首藥控股(688197.SH):調整BTK抑制劑SY-1530開發策略
格隆匯11月6日丨首藥控股(688197.SH)公佈,截至目前,全球已有多款BTK抑制劑獲批上市,國內已有5款藥物獲批上市,還有多款管線處於臨牀研究階段。經公司對候選藥物SY-1530的市場競爭格局、開發進度情況、後續註冊臨牀試驗預計投入規模、未來的市場份額及商業回報等因素進行審慎評估,並結合其他核心候選藥物關鍵性臨牀試驗及註冊申報工作的人力、物力和資金需求,公司決定調整SY-1530的後續開發策略,主動終止單藥治療復發/難治性套細胞淋巴瘤(MCL)等B細胞來源非霍奇金淋巴瘤(NHL)的臨牀開發;未來,公司計劃探索SY-1530在其他適應症上的潛力。
SY-1530(注:自2016年起公司統一使用“SY”進行編號命名自研管線,在國家藥品監督管理局等官方平台查詢時需使用CT-1530編號)系公司自主研發的高選擇性、不可逆的新一代BTK激酶抑制劑,按照《化學藥品註冊分類及申報資料要求》相關規定,SY-1530原料藥及製劑屬於1類新藥,並於2016年8月獲得臨牀批件。
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