基石藥業-B(02616.HK)：avapritinib新藥上市申請在香港地區獲受理用於治療PDGFRAD842V突變無法切除或轉移性胃腸道間質瘤成人患者
格隆匯5月12日丨基石藥業-B(02616.HK)公吿，公司欣然宣佈胃腸道間質瘤("胃腸道間質瘤")同類首創精準靶向藥avapritinib香港地區的新藥上市申請("NDA")已獲受理，用於治療攜帶PDGFRAD842V突變無法切除或轉移性胃腸道間質瘤成人患者。Avapritinib由基石藥業合作伙伴Blueprint Medicines Corporation (NASDAQ:BPMC) 開發，是一款強效、高選擇性口服KIT和PDGFRA抑制劑。
基石藥業首席醫學官楊建新表示：“我們很高興看到avapritinib的新藥上市申請在香港地區獲得受理，這是該產品走向中國患者的又一重要里程碑。由於現有療法的獲益極為有限，PDGFRAD842V突變的GIST患者具有高度未被滿足的治療需求。2020年中國臨牀腫瘤學會("CSCO")會議公佈的數據顯示，avapritinib治療攜帶PDGFRAD842V突變的患者中，所有患者靶病灶均有縮小，並且安全性和耐受性良好，研究中報吿的治療相關不良事件大部分為1級或2級。我們期待avapritinib能夠早日在香港地區獲批上市，惠及更多胃腸道間質瘤患者。”
2020年CSCO會議上公佈的avapritinib的研究數據來自一項開放標籤、多中心的I/II期橋接研究，該研究旨在評估avapritinib治療不可切除或轉移性晚期胃腸道間質瘤中國患者的安全性、藥代動力學特徵和抗腫瘤療效。截至數據截止日期2020年3月31日，共計50例患者納入avapritinib的安全性評估，8例攜帶PDGFRAD842V突變的胃腸道間質瘤患者療效可評估，由研究者依據實體瘤療效評價標準1.1版("RECIST")進行療效評估。
基石藥業與Blueprint Medicines達成獨家合作和授權協議，獲得了包括avapritinib在內的多款藥物在大中華區地區(包括中國大陸、香港、澳門和台灣地區)的獨家開發和商業化授權。Blueprint Medicines將保留全球其他地區的開發和商業化權利。
胃腸道間質瘤是發生於胃腸道("胃腸道")壁的肉瘤，肉瘤是發生在骨內或源自結締組織的腫瘤。胃腸道間質瘤起源於胃腸道壁中的細胞，並且最常發生在胃或小腸中。大多數患者的確診年齡在50至80歲間，通常在胃腸道出血、做手術或醫學影像檢查時發現，極少在腫瘤破裂或胃腸道發生梗阻後確診。原發胃腸道間質瘤中，約有5％至6％的病例由PDGFRAD842V突變導致，這種突變是最常見的PDGFRA外顯子18突變。
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.
