CDE drug review weekly report (January 11, 2016 to January 17, 2016)

Here's the point There are too many points this week Let's open our eyes and take a closer look In review 1, cabotinib malic acid capsule: developed by exelixis Inc, it can inhibit the following receptor tyrosine kinases: RET, met, VEGFR (1-3), kit, TrkB, Flt-3, Axl and Tie-2 It was awarded the title of "orphan drug" by FDA, and was approved for marketing by FDA priority review channel in November 2012, for the treatment of progressive and metastatic medullary thyroid cancer At present, there are 6 domestic enterprises applying for clinical application of this product, among which Zhengda Tianqing has applied for clinical application in categories 3.1 and 1.6, and Jiangsu aosaikang has also applied for clinical application in categories 1.6 (acceptance No cxhl1502425, cxhl1502426) on the basis of category 3.1 This week, it entered the stage of evaluation For this kind of tyrosine kinase inhibitor with many targets, there are still many tumor indications Let's do it and see who has a better vision! 2 Milabellon sustained release tablets: This product is a new type of OAB (bladder hyperactivity disorder) treatment drug developed by Astaire, Japan It was listed in Japan on September 16, 2011, and the compound patent expires in 2018 This week, Ansteel applied for the listing of this product (jxhs16000001, jxhs16000002, I feel that this is the first two acceptance numbers for the declaration and production of imported chemicals in 2016!) In addition, at present, some domestic enterprises are also applying for class 3.1 clinical application According to the speed of the current batch of clinical trials and the difficulty of clinical trials, I feel that it's better to import in recent years, and the patent expiration can't catch up with it 3 Recombinant anti RANKL all human monoclonal antibody injection: This product is a drug for the treatment of osteoporosis The most famous drug in foreign countries is Anxin's dinosemide, which was approved by FDA in 2011 to prevent bone related events caused by cancer that has spread to bone Since then, it has increased its indications for the treatment of giant cell tumor of bone in adults and some teenagers In 2014, domestic Qilu pharmaceutical first declared the biological products of this target Jiangsu Taikang was a little later This week, Zhejiang Haicheng became the third enterprise to declare the RANKL inhibitor monoclonal antibody Its recombinant anti RANKL all human monoclonal antibody injection entered the review status, acceptance No cxsl1500116 In the examination and approval 1 The product is a new type of fluoroquinolone free drug, and also a high-end product of quinolones Since the beginning of the application, it has attracted market attention Zhejiang Pharmaceutical (Stock Code: sh600216) has its patent use right and sales right in China In November 2006, she applied for clinical application and obtained clinical approval in December 2007 However, eight years later, her daughter-in-law will finally become a mother-in-law This drug began to apply for on-site verification in February 2015 Before that, the industry thought that it would be approved in 2015 However, 2015 was destined to be turbulent At the beginning of 2016, the CDE review was finally completed, so we have to wait At least, the process must be completed before it can be listed Sincerely wish the road ahead is smooth! 2 Noratrix hydrochloride for injection: This product is a class 1.1 chemical developed by Kangchen pharmaceutical, which is mainly used in the treatment of advanced head and neck squamous cell carcinoma After 15 years of long research and development process, all materials of this product were reported to the market at the beginning of 2015 However, it went to the drug review consultation in October 2015 At present, it can be concluded that the production is not approved and a clinical approval document has been given Fight back to the world and come back 3 Shr7390 tablets: This product is declared by Jiangsu Hengrui as a 1.1 class anti-tumor drug, known target is MEK kinase inhibitor In December 2014, it undertook four acceptance numbers including API, which are special approved varieties At present, the review is completed and the clinical application is approved Hengrui needs to get the clinical approval documents soft recently 4 Sutetinib maleate capsule: This product is declared by Jiangsu Suzhong Pharmaceutical Co., Ltd in category 1.1 It is a targeted anti-tumor drug developed by Jiangsu Suzhong and a science and technology company Its curative effect is obviously superior to that of the same kind of drug with the best clinical effect In February 2015, it undertook three acceptance numbers including API, which are special approved varieties At present, the review is completed and approved for clinical application 5 Fubitavir tablets: This product was declared by Changzhou Yinsheng Pharmaceutical Co., Ltd as a class 1.1 anti hepatitis C drug, which was jointly developed by Sichuan University and Shanghai yaomingkant This product was undertaken in September 2015 It is a major special and special review product This week, it has been reviewed and approved for clinical use It's really fast! So many key drugs are introduced Here are a few statistics (all calculated by acceptance number): this week's total