基石藥業-B(02616.HK):泰吉華® (阿伐替尼片)轉移至境內生產的藥品上市註冊申請已獲中國藥監局批准
格隆匯6月13日丨基石藥業-B(02616.HK)今日欣然宣佈泰吉華® (阿伐替尼片,300mg)轉移至境內生產的藥品上市註冊申請已獲中國國家藥品監督管理局批准。預計將於2024年底或2025年初起逐步替代現有進口產品,從而實現國產化供應。
基石藥業首席執行官、研發總裁、董事會執行董事楊建新博士表示:"泰吉華®轉移至境內生產的藥品上市註冊申請獲批,標誌着基石藥業在中國市場邁出了堅實的一步。目前,泰吉華®已被納入國家醫保目錄,其可及性和可負擔性顯着提高。地產化產品的上市將進一步提升產品在國內供應的可及性及靈活性,更好地惠及國內患者,繼續強化泰吉華®在中國市場的影響力。該上市申請的獲批是地產化產品在生產工藝、質量標準、體內生物等效性等多維度的研究被監管機構認可的體現。基石藥業將一如既往地致力於通過先進的製造技術、嚴格規範的生產和質量管理體系,確保能夠為國內患者供應高質量的地產化產品。"
泰吉華® 100mg規格地產化上市註冊申請預計將在近期獲批,為醫生和患者提供靈活的用藥規格選擇。此外,基石藥業另一款精準治療藥物普吉華®(普拉替尼膠囊)的地產化上市註冊申請已於今年4月獲得受理,目前正處於審評階段。
泰吉華®已於2021年3月獲中國國家藥品監督管理局(NMPA)批准上市,用於治療攜帶PDGFRA外顯子18突變 (包括PDGFRA D842V突變) 的不可切除性或轉移性GIST成人患者。作為全球首個按驅動基因獲批的GIST精準治療藥物,泰吉華®已在多個臨牀試驗中展示了卓越的療效。在大中華區商業化方面,基石藥業已經通過廣泛的醫生教育和診斷及治療標準化加強了泰吉華®的市場影響力。泰吉華®獲得了國內外多款指南的推薦,包括2023 CSCO胃腸間質瘤診療指南,2022胃腸間質瘤病理診斷臨牀實踐指南,中國系統性肥大細胞增多症診療指南,2023 NCCN胃腸間質瘤指南和2023 NCCN系統性肥大細胞增多症指南。
泰吉華®是由基石藥業合作伙伴Blueprint Medicines公司開發。基石藥業與Blueprint Medicines公司於2018年達成獨家合作和授權協議,獲得了泰吉華®在大中華地區(包括中國大陸、中國香港、中國澳門和中國台灣地區)的獨家開發和商業化權利。
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 this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.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.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.