CDE drug review weekly report (2016.05.09-2016.05.15)

Six 1.1-class chemicals entered CDE this week, waiting in line for review After 12 months, the review of dtrmwxhs-12 capsule, an anti-tumor drug of Haizheng pharmaceutical industry, was finally completed In addition, the hot 3.1-class drugs continued to be intensively reviewed After the drugs that were not approved and certified by the State Administration in the past two weeks, a lot of drugs entered the state of review, approval and certification this week The key points are as follows: 1 Hefei medical industry pharmaceutical Co., Ltd 1.1-class chemical hy-021068 tablets, Qilu pharmaceutical 1.1-class chemical wx-0593 tablets, Hubei Biomedical Industry Technology Research Institute 1.1-class chemical wxfl10230486 capsules, Yangzijiang pharmaceutical 1.1-class chemical y Zj-1139 tablets, zl-2303 tablets of zaiding pharmaceutical, and 1.1-class chemical medicine of Zejing biological, jaketinib hydrochloride, are all in the review stage; 2 The clinical application of dtrmwxhs-12 capsule, a 1.1-class new drug of Zhejiang Daoming pharmaceutical, a subsidiary of Haizheng Pharmaceutical Co., Ltd., has gone through 12 months, and the final review has been completed; 3 This week, there are several enterprises respectively The clinical application review of aprost tablets, etrapa tablets, dagglijing tablets and vortexitin hydrobromide tablets has been completed; the application of key drug hy-021068 tablets: Hefei medical industry pharmaceutical Co., Ltd has not found any information at present In the past five years, the company has applied for two class 1.1 chemicals, this is the second one, the first one is piragrex sodium injection, which was applied in 2013, and obtained clinical approval documents in the same year Wx-0593 tablets: Qilu pharmaceutical declared that no information has been found at present The last chemical of category 1.1 declared by Qilu pharmaceutical It can also be traced back to qlnc-3a6 dimethoate tablet in 2013 The drug has obtained clinical approval in 2014 The small editor has looked at the CDE clinical trial registration platform Currently, only the class 1.1 chemical drugs registered in Qilu have obtained clinical approval in 2012, which is selatinib toluene sulfonate tablet (biological products are not rare) Qlnc-3a6 dimethoate tablet has not been done or transferred Wxfl10230486 capsule: This product is jointly developed by Hubei Biomedical Industry Technology Research Institute Co., Ltd (a wholly-owned subsidiary of Wuhan Guanggu humanwell biomedical Co., Ltd.) and humanwell pharmaceutical It is a Btk (Brunton tyrosine kinase) inhibitor with two specifications, 0.5mg and 5mg The indication is rheumatoid arthritis The drug has a novel compound structure Humanwell pharmaceutical has submitted related compound Chinese patent applications (201410251204.2, 201510018849.6) and compound PCT international patent applications (PCT / cn2014 / 080887, PCT / cn2015 / 081686) Attached are the current research projects of the Research Institute: in addition, there is no specific information about jacketinib hydrochloride tablets of Zejing in Suzhou and yzj-1139 tablets of Yangtze River, while zaiding Pharmaceutical Co., Ltd has applied for another 1.1-class zl-2303 tablets after applying for 1.1-class respiratory system drug zl-2102 capsule in 2015, but there is no detailed information Dtrmwxhs-12 capsule: This product was declared by Zhejiang Daoming Pharmaceutical Technology Co., Ltd., which was established with 73.4 million yuan invested by Zhejiang Haizheng, accounting for 73.4% of the shares This product is an anti-tumor drug The specific target is unknown It was undertaken by CDE in May 2015, with acceptance numbers of cxhl1501468, cxhl1501468 and cxhl1501470 After 12 months, it has been in the approval stage.