Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for CMAB009, a biosimilar of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab, which is marketed under the trade name Erbitux. The EGFR-targeted monoclonal antibody (mAb) was co-developed with Mabpharm Ltd (HKEX: 2181) and is now approved for use in combination with the FOLFIRI regime to treat first-line metastatic colorectal cancer (mCRC) with wild type RAS/BRAF.
Erbitux, the reference product, was approved for marketing in the United States in 2004 and was granted marketing authorization in China in 2005.
CMAB009 is classified as a Category 2.4 modified drug. The commercialization rights for this drug in mainland China were secured by Simcere through an agreement with Mabpharm in August 2023.- Flcube.com
