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基石藥業-B(02616.HK):基石藥業首次美國研發論壇在紐約成功舉辦
格隆匯 01-24 18:38

格隆匯1月24日丨基石藥業-B(02616.HK)公告,2020年基石藥業美國研發論壇於2020年1月21日在美國紐約市成功舉辦。通過此次論壇,基石藥業的管理層分享了公司成立至今在臨牀進展、商務拓展、商業化策略及進程等方面所取得的各項重要成就,並介紹了公司目前的管線戰略佈局。會議期間,中美頂尖學者與關鍵意見領袖共同探討了中國腫瘤治療領域變革發展的最新趨勢。

2020年,公司預計在中國大陸及台灣遞交針對五個適應症的三個新藥上市申請,同時亦計畫披露七項重要臨牀試驗資料,這些進展基於抗PD-L1單抗CS1001、RET抑制劑pralsetinib和KIT及PDGFRA抑制劑AYVAKIT™(avapritinib)。公司也將繼續以滿足中國和全球患者需求為目標,專注開發與商業化創新腫瘤免疫藥物及精準藥物,進一步完成"管線2.0"創新升級,向成熟的創新平台與商業化階段轉型。未來兩至三年內,公司計畫將提交針對大約十個適應症的四個新藥申請。

基石藥業董事長、執行董事兼首席執行官江寧軍表示:"中國生物製藥正處於轉型提升的重要階段,基石藥業是其可喜成果的見證者與推動者一。我們以中國高發癌種及患者需求為出發點,以聯合療法為核心,正高效地推進三十餘項臨牀試驗,包括十三項註冊臨牀試驗和十四項聯合療法試驗。目前本公司正處於從臨牀研發階段向商業化公司轉型的關鍵點,非常高興趙萍在此時作為大中華區總經理和商業運營負責人加入本公司。未來兩至三年內,她將全面領導商業化能力的建設,推動多款創新產品在大中華區成功上市。本公司也將藉助特有的高效早期臨牀藥物研究平台,計畫進一步升級管線,助力中國生物創新走得更遠。"

有關基石藥業的重點消息包括:基石藥業15款腫瘤候選藥物中,五款已處於關鍵性臨牀後期,且註冊性臨牀試驗達13項。公司現階段已完成了早期產品線和聯合治療的戰略佈局,以臨牀開發為引擎,正向商業化階段轉型。2020年,公司預期里程碑最多可達13項。其中包括:

TIBSOVO®(ivosidenib)有望在台灣獲批新藥上市申請,成為公司管線內首款在大中華區商業化上市的產品。該藥將用於治療IDH1突變的復發難治急性髓系白血病。在中國大陸和台灣遞交抗PD-L1單抗CS1001、RET抑制劑pralsetinib和KIT及PDGFRA抑制劑AYVAKIT™(avapritinib)共計五個適應症的新藥上市申請,並計劃披露以上三款藥物共計七項重要臨牀試驗資料。未來兩至三年內,公司將有望在大中華地區上市四款創新產品,覆蓋多個適應症。同時,公司將藉助特有的高效研發平台,進一步升級創新管線,確保本公司管線的持續競爭力。

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