CDE Drug Evaluation Weekly Report (2015.5.17-2015.5.24)

1 In the approval week (2015.5.17-2015.5.23), a total of 14 drugs (calculated according to the acceptance number, the same below) entered the approval stage, including 13 chemicals and 1 Traditional Chinese medicine The key chemicals are as follows: 1 Beretinib enteric coated capsule: This product is a c-met inhibitor, which is used to treat tumors The specific indications need to wait and see in the later clinical stage Beretinib declared in April 2014 that the raw material + 2 specifications of the capsule are special approved varieties, which have not been supplemented in the middle and are approved for clinical use at one time Beijing puruno Biotechnology Co., Ltd also declared this one variety 2 Inc280 tablets: This product is also a c-met inhibitor, commonly known as capmatinib, currently in the highest research and development status of phase 2 clinical Capsule and tablet have been declared in China, and the capsule has been used in two phases of clinical practice in China, including non-small cell carcinoma and liver cell carcinoma Other indications of this product for stage 2 clinical use include melanoma, renal cell carcinoma and solid tumor See the final annex for other drug information 2 After approval, three drugs have been approved this week, all of which are chemical drugs applied for clinical application, and there are no varieties of special concern See the final annex for drug information 3 After the completion of the preparation, 6 drugs have been completed this week, all of which are chemical drugs, including 2 varieties, one of which is mainly introduced: 1 Perreotide: including perreotide for injection and perreotide Aspartate Injection This product is a somatostatin analogue, approved by FDA for the treatment of acromegaly and Cushing's syndrome It has been declared for production in China, while many other clinical applications have been reported In April 2015, CDE released an overview of the review of perreotide Aspartate Injection, which is mainly used for the treatment of Cushing's syndrome At present, there is no treatment drug for Cushing's disease in China, pareptide, may be the first Attached