Shots:
The EMA has validated MAA of HLX11, a biosimilar version of Perjeta (pertuzumab) for all indications of the reference product
Submission was supported by P-III trial evaluating HLX11 vs Perjeta as neoadj. therapy in HER2+/HR-, early stage or locally advanced breast cancer as part of complete treatment regimen. Study met its 1EP of total…
Shots:
The P-III study assessing safety & efficacy of HLX11 vs Perjeta (pertuzumab) in addition to trastuzumab & docetaxel (Q3W, 4 cycles) as a neoadjuvant regimen for treating patients, randomized 1:1, with HER2+/HR- locally advanced breast cancer has reached the 1EP
The 1EP of the trial includes total pathological complete response (tpCR) rate as…

