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.
基石药业(02616.HK)合作伙伴向美国FDA提交pralsetinib治疗晚期RET突变和RET融合阳性甲状腺癌新药上市申请
格隆汇 07-20 08:15

格隆汇 7 月 20日丨基石药业-B(02616.HK)发布公告,公司的合作伙伴 Blueprint Medicines Corporation(纳斯达克股份代号:BPMC)于2020年7月上旬宣布向美国食品和药物监管局(“FDA”)提交了 pralsetinib 的新药上市申请,用于治疗晚期或转移性 RET 突变甲状腺髓样癌(“MTC”)和 RET 融合阳性甲状腺癌患者。pralsetinib 是一种在研口服、强效,高选择性抑制 RET 融合和突变,包括预测性耐药突变的精准靶向治疗药物,每日一次服用方便。

Blueprint Medicines 在美国 FDA 即时肿瘤学审评试点项目(“RTOR 专案”)下提交了这一新药上市申请,RTOR 专案是美国 FDA 肿瘤卓越中心的一项新举措。RTOR 专案旨在探索更高效的审查流程,以确保患者尽早获得安全有效的治疗,同时保持并提高美国 FDA 的审查品质。

Blueprint Medicines 于2020年5月宣布,pralsetinib 治疗 RET 融合阳性局部晚期或转移性非小细胞肺癌(“NSCLC”)在美国和欧盟的上市申请已分别获得美国 FDA 受理和欧洲药品管理局验证。

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