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    Home > Medical News > Latest Medical News > [weekly report] chemical class 1 innovative drug, two major severe cases of double pipe

    [weekly report] chemical class 1 innovative drug, two major severe cases of double pipe

    • Last Update: 2016-12-21
    • Source: Internet
    • Author: User
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    Introduction: 1 Naprotinib dimethylbenzenesulfonate tablets, the first targeted anti NSCLC drug for egfr19 exon deletion and exon 21 mutation, submitted by the subsidiary of Haiwang biology 2 Rituximab of Hualan gene and jintuximab injection of Changchun Jinsai are two kinds of new drugs of biological products for treatment, and they have obtained the approval of clinical trials this week 3 Pantoprazole sodium and its tablets declared by the subsidiary of Zhongsheng pharmaceutical have recently obtained the approval of clinical trials 4 This week (2016.12.12-2016.12.16), 57 drugs (calculated by acceptance number, the same below) entered the CDE evaluation center, including 7 traditional Chinese medicine, 45 chemical drugs and 5 biological products Focus on: 1 The clinical trial application of zsp1603 and its capsule (acceptance No.: cxhl1600283-89), which was declared by Guangdong Zhongsheng pharmaceutical and Shanghai yaomingkant, has been accepted by CFDA this week Zsp1603 is an innovative drug jointly developed by Zhongsheng pharmaceutical and yaomingkant, which has a clear mechanism of action and independent intellectual property rights It is mainly used to treat idiopathic pulmonary fibrosis (IPF) and malignant tumors The compound related to this product has been patented Idiopathic pulmonary fibrosis (IPF) is a fatal disease characterized by diffuse alveolitis and disordered alveolar structure, which leads to the progressive development of pulmonary interstitial fibrosis At present, only pirfenidone of Roche and 2 drugs of Neda Knibb of Blyngju G John have been approved for marketing; Lung cancer, stomach cancer, liver cancer, esophageal cancer and colorectal cancer are the most common tumors in China The prognosis of these tumors is poor and the mortality rate is high According to the existing data, international companies such as bringer Ingelheim and Weicai have approved drugs with similar targets According to the preclinical study, zsp1603 has good activity on IPF and malignant tumor, and there is no domestic enterprise applying for the same target innovative drug for IPF and tumor treatment According to the data, the global market of IPF in 2015 was US $907 million, and the treatment of malignant tumors has always been a key area of research and development of major pharmaceutical enterprises in the world It can be predicted that after zsp1601 and zsp1602, zsp1603, as the third innovative drug of Zhongsheng pharmaceutical industry this year, has not only blown the domestic innovative drug whirlwind, but also brought phased results for the innovation and transformation of Zhongsheng pharmaceutical industry 2 Naprotinib xylenesulfonate and its tablets (acceptance No.: cxhl1600240, cxhl1600246) are chemical class 1 new drugs submitted by Shenzhen Haiwang pharmaceutical science and Technology Research Institute Co., Ltd., which have been undertaken by CDE Naprotinib dimethylbenzenesulfonate tablet is the first anti-small cell lung cancer drug targeting EGFR exon 19 deletion and exon 21 mutation in China Berlin Ingelheim company, together with the target drug afatinib, was approved to be listed in 2013, with global sales of 231 million US dollars in 2015 At present, there is no same product on the market in China 3 Wxfl10040340, a new chemical class 1.1 drug, and its capsule (i.e polyadenyldiphosphate ribose polymerase inhibitor, PARP inhibitor) (acceptance No.: cxhl1600117, cxhl1600118, cxhl1600124) jointly declared by Hubei Biomedical Industry Technology Research Institute Co., Ltd and Wuhan kemeide biomedical Co., Ltd have recently obtained the approval of clinical trials PARP inhibitors are used alone or in combination with radiotherapy and chemotherapy for BRCA mutations or deletions and overexpression of PARP enzymes in malignant solid tumors The compound structure of this product is novel, and relevant patent applications have been submitted According to the data, there is no drug with the same structure at home and abroad in clinical or marketing 4 The recombinant human anti-human tumor necrosis factor α monoclonal antibody (at132) (acceptance No.: cxsb1600009, cxsb1600010) for injection of class 1 new therapeutic biological products was applied by Zhuhai Lizhu monoclonal antibody Biotechnology Co., Ltd and has been approved for phase II and phase III clinical trials this week At132 is suitable for rheumatoid arthritis This product is a monoclonal antibody targeting at TNF - α Its mechanism of action is to form a complex with TNF - α, prevent its binding with the receptor, and play a role in neutralizing the pathological role of TNF - α For the humanized monoclonal antibody targeting TNF - α, its molecular sequence is unique, which is different from the domestic and foreign listed varieties and has independent intellectual property rights At present, adamumumab injection (trade name: sumilar, Humira ®) of abbvie Ltd, the same target drug in China, was approved for import in August 2010 According to IMS data, in 2015, xiumeile's domestic sales volume was about 36 million yuan, and the global sales volume was about 14 billion US dollars Note: This article is original by the author of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!  
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