Shi Guibao "Abisip Injection" approved by the State Drug Administration for listing
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Last Update: 2020-05-31
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Source: Internet
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Author: User
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The figure below is from insight database reporting progress (https://db.dxy.cn)Abatacept, the trade name Orencia, a soluble fusion protein developed by Baxter Squibb, incisive T lymphocytic antigen 4 (CTLA-4) extracellular region and human IgG1Fc regionAs a selective T-cell co-stimulation regulator, Orencia inhibits T-cell activation by binding to CD80 and CD86 on antigen-presenting cells to block the latter's interaction with CD28 on the T cellThe activated T-cells are thought to be associated with a variety of inflammatory diseasesOrencia was first approved by the FDA in December 2005, EMA in May 2007 and PMDA in July 2010, orencia is currently marketed with intravenous (IV) and subcutaneous injection (SC), and three indications approved in the United States, namely adult rheumatoid arthritis (RA) and juvenile arthritis (PA)In addition to the three indications mentioned above, Orencia has been developed for use in other diseases, and in December last year, the FDA granted Orencia a breakthrough therapy for the prevention of moderate to severe acute transplantation of non-related donor hematopoietic stem cell transplants (GvHD)Since its launch in 2006, Orencia has benefited millions of patients worldwide with its unique mechanisms and outstanding clinical results, and annual sales have been climbing (see table below), making It a heavyweight with annual sales of more than $1 billion in 2012, however, Orencia has not yet been approved for listing in ChinaHowever, as early as 2013, Boxei Squibb reached a strategic partnership with Syngenta Pharmaceuticals to jointly develop Abassip in China, with a view to accelerating the listing process in ChinaIn July 2018, CDE began processing applications for the listing of Abaprostod injections, which are present in the country for rheumatoid arthritisAccording to the Insight database, the Abassip injection is in the process of being used in the international multicenter Phase III clinical trial for the treatment of active type III or type IV lupus nephropathyhowever, the prospect of abislop injections in the domestic treatment of rheumatoid arthritis is not optimistic, mainly because the domestic field has a number of biological agents to treat rheumatoid arthritis approved for listing, and three of the students of the national health yisep has an absolute market advantage, and has entered health insuranceAccording to the 2017 Sansheng Pharmaceuticals results report, Essep accounted for 60.4% of the market share in 2017 with full-year sales of RMB1.013 billion, while Johnson and Johnson's Class of C.Saccounted for approximately 20% of the market share, while several of the other drugs performed poorly in the domestic marketin addition, due to the current domestic biologics market penetration and national capacity to pay and other reasons, the future prospects of Abassip injections in the country is not expected to be very optimisticoriginal title: BMS/Syngenta Pharmaceuticals "Abassip Injection" approved for listing
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