亞盛醫藥-B(06855.HK)又獲一項美國FDA孤兒藥認證 2020年總量高達9項創中國生物藥企之最
格隆匯 1 月 5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，用於治療急性髓系白血病(AML)。這是APG-2575繼華氏巨球蛋白血癥(WM)、慢性淋巴細胞白血病(CLL)、和多發性骨髓瘤(MM)適應症之後，獲得的第四個FDA授予的孤兒藥資格認定。截至本公吿日期，亞盛醫藥於2020年共有4個在研新藥獲得共9項FDA孤兒藥認證，創中國生物醫藥企業之最。
AML是一種具有高度異質性的血液系統惡性腫瘤，且主要為一種老年患者疾病，診斷時的中位年齡為68歲。美國國家癌症研究所(NCI)最新的SEER (Surveillance Epidemiology and End Results Program)預估數據顯示，2020年美國將有19,940例新診AML病例，並將有11,180人死於該疾病。儘管近年來在AML的治療方面取得了一定進展，但該疾病的5年生存率為25%–30%，因此臨牀上仍迫切需要更安全、更持久有效的治療手段。
“孤兒藥”又稱為罕見藥，指用於預防、治療、診斷罕見病的藥品。在美國，罕見疾病是指患病人數少於20萬人的疾病。自1983年以來，美國通過《孤兒藥法案》的實施，給予企業相關政策扶持，以鼓勵罕見病藥品的研發。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，特別是該藥物獲批准治療該適應症後可獲得美國市場7年獨佔權。
隨着中國生物醫藥創新力量的崛起，中國生物藥企近年來的“出海”趨勢日益明顯，獲得FDA孤兒藥認定等資格認定也被視為重要的全球化創新實力指標之一。作為一直堅持全球創新的領軍企業，亞盛醫藥無疑是其中佼佼者。截至本公吿日期，亞盛醫藥於2020年共有4個在研新藥獲得共9項FDA孤兒藥認證。公開信息顯示，該數量在中國生物醫藥企業中目前最為領先。
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.
