CDE drug review weekly report (February 15, 2016 to February 20, 2016)

This week's focus declaration 1 This week, only 50 drugs (according to the acceptance number, the same below) entered the review status, and the declaration volume has been kept at a relatively low level It seems that under various policies, everyone's enthusiasm has been hit to some extent Key drugs: 1 Scc-31 capsule: This product is declared by Shandong Luoxin as a 1.1 chemical As we all know, rohin has been committed to making generic drugs This drug is the first innovative drug declared by rohin, and it is also the pace of preparing to explore new territory Scc-31, acting on PI3K-Akt-mTOR signaling pathway, is a competitive and specific mTOR kinase small molecule inhibitor of ATP, which has a more effective and broad-spectrum effect than the listed rapamycin like mTOR allosteric inhibitors PI3K-Akt-mTOR inhibitor is the most popular small molecule target at present There are nearly 50 molecules in the clinical research stage, and the indications are all over cancer, immunity, cardiovascular, metabolism, nerve and other major diseases I hope this product can also be successfully used in various diseases 2 Atezolizumab injection: This product is the first clinical application of Roche in China It is a PD-L1 inhibitor At present, it has achieved great success in a clinical phase II study on the treatment of non-small cell lung cancer and bladder cancer PD-1 / PD-L1 is getting hotter and hotter Bristol Myers Squibb, Roche, MSD, AstraZeneca, etc all join in this army There are also domestic manufacturers that develop innovative drugs for this target Let's wait and see 3 Abt-493 / abt-530 tablets: This product was first applied for clinical application by Alberta in China Abt-493 / abt-530 is a full oral, pan gene hepatitis C cocktail, developed for the treatment of all six genotypes of hepatitis C This product is a full oral, once a day, ribavirin free, pan gene hepatitis C cocktail The prescription specification is 300mg / 120mg, of which abt-493 is an NS3 / 4A protease inhibitor and abt-530 is an NS5A inhibitor As the only company that can compete with Gillette in the field of hepatitis C, Aberdeen is really hard Approval 2: there are 268 drugs entering the approval status this week, 443 drugs having been approved, 169 drugs having been certified, of which a large number of class 1.1 drugs have been approved for clinical use Here are the key drugs that have no conclusion before, and the drugs that have no conclusion will automatically roll into next week: 1 Iritinib maleate capsule : This product is a class 1.1 anti-tumor drug declared by Dong Yangguang It was undertaken in March 2015 and is a special approved variety At present, the review is completed and approved for clinical use East Sunshine has a special love for TiNi Iritinib is the fourth TiNi drug declared by Guangdong East Sunshine in recent three years after ninggetinib, lelotinib and boxitinib At present, it has all obtained clinical approval 2 Hemay102 for injection: This product was declared by Hainan Hailing as a class 1.1 chemical drug, which was undertaken in September 2013 It is a special approved variety After two times of supplement, it was finally approved for clinical use It is found that the specific target of this product for the treatment of liver cancer is unknown 3 Zhifeishaban tablet: developed by Tianjin Pharmaceutical Research Institute, it is a factor Xa inhibitor, used to prevent and treat acute and serious cardiovascular and cerebrovascular diseases such as venous thrombosis, pulmonary embolism and systemic embolism caused by atrial fibrillation At present, zhifeisaban has been approved for clinical use It is the first Saban anticoagulant drug independently developed and entering the clinical research stage in China 4 Ketamine capsule: the class 1.1 chemical drug declared by Guangzhou Shunjian Biomedical Technology Co., Ltd is supposed to be an anti leukemic drug It was undertaken in September 2014 and is a special approved variety At present, it has been approved and approved for clinical use 5 Hsk3486 emulsion injection: This product is developed and declared by Sichuan hisico It is a new type of GABAA receptor (also known as γ - aminobutyric acid type a receptor) agonist It is a fluorine derivative of propofol, which has sedative hypnotic and anesthetic effects This product was also undertaken in September 2014 It is a special approved variety and has been issued and supplemented once At present, it has been approved for clinical use 6 Piperidolone tablets: This product is declared by Guangdong South China new drug development center, which is also category 1.1, code AD16 As a neuroinflammatory inhibitor, the compound has a revolutionary breakthrough in Alzheimer's disease, and points out a new direction for future anti Alzheimer's drugs The preclinical pharmacodynamic study showed that the mechanism of action of AD16 was different from that of traditional drugs, and the effect of AD16 was equivalent to that of donepezil and memantine, which were currently on the market, and the drug-forming effect of AD16 was better than that of the same kind of foreign developed varieties This product was undertaken in January 2015 It is a special approved variety At present, it has been approved and approved clinically 7 Bgb-3111 capsule: This product was applied by Baiji Shenzhou research and Development Co., Ltd and entered CFDA drug evaluation center in February 2015, which is a special approved product Bgb-3111 is a Btk inhibitor, which is said to have higher selectivity than ibrutinib, the first Btk inhibitor on the market in the world It took 12 months, and now it has been approved and approved clinically 8 Xccs605b for injection: This product is applied for clinical application by Xinchang pharmaceutical factory of Zhejiang Pharmaceutical Co., Ltd in class 1.1 It is a sensitizer for tumor treatment It was undertaken in February 2015 and is a special approved variety At present, it has been approved and approved for clinical application 9 Ximingpirui tablets: This product was developed and applied by Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences, and entered the evaluation center in August 2015 At present, it has been approved and lasted only 7 months The reason can be counted as "double identity" varieties, namely major special varieties and special approved varieties This product is a PARP1 inhibitor and should be used for anti-tumor 10 Polyethylene glycol irinotecan for injection: This product is a class 1.1 chemical medicine declared by Tianjin keyvia Technology Co., Ltd It is a PEG modified drug for irinotecan, which is already on the market, for anti-tumor treatment PEG modified drugs can give peg excellent properties to the formed compounds, enhance the water solubility of drugs, prolong the elimination time and improve the biological distribution This product entered the review center in September 2014, which is a special approved variety The review took 16 months At present, it has been approved and approved clinically Tianjin keyvia is specialized in the research and development and production of polyethylene glycol and new polyethylene glycol active derivatives In addition, category 1.1 drugs involved in the approval include sodium pyruvate inhaler, cefditoren phosphate for injection, tpn171h, hyc11395 for injection, CM118 tablets, gaggliptin tablets, ketamine capsules, al8326 tablets, boxitinib hydrochloride capsules, shr7390 tablets and sutitinib maleate Interested friends can go to Xianda new drug blog (http:// to search for information about related drugs Among the drugs approved this week, there are 203 categories 3.1, among which, except for the production declaration withdrawn by announcement, the rest are clinical declarations, all of which have been approved clinically, with the approval rate of 100% And 114 6 categories, 103 approved clinical, approval rate is very high However, there are only 7 approved imported varieties, 6 of which have been approved for clinical use, and the inconclusive ones are production applications, which are estimated to be in suspense.