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 pathological complete response (tpCR) per IRC & demonstrated comparable 2EPs
- Additionally, Henlius granted Organon exclusive global commercialization rights (excl. China) for 2 biosimilar candidates, incl. HLX11, as per a license & supply agreement signed in 2022
Ref: Businesswire | Image: Henlius & Organon
Related News:- Organon and Shanghai Henlius Biotech Provides Update on P-III Trial of HLX11 (Biosimilar, Perjeta)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
