康寧傑瑞製藥-B(09966.HK):KN046 II期臨牀試驗於美國獲IND批准
格隆匯3月8日丨康寧傑瑞製藥-B(09966.HK)公吿,一項新藥臨牀申請(IND)已於2021年3月5日獲美國食品藥品監督管理局批准,以在美國啟動集團自主研發的全球首創PD-L1/CTLA-4雙特異性抗體KN046的開放式標籤、多中心II期臨牀試驗(KN046-205)。
KN046-205是一項旨在評估KN046在胸腺癌治療中的療效、安全性及耐受性的臨牀試驗。KN046是集團自主研發的全球首創PD-L1/CTLA-4雙特異性抗體。KN046同時靶向兩個臨牀驗證的免疫檢查點,PD-L1及CTLA-4。目前,KN046在澳大利亞和中國已開展覆蓋十多種腫瘤(包括非小細胞肺癌、三陰乳腺癌、食管鱗癌、肝細胞癌及胰腺癌)的約20項不同階段臨牀試驗。該等臨牀試驗結果初步顯示出KN046具有良好的安全性和有效性。基於在中國及澳大利亞取得的臨牀試驗結果,美國食品藥品監督管理局已批准本集團於美國直接進入KN046的II期臨牀試驗,並已就KN046授予孤兒藥資格,用於治療胸腺上皮腫瘤。目前,旨在評估KN046聯合含鉑化療對局部晚期不可切除或轉移性鱗狀非小細胞肺癌患者的療效及安全性的III期臨牀試驗已在中國啟動。
KN046的臨牀前及臨牀試驗結果展現出良好的有效性,並表明可顯著減少對人體外周系統可能產生的毒副作用。公司認為,KN046有望成為突破性腫瘤免疫特效藥。
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.