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    Home > Active Ingredient News > Drugs Articles > Forty-nine drug approval documents, such as Shagritin, Nirapali and Devasaban, are pending.

    Forty-nine drug approval documents, such as Shagritin, Nirapali and Devasaban, are pending.

    • Last Update: 2020-10-24
    • Source: Internet
    • Author: User
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    On September 11, 2020, the official website of the State Drug Administration released the drug approval documents to be received, which related to the shagritin tablets, the toluene sulfonate nirapali capsules of Reding Pharmaceuticals, and the Devasalban tablets of Jiayi Pharmaceuticals of Jiangsu Province. Nirapalani Rapali is a daily oral small molecule PARP inhibitor developed by TESARO, and in September 2016, Reding Pharmaceuticals entered into a strategic cooperation agreement with TESARO to obtain the exclusive research and development and sales rights of Nirapali in the Chinese market, while TESARO reserves the option to participate in Niraparib's joint sale in China.
    was first approved in the United States in March 2017 for the maintenance of patients with relapsed epitheliotic ovarian, fallopian tube, or primary peritoneal cancer with full or partial remission of platinum chemotherapy, and was approved in Europe in November of the same year.
    based on approvals in the United States and Europe, Nirapali has been approved for listing in Hong Kong and Macau, China, in the previous two years.
    In December last year, the State Drug Administration approved the mainland listing of Nirapali capsules for maintenance treatment in adult patients with platinum-sensitive relapsed epitheliote cancer, fallopian tube cancer or primary peritoneal cancer after platinum-containing chemotherapy has reached full or partial remission.
    And this time Nirapali was approved is the second adaptation the drug has been applied for domestically - for the maintenance of adult patients with advanced epitheliotic ovarian cancer, fallopian tube cancer or primary peritoneal cancer who are fully or partially relieved by first-line platinum-containing chemotherapy.
    new adaptations will further expand Nirapali's prospects for domestic market applications.
    shagritin tablets are a category 4 generic drug, this time through a consistent evaluation, became the second imitation of the species.
    Shagritin was originally developed by BMS as a dipeptide peptide enzyme-4 (DPP-4) inhibitor that selectively inhibits DPP-4, raises endogenetic glucoglycline-like peptide-1 (GLP-1) and glucose-dependent insulin-released polypeptide (GIP) levels and regulates blood sugar, primarily for the treatment of type 2 diabetes in adults.
    the drug was first approved by the FDA in July 2009 and was acquired by AstraZeneca under the name Onglyza®/Anlize ®;
    2019, AstraZeneta's Shagritin sales were $527 million.
    another domestic shagritin generic drug developed by Osaikang, which was approved for sale in China in January 2019, becoming the first domestic DPP-4 inhibitor.
    addition to the two domestic generics already approved for sale, Qilu Pharmaceuticals and Howson Pharmaceuticals have also submitted applications for the listing of Shagritin and are in the "review" phase.
    In addition to shagritin, there are currently 4 varieties (unilateral) of THEP-4 inhibitors listed, respectively, Sigletin, Viglitin, Agritin, Ligligletin, are included in the list of health insurance Class B, and have domestic generic drugs on the market.
    Viglitin is one of the largest number of generic drug listed enterprises, in addition to the original research has been approved for the market of 8 generic drugs, and Viglitin has been included in the volume of procurement, in this national harvest with a maximum of 89% (non-difference ratio) of the decline in the winning bid.
    Deva Saban Jiayi Pharmaceutical 4 classes of generic drugs Deva Saban tablets this review listed, becoming the domestic after Zhengda Qing, Shi Medicine Ohyi, Yangzijiang Pharmaceuticals and Nanjing Zhengda Tianqing after the fifth enterprise of the variety through the consistent evaluation.
    Devasalban is an anticoagulant for adult patients with selected hip or knee replacement surgery to prevent venous thrombosis; Non-valve atrial fibrillation in adult patients with multiple risk factors (e.g. congestive heart failure, hypertension, age ≥75 years of age, diabetes, stroke, or transient cerebral ischemic episodes) reduced the risk of stroke and systemic embolism.
    it is understood that devassaban's original drug was jointly developed by Bayer and Johnson and Johnson.
    Devasalban was first approved for the EUROPEAN market in September 2008 and soon replaced the European market for the drug of its kind.
    March 2009, Deva Saban was approved for listing in China under the name Byrito.
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