Mabpharm Limited announce that the new drug application ("NDA") of CMAB009, a core product of the Company, was recently accepted by the National Medical Products Administration ("NMPA") of the People's Republic of China for the treatment of metastatic colorectal cancer. Generic name of the drug: Subject to approval by the NMPA, Dosage form: Injections, Specification: 100mg/10ml/vial, Application classification: Therapeutic biological products Class 2.4, Drug manufacturer: Taizhou Mabtech Pharmaceutical Limited. Drug application number: CXSS2300012.

CMAB009, a recombinant anti-epidermal growth factor receptor ("EGFR") chimeric monoclonal antibody, is new drug candidate based on cetuximab for first-line treatment of metastatic colorectal cancer ("mCRC") in combination with FOLFIRI. CMAB009 is the first anti-EGFR monoclonal antibody drug developed in China that applied with the NMPA for NDA for treatment of colorectal cancer. CMAB009 uses the Chinese Hamster Ovary ("CHO") expression system, which is different from the mouse myeloma cell SP2/0 expression system used in marketed cetuximab products.

The safety and efficacy of CMAB009 have been confirmed from the results of two completed clinical trials. Based on ur clinical trial results compared to published clinical trial results for currently marketed cetuximab products, CMAB009 is equally effective as the cetuximab drug currently available for treatment of mCRC, and significantly reduces immunogenicity and decreases the incidence of adverse reactions, such as severe hypersensitivity.