CDE drug review weekly report (April 26, 2015 to May 2, 2015)

Introduction: 1 Zhengda Tianqing is the second one in China to declare its class 3.1 non-small cell lung cancer and small cell cancer treatment drug adrobicin; 2 Zhengda Tianqing is the second one in China to declare its tablets after declaring its application of tertiazem phosphate for injection; 3 After Guangdong Dongguang, it is the second one in China to imitate its application of entacapone tablet; 4 The new inhalation powder spray of GlaxoSmithKline for COPD has been approved ★ in the review, amrubicin is an anthracycline drug, which is an embedded topoisomerase II inhibitor, causing DNA breakage and inhibiting tumor cell proliferation It was first listed in Japan in 2002, but it has not been launched in China At present, the original research Sumitomo pharmaceutical industry is only in phase 3 clinical stage in China The indications of this product are in line with the increasing lung cancer caused by environmental problems in China It is effective for both non-small cell lung cancer and small cell lung cancer Domestic enterprises were the first to declare amroubixin maleate by hausen It has been approved for clinical application since 2005 and has not yet declared for production And what Zhengda Tianqing declared this time is the raw material and injection of amrobicin hydrochloride In addition, Zhengda Tianqing also declared its tablets after it declared tertiazem phosphate for injection in January this year Terdiazolamine is the first or FDA approved second-generation oxazolidinone antibiotics It is a protein synthesis inhibitor, which can inhibit the synthesis of bacterial proteins Compared with the first generation of linezolid, it has a longer half-life This product was listed in the FDA in June 2014 and was approved as a "qualified anti infective drug" design In January 2015, Zhengda Tianqing and Ouyi Pharmaceutical Co., Ltd of Sinopharm group declared the first injection of this product in China at the same time However, Sinopharm group did not declare tablets at present, but Tianqing further declared tablets Entacapone is a reversible and specific COMT inhibitor, which mainly acts on the peripheral blood It is used together with levodopa to treat Parkinson's disease At present, only imports are listed in China, and the patent has expired Guangdong dongyangguang Pharmaceutical Co., Ltd was the first domestic enterprise to apply for this product in February 2014, while Hainan rizhongtian Pharmaceutical Co., Ltd was the second domestic enterprise to apply for this product at the end of April 2015 The sales volume of this product has increased all the way since it was put on the market In 2014, the sales volume of sample hospitals reached more than 30 million ★ of the 15 drugs approved to enter the approval process this week, 14 are chemical drugs and 1 is biological product for prevention Chemical drugs are almost three types, and all of them are clinically approved It is worth mentioning that fluticasone furoate / umeclidinium bromide / vilanterol triphenylacetate, a tripartite drug developed by GlaxoSmithKline, has been approved for clinical use for the first time in China At present, only umeclidinium / vilantro and fluticasone / vilantro are listed in the United States, but the three parties have not yet been approved The specific drugs and results are as follows: ★ of the 17 drugs approved this week, only 3 are chemical drugs, and the rest are traditional Chinese medicine Among chemical drugs, 1 is imported, 1 is of category 3.3, and 1 is imported for re registration Gligligliptin tablets (jxhs1400057) imported and declared by bringlingham Class 3.3 of Nanjing Xiansheng Dongyuan pharmaceutical declared ibuprofen injection (cxhl1100436), which is currently approved for clinical use Anstelai pharmaceutical imports and re registers tacrolimus capsule ★ after the completion of the preparation of the certificate, there are two drugs completed this week, which are the same product: tosfloxacin toluenesulfonate tablets (jxhl1000229, jxhl1000230) of Fushan Chemical Industry Co., Ltd., all of which are approved for clinical use.