CDE Drug Evaluation Weekly Report (2015.6.1-2015.6.5)

In the approval process, 16 drugs have entered the approval process this week, including 12 chemicals, 1 Traditional Chinese medicine and 3 biological products for prevention The key information is as follows: chemical medicine: 1 Cefetamet hydrochloride, a class 1.1 antibiotic of Yangzijiang Pharmaceutical Group, and its sterile sub packaged injection entered the ind sequence in September 2013 It is a major special and special approved variety In October 2014, it underwent a supplement At present, it has been reviewed and approved for clinical use 2 L-ornidazole phosphate disodium, a class 1.1 antibacterial agent synthesized in Shaanxi Province, and L-isomer phosphate derivative sodium salt injected with Ornidazole were used in the treatment of sensitive protozoa and anti anaerobic bacterial infection In 2014, it entered the ind sequence, in which it did not go through the issuance of supplements At present, the review has been completed and the clinical approval has been successfully obtained See the following table for specific application information: 58 drugs have been approved this week, including 54 chemicals, 1 biological product for treatment and 3 biological products for prevention The key information is as follows: chemical drugs: of the 54 chemical drugs approved this week, 31 are classified as 3.1, 1 as 5, 1 as 6, 15 as imported and 6 as re registered 1 Flupentixicine capsules: Chengdu Beite Pharmaceutical Co., Ltd has applied for listing of flupentixicine hydrochloride raw materials, flupentixicine hydrochloride raw materials and flupentixicine capsules in category 3.1 + 3.1 + 5, and is currently undergoing a three in one review Visual inspection is not about to be launched At present, there are only three tablets in China, and Chengdu Beite is about to be launched as an exclusive dosage form 2 Palonosetron hydrochloride injection: Kunming Jida Pharmaceutical Co., Ltd applies for palonosetron hydrochloride and its injection in category 3.1 + 3.1 At present, the three in one audit is under way, and it will soon be listed Although this product has been listed in many domestic injection companies, this 3.1 product has finally been listed 3 Lamivudine tablets: Shaanxi Xingbang Pharmaceutical Co., Ltd is a class 6 declared anti HIV drug, which has been approved for production 4 Jnj-38518168-zbq tablet: it is applied by Johnson & Johnson company, also known as jnj-38518168, for the treatment of rheumatoid arthritis At present, it is in the second phase of clinical stage abroad The specific application information is as follows: after the completion of the preparation of the certificate, 41 drugs have been prepared this week, including 33 chemicals, 6 traditional Chinese medicines and 2 biological products for treatment The key information is as follows: 1 Trastuzumab-mcc-dm1 for injection: This product is an antibody coupling drug developed by Roche pharmaceutical, which is used to treat advanced metastatic breast cancer and has been listed in the United States At present, the production application in China has been completed and is expected to be imported The specific declaration information is as follows: