聖濟堂(600227.SH):聖濟堂製藥鹽酸文拉法辛片通過仿製藥一致性評價
格隆匯1月17日丨聖濟堂(600227.SH)公佈,2023年1月17日,公司全資子公司貴州聖濟堂製藥有限公司(簡稱“聖濟堂製藥”)收到國家藥品監督管理局頒發的關於鹽酸文拉法辛片50mg(按C17H27NO2計)規格(商品名稱:聖濟樂,簡稱“該藥品”)的《藥品補充申請批准通知書》(通知書編號:2023B00182),該藥品通過仿製藥質量和療效一致性評價。
鹽酸文拉法辛片原研廠家為美國惠氏製藥公司,劑型為片劑,上市有多種規格,批准上市的適應症為治療抑鬱症。鹽酸文拉法辛製劑目前在歐盟、美、日等國均有上市。
文拉法辛是選擇性5-羥色胺和去甲腎上腺素再攝取抑制劑(SNRIs)類抗抑鬱藥,是多個國家抑鬱症和廣泛性焦慮障礙防治指南推薦的一線治療藥物。臨牀上具有雙重抑制效果——治療抑鬱症與焦慮症症狀,且不會產生口乾、便祕和視物模糊等副作用,根據其作用機制劃分為第三代抗抑鬱藥物。
截至公吿日,鹽酸文拉法辛片僅有重慶藥友製藥有限責任公司的5個品規視同通過一致性評價,聖濟堂製藥成為鹽酸文拉法辛片劑第2家通過一致性評價的公司。該藥品開展一致性評價工作以來,公司累計投入研發費用約為人民幣263.44萬元。
據米內網數據顯示,2021年中國城市公立醫院、縣級公立醫院、城市社區中心以及鄉鎮衞生院終端和中國城市實體藥店終端鹽酸文拉法辛口服制劑銷售額合計超過7億元。
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.