百奧泰(688177.SH):注射用BAT8006獲得臨牀試驗批准通知書
格隆匯3月9日丨百奧泰(688177.SH)公佈,公司於近日收到國家藥監局核准簽發的關於公司在研藥品注射用BAT8006的《臨牀試驗批准通知書》。
BAT8006是百奧泰開發的靶向葉酸受體α(FRα)的抗體藥物偶聯物(ADC),擬開發用於實體腫瘤治療。FRα是一種位於細胞膜上的葉酸結合蛋白,在多種實體腫瘤如卵巢癌、肺癌、子宮內膜癌和乳腺癌中過表達。而FRα在正常人體組織中的分佈侷限於腎、肺、脈絡膜叢等器官的頂端表面,表達水平較低。腫瘤組織和正常組織中表達水平的差異使得FRα成為ADC治療FRα表達腫瘤的一個有吸引力的靶點。
BAT8006由重組人源化抗FRα抗體與毒性小分子拓撲異構酶I抑制劑,通過自主研發的可剪切連接子連接而成。BAT8006具有高效的抗腫瘤活性,毒素小分子有很強的細胞膜滲透能力,在ADC殺傷癌細胞後能釋放並殺死附近的癌細胞,產生旁觀者效應,有效克服腫瘤細胞的異質性。
根據《Clinical Development Success Rates2006-2015》公佈的數據,通常情況下對於抗腫瘤藥物,一般I/II期臨牀研究階段持續約2年時間,I期完成進入II期的比率約62.8%,II期完成進入III期的比率約24.6%,公司將分析試驗數據,如果數據能夠成功證明藥物的安全性和有效性,我們將進一步推動後續臨牀試驗。
截至本公吿發布日,全球尚無已獲批上市的抗FRα抗體藥物偶聯物,國內僅有一個抗FRα抗體藥物偶聯物正在進行臨牀試驗,未來相關競品可能會擁有先行者優勢,注射用BAT8006可能在未來面臨激烈的市場競爭。
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.