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    Home > Active Ingredient News > Drugs Articles > 2 imported new drugs to submit a listing application! From Amjin, Bayer

    2 imported new drugs to submit a listing application! From Amjin, Bayer

    • Last Update: 2021-02-14
    • Source: Internet
    • Author: User
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    On February 3, CDE's official website revealed that the application for the listing of Otezla, a PDE-4 inhibitor, and Finerenone, a Bayer MR subject antagonist, was officially accepted by CDE.
    apremilast is a small molecule of phosphodiesterase 4 (phosphodiesterase 4, PDE-4) inhibitor, mainly by regulating intracellular inflammatory factors and anti-inflammatory factors.
    Waste was first approved in the U.S. in March 2014 to treat adult active psoriasis arthritis, and later expanded its adaptation to treat moderate to severe plaque psoriasis and behcet-related mouth ulcers.
    November 2018, April was included in the CDE's list of "first clinically urgent new drugs abroad" on the grounds of "good therapeutic effect and tolerance, oral administration, new target of action, and the current domestic market for psoriasis treatment of drugs without such a mechanism".
    by the Pharmaceutical Rubik's Cube PharmaGo database can be found that there are currently 9 enterprises in The United States to carry out a clinical study of AbsterBE.
    was developed by BMS, a subsidiary of BMS, and in August 2019, Amplity received a global development interest in Apuster for $13.4 billion.
    2020 global sales of $2.195 billion, according to the latest financial results from AXN.
    Finerenone film film piece Finerenone, developed by Bayer, is a potential first-in-class nonsteroidal selective salt corticosteroid inhibitor antagonist (MRA) that reduces the harmful effects of overactivation of salt corticosteroids (MR) (the overactivation of salt corticosteroids is a major driver of kidney and heart damage).
    is currently developing finderone for the treatment of patients with chronic kidney disease (CKD) with type 2 diabetes (T2D).
    Phase III study, codenum FIDELIO-DKD (NCT02540993), showed that finerenone significantly reduced kidney failure in patients with diabetic nephropathy, eGFR decreased by more than 40% from the baseline, or compound incidence of kidney-related deaths, and good safety tolerance compared to placebo.
    January 14 this year, Bayer announced that the FDA had accepted Finerenone's NDA application and granted it priority review eligibility for the treatment of patients with chronic kidney disease (CKD) with type 2 diabetes (T2D).
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