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    Home > Medical News > Latest Medical News > Good news! The domestic diabetes market will change, and the application for production of heavy natural medicine will be undertaken, and it is expected to be listed in 2018! Another first-line lung cancer treatment drug, Freida cotinib will be in China in the future!

    Good news! The domestic diabetes market will change, and the application for production of heavy natural medicine will be undertaken, and it is expected to be listed in 2018! Another first-line lung cancer treatment drug, Freida cotinib will be in China in the future!

    • Last Update: 2018-05-28
    • Source: Internet
    • Author: User
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    I new undertaking of drug review and approval: this week (may 19-may 25, 2018), the new undertaking of domestic drugs is as follows: A kind of On May 24, the application for the production of total alkaloids of Ramulus Mori from Wuhe Boao Pharmaceutical Co., Ltd was undertaken by the Institute of medicine of Chinese Academy of Medical Sciences The total alkaloids of Ramulus Mori are the core products of Wuhe Boao Pharmaceutical Co., Ltd and the representative varieties of modern traditional Chinese medicine The Institute of medicine of Chinese Academy of Medical Sciences has achieved 15 years of independent innovation It is a major breakthrough in the realization of diabetes treatment with modern natural drugs: to make up for the short board of "potential safety hazard in the long-term use of single target chemical drugs"; to break through the defects of "unclear material basis, uncontrollable quality, uncertain curative effect and no quantitative effect relationship of crude Chinese medicine"; to change the "oral hypoglycemic drug market has been dominated by chemical drugs, although there are many varieties of traditional Chinese medicine, but the market share is very small" An awkward situation It is a new glycosidase inhibitor from natural "mulberry branch" It can selectively inhibit the activity of disaccharidase, has no effect on amylase, and has lower adverse effect on flatulence The mechanism of action is clear The reversibly competitive combination of glycosidase inhibitor and small intestine brush border glycosidase can reduce blood sugar and "glycosylated hemoglobin" The curative effect is definite and the dose effect relationship is obvious Because this product will not produce hypoglycemia, less absorption into the blood, less long-term use of hepatorenal toxicity, glycosidase selectivity, less side effects Compared with the internationally recognized chemical medicine or the traditional Chinese crude preparation, the alkaloids of Ramulus Mori have obvious market competitive advantages It is expected that the products will be put on the market in 2018, and the annual sales volume after delivery is expected to exceed 1 billion yuan, creating a natural medicine heavyweight drug A kind of On May 24, the application for clinical trial of hdcd19car-t cell product developed by Huadao biology was undertaken This product is the first car-t product applied for clinical trial of Huadao biology For CD19 target, indications include acute lymphocytic leukemia (all) and non Hodgkin's lymphoma (NHL) The domestic application heat of car-t has not been eliminated Currently, only two products are listed in the United States: kymriah (tisagenlecleucel) of Novartis and yescarta developed by kit pharma The former is used to treat all and is currently expanding the indications; the latter is targeted at specific non Hodgkin's lymphoma treatment A kind of Another McAb clinical application of Hualan gene was undertaken On May 21, the clinical application of recombinant anti-CTLA-4 all human monoclonal antibody injection of Hualan gene was undertaken CTLA-4 is a leukocyte differentiation antigen and a transmembrane receptor on T cells It shares B7 ligand with CD28 CTLA-4 is a promising new immunosuppressive drug, which has significant therapeutic effect on transplant rejection and various autoimmune diseases CTLA-4 antibody and PD-1 antibody are both popular anti-tumor drugs A kind of Dakotinib, which is better than gefitinib in the first-line treatment of lung cancer, will be accepted on May 21, China Daktinib is the second generation of human epidermal growth factor receptor (her) inhibitor developed by Pfizer for the first-line treatment of advanced non-small cell lung cancer (NSCLC) Like afatinib, daktinib is irreversibly bound to EGFR kinase At the 2017 ASCO annual meeting, it was reported that the first-line treatment of lung cancer by dacomitinib was better than that by gefitinib The results showed that the median progression free survival was 14.7 months, and dakotinib was better than irizazide in progression free survival Compared with irizazide, dakotinib showed significant and clinically significant efficacy improvement and controllable safety spectrum, but the side effect of irizazide was smaller Early clinical trials showed that gefitinib was effective in the treatment of advanced lung adenocarcinoma, and the side effects of gefitinib were mild, the patients' compliance and tolerance were good If dakotinib comes to China, it will provide a new choice for the first-line treatment of such patients A kind of On May 23, Zhengda Tianqing's API production application was undertaken, and Zhengda Tianqing's API production application was undertaken Eliquis is a new, oral, reversible, highly selective and direct XA factor inhibitor for adult patients undergoing hip or knee arthroplasty to prevent venous thromboembolism (VTE) In May 2011, it was approved by the European drug regulatory agency, and in November, the drug's listing application in the United States was accepted by the U.S FDA On April 12, 2013, it was announced to be officially listed in China As a popular anticoagulant FXa inhibitor, eliquis continued to enjoy a good sales situation In 2017, eliquis became the best-selling drug in the cardiovascular field, with annual sales of US $7.4 billion, up 46.24% year-on-year It was jointly sold by Pfizer and Bristol Myers Squibb, with Bristol Myers Squibb contributing US $4.872 billion and Pfizer contributing US $2.523 billion The generic drug of apixaban tablet applied by Zhengda Tianqing has been approved in 2016 In addition, in China, 16 enterprises have applied for generic drugs, all of which have been approved for clinical application Anda applied by Sichuan Kelun and Jiangxi Qingfeng is in progress In addition, 12 enterprises, including Zhengda Tianqing, Qilu, Kelun, Qingfeng and Chengdu Beite, have applied for new drugs and obtained clinical approval 2 Update of drug review and approval status this week's update of domestic drug status is shown in the figure below: 3 Other important information A kind of Fosun rituximab completed phase III clinical trial and is expected to be approved for market in the third quarter On the evening of May 24, Fosun Pharmaceutical announced that the rituximab injection developed by its holding subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd (hereinafter referred to as "Fuhong Hanlin") was used for the treatment of non Hodgkin's lymphoma and completed the phase III clinical trial The results showed that the primary end point and secondary end point (safety, immunogenicity, pharmacokinetics) of rituximab injection and the original drug (rituximab ®) in the initial treatment of CD20 positive diffuse large B non Hodgkin lymphoma (DLBCL) reached the preset standard As of April 2018, Fosun Pharmaceutical has invested about 330 million yuan in research and development of the new drug (including non Hodgkin lymphoma indications and rheumatoid arthritis indications) According to the prediction of Zhongtai Securities Research Institute, rituximab has been included in the priority review and is expected to be approved for listing in the third quarter of this year, becoming the first biosimilar drug approved for listing in China, with a market potential of more than 3 billion yuan In addition to the successful phase III clinical trial of rituximab, the public information shows that Fosun medicine trastuzumab and adalimumab are in phase III clinical stage, and it is expected to submit the listing application in 2018 and be approved for listing in 2019; badazumab is in phase III clinical trial At present, Fosun Pharmaceutical has 8 approved clinical products, including 5 bio similar drugs and 3 bio innovative drugs It is one of the few enterprises with anti-PD-1 monoclonal antibody and anti-PD-L1 monoclonal antibody at the same time A kind of Methylprednisolone tablet of TIANYAO Co., Ltd approved by Anda On the evening of May 23, TIANYAO announced that recently, Tianjin TIANYAO Pharmaceutical Co., Ltd received a notice from the U.S Food and Drug Administration (FDA) that the company applied to the U.S FDA for the new drug brief application of methylprednisolone tablets (anda, i.e the U.S generic application, applying for the review and approval of the U.S FDA means that the applicant can produce and sell the product in the U.S market) Approved Methylprednisolone tablet is a kind of hormone medicine, which is widely used in clinic It is mainly used to treat rheumatic diseases, collagen diseases, skin diseases, allergic states, eye diseases, respiratory diseases, etc The drug was developed by famasia puqiang company and is currently a product of Pfizer in the United States It was listed in the United States in 1954 Up to now, the company has invested about 47 million yuan in research and development of methylprednisolone tablets In 2017, the sales volume of methylprednisolone tablets in the U.S market was about 126 million US dollars In 2015 and 2016, the sales volume of methylprednisolone tablets in the domestic market was 260 million yuan and 270 million yuan, respectively The first drug in the domestic similar drug sales market was mettrex, and the methylprednisolone tablets of TIANYAO Co., Ltd was the second A kind of On the evening of May 23, Nanjing Xinbai announced that the company issued shares to acquire shiding Hong Kong and raised supporting funds, which was approved by the merger and reorganization Review Committee of listed companies of CSRC Before that, Nanjing Xinbai issued the plan to acquire dendreon, and planned to purchase 100% of the shares of Shiding Biotechnology (Hong Kong) Co., Ltd held by it through non-public issuance of shares to Sanbei group, the controlling shareholder, and raise supporting funds The transaction price of the underlying assets was 5.968 billion yuan Meanwhile, Nanjing Xinbai will issue 180 million shares to Sanyou group at a price of 33.11 yuan It is reported that the main operating assets of Sedin Hong Kong are the total equity of dendreon, a US biomedical company Devenge, the core product of dendreon, is the first cell immunotherapy drug approved by FDA in the United States and the only cell immunotherapy drug for prostate cancer at present After the completion of the acquisition, Nanjing Xinbai will become the first A-share listed company with cell immunotherapy drugs approved by the US FDA International hot drug news I approval of new drugs A kind of The new prostate cancer drug was approved by FDA on May 23, India sun Pharmaceutical Co., Ltd including its subsidiaries and Churchill pharmaceuticals, LLC announced that the US FDA approved the listing application of innovative drug yonsa Yonsa is an innovative formulation of abirateron acetate, which will be used with methylprednisolone to treat patients with metastatic castrated resistant prostate cancer (mcrpc) In April 2018, the company's biological monoclonal antibody, tidrakizumab, was also approved by the FDA for the treatment of moderate to severe psoriasis A kind of GlaxoSmithKline's new asthma drug has been approved by the FDA recently, GlaxoSmithKline announced that its new drug, arnulity, has been approved by the FDA, a daily inhaled corticosteroid (ICS) drug, which is suitable for the preventive treatment of 5-11-year-old children with asthma Arnuity is one of the few asthma treatments in the U.S in the 5-11 age group A kind of Dova pharmaceuticals announced the approval of its subsidiary, akarx's new drug doplet (avatrombopag) tablet for the treatment of adult patients with chronic liver disease (CLD) who plan to undergo medical or dental surgery It is worth mentioning that this is the first drug currently approved for this use Doplet (avatrombopag) is the first thrombopoietin (TPO) receptor agonist in the second generation, once a day II Important clinical progress A kind of On May 25, abbvie announced that its phase 3 clinical trial illuminate (pcyc-1130) reached the main end point of PFS improvement This study evaluated the efficacy of imbruvica (ibrutinib) combined with gazyva (obinutuzumab) in the treatment of primary patients (the most common adult leukemia) with chronic lymphoid leukemia or small Lymphoid Lymphoma (CLL / SLL) Imbruvica (ibrutinib) is a first-in-class oral, once-a-day therapy, which works mainly by blocking Btk At present, imbruvica has been approved by FDA for 6 kinds
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