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.
開拓藥業(09939.HK)完成普克魯胺III期註冊性臨牀試驗患者入組
格隆匯 08-05 06:17

格隆匯 8 月 5日丨開拓藥業-B(09939.HK)發佈公告,截至2020年8月4日,集團已在中國就轉移去勢抵抗性前列腺癌(“mCRPC”)根據普克魯胺III期臨牀試驗的最終試驗方案完成患者入組。普克魯胺是一款治療mCRPC的潛在同類最佳藥物。

集團的普克魯胺III期臨牀試驗設計已於2018年4月獲國家藥品監督管理局批准,並於2018年5月開展mCRPC的普克魯胺III期臨牀試驗。集團開展多中心、隨機、雙盲、安慰劑對照的臨牀試驗,評估對阿比特龍及多西他賽治療失敗的mCRPC患者中普克魯胺的安全性及療效。III期臨牀試驗的主要目的為評估對放射線無惡化存活時間(rPFS)及總生存時間(OS)的影響、安全性以及生物標記的發現與普克魯胺藥片(與安慰劑相比)在阿比特龍及多西他賽治療失敗的mCRPC患者中治療mCRPC療效之間的關係,可為普克魯胺的新藥上市申請(“NDA”)提供關鍵臨牀基礎。根據最終試驗方案,集團從全國38個地點招募合共330名合資格患者,並按2:1的比例將彼等隨機分配至測試組及對照組。測試組及對照組的患者數分別為220名及110名。就測試組患者而言,普克魯胺的劑量為每天200毫克(餐後服用)。

III期臨牀試驗進展順利,並未因爆發COVID-19疫情而受到重大影響。集團的目標是在2020年底前向國家藥品監督管理局提交NDA,以將普克魯胺商業化。

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