新天藥業(002873.SZ)：參股公司子公司獲藥品註冊批件 涉及阿伐那非片
格隆匯5月21日丨新天藥業(002873.SZ)公佈，公司參股公司上海匯倫生物科技有限公司(“匯倫生物”)的全資子公司上海匯倫江蘇藥業有限公司(“匯倫江蘇藥業”)近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》(批件號：2021S00457、2021S00458、2021S00459)，藥品名稱為阿伐那非片。
阿伐那非片為匯倫江蘇藥業開發的仿製藥產品，是一種口服速效的高選擇性磷酸二酯酶-5(PDE-5)抑制劑，用於治療勃起功能障礙(ED)，規格為200mg/片、100mg/片、50mg/片。該品種於2016年10月獲得國家食品藥品監督管理總局頒發的《藥物臨牀試驗批件》，在完成BE研究和III期臨牀研究後，匯倫江蘇藥業於2019年8月按註冊分類3類(境內申請人仿製境外上市但原研未在境內上市)，遞交了上市申請。
根據《美國泌尿外科學會(AUA)發佈的勃起功能障礙管理指南(2018)》，推薦用於ED的口服PDE5抑制劑主要包括西地那非、他達拉非、伐地那非、阿伐那非。與其他PDE-5抑制劑相比，阿伐那非可以在最短時間內起效(15分鐘)，明顯快於現有PDE-5抑制劑類藥物——他達拉非(30分鐘)、西地那非(1小時)、伐地那非(1小時)。且阿伐那非對PDE-1和PDE-6有更高的選擇性，不良反應較其他幾類PDE5抑制劑更小。阿伐那非片最初是由日本田邊三菱製藥株式會社授權美國Vivus公司開發的用於治療男性勃起功能障礙的藥物，於2012年4月27日經美國FDA批准在美國上市，商品名為Stendra。
匯倫生物的全資子公司匯倫江蘇藥業本次獲得“阿伐那非片”藥品註冊證書，有利於公司進一步優化產業佈局，加快在小分子化藥領域的業務拓展，包括抗腫瘤、心腦血管、呼吸及消化系統等疾病的仿製藥及創新藥領域，對公司未來發展將產生積極影響，但不會對公司當期經營業績產生重大影響。
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.
