康寧傑瑞製藥-B(09966.HK)：KN046III期臨牀試驗(聯合化療治療晚期不可切除或轉移性鱗狀NSCLC)完成患者入組
格隆匯10月15日丨康寧傑瑞製藥-B(09966.HK)公吿，公司研發的重組人源化PD-L1/CTLA-4雙特異性抗體KN046(研究編號：ENREACH-LUNG-01)的III期臨牀試驗已於2021年10月完成患者入組。
ENREACH-LUNG-01是一項KN046聯合含鉑化療在晚期不可切除或轉移性鱗狀非小細胞肺癌患者中開展的多中心、隨機、雙盲、安慰劑對照性III期臨牀試驗，用以評估KN046的療效及安全性。在中國內地(不包括香港、澳門或台灣)約61家研究中心進行並已入組482例患者。
KN046是集團自主研發的全球性首創PD-L1/CTLA-4雙特異性抗體，同時靶向具有明顯結構差異的PD-L1及CTLA-4，可改變腫瘤微環境的定位及減少脱靶毒性。目前，KN046在中國、美國和澳大利亞已開展覆蓋NSCLC、三陰乳腺癌、食管鱗狀細胞癌、肝細胞癌、胰腺導管腺癌、胸腺癌等10餘種腫瘤的近20個不同階段臨牀試驗。該等臨牀試驗的結果初步顯示KN046在治療中具有良好安全性和顯著療效。
其中，中國II期臨牀試驗的初步結果顯示KN046作為單一療法以及聯合化療在治療NSCLC、胰腺導管腺癌及三陰乳腺癌方面具有良好活性。本集團已發佈KN046在治療既往免疫檢查點抑制劑治療失敗患者的初步及良好安全性和療效數據。本集團已啟動KN046的2項治療NSCLC的關鍵性III期臨牀試驗及1項治療胸腺癌的關鍵性試驗。
集團亦正在探索與其商業合作伙伴候選藥物聯合開展KN046臨牀試驗合作機會，從而實現更好的療效。本集團在選擇適應症時已採用快速╱率先上市方法，且計劃於2022年中在中國提交KN046的首個生物許可證申請。
KN046的臨牀前及臨牀試驗結果顯示出前景良好的療效，並表明KN046可大幅減少對人體外圍系統的毒性。公司相信KN046有潛力被開發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.
