SYSA1901 (pertuzumab biosimilar)
/ CSPC Pharma
- LARVOL DELTA
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November 12, 2025
MARKETING AUTHORISATION APPLICATION FOR PERTUZUMAB INJECTION ACCEPTED BY THE NMPA
(HKEXnews)
- "The Product has been applied for as a Class 3.3 therapeutic biological product. It is indicated for the treatment of HER2-positive breast cancer. The Product is a recombinant humanised anti-HER2 monoclonal antibody injection administered once every three weeks....This application is primarily supported by a Phase III equivalence clinical trial enrolling patients with early-stage or locally advanced HER2-positive breast cancer."
China filing • HER2 Positive Breast Cancer
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