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.
亞盛醫藥-B(06855.HK):APG-2575獲美國FDA第五個孤兒藥資格認證
格隆匯 01-29 08:01

格隆匯 1 月 29日丨亞盛醫藥-B(06855.HK)發佈公吿,美國食品和藥品監督管理局(FDA)日前授予公司在研原創新藥Bcl-2抑制劑APG-2575孤兒藥資格認定,用於治療濾泡性淋巴瘤(FL)。這是APG-2575繼華氏巨球蛋白血癥(WM)、慢性淋巴細胞白血病(CLL)、多發性骨髓瘤(MM)和急性髓系白血病(AML)適應症之後,獲得的第五項FDA授予的孤兒藥資格認定。截至本公吿日期,亞盛醫藥共有4個在研新藥獲得共10項FDA孤兒藥認證,創中國藥企之最。

孤兒藥”又稱為罕見藥,指用於預防、治療、診斷罕見病的藥品。濾泡性淋巴瘤(FL)是一種異質性疾病,在美國屬於非霍奇金淋巴瘤(NHL)的第二常見類型,約佔所有NHL病例的20%。FL是最常見的惰性B細胞淋巴瘤,由生髮中心B細胞的惡性增殖引起。本次APG-2575獲得美國FDA授予的孤兒藥資格認定,將有助於該藥物在美國的後續研發及商業化開展等方面享受一定的政策支持,包括享有臨牀試驗費用税收減免、免除新藥上市申請(NDA)費用、獲得研發資助等,特別是批准上市後可獲得美國市場7年獨佔權。

APG-2575是亞盛醫藥在研的新型口服Bcl-2選擇性小分子抑制劑,通過選擇性抑制Bcl-2蛋白來恢復腫瘤細胞程序性死亡機制(細胞雕亡),從而殺死腫瘤,擬用於治療多種血液惡性腫瘤。APG-2575是首個在中國進入臨牀階段的、本土研發的Bcl-2選擇性抑制劑。APG-2575現已獲得美國、中國、澳大利亞多項Ib/II期臨牀試驗許可,正在全球同步推進多個血液腫瘤適應症的臨牀開發。

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