1. Medical Review Department 1, Center for Drug Evaluation; China National Medical Products Administration; No. 128 Jianguo Road, Chaoyang District Beijing 100022 P. R. China
2. Center for Drug Inspection; China National Medical Products Administration; Beijing 100037 P. R. China
3. Department of Medical Oncology; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing 100021 P. R. China