科倫藥業(002422.SZ):枸櫞酸託法替布片獲藥品註冊批件
格隆匯 6 月 30日丨科倫藥業(002422.SZ)公佈,公司子公司湖南科倫製藥有限公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“枸櫞酸託法替布片”的《藥品註冊批件》。
枸櫞酸託法替布片是輝瑞公司開發的Janus激酶(JAK)抑制劑,2012年在美國首上市,2017年在中國批准進口,用於治療甲氨蝶呤療效不足或對其無法耐受的中重度活動性類風濕關節炎。
類風濕關節炎(RA)是一種以侵蝕性關節炎為主要臨牀表現的自身免疫疾病,臨牀以達到疾病緩解和降低疾病活動度為治療目標,治療藥物包括改善病情抗風濕藥(DMARDs)和對症藥物(非甾體抗炎藥、糖皮質激素等)。改善病情抗風濕藥分為傳統合成類藥物、生物製劑和靶向藥物。
枸櫞酸託法替布片為全球首個批准用於類風濕關節炎的靶向類改善病情抗風濕藥,具有起效速度快、療效優於傳統合成類DMARDs、療效和安全性與生物制劑類DMARDs相當的優勢,目前已被美國風濕病學會《類風濕關節炎治療指南(2015)》、歐洲抗風濕病聯盟《關於改善病情的抗風濕藥物治療類風濕關節炎的建議(2019)》、中國《類風濕關節炎診療指南(2018)》等國內外權威指南或專家建議推薦使用。枸櫞酸託法替布片已進入2019年國家乙類醫保目錄。
2015年國家藥監政策改革,要求新申報的仿製藥必須與原研質量和療效一致。公司本次獲批的枸櫞酸託法替布片(5mg)即是按照這一要求研發,並獲批上市。藥監局公佈的原研產品信息如下:商品名:Xeljanz,持證商:PF PRISM C.V.。
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.