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    Home > Active Ingredient News > Antitumor Therapy > NMPA: Amjin company's land Shudan resistance in the domestic conditional approval

    NMPA: Amjin company's land Shudan resistance in the domestic conditional approval

    • Last Update: 2020-06-16
    • Source: Internet
    • Author: User
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    According to official information released by the State Drug Administration, the application for import registration of the dissudan anti-injection injection developed by Amgen Corporation (AMGN.US) is now conditional lying in ChinaThis also means that the total number of domestic listed mono-resistant products has reached 26And the first batch of clinically urgent need for new drugs from overseas list, there are also 14 have been approved for listingOn May 22, 2019, the State Drug Administration issued a notice saying that the disshusm anti-injection fluid developed by Amgen corporation is now in the country and is now approved for treatment in adults with non-surgical or surgical removal of bone cytomegalocyts that may cause severe dysfunction in adults and mature bone developmentData show that disukalitais is amgenford for osteoporosis treatment field heavy-duty drugs, and is the world's first approved listed RANKL inhibitor, ranked rankL's all-humanized monoclonal IgG2 antibodyIn 2017, sales of the product reached $1,968 millionOn May 28 and June 1, 2010, the European Union and the U.SFDA approved Amgen's Ground restiturate injections (commodity name: Prolia) for the treatment of patients with osteoporosis (with a history of osteoporosis or multiple risk factor fractures) or who cannot tolerate other existing osteoporosis drugs in postmenopausal women at increased risk of fracturesIn china, the listing application for Dishu Singanti was requested by CDE on October 26, 2018 and entered into priority reviewIt is worth noting that dissethalsainisis is one of the first clinically urgently needed new drugs from abroad that CDE officially released on November 1, 2018, so you can enjoy the CDE special channel to expedite the reviewAt the time, the industry was expected to be approved in the third quarter of 2019, and for now, it is ahead of scheduleAnd with the listing of ground-seun-singofa, the domestic approved single-drug drug lineup has expanded againAccording to E drug managers according to the State Drug Administration statistics, up to now, the domestic has been listed 23 single anti-drugs, of which 8 domestic, the remaining 18 for importsFrom the perspective of indications, the current approved mono-anti-resistant products are still mainly targeted for several anti-tumor, such as HER2, CD20, PD-1/PD-L1, EGFR, VEGF (R2) and so onAlready listed are Roche's patuju sing-it-and-injector-using querceta, while the country's fastest-growing domestic development in the research phase is Sansheng Guojian, which was submitted to NDA in September 2018 and is expected to be approved for listing in 2019In addition in Phase III clinical is Anke Bio, Bai Otai, Haizheng Pharmaceuticals, Watson Bio (Jiaandi Bio), Zhengda Now on the market is Roche's rituximab Fu HongHan's biosimilar drug was approved for sale in February 2019 for the treatment of non-Hodgkin's lymphoma , becoming the first biosimilar drug to be listed in China In addition, Cinda Bio (01801), Haizheng Pharmaceuticals, Shenzhou cells are in Phase III clinical The typical representatives of PD-1/PD-L1 are THE BMS's NavuliU monotagandaph and MSD's Paboli Sebuta, and the Trepri sediton of Junshi and the Cinda Bio's Sindilisare are typical representatives of the domestic PD-1 In addition, Hengrui, Baiji Shenzhou (06160) are also in the PD-1 field layout VEGFR stands for the listed company is Roche's Beval-Bead single The fastest-growing bewarzumab in The Country is Qilu Pharmaceuticals, which submitted to NDA in August 18, and Xinda Bio, which submitted to NDA in January 19, and Hengrui Pharmaceuticals, Fuhong Hanxuan, Zheng da Tianqing, Hualan Bio (Hualan Gene), Watson Bio (Jiaandi Bio) and other enterprises are in Phase III clinical phase CD20, listed for Baxter's Nitozumab, and Merck's Sitoxix monotoniac in Germany In addition, Colleen and Maybo Pharmaceuticals have similar layouts Author: Amin Source: Amjin
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