Today, when all kinds of policies are uncertain, only innovative drugs can enter CDE bravely

Source: Xianda data Hengyan 2016-05-15 after the drugs that were not approved and certified by the State Administration in the previous two weeks, a lot of drugs entered the state of review, approval and certification this week The key points are as follows: 1 Hy-021068 tablets of 1.1 class chemicals of Hefei medical industry pharmaceutical Co., Ltd., wx-0593 tablets of 1.1 class chemicals of Qilu Pharmaceutical Co., Ltd , wxfl10230486 capsule, yizj-1139 tablets, zl-2303 tablets of Yangzijiang Pharmaceutical Co., Ltd and jaketinib hydrochloride tablets of Zejing biological Co., Ltd are all in the review stage; 2 Clinical application of dtrmwxhs-12 capsule, class 1.1 new drug of Zhejiang Daoming Pharmaceutical Co., Ltd., a subsidiary of Haizheng Pharmaceutical Co., Ltd Three months later, the final review was completed; 3 This week, the clinical applications of aprost tablets, etrapa tablets, daggliptin tablets and wotixitin hydrobromide tablets of several enterprises were reviewed; the key drug hy-021068 tablets: Hefei medical industry pharmaceutical Co., Ltd applied, but no information has been found recently 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 class 1.1 chemical applied by Qilu pharmaceutical also dates back to qlnc-3a6 emalaite tablet in 2013 The drug has obtained clinical approval documents in 2014 A small editor has looked at the CDE clinical trial registration platform Currently, only the class 1.1 chemical registered in Qilu has obtained the clinical approval document of toluenesulfonate seratinib tablet in 2012 (there are many biological products), qlnc-3a6 I don't know whether ermalainate tablet has been made 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 This article is also introduced in 46 issues of weekly report Click the link below the text to view.