Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)
Shots:
- The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors
- Novolumab is an mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma
- HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I studies with initial patient dosing completed. HLX18 (nivolumab biosimilar) is being evaluated across multiple solid tumor indications
Ref: Henlius | Image: Henlius| Press Release
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