You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
復宏漢霖(02696.HK):HLX208(BRAF V600E抑制劑)用於治療BRAFV600E突變的成人朗格漢斯細胞組織細胞增生症(LCH)和Erdheim-Chester病(ECD)獲國家藥品監督管理局藥品審評中心正式納入突破性治療藥物程序
格隆匯 04-06 17:50

格隆匯4月6日丨復宏漢霖(02696.HK)公吿,近日,HLX208(BRAF V600E抑制劑)("HLX208")用於治療BRAF V600E突變的成人朗格漢斯細胞組織細胞增生症(LCH)和Erdheim-Chester病(ECD)獲國家藥品監督管理局("NMPA")藥品審評中心("CDE")正式納入突破性治療藥物程序。根據《藥品註冊管理辦法》和《國家藥監局關於發佈<突破性治療藥物審評工作程序(試行)>等三個文件的公吿》(2020年第82號)的相關規定,CDE對納入突破性治療藥物程序的藥物優先配置資源進行溝通交流,加強指導並促進藥物研發。

HLX208是公司於2021年5月自蘇州潤新生物科技有限公司引進的靶向人類BRAF蛋白V600E突變的小分子抑制劑,其在臨牀前研究中展現出優異的療效與安全性。BRAF蛋白是MAPK/ERK信號通路中重要的上游調節因子,其V600E突變可使BRAF蛋白持續激活,是包括結直腸癌、甲狀腺瘤、黑色素瘤、肺癌、腦癌等在內的多種腫瘤及成人朗格漢斯細胞組織細胞增生症(LCH)和Erdheim-Chester病(ECD)等罕見病的潛在靶點。

2022年1月,HLX208單藥或聯合治療BRAF V600E或BRAF V600突變陽性的晚期實體瘤的1b/2期臨牀試驗申請獲NMPA批准。同月,HLX208用於BRAFV600E突變的成人朗格漢斯細胞組織細胞增生症(LCH)和Erdheim-Chester病(ECD)治療的2期臨牀研究於中國境內(不包括港澳台地區,下同)完成首例患者給藥。

2022年11月,HLX208聯合漢斯狀®(斯魯利單抗注射液)及其聯合療法用於治療BRAF V600E或BRAF V600突變陽性的晚期實體瘤的1b/2期臨牀試驗申請(IND)獲NMPA批准。2023年2月,HLX208聯合漢斯狀®(斯魯利單抗注射液)用於非小細胞肺癌(NSCLC)治療的1b/2期臨牀研究於中國境內完成首例患者給藥。

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.
uSMART
Wealth Growth Made Easy
Open Account