Shanghai Henlius Gains FDA Nod for Denosumab Biosimilar

Shanghai Henlius Biotech, Inc. Class H (HK:2696) has released an update.

Shanghai Henlius Biotech, Inc. has announced that the FDA has accepted its Biologics License Application for HLX14, a biosimilar to the osteoporosis treatment denosumab. This development positions the company to potentially tap into the lucrative global market for denosumab, which reached sales of $6.83 billion in 2023. Investors are advised to be cautious as the commercial success of HLX14 remains uncertain.

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