海普瑞(09989.HK):注射用Oregovomab III期臨牀試驗申請獲得受理
格隆匯4月27日丨海普瑞(09989.HK)發佈公吿,近日,公司控股子公司深圳昂瑞生物醫藥技術有限公司收到通知,其擁有大中華區權益的針對腫瘤抗原CA125的鼠源IgG1單克隆抗體Oregovomab的III期藥品臨牀試驗申請已獲國家藥品監督管理局受理。
Oregovomab是一個針對腫瘤抗原CA125的鼠源IgG1單克隆抗體。通過在體內與CA125結合成為一種新抗原,從而使其作為免疫靶點且更具免疫原性;進而通過樹突狀細胞的抗原遞呈,可以激活人體細胞免疫系統和抗原特異性T細胞。Oregovomab的全球Ⅱb期臨牀試驗數據顯示了其聯合現有的卵巢癌一線標準化療(以下簡稱“SOC”)與SOC相比,對無進展生存期(PFS)和總生存期(OS)都可帶來顯着臨牀獲益。其中中位無進展生存期(mPFS)達到對照組的3.5倍(分別為41.8個月和12.2個月);與現有SOC相比,病情進展和死亡的風險降低了50%以上;而且安全性數據表明,Oregovomab聯合SOC的治療並沒有導致更多的毒性,這有利於在獲批後Oregovomab與現有卵巢癌一線SOC聯合的治療方案得到臨牀廣泛應用。
Oregovomab獲得了美國食品和藥品監督管理局(FDA)和歐洲藥品管理局(EMA)的孤兒藥資質認定。目前,Oregovomab全球多中心III期臨牀試驗在全球多個臨牀試驗中心招募患者,其中美國臨牀試驗中心已於2020年四季度完成了首例患者給藥。
昂瑞生物為公司與加拿大Oncoquest Inc.在深圳設立的合資公司,納入公司的合併範圍。截至本公吿日,公司在昂瑞生物的持股比例約為 54%。
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.