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.
香雪製藥(300147.SZ)接到Athenex通知:口服紫杉醇在美國的NDA申請獲得優先審評
格隆匯 09-01 20:25

格隆匯 9 月 1日丨香雪製藥(300147.SZ)公佈,公司ATHENEX, INC. (“Athenex”)201912簽署了《授權協議》,就Athenex在研產品口服紫杉醇、口服伊立替康和KX2-391軟膏的研發、商業化進行合作Athenex授予公司上述在研產品、在授權區域內及領域內獨家開展商業化(包括但不限於開發、標籤、包裝、推廣、生產、分銷、製作、使用、銷售、銷售支持、註冊、商業化或其他在約定領域對許可產品的開發等商業化行為)的權利及為該等商業化目的而享有相關知識產權的權利,截止目前,公司已按協議約定完成技術盡職調查並支付了3000萬美元的預付款。

Athenex早前在美國將用於治療轉移性乳腺癌的口服紫杉醇向美國食品和藥物管理局(FDA)遞交了新藥申請(NDA);近日,公司接到Athenex通知,Athenex收到FDA已完成備案審查正式受理進行實質性審查,並給予申請優先審評權的批復;FDA給予優先審評的標準是申請產品的療法若獲得批准與標準療法相比在治療、診斷或預防嚴重疾病的安全性或有效性得到顯著改善,審評時間將較常規時間短。根據美國處方藥使用者付費法(PDUFA),FDA擬定目標審批日為2021228日。FDA也表明目前來講不準備開諮詢委員會會議來討論此次申請。

Athenex 開發的新一代口服紫杉醇通過與P-gp 抑制劑聯合給藥,能夠有效提高紫杉醇的口服吸收率,降低出現耐藥機制機率。此次口服紫杉醇在美國的NDA申請獲得優先審評,公司認為標誌着該產品在治療轉移性乳腺癌與標準治療手段相比更安全有效的結果得到FDA的肯定,將積極推動口服紫杉醇在中國的申報工作。

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