德琪醫藥-B(06996.HK)：美國合作伙伴研製的XPOVIO®(Selinexor)已獲美國FDA批准用於治療既往接受過至少一次治療的多發性骨髓瘤患者
格隆匯 12 月 20日丨德琪醫藥-B(06996.HK)宣佈，美國食品藥品監督管理局("美國FDA")已批准其合作伙伴Karyopharm Therapeutics Inc.(納斯達克：KPTI)就口服型XPOVIO®(selinexor,ATG-010)提交的補充新藥物申請("sNDA")－與硼替佐米和地塞米松聯合治療既往接受過至少一次治療的多發性骨髓瘤成人患者，此藥物為全球首創口服型選擇性核輸出抑制劑("SINE")。基於驗證性BOSTON三期研究的結果，此項適應症早於Prescription Drug User Fee Act("PDUFA")日期整整三個月獲得批准。
此前，XPOVIO®已經在美國FDA的加速審批計劃中獲得批准，用於治療復發難治性多發性骨髓瘤("rrMM")成人患者，這些患者既往至少接受過包括兩種蛋白酶體抑制劑、兩種免疫調節劑和一種CD38單克隆抗體在內的四次治療。
XPOVIO®是同類首款且唯一一款口服型SINE化合物，也是目前同類首款且唯一一款獲美國FDA批准可用於治療多發性骨髓瘤與瀰漫性大B細胞淋巴瘤的藥物，由Karyopharm研發，德琪醫藥現進行研究。德琪醫藥擁有XPOVIO®包括中國在內的亞太市場的若干獨家開發和商業化授權。2020年12月，美國國家綜合癌症網絡("NCCN®")將三種不同的XPOVIO®治療復發難治性多發性骨髓瘤的聯合方案納入腫瘤臨牀實踐指南("NCCN® Guidelines")。
德琪醫藥已在中國開展兩項XPOVIO®註冊性二期臨牀試驗，分別用於治療復發難治性多發性骨髓瘤(代號：MARCH)和復發難治性瀰漫性大B細胞淋巴瘤(代號：SEARCH)，同時，一項隨機對照、開放性及多中心三期BENCH試驗已獲中國國家藥品監督管理局("NMPA")的臨牀試驗批准。德琪醫藥致力於實現XPOVIO®在亞太地區的商業化，並向新加坡衞生科學局("HSA")與澳大利亞醫療用品管理局("TGA")提交了XPOVIO®用於三種適應症的新藥上市申請("NDAs")，其中包括用於治療既往接受過至少一次治療的多發性骨髓瘤患者。
德琪醫藥創始人、董事長兼首席執行官梅建明博士表示："這是XPOVIO®第三個獲批上市的適應症，凸顯出該產品的臨牀應用潛力與廣闊的市場前景。XPOVIO®為多發性骨髓瘤患者及醫生提供了一款首創的口服型藥物－SINE化合物，也為亟待滿足臨牀需求的癌症患者提供了更多的治療選擇。憑藉自身搭建的商業基礎和經驗豐富的國際化團隊，我們將在取得批准後儘快在亞太地區推出XPOVIO®，造福於rrMM和rrDLBCL患者。"
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.
