Henlius Receives NMPA's IND Approval for its HLX13 (biosimilar- ipilimumab)
Shots:
- The approval follows the trials which involves assessing of HLX13 vs originator ipilimumab to evaluate its pharmacology- pharmacokinetics and toxicokinetics profiles- immunogenicity- and toxicity
- The study resulted in biosimilarity data in terms of in vivo and in vitro pharmacology- PK- toxicokinetics- immunogenicity and toxicity characteristics
- HLX13 is a recombinant anti-CTLA-4 fully human mAb injection resulting in T cell activation in anti-tumour immune response and is developed under Chinese Biosimilar Guidelines approved for unresectable or metastatic melanoma- advanced RCC- MSI-H or dMMR Mcc and adjuvant treatment of melanoma
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