澤璟製藥(688266.SH):在研產品鹽酸傑克替尼片獲得FDA孤兒藥資格認定
格隆匯 12 月 16日丨澤璟製藥(688266.SH)公佈,近日,公司在研產品鹽酸傑克替尼片獲得美國食品藥品監督管理局(“FDA”)頒發孤兒藥資格認定(Orphan-drug Designation),用於治療骨髓纖維化,包括原發性骨髓纖維化、真性紅細胞增多症或原發性血小板增多症繼發的骨髓纖維化。
孤兒藥(Orphan-drug)又稱為罕見病藥,指用於預防、治療、診斷罕見病的藥品。此次獲得FDA頒發的孤兒藥資格認定,有助於鹽酸傑克替尼片在美國的後續研發、註冊及商業化等方面享受一定的政策支持,包括但不限於:(1)臨牀試驗費用的税收抵免;(2)免除新藥申請費;(3)享有7年的市場獨佔權且不受專利的影響。此次認定將在一定程度上降低新藥研發投入,加快推進臨牀試驗及上市註冊的進度。
目前鹽酸傑克替尼片尚未在美國正式開展臨牀試驗。此次獲得孤兒藥資格認定後,公司仍需就鹽酸傑克替尼片用於治療骨髓纖維化的後續臨牀試驗、註冊申報方案等與FDA進行溝通與協商,最終能否成功完成臨牀試驗、獲得FDA上市許可及上市時間均具有不確定性。
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.