CDE Drug Evaluation Weekly Report (2016.3.21-2016.3.27)

This week, three class 1.1 chemicals entered the review status, three imported drugs applied for clinical application for the first time in China, and three class 1.1 drugs were reviewed In this issue, 1 The Institute of medicine of the Chinese Academy of medical sciences applied for the application of 1.1-class antineoplastic drug kangmotasai injection; 2 Xi'an Libang Pharmaceutical Co., Ltd applied for 1.1-class chemical drug isopropylbisphenol injection; 3 Shenyang Pharmaceutical University applied for 1.1-class nucleoside antineoplastic drug cytarabine hydrochloride valine ester tablet; 4 The antidote of dabigatran ester, idarucizumab, was first imported by Boehringer Ingelheim in China; 5 The antidotes of PD-L1 inhibitor, avelumab and pdr001, were first imported by Merck and Novartis in China; 6 The evaluation of tnp-2092 capsule, a class 1.1 digestive system drug of Dano medicine, was completed; 7 The evaluation of ro6889678 capsule, a new Roche sedative and hypnotic drug, was completed; 8 The review of tq-b3395 capsule of Zhengda Tianqing 1.1 new drug has been completed; 9 84 drugs are in the review stage this week, with no significant difference in the number of 3.1 and 6 categories, and 130 drugs are in the review and approval stage, of which 3.1 is the most Key drug: commutase injection: This product was developed and declared by the Institute of medicine of the Chinese Academy of Medical Sciences According to its name, it should be taxol drug However, the current research drug of this institute was compiled and checked, only azitase and semorillin were found, so other information of this product could not be understood in detail Isopropylbisphenol injection: This product was developed by Xi'an Libang, and no information has been found at present However, Xi'an Libang has an anesthetic called bispropofol injection I don't know how the two relate Cytarabine hydrochloride valine ester tablets: cytarabine is a kind of nucleoside anti-tumor drug Its oral bioavailability is very low due to its poor membrane permeability and low metabolic stability Therefore, it is not suitable for oral administration in clinical practice, but it must be injected intravenously After the formation of cytarabine and valine ester, the oral bioavailability of cytarabine was improved, and it was developed into tablet for oral use Idarucizumab: This product is a specific reversal drug of dabigatran ester It is a human monoclonal antibody fragment (FAB) that can be combined with dabigatran ester The affinity of acyl glucuronide metabolite to thrombin is higher than that of dabigatran ester to thrombin, which can neutralize the anticoagulant effect of dabigatran ester FDA approved its listing on October 16, 2015 At present, its developer, bringer Ingelheim, has applied for the clinical application of this product for the first time in China Avelumab: developed by Merck, this product is a humanized monoclonal antibody against PD-1 inhibitor Currently, it is jointly developed by Pfizer and Merck In October 2015, FDA announced that it will accelerate the approval of Merck's xuelanuo / Pfizer's PD-1 inhibitor avelumab in Merkel cell carcinoma, a rare skin cancer At the same time, this product is also in the phase III clinical trial of non-small cell lung cancer, ovarian cancer, urothelial cancer and renal cell cancer This week, it applied for clinical application for the first time in China and entered the stage of evaluation Pdr001: This product was obtained when Roche acquired costim, and it is also a PD-1 inhibitor At present, it is in the phase II clinical stage and used to treat solid tumors This week, it applied for clinical application for the first time in China and entered the stage of evaluation Tnp-2092 capsule: This product is declared by Danuo medicine It is a new antibacterial drug with double targets of Helicobacter pylori and Clostridium difficile, which is used to treat gastrointestinal infection This product entered the review center in April 2015 and is a special approved drug At present, the review has been completed and it is presumed to be approved clinically Dano pharmaceutical is an enterprise specialized in the research and development of new drugs of digestive tract diseases, which has a unique double target molecular new drug research and development platform and global protection of intellectual property rights Ro6889678 capsule: developed by Roche, it is a kind of midazolam, which is used for hypnosis and sedation At present, no phase I clinical trial has been completed It entered the review center in April 2015 and is a special approved drug, which has been reviewed at present Tq-b3395 capsule: This product was developed by Zhengda Tianqing, and its indication is unknown at present It entered the review center in June 2015 and is a special approved drug, which has been reviewed at present.