CDE Drug Evaluation Weekly Report (2015.7.19-2015.7.25)

In the review this week (2015.7.19-2015.7.25), 117 drugs (calculated by acceptance number) entered the review status, 110 chemicals, including 5 1.1, 60 3.1, 4 3.2, 2 3.3, 3 5, 25 6, 9 imports In addition, there are 5 biological products for treatment, 1 biological product for prevention and 1 Traditional Chinese medicine The key points are as follows: 1 Dtrmwxhs-12 capsule: This product was declared by Zhejiang Daoming Pharmaceutical Technology Co., Ltd., which was established by Zhejiang Haizheng with a capital of 73.4 million yuan, accounting for 73.4% of the shares Dr He Wei, general manager, took 26.6% of the global intangible assets of five first-class new drug research projects (yp17 enzyme inhibitor, mTOR kinase inhibitor, male kinin receptor antagonist, JAK inhibitor, etc.) At present, there are two Chinese patents, namely, JAK inhibitor and alk inhibitor, which are used to treat immune related diseases and tumors However, the specific target and indications of dtrmwxhs-12 capsule have not been found in the small edition, and it is speculated that it is one of the disclosed information 2 Metoclopramide tablets: This product is declared by Guangzhou Nanxin Pharmaceutical Co., Ltd., which has been purchased by Hunan Nonferrous Kaibai biopharmaceutical Co., Ltd Metafeni speculated that it was based on sorafenib, which was also an inhibitor of VEGFR and RAF 3 Salfenamide mesylate tablets: This product is jointly developed by newron company and zambond company for the treatment of idiopathic Parkinson's disease It was approved by EMA in February 2015 and has not yet been approved by FDA for listing Salfenamide mesylate is a highly selective monoamine oxidase-B (MAO-B) inhibitor, which can cause the extracellular dopamine level in striatum and play an anti Parkinson role In addition, it can regulate the release of excitatory neurotransmitter glutamate by inhibiting voltage-gated Na + channels At present, Guizhou Hengshun pharmaceutical research and Development Co., Ltd is the first company to declare in China Recently, the company has rapidly declared a lot of 3.1 chemicals, including trogliptin declared in May, vinorazan fumarate declared in June, and L-proline and terdiazolamine phosphate declared in this week 4 Daratumumab injection: This product is an oncology product developed by Johnson & Johnson (Johnson and genmab signed an agreement of US $1.1 billion in 2012 and obtained the exclusive right of daratumumab) In May 2013, FDA granted daratumumab a breakthrough drug qualification for the treatment of multiple myeloma Daratumumab is a kind of humanized anti-CD38 monoclonal antibody, which has broad-spectrum killing activity It targets the transmembrane extracellular enzyme CD38 which is highly expressed on the surface of multiple myeloma cells, and can induce the rapid death of tumor cells through various mechanisms At present, the application for license of biological products for treatment of multiple myeloma by daratumumab has been started At present, clinical application has also been submitted to China 5 Vedolizumab for injection: This product is developed by Takeda pharmaceutical for the treatment of moderate and severe Crohn's disease and ulcerative colitis (UC) It is an injectable monoclonal antibody, which is suitable for those patients who do not respond to one or more conventional treatments (such as glucocorticoids, immunomodulators, tumor necrosis factor inhibitors) This product is an integrin receptor antagonist It provides an alternative treatment for natalizumab (natalizumab, a drug with similar mechanism, may increase the risk of progressive multifocal leukoencephalopathy and brain infection, which has been withdrawn from the market at present) It also provides another option for patients who cannot tolerate standard treatment At present, Takeda pharmaceutical has also submitted clinical application to CFDA In the approval week (2015.7.19-2015.7.25), 12 drugs (calculated according to the acceptance number, the same below) are in the approval status, all of which are chemical drugs Key drugs: 1 C118p for injection: This product was declared by Nanjing Shenghe Pharmaceutical Co., Ltd and entered the CDE review sequence in August 2014 It is a major special product and a special approved product It has not been issued and supplemented, and has been approved for clinical use This product is a new type of tubulin polymerization inhibitor Compared with the listed tubulin inhibitors (such as vincristine, paclitaxel, etc.) and molecular targeted drugs (such as sorafenib, sunitinib, etc.), it has a unique anti-tumor mechanism At present, CA4P with similar structure and mechanism is in phase III clinical research stage in foreign countries See attached table 1 for drug information under approval After approval, 56 drugs were approved this week, including 54 chemicals and 2 traditional Chinese medicines Key drugs: 1 Bgb-283 capsule: This product was declared by Baiji Shenzhou and entered the CDE review sequence in May 2014 It is a major special product and a special approved product It has not been issued and supplemented, and has been approved for clinical use This product is a dual inhibitor of BRAF and EGFR, which is used to treat tumor 2 Eugliptin tablets: This product was declared by Chengdu Yuandong Pharmaceutical Co., Ltd and entered the CDE review sequence in February 2014 It is a special approved variety and has not been supplemented It has been approved for clinical use This product is a DPP-4 inhibitor for the treatment of type 2 diabetes At present, there are a lot of 1.1 DPP-4 in China, and Hengrui's henggliptin has applied for production With so many kinds of statins, the competition is really fierce 3 Shuangtinita for injection: This product was declared by Guangzhou biebert Pharmaceutical Technology Co., Ltd and entered the CDE evaluation sequence in April 2014 It is a special approved product without any supplement It has been approved for clinical use This product is an anti-tumor drug, the specific target is unknown 4 Mepyridone hydrochloride tablets: This product was declared by Zhejiang Huahai Pharmaceutical Co., Ltd and entered the CDE evaluation sequence in March 2014 It is a major special product and a special approved product It was supplemented in April 2015 and has been approved for clinical use This product is a 5-HT1A receptor agonist / 5-HT reuptake inhibitor for the treatment of depression See attached table 2 for the approved chemical information There are 12 drugs approved this week, including 10 chemicals and 2 traditional Chinese medicines See attached table 3 for the chemical drugs after the completion of the preparation Attachment: