恆瑞醫藥(600276.SH)：SHR6390片納入擬突破性治療品種公示
格隆匯 3 月 18日丨恆瑞醫藥(600276.SH)公佈，公司的SHR6390片近日被國家藥品監督管理局藥品審評中心(“藥審中心”)納入擬突破性治療品種公示名單，公示期7日。
擬定適應症(或功能主治)：SHR6390片聯合氟維司羣用於經內分泌治療後進展的激素受體(HR)陽性、人表皮生長因子受體2(HER2)陰性的復發或轉移性乳腺癌的治療。
理由及依據：經審核，本申請符合《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)有關要求，同意納入突破性治療藥物程序。
SHR6390是江蘇恆瑞醫藥股份有限公司研發的1類新藥，是一種口服、高效、選擇性的小分子CDK4/6抑制劑。全球首個上市的CDK4/6抑制劑為輝瑞公司研發的palbociclib，商品名Ibrance，於2015年2月通過加快審評途徑獲美國食品藥品監督管理局批准上市，用於與來曲唑聯合作為初始內分泌療法治療HR+/HER2-的晚期乳腺癌，並於2016年2月獲批新適應症聯用氟維司羣治療HR+/HER2-內分泌治療後進展的晚期或轉移性乳腺癌。目前Ibrance已在歐盟、日本等多個國家和地區上市；2018年7月輝瑞palbociclib在中國獲批，商品名為愛博新，用於聯用芳香化酶抑製劑作為初始內分泌療法治療HR+/HER2-局部晚期或轉移性乳腺癌。其他已被FDA批准上市的CDK4/6抑制劑有諾華研發的Ribociclib(商品名Kisqali)和禮來研發的Abemaciclib(商品名Verzenio)。目前，輝瑞公司的哌柏西利膠囊(Palbociclib)及禮來公司的阿貝西利片(Abemaciclib)已在中國獲批。經查詢，該產品的同類產品2020年全球銷售額約69.92億美元。
截至目前，SHR6390相關項目累計已投入研發費用約23568萬元。
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.
