Drug intelligence review weekly report (2016.9.10-2016.9.19)

Introduction: 1.zsp1602 the second innovative drug with independent intellectual property rights submitted by Guangdong Zhongsheng Pharmaceutical Co., Ltd for clinical trial registration 2 Three tenofovir dipivoxil fumarate capsules were approved for clinical trials in China 3 Capecitabine is an oral cytotoxic agent with selective activity for tumor cells 4.71 drugs (calculated according to the acceptance number, the same below) enter the CDE evaluation center, including 9 traditional Chinese medicine, 49 chemical drugs, 12 biological products and 1 pharmaceutical excipient The human anti-CD38 monoclonal antibody (daratumab) injection (acceptance No.: jxs1600049, jxs1600050) is the second application biological product of Johnson & Johnson, which has been accepted This product is a kind of igg1k antibody, with broad-spectrum killing activity, targeting to combine with the transmembrane extracellular enzyme CD38 highly expressed on the surface of multiple myeloma cells It can induce the rapid death of tumor cells through various mechanisms It is the first single clone antibody approved for the treatment of multiple myeloma Due to the lack of treatment for multiple myeloma in the market at present, the approval of this product has brought a glimmer of hope for patients 2 Zsp1602 and its capsule (acceptance No.: cxhl1600224, cxhl1600225, cxhl1600226), a new chemical class 1 drug jointly developed by Guangdong Zhongsheng Pharmaceutical Co., Ltd and Wuxi Pharmaceutical Co., Ltd., have been undertaken by CDE This product is suitable for the treatment of small cell lung cancer and other cancer innovative drugs, relevant information has been applied for domestic patents and international PCT patents According to the existing data, five similar drugs developed by Roche, Novartis and Pfizer are in different stages of development, and no similar drugs have been listed in China This is the second innovative drug with independent intellectual property rights in Zhongsheng pharmaceutical industry If it can be successfully developed and listed, it will be a huge breakthrough for the treatment of small cell lung cancer, and the market prospect will be broad 3 New RISTA and its tablets (acceptance No.: cxhl1501827, cxhl1501828) are class 3.1 new drugs declared by Shaanxi step hi tech Pharmaceutical Co., Ltd and have been reviewed this week Neorista is a long-acting and powerful specific gastrointestinal lipase inhibitor, which is used to treat obesity and type II diabetes The biggest advantage of the drug is that it does not act on the nervous system, does not affect the activity of other enzymes in the gastrointestinal tract, is not absorbed into the blood, does not inhibit appetite, and does not need to limit diet According to the drug intelligence data, the drug has not been approved in China, only two applications for clinical application, none of which has been approved 4 The approval for clinical trial of capecitabine tablets (acceptance No.: cyhs1101644), a chemical 6-class generic drug, declared by Hainan Jinrui Pharmaceutical Co., Ltd., has recently been received from the drug administration Capecitabine is an oral cytotoxic agent with selective activity for tumor cells As an oral drug for tumor activation, it has high selectivity and specificity for anti-tumor This product is suitable for the treatment of colon cancer, colorectal cancer, breast cancer and gastric cancer 5 The new chemical 3.1 drug tenofovir dipivoxil fumarate capsule (acceptance No.: cxhl1300920) was jointly declared by Hainan Lingkang Pharmaceutical Co., Ltd and Hainan Yongtian Pharmaceutical Research Institute Co., Ltd., and has obtained clinical approval at present This product is suitable for use with other antiretroviral drugs to treat adults and patients over 2 years old who are infected with HIV-1 It can also treat chronic hepatitis B in adults and children over 12 years old Tenofovir fumarate dipivoxil is a new type of nucleotide reverse transcriptase inhibitor produced and developed by Gilead Sciences in the United States In 2001 and 2008, it was approved by the U.S FDA for the treatment of AIDS and chronic hepatitis B in adults According to the pharmaceutical intelligence data, three domestic enterprises have obtained clinical approval documents, and Chengdu Beite Pharmaceutical Co., Ltd has completed the bioequivalence test At present, the drug has not been approved for marketing Note: This article is the original of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!