Shots:
- The Chinese NMPA has granted IND approval to HLX18, a biosimilar version of Opdivo (nivolumab) for the treatment of certain resected solid tumors following the US FDA IND clearance
- Additionally, HLX17 (biosimilar, Keytruda) & HLX13 (biosimilar, Yervoy) are under P-I trials with first patient dosing completed, while the IND for HLX15-SC (biosimilar, Darzalex), was also cleared by both the NMPA & FDA
- Also, HLX43, a PD-L1-targeting ADC, has shown favorable early efficacy & manageable safety in solid tumors, incl. NSCLC, & has advanced into a global P-II/III trial in the US for advanced or metastatic squamous NSCLC
Ref: Henlius | Image: Henlius | Press Release
Related News: Henlius Reports the FDA IND Clearance to Initiate P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro)
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