貝達藥業(300558.SZ):MCLA-129注射液藥品臨牀試驗申請獲受理
格隆匯 1 月 11日丨貝達藥業(300558.SZ)公佈,今日,公司收到國家藥品監督管理局簽發的《受理通知書》(受理號:CXSL2100011國),公司申報的MCLA-129注射液的藥品臨牀試驗申請已獲得國家藥品監督管理局受理。
MCLA-129是一款針對EGFR和c-Met雙靶點的雙特異性抗體,擬用於EGFR或MET異常的晚期實體瘤患者的治療。2019年1月,公司與Merus N.V.(NDAQ:MRUS,下稱“Merus公司”)宣佈達成戰略合作,公司取得在中國開發和商業化MCLA-129的獨佔實施許可並負責CMC相關工作,Merus公司保留中國以外的所有全球權益。
一般而言,患者在接受EGFR抑制劑治療一定時間後會產生獲得性耐藥,而c-Met擴增或過表達是獲得性耐藥常見的分子生物學機制。MCLA-129的臨牀前數據顯示,MCLA-129與不同EGFR/c-Met表達水平且不同EGFR突變類型的NSCLC細胞系均能結合,在動物實體瘤移植模型上展現了良好的抗腫瘤作用,理化及藥代動力學性質和安全性均良好。MCLA-129有望有效解決多種機制(特別是c-Met擴增或過表達)產生的EGFR抑制劑耐藥問題,具有為耐藥性NSCLC患者提供益處的潛力。
截至公吿披露日,強生集團楊森公司的EGFR/c-Met雙特異性抗體Amivantamab於2020年12月分別向美國FDA和歐洲EMA遞交了生物製品許可申請(BLA)和營銷授權申請(MAA),用於治療鉑類化療後進展、攜帶EGFR外顯子20插入突變的轉移性非小細胞肺癌患者。國內外其它的同靶點類似藥物均處於臨牀前或臨牀試驗階段,尚無藥物上市。MCLA-129屬於境內外均未上市的治療用生物製品,其註冊分類為治療用生物製品1類。
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.