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The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors

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The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors

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  • The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer  
  • HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity b/w the two drugs 
  • HLX17 (mAb) works by binding with PD-1 receptor to prevent its interaction with PD-L1 & PD-L2, restoring T-cell immune surveillance and enhancing anti-tumor activity 

Ref: Shanghai Henlius | Image: Shanghai Henlius

Related News:- Shanghai Henlius and Organon Got EMA’s Validation for the MAA of HLX14 (Biosimilar, Prolia & Xgeva)

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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