Brief introduction of drugs accepted by CDE in March 2014

In March 2014, the CDE received 745 drug applications, an increase of nearly 40% over February Among them, 212 new drug applications, 193 copy applications and 68 import applications all increased to varying degrees compared with February Figure distribution of drug application types accepted by CDE in March 2014 All the new drug applications registered as category 1 are clinical applications for new drugs, with 16 applications involving 7 varieties, all of which are chemicals, including 6 varieties of 1.1 and 1 variety of 1.6 In addition to the treatment category of shr4640 APIs and preparations declared by Hengrui pharmaceutical, 5 of the other 6 varieties are anti-tumor drugs, and 1 variety is mental disorder drugs Shenyang Pharmaceutical University applied Mitoxantrone Hydrochloride Injection for lymph tracing The tracer is usually used to clean the peripheral lymph nodes, especially after tumor resection Mitoxantrone is commonly used in malignant lymphoma, breast cancer and all kinds of acute leukemia There should be micro innovation in the structure of mitoxantrone for tracing, so it should be applied as a new drug of 1.1 Peg-sn38 is a camptothecin derivative, and Haizheng pharmaceutical is licensed from enzonpharmaceuticals Peg-sn38 is a polyethylene glycol modifier of sn38 (3-ethyl-10-hydroxy-camptothecin, the active metabolite of irinotecan) Enzonpharmaceuticals has published the phase I clinical trial results of peg-sn38 in the treatment of recurrent / refractory neuroblastoma and other solid tumors in children Sklb1028 is a multi-target tyrosine kinase inhibitor obtained by Shiyao group from Sichuan University, which can act on EGFR, FLT3 and ABL The transfer price of sklb1028 is 20 million yuan Another tyrosine kinase inhibitor, mehuatinib, has been declared by Huadong pharmaceutical So far, CDE has accepted more than 20 varieties of tinib class 1 new drugs The irinotecan hydrochloride liposome injection declared by orsacom is of class 1.6 At the same time, orsacom has also submitted an application for the registration of the variety as class 5 Prior to this, Hengrui pharmaceutical and Qilu pharmaceutical respectively submitted clinical applications for this variety in 2011 and 2013, with registration classification of 5 categories As HT receptor agonist / 5-HT reuptake inhibitor, mepyridone is used to treat depression It is a project jointly developed by Huahai pharmaceutical and Academy of Military Medical Sciences It is also the first class 1 new drug declared by Huahai pharmaceutical, reflecting the improvement of Huahai pharmaceutical's R & D line positioning Table 1 clinical application of new drugs of category 1 accepted by CDE in March 2014