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    Home > Medical News > Medicines Company News > Tiansli osteoporosis drug minoic acid tablets were approved for drug registration

    Tiansli osteoporosis drug minoic acid tablets were approved for drug registration

    • Last Update: 2021-01-15
    • Source: Internet
    • Author: User
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    On January 6, Tiansli announced that its wholly-owned subsidiary, Jiangsu Tiansli Diyi Pharmaceutical Co., Ltd., received a "drug registration approval" approved by the State Drug Administration for the treatment of osteoporosis in postmenopaedic women.
    was approved clinically in May 2014, human pharmacodynamics trials were completed in December 2015, clinical trials were completed in January 2018, and human bioethics were completed in January 2018 (BE) test, in June 2018 declared CDE (receiving number CYHS1800139), by CDE technical review, and then by the national audit and inspection center clinical site verification, recently obtained the Approval of the State Drug Administration issued the "Drug Registration Approval."
    minophosphate is a new type of nitrogen-containing hexaline bisphosphonate compound, can be used as a first-line treatment for osteoporosis, the drug by inhibiting the bone-breaking cells in the pathways of the synthesis of fankigiophosphate hydroxypropy (FPP), showing the effectiveness of inhibiting bone absorption, and thus the bone metabolic cycle decline, thus playing a role in treating osteoporosis.
    in terms of inhibiting bone absorption, minoic acid is equivalent to pyrethroid acid, 10 times the alenoic acid, 3000 times chloroic acid, and 10,000 times the ethyroic acid.
    Compared to the same oral alenoic acid, minoic acid in a similar effect, the dose of the use of significantly decreased (alenoic acid for 10 mg / day, minolic acid for 1 mg / day), improve patient compliance and reduce the common gastrointestinal adverse reactions of bisphosphonate drugs.
    (Source: Tohoku J Exp Med 230: 141-149) Minoic acid tablets by Japan's Ono Pharmaceutical Industry Co., Ltd. and Japan's Astellas Pharmaceutical Co., Ltd. Jointly developed, it was first approved for listing in Japan in January 2009 under the trade names "Recalbon®" and "Bonoteo®" (Astellas Pharmaceuticals), and has not yet been listed in Japan.
    company's generic drugs and the quality and efficacy of the original drug consistent.
    , the company has invested a total of 22.6898 million yuan in research and development of the project.
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