Shots:
- The NMPA has approved Enlituo + CT (FOLFIRI), a biosimilar version of cetuximab beta, as a 1L treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC)
- The approval was based on a P-II/III trial (n=505) evaluating cetuximab beta + CT vs CT, showing a PFS of 13.133mos. vs 9.567mos., an ORR of 69.1% vs 42.3% & OS of 2.322yrs. vs 1.900yrs. & a P-III confirmatory trial
- Enlituo (CMAB009), a recombinant EGFR mAb developed in partnership with Mabpharm, is categorized as a 2.4 class modified biologic & is produced by utilizing a protein production technology that prevents glycosylation modification which results in hypersensitivity
Ref: Simcere Zaiming | Image: Simcere Zaiming| Press Release
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