綠葉製藥(02186.HK)LY03010在美國NDA審評進程無專利障礙 進展符合預期
綠葉製藥(02186.HK)公佈,向美國食品藥品監督管理局(FDA)提交的棕櫚酸帕利(口派)酮緩釋混懸注射液(LY03010)的新藥上市申請(NDA),在受理後及《美國聯邦食品、藥品和化妝品法》規定的訴訟時限內,未被提起專利侵權訴訟,意味着LY03010在美國NDA審評進程中的專利挑戰獲得成功。
根據《處方藥申報者付費法案》(PDUFA),美國FDA對於LY03010的NDA作出決議的目標日期,爲美國時間2024年7月26日。集團預計將於該產品在美獲批上市後,第一時間開展在美國的商業化推廣。
LY03010是集團自主研發的創新制劑,用於治療精神分裂症和分裂情感性障礙。該產品於2023年獲得美國發明專利授權,專利將於2039年到期。
集團相信,LY03010有望成爲首個在美國獲批的具有自主知識產權的國產棕櫚酸帕利(口派)酮長效注射劑。該產品在美國的上市審評進展符合預期,集團將積極配合FDA的審評要求,併爲接下來的上市批準前檢查做好全面準備。除了在美國,LY03010在中國也已進入上市審評階段。
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.