CDE drug review weekly report (February 22, 2016 to February 27, 2016)

Four 1.1 and 40 3.1 chemicals have entered the review stage this week, and 23 of 3.1 chemicals are in good weather! In addition, four new 1.1 chemicals were added this week and approved Key chemicals and key chemicals are as follows: key biological products and key biological products: three class 1 therapeutic biological products entered the review stage this week: recombinant human vascular endothelial growth factor receptor antibody fusion protein eye injection of Huabo biological medicine, recombinant anti EGFR of Shanghai Fuhong Hanlin Humanized monoclonal antibody injection, Chongqing Zhixiang Jintai recombinant all human anti EGFR monoclonal antibody injection This week, an imported therapeutic biological product was approved for the first time in China: Pfizer's rn316 injection This week's situation: this week's situation is introduced in the following parts: 1 In this week, 90 drugs (calculated by acceptance number, the same below) entered the review stage, 40 of which were classified as 3.1, while Zhengda Tianqing obtained 23 drugs, including edranide and tablets, trogliptin succinate and tablets, pabosini and capsules, sakubitravalin and tablets, and dacatavir hydrochloride and tablets, etc 2 202 drugs entered the approval stage this week, including 131 drugs of 3.1, 6 drugs of 6 categories, 170 of which obtained clinical approval documents; 424 drugs were approved, 243 of which were approved clinical, 125 of which were withdrawn by announcement; in addition, only 13 drugs were completed 3 Hmpl-453 tartrate and tablet: This product is a new type of high selective small molecule fibroblast growth factor receptor (FGFR) inhibitor, and its main indications include small cell lung cancer, breast cancer, multiple myeloma, gastric cancer and bladder cancer 4 Ro7020322 and capsule: This product is a drug declared by Roche for the treatment of chronic hepatitis B, currently in phase I clinical stage in the United States 5 Ac0058ta and capsule: ac0058 is a new mechanism small molecule compound, which is used to treat systemic lupus erythematosus, rheumatoid arthritis and other autoimmune diseases by specifically inhibiting the key regulatory molecule of B lymphocyte and other inflammatory cells At present, it has obtained clinical approval in the United States and will carry out phase I clinical research in the United States In China, it has just entered the review center 6 Fudanafil tablet: fudanafil is a PDE-5 inhibitor with brand-new characteristics It is the first urogenital system drug independently developed by xuanzhu pharmaceutical It is clinically used to treat the symptoms and signs (bph-luts) and erectile dysfunction (ED) of benign prostatic hyperplasia At present, there are no drugs to treat bph-luts and ed at the same time in China, and fudanafil has made up the gap in this field There are 2 specifications of the product, of which the time for raw materials and 1 specification of the preparation to enter the review stage is February 2, and the second specification of this week enters the review stage 7 Entenole tablets: This product was declared by Yiteng Pharmaceutical Co., Ltd and its English name is entinostat It entered the evaluation center in March 2015 It is a special approved product and has been approved for clinical use Entenole is a histone deacetylase (HDAC) inhibitor in research, which is used in the treatment of advanced breast cancer (stage III) and non-small cell lung cancer (stage II) The drug, developed by syndax pharmaceutical in the United States, was recognized as FDA breakthrough therapy in 2013 8 Cvi-lm001 and tablets: This product is a class 1.1 small molecule PCSK9 inhibitor declared by ciweier medicine, which is used to treat hyperlipidemia Cvi-lm001 has been in the evaluation center since 2014 Although it is a major special and special approved variety, it is in the approval stage and approved for clinical application after a supplement 9 Taselisib tablet: developed by Roche, this product is a selective inhibitor of PIK3CA, used to treat breast cancer, primary uterine contraction serous cancer, etc This product was first undertaken in March 2015 in China It is a special approved product and has been approved for clinical use In addition, clinical application was submitted in December 2015 10 Azd3759 and tablets: developed by AstraZeneca, this product is a new drug for the treatment of non-small cell lung cancer with central nervous system metastasis, aiming at EGFR mutation This product entered the evaluation center on April 23, 2015, which is a special approved variety and has been approved for clinical use 11 Hs-10241 and tablets: developed by Haosen, Jiangsu Province, this product is a c-met inhibitor, used to treat tumors Hs-10241 entered the evaluation center in April 2015 It is a special approved variety and has been approved clinically.