Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced a market approval filing for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (NYSE: MRK/BMS, NYSE: BMY) cetuximab, known under the trade name Erbitux. The filing is currently under review by China’s National Medical Products Administration (NMPA).
Erbitux’s Market History and Indications
Erbitux, a monoclonal antibody used to treat metastatic colorectal cancer (mCRC) and head and neck squamous cell cancer, among other indications, was first approved for marketing in the United States in 2004 and subsequently gained market approval in China one year later. To date, no biosimilar version of the drug has been approved for marketing in China, making the potential approval of A140 a significant development in the country’s pharmaceutical landscape.
Competition in the Biosimilar Space
Sichuan Kelun is likely to face competition from MabPharm Ltd’s (HKG: 2181) CMAB009, another biosimilar version of cetuximab that is already awaiting a regulatory decision in China. The approval of A140 could position Sichuan Kelun as a key player in the biosimilar market, offering an alternative treatment option for patients in need of affordable and effective therapies.-Fineline Info & Tech
