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    Home > Medical News > Latest Medical News > [yaogajun] the first "Gleevec" passed the consistency evaluation, adding another competitor? Hengrui will have two first imitations? Annual sales of 3 billion exclusive large varieties, two enterprises fierce competition?

    [yaogajun] the first "Gleevec" passed the consistency evaluation, adding another competitor? Hengrui will have two first imitations? Annual sales of 3 billion exclusive large varieties, two enterprises fierce competition?

    • Last Update: 2018-06-11
    • Source: Internet
    • Author: User
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    This week (6.2-6.9), there are 21 acceptance numbers, 17 new varieties of new drugs have new trends, 4 class 1 chemicals, 10 class 1 biological products, 2 class 2.2 chemical drugs, 1 class 6 preventive biological products In addition to the application for production of tetravalent influenza virus split vaccine of Hualan biology, other applications are clinical applications, including 10 drugs for special approval and 2 for priority review The specific situation is shown in the following figure: drug undertaking This week, a total of 13 new drug clinical application acceptance numbers were accepted, involving 9 drugs, including 7 chemicals of category 1, 1 biological product for prevention of category 15, and 1 biological product for treatment of category 1 The details are shown in the figure below: in addition, 10 generic drug listing application acceptance numbers have been undertaken this week, involving 9 drugs The specific situation is shown in the following figure: the listing application of imatinib mesylate tablets has been undertaken On June 6, the generic application of imatinib mesylate applied by xinlitai was accepted The drug was used to treat patients with chronic myeloid leukemia (CML) in acute stage, accelerated stage or after failure of α - interferon treatment; patients with malignant gastrointestinal stromal tumor (GIST) who could not be surgically removed or metastasized Imatinib mesylate, developed by Novartis, was first approved by the US Food and Drug Administration (FDA) on May 10, 2001 (trade name: Gleevec) According to public data, imatinib mesylate tablets sold more than 4 billion US dollars in 2016 According to pharmaceutical intelligence data, at present, there are three domestic enterprises that have obtained the production approval documents of imatinib mesylate, including Zhengda Tianqing capsule, Jiangsu Haosen and Ouyi tablet There are only two enterprises applying for conformity assessment, Zhengda Tianqing and Jiangsu Haosen This week, the conformity assessment status of imatinib mesylate tablets in Jiangsu Haosen has shown that "approval is completed and certification is pending" The first enterprise to pass the conformity assessment will seize the opportunity of domestic market and gain market advantage If xinlitai's tablet is listed successfully, it will also compete for some market share China Resources Shuanghe, an exclusive big product with an annual sales volume of 3 billion yuan, has applied to be listed in Anda for dizosin injection, which is a large variety of analgesics and has a terminal sales volume of more than 3 billion yuan Dizosin began research and development in Wyeth ayerst laboratory in 1978, and was listed in the United States in 1990 In October 2009, China's CFDA approved the first generic listing of dizosin injection produced by Yangtze River Pharmaceutical Co., Ltd for the treatment of various kinds of pain using opioid analgesics After being put on the market, with its high analgesic activity, less adverse reactions such as respiratory inhibition, constipation, analgesic tolerance and addiction, the dosage increased rapidly As an exclusive large variety, many enterprises have been coveting it In January, Enhua pharmaceutical applied for the listing of dizosin injection generic drugs On June 4, China Resources Shuanghe Limin Pharmaceutical Co., Ltd also joined the generic application army, hoping to take a share in the domestic market of this large variety of analgesics, which is 3 billion yuan Another listing application of Hengrui was accepted On June 4, Hengrui's application for listing of glulammonium bromide injection was accepted Gelong ammonium bromide injection was first developed by Baite pharmaceutical and was listed in the United States in February 1975 Its trade name is robinul ®, and its prescription contains the preservative benzyl alcohol It can be directly used for intramuscular or intravenous injection, for gastrointestinal diseases or anesthesia, and has been listed in the United States, the United Kingdom, Canada, Australia and other countries, with a market specification of 0.2mg/ml Among them, Omega Canada's listed products do not contain the preservative benzyl alcohol in the prescription In 2016, the global market sales of glulammonium bromide injection was about US $235 million At present, only Hengrui's generic drug listing application has been undertaken in China In addition, 3.3 new drugs applied by Hengrui, Chengdu Xinjie, Jiangsu Huatai Chenguang and Chengdu Tianyi medicine have been approved for clinical application, and 3.1 new drugs applied by Chongqing Juqi Nome have been approved for clinical application The listing application of valsartan amlodipine (I) of Baiao Pharmaceutical Co., Ltd was undertaken On June 4, it competed with Hengrui for the first copy On June 4, the listing application of valsartan amlodipine (I) of Baiao Pharmaceutical Co., Ltd was undertaken The drug is a film coated tablet, and the film coated tablet is white For the treatment of essential hypertension, for single drug treatment can not fully control blood pressure patients At present, there are only imported drugs originally developed by Novartis in China, and now Hengrui and Baiao are making rapid progress In 2018, the average bid winning price of valsartan amlodipine tablets (I) with the specification of 80 mg of valsartan and 5 mg of amlodipine * 7 was 51.33 yuan On June 8, Zhejiang Haizheng Pharmaceutical Co., Ltd (hereinafter referred to as "Haizheng pharmaceutical") received the approval for drug registration issued by the State Food and Drug Administration (SFDA) Epirubicin is suitable for the treatment of malignant lymphoma, breast cancer, lung cancer, soft tissue sarcoma, esophageal cancer, gastric cancer, liver cancer, pancreatic cancer, melanoma, colorectal cancer, ovarian cancer, multiple myeloma, leukemia, etc Epirubicin was developed by Italy's French company It was first listed in Italy in December 1984 and in China in 1998 In October 1999, the company obtained the new drug certificate and production approval for epirubicin hydrochloride and injection; in 2012, the company and Pfizer Luxembourg Co., Ltd jointly established Haizheng Pfizer Pharmaceutical Co., Ltd (Haizheng Pfizer), and epirubicin hydrochloride for injection was injected into Haizheng Pfizer The registration approval document of epirubicin hydrochloride for injection obtained by Haizheng pharmaceutical is a new product developed with the original famaxine instant formula as the reference preparation, which is convenient for clinical use Up to now, in addition to Haizheng pharmaceutical industry, there are 4 companies in China, including Haizheng Pfizer Pharmaceutical Co., Ltd and Pfizer Pharmaceutical (Wuxi) Co., Ltd., which hold the approval number of epirubicin hydrochloride for injection After querying IMS database, the global sales volume of epirubicin hydrochloride for injection in 2016 was US $216.91 million, including US $96.84 million in China; the global sales volume in 2017 was US $216.54 million, including US $95.91 million in China Heavyweight anti Alzheimer's first generic drug officially launched in China! Beijing New Pharmaceutical Co., Ltd announced in the evening of June 4 that the company's kabaratin heavy tartrate capsule had obtained the drug registration approval Kabalatin tartrate is a first-line drug developed by Novartis in Spain for the treatment of mild and moderate Alzheimer's dementia, which has been on the market for many years in China The company is the first manufacturer in China to obtain the approval for the production of cabalatine heavy Tartrate Capsules So far, Jingxin pharmaceutical's anti Alzheimer's disease (hereinafter referred to as AD) domestic heavyweight and first generic drug - "jingmeiting ® heavy tartaric acid kabarating capsule" was officially launched Bortezomib, a first-line specific drug for targeted treatment of myeloma, was successfully developed by Qilu Pharmaceutical Co., Ltd for 6 years and officially launched in China on June 2, 2018 Bortezomib is currently a first-line specific drug for clinical treatment of multiple myeloma In the near future, qipler will submit the application for conformity assessment as required In addition, Qilu pharmaceutical is currently carrying out the international registration of qipler ® In 2017, Qilu pharmaceutical has submitted an anda application for bortezomib injection to the regulatory markets of the United States and the European Union, which will be approved in succession On the evening of June 4, the group announced that its "paclitaxel for injection (albumin binding type)" has been included in the list of Chinese listed drugs This drug is a product directly reported for production according to the new classification of chemical drugs after the completion of be If it is directly included in the catalogue of Chinese listed drugs, the mark of "through consistency evaluation" can be used to indicate that the drug is consistent with the quality and efficacy of the original research drug, can realize the clinical substitution of the original research drug, and can provide patients with high-quality and good price drug selection In February 2018, taxol for injection (albumin binding type) obtained the drug registration approval issued by the former State Food and Drug Administration of the people's Republic of China, and the first copy was successfully approved for listing According to pharmaceutical intelligence data, there are also enterprises applying for listing in China, including Zhejiang Haizheng, Qilu pharmaceutical, Yangzijiang pharmaceutical, Jiangsu Hengrui and Jiangsu Kanghe biology In the evening of June 4, Cologne Pharmaceutical Co., Ltd issued two successive announcements that it had recently obtained the approval document for drug registration of zoledronic acid injection and dextrometeridine hydrochloride injection approved and issued by the State Drug Administration Zoledronic acid injection is the third generation of bisphosphonates It was originally developed by Novartis (trade name: Aclasta ® / reclast ®) Since it was first listed in Europe in 2005, zoledronic acid injection has been approved for the treatment of Paget's disease and osteoporosis So far, it has been listed in Europe, the United States, Japan and other countries, with more than 10 years of clinical application experience It was listed in China in 2008, with the trade name of migunda ®, national medical insurance class B in 2016, the sales volume in China was about 574 million yuan The applicant of dexmedetomidine hydrochloride injection is Hunan Kelun Pharmaceutical Co., Ltd., a subsidiary of Kelun pharmaceutical The drug is a highly selective adrenergic receptor agonist, which is used for the sedation of tracheal intubation and mechanical ventilation in patients undergoing general anesthesia It is a sedation of anesthesia combined with drugs and invasive examination or treatment during operation The original research was jointly developed by Orion Pharma of Finland and abott of the United States It was first listed in the United States in 1999, with the trade name of preciedextm At present, it has been listed in at least 11 countries such as Japan, the United Kingdom, South Korea and Germany In 2009, dexmedetomidine hydrochloride injection was listed in China In 2016, the sales volume of dexmedetomidine hydrochloride injection in China was about 1.53 billion yuan, which was a class B product of national medical insurance Roche, the Swiss pharmaceutical giant, announced that the US Food and Drug Administration (FDA) has approved rituxan (generic name: rituximab, rituximab) for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV) This approval makes rituxan the first biotherapy approved by FDA to treat PV, marking the first significant progress in the clinical treatment of PV in more than 60 years Previously, the FDA has granted rituxan priority qualification for PV treatment, breakthrough drug qualification, orphan drug qualification Rituxan is a therapeutic monoclonal antibody that targets the CD20 antigen on the surface of normal and malignant B cells, then mobilizes the natural defense of human body, attacks and kills the labeled B cells According to FDA's decision today, rituxan has now been approved to treat four autoimmune diseases, including rheumatoid arthritis (RA), granulomatous polyangitis (GPA), microscopic polyangitis (MPA), and PV On June 2, Eli Lilly and Incyte announced that the US FDA approved the launch of their new drug, olumiant (barictinib), to treat adult patients with moderate to severe rheumatoid arthritis who could not benefit from the treatment of TNF inhibitors Olumiant is a potential new drug, a daily oral JAK inhibitor, which can effectively inhibit Jak1, JAK2, and Tyk2 In human body, many cytokines depend on the activity of JAK, which has potential role in the pathogenesis of many inflammatory diseases and autoimmune diseases By inhibiting the activity of various JAKs, olumiant is expected to bring good news to patients with rheumatoid arthritis Simultaneous treatment of hypertension
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