) of the usa.
On October 30, Grondlion | Henlius (02696.HK) announced that the Biologics License Application (BLA) for HLX14, a biosimilar of PROLIA/XGEVA (denosumab), a recombinant anti-RANKL fully human monoclonal antibody injection, developed independently by the company, has been accepted by the USA Food and Drug Administration (FDA). The indications covered by this BLA include: consistent with all indications of PROLIA (denosumab) approved for marketing in the USA: (1) postmenopausal women with a high risk of fractures suffering from osteoporosis.
Henlius (02696): The biological product license application (BLA) for HLX14, a biosimilar to denosumab (recombinant anti-RANKL fully human monoclonal antibody injection), has been accepted by the Food and Drug Administration (FDA) in the USA.
Henlius (02696) announced recently that the company's self-developed PROLIA/ XGEVA(...
Express News | Henlius: HLX14 biological product license application accepted by the FDA.
Shanghai Henlius Biotech Doses 1st Patient in Metastatic Colorectal Cancer Drug in Japan
No Data
No Data