Henlius Receives the NMPA IND Clearance for HLX319 (Biosimilar, Phesgo)
Shots:
- The Chinese NMPA has granted IND clearance to HLX319, a biosimilar version of Phesgo (pertuzumab, trastuzumab & hyaluronidase), for neoadj./adj. treatment of HER2+ early or locally advanced breast cancer, as well as for the treatment of metastatic breast cancer
- Pertuzumab & trastuzumab in HLX319 are Henlius’ HLX11 & Hanquyou, respectively, with HLX11 under review by NMPA, Health Canada, & EMA, while SC delivery is enabled by Henlius’ hyaluronidase excipient, Henozye
- Phesgo, a fixed-dose SC combination, enables trastuzumab & pertuzumab dosing in 5-8 mins without weight-based adjustment, with comparable efficacy & safety to IV regimens
Ref: Henlius | Image: Henlius | Press Release
Related News: Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)
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