迪哲醫藥(688192.SH):戈利昔替尼全球註冊臨牀研究成果在2023年美國血液學會(ASH)年會口頭報吿並獲《柳葉刀·腫瘤學》同步發表
格隆匯12月10日丨迪哲醫藥(688192.SH)公佈,公司在第65屆美國血液學會(ASH)年會上,以口頭報吿形式公佈了核心產品戈利昔替尼的全球註冊臨牀試驗(JACKPOT8研究的B部分)的結果,戈利昔替尼治療復發/難治性外周T細胞淋巴瘤(r/rPTCL),中位緩解持續時間(DoR)達20.7個月,相較現有療法呈現出持久的臨牀獲益。這一研究成果同時刊登於國際頂級期刊《柳葉刀·腫瘤學》(Lancet
Oncology,影響因子54.4)。
《柳葉刀·腫瘤學》和ASH年會分別是國際權威的腫瘤學專業期刊和血液學盛會,在全球醫學界享有盛譽。此次戈利昔替尼全球註冊臨牀研究結果在國際頂級學術會議和期刊同步發表,進一步彰顯了國際學術界對該研究和戈利昔替尼臨牀價值的高度肯定。此外,戈利昔替尼的全球I期臨牀研究成果於今年9月刊於《腫瘤學年鑑》(Annals
of
Oncology,影響因子51.8),3個月內連登2大國際頂刊,累計影響因子超100。戈利昔替尼接連斬獲國際最高學術認可,有望為r/rPTCL患者帶來突破性治療新選擇。
戈利昔替尼是全球首個且唯一針對外周T細胞淋巴瘤(PTCL)的高選擇性JAK1抑制劑,於2022年2月獲美國食品藥品監督管理局(FDA)“快速通道認定”(Fast
Track Designation),新藥上市申請於2023年9月獲國家藥品監督管理局(NMPA)藥品審評中心(CDE)受理,並納入優先審評。
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