德展健康(000813.SZ):VGX-3100項目三期試驗達到臨牀療效的主要終點和所有次要終點
格隆匯3月4日丨德展健康(000813.SZ)宣佈,公司於2021年3月3日收到子公司北京東方略生物醫藥科技股份有限公司(簡稱“東方略”)的吿知函,東方略的美國合作方Inovio Pharmaceuticals, Inc.(NASDAQ:INO)(簡稱“Inovio”)公司宣佈了其與東方略聯合研發的一項DNA治療藥物VGX-3100與器械CELLECTRATM 5PSP聯合治療HPV-16/18相關宮頸高度鱗狀上皮內病變(HSIL)的首個III期臨牀試驗(REVEAL 1)的積極結果,在全部可評估受試者中,達到臨牀療效的主要終點和所有次要終點。
VGX-3100是東方略與Inovio公司在DNA免疫治療領域的重點合作開發項目,用於治療由人類乳頭狀瘤病毒(HPV)導致的癌前病變,東方略擁有產品在大中華區(中國大陸、香港、澳門、台灣)開發、生產和商業化的獨家權利,目前已經取得中國CFDA的三期臨牀試驗批件,正在中國同步開展三期臨牀試驗。
VGX-3100一旦獲批上市,將是全球首個被開發用於治療HPV相關癌前病變(宮頸癌前病變、肛門癌前病變、外陰癌前病變等)的非手術治療手段,也是全球第一個DNA藥物。在全球範圍內,這三個適應症目前均無手術之外的治療方式,藥物治療方面暫為空白。
目前VGX-3100正在開展兩個國際多中心III期臨牀試驗,包括REVEAL 1(關鍵性III期試驗)和REVEA L2(驗證性III期試驗),旨在評估和驗證VGX-3100的安全性、耐受性、免疫原性和有效性。REVEAL 1是一項隨機、雙盲、安慰劑對照的臨牀研究,該項臨牀試驗招募了201名HPV-16/18相關宮頸高度鱗狀上皮內病變患者。
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.