迪哲醫藥(688192.SH)：戈利昔替尼(DZD4205)臨牀研究數據獲選2022年第27屆歐洲血液學協會年會口頭報吿
格隆匯5月13日丨迪哲醫藥(688192.SH)公佈，公司領先在研產品戈利昔替尼(golidocitinib，DZD4205)臨牀研究數據入選2022年第27屆歐洲血液學協會(European Hematology Association，EHA)年會口頭報吿，將於2022年6月12日(北京時間)做大會報吿，摘要內容已在大會官網公佈。截至2021年5月31日的臨牀數據顯示戈利昔替尼單藥腫瘤緩解率(ORR)達到42.9%，最長緩解持續時間(DoR)超過14個月。
戈利昔替尼用於治療復發難治性外周T細胞淋巴瘤(r/rPTCL)已於2022年2月獲美國食品藥品監督管理局(FDA)“快速通道認定”(Fast Track Designation)，其早期研究成果已在2021年第16屆國際惡性淋巴瘤大會(ICML)和第24屆全國臨牀腫瘤學大會暨2021年CSCO學術年會入選口頭報吿。
外周T細胞淋巴瘤(PTCL)為惡性非霍奇金淋巴瘤，預後極差。一線治療失敗後，r/rPTCL患者缺少有效治療手段，ORR和五年生存率均低於30%。戈利昔替尼是新一代口服、JAK1特異性抑制劑，對其他JAK家族成員有高於200~400倍的選擇性，因而有望解決其它JAK抑制劑的安全性風險。
戈利昔替尼是T細胞淋巴瘤領域全球首個且迄今為止唯一處於全球關鍵性註冊臨牀階段的高選擇性JAK1抑制劑，也是公司轉化科學的重要研究成果之一。幾年前公司最早注意到JAK/STAT通路可能介導PTCL的發生發展，是治療PTCL的高潛力靶點，並通過體外和體內多種研究模型驗證了戈利昔替尼抗腫瘤活性。公司隨即在全球開展戈利昔替尼用於治療r/rPTCL的臨牀研究，於2019年9月完成首例受試者給藥，目前處於全球關鍵性註冊臨牀試驗階段。除r/rPTCL外，戈利昔替尼對多種血液腫瘤、實體瘤和自身免疫性疾病都有潛在療效。
戈利昔替尼，新一代JAK1特異性抑制劑，對其他JAK家族成員有高於200~400倍的選擇性，首個適應症用於治療r/rPTCL，正在中國、美國、韓國和澳大利亞等國家開展關鍵性註冊臨牀試驗。國際多中心I/II期臨牀試驗顯示戈利昔替尼對於r/rPTCL患者療效顯著，且安全性和耐受性良好，有潛力成為全新的、更有效的靶向治療方案。
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.
