聖濟堂(600227.SH):甲巰咪唑原料藥通過CDE技術審評
格隆匯2月21日丨聖濟堂(600227.SH)公佈,近日,公司全資子公司貴州聖濟堂製藥有限公司(以下簡稱:聖濟堂製藥)甲巰咪唑原料藥通過國家食品藥品監督管理總局藥品審評中心(以下簡稱:CDE)技術審評。
藥品適應症:1.甲狀腺功能亢進的藥物治療,尤其適用於不伴有或伴有輕度甲狀腺增大(甲狀腺腫)的患者及年輕患者。2.用於各種類型的甲狀腺功能亢進的手術前準備。3.對於必須使用碘照射(如使用含碘造影劑檢查)的有甲狀腺功能亢進病史的患者和功能自主性甲狀腺瘤患者作為預防性用藥。4.放射碘治療後間歇期的治療。5.在個別的情況下,因患者一般狀況或個人原因不能採用常規的治療措施,或因患者拒絕接受常規的治療措施時,由於對甲硫咪唑片劑(在儘可能低的劑量)耐受性良好,可用於甲狀腺功能亢進症的長期治療。
藥理作用與作用機制:1.通過抑制甲狀腺過氧化物酶所介導的酪氨酸的碘化及偶聯,使氧化碘不能結合到甲狀腺球蛋白上,從而抑制甲狀腺激素的生物合成,但對甲狀腺過氧化物酶並沒有直接抑制作用;2.抑制外周組織的T[XB4 .gif]轉化為T[XB3 .gif];3.輕度抑制免疫球蛋白的合成。
聖濟堂製藥甲巰咪唑原料藥通過CDE技術審評,表明該原料藥通過GMP認證後可生產銷售至國內市場。聖濟堂製藥甲巰咪唑腸溶片(10mg),商品名:“佳必定”於2008年獲得《藥品註冊批件,國藥準字H20080775》,由於無法購買到原料藥,於2012年停產至今,現甲巰咪唑原料通過CDE技術審評,將有利於該藥品未來的市場銷售和市場競爭,對公司的經營業績產生積極影響。公司將密切關注該原料藥的後續進展,並嚴格按照法律法規及時履行信息披露義務。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.