You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
苑東生物(688513.SH):鹽酸帕洛諾司瓊注射液獲得藥品註冊證書
格隆匯 04-14 16:01

格隆匯4月14日丨苑東生物(688513.SH)公佈,公司於近日收到國家藥監局核准簽發的《藥品註冊證書》,藥品名稱:鹽酸帕洛諾司瓊注射液。經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。質量標準、説明書、標籤及生產工藝照所附執行。藥品生產企業應當符合藥品生產質量管理規範要求方可生產銷售。

鹽酸帕洛諾司瓊注射液,其主要成分為鹽酸帕洛諾司瓊,該藥品適用於預防成人術後24小時內噁心嘔吐(PONV)。鹽酸帕洛諾司瓊是一種新型的第二代5-HT3受體拮抗劑,與其他5-HT3受體拮抗劑相比,鹽酸帕洛諾司瓊具有安全性高、給藥劑量小、半衰期長等優點。

鹽酸帕洛諾司瓊注射液的原研公司為HelsinnHealthcareSA公司,最早於2003年7月在美國上市,隨後在歐洲瑞士、愛爾蘭等多個國家上市銷售,2018年獲批在中國上市,目前為國家醫保乙類品種。國家藥監局官網顯示,國內已有恆瑞醫藥、奧賽康、齊魯製藥等多家企業獲得了該藥品的生產批件。另據米內網數據,鹽酸帕洛諾司瓊注射液2020年在城市公立醫院銷售額近14億元,2021年上半年銷售額約7.39億元。

2021年3月4日,公司向國家藥監局提交的鹽酸帕洛諾司瓊注射液註冊申請獲得受理,截至目前,公司在該產品累計已投入研發費用人民幣約653.49萬元。

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.
uSMART
Wealth Growth Made Easy
Open Account