恆瑞醫藥(600276.SH):上海司太立獲碘帕醇注射液《藥品註冊批件》
格隆匯5月22日丨恆瑞醫藥(600276.SH)公佈,公司此前披露,2020年5月11日,公司與浙江司太立製藥股份有限公司(“浙江司太立”)、上海司太立製藥有限公司(“上海司太立”,浙江司太立和上海司太立合稱“司太立”)簽署合作協議,就碘海醇注射液及碘帕醇注射液的生產、供應及商業化運營開展合作。
上海司太立於近日收到國家藥監局核准簽發的碘帕醇注射液《藥品註冊批件》,藥品名稱:碘帕醇注射液;劑型:注射劑;規格:100ml:37g(I);藥品有效期:12個月;藥品批准文號有效期:截至2025年5月11日。
該藥品適應症:神經放射學:脊髓神經根造影,腦池造影和腦室造影。血管造影:腦血管造影,冠狀動脈造影,胸主動脈造影,腹主動脈造影,心血管造影,選擇性內臟動脈造影,周圍動脈造影和靜脈造影。數字減影血管造影(D.S.A.):大腦動脈D.S.A.,周圍動脈D.S.A.,腹部D.S.A.。尿路造影:靜脈尿路造影。CT檢查中增強掃描。關節造影。瘻道造影。
該藥品的藥品註冊分類為化學藥品4類。根據國家藥監局《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)文件相關規定,該藥品視為通過仿製藥質量和療效一致性評價。
該藥品提交註冊申請並獲得正式受理的時間為2017年10月16日,截至目前,該藥品累計研發投入共計1156.22萬元。
上海司太立獲得國家藥監局簽發的碘帕醇注射液《藥品註冊批件》,標誌着恆瑞和司太立的合作進入了實質階段。恆瑞將在適當的時間對碘帕醇注射液進行商業化運作,並在相關法律、行政法規或部門規章允許的情況下與司太立共同辦理批件轉讓手續,這有利於加深恆瑞和司太立在碘造影劑領域的合作與發展。
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.