Medical network - on April 14, recently, the CFDA drug approval for examination and approval system reform and the new action, released on March 17, adjusting draft imported drug registration management items, let the industry generally imported drugs is expected to usher in the peak period of development. Sure enough, in March the CDE accepts the application for drug registration, the imported drugs in clinical application and listed the application have soared, relevant policies of early release seems to be a clue, the following together to know about the drug registration application in March to accept the situation. 

 

Clinical application: domestic drug declare smoothly, imported drugs increase obviously 

 

March to accept the new drug clinical trial application for 100, a growth of 16% last month. Among them, the domestic new drug clinical trials for 54 pieces, fell slightly, and applications for new drug clinical trials 46, is up more than 70% last month, rising 5.1 class new medicine clinical trial application is the main growth. 

 

Points drug type, biological products clinical trials filings by 29 this month back to 16 pieces, chemical drug clinical trial applications are surging, holds the scale of the 8 into afresh, traditional Chinese medicine and natural medicine application for clinical trials is less (4%). Acceptance of chemical drugs in the clinical trial application, domestic drug is given priority to with class 1 new drug (over 90%), import drugs with 5.1 class new multiple (about 60%), in addition to class 1 and 2 class each account for about 20%. 

 

1 March for the first time in our country, put forward the clinical application of chemical drugs have 14, 3 a month earlier. Jiangsu hengrui pharmaceutical and guangdong east sunshine pharmaceutical this month have two class 1 new drug in the process of registration, jiangsu orsay kang pharmaceutical co., LTD. And hangzhou if mai xing pharmaceutical technology co., LTD. New class 1 new drug research and development, declaration of completed his first new class of drugs (table 1). 

 

Table 1. For the first time in March, 2017 declaration of clinical type 1 chemical drugs 

 

Data sources: China's new drug research and development monitoring database of CPM 

 

New drug applications: import c star treatment medicine cluster rushed off 

 

March to accept the new drug applications has 21 pieces, for the above 20 pieces for the first time since march last year. Declare the listed products includes four domestic new drugs and nine imported drugs (table 2). Domestic medicine, pharmaceutical zhengda shine after nearly seven years the class 1 new drug in development for attention, declaration of production. According to the report, this product is a kind of small molecular targets more tyrosine kinase inhibitors, targets including VEGFR, PDGFR, FGFR, c - Kit, zhengda shine the examination and approval of non-small cell lung cancer as the first indication, the public according to Ann ROM for Nepal Ⅲ period clinical trials to select the overall survival (OS) as the primary efficacy end point, hoping to become non-small cell lung cancer three line landmark in the field of drug treatment. 

 

Imported drugs, 3 c drug for star than Mr Parry, da wei wei and suo phosphorus cloth stuffed cloth successively filing, domestic market swoon hepatitis c treatment. Listed above three varieties added before has already declared ShuRuiWei o, dara he wei, west meirui wei and darrow rui wei, arrive at present in our country the listed before the final pass c direct antiviral drugs has reached 7, in view of these drugs have been incorporated into CDE priority review directory, so this year is likely to be several hepatitis c antiviral drug innovation directly, for patients with hepatitis c in China has a sense of "happiness too quickly". 

 

Table 2. In March 2017 to accept the new drug applications 

 

Data sources: China's new drug research and development monitoring database of CPM 

 

Generic drugs registration: first imitation drugs for Greg los battle a sixpence 

 

This month, dealt with generics to apply for a total of 51, rose more than 40%. With clopidogrel subsequent outstanding varieties for astrazeneca's Greg los first imitation medicine dispute is a sixpence. For Greg to the first direct effect, reversible P2Y12 receptor antagonist, since gaining public for the first time in December 2010, its annual sales have topped $600 million, become the domestic imitation popular varieties. On March 9, litai shenzhen letter according to the classification of new chemical drug registration for Greg to declare los listed applications for CDE accepted, accidentally in the first obtain the approval documents of clinical shiyao group the meaning in the front of the pharmaceutical industry. However, the Italian pharmaceutical applications submitted on March 23, in the subsequent got CDE to accept, now both sides in the queue for review, but the Italian pharmaceutical in line behind the serial number on the letter litai nearly 30. The first copy medicine battle will be reversed in the future? Let us wait and see.