科倫藥業(002422.SZ):創新藥KL130008膠囊獲批開展臨牀試驗
格隆匯3月23日丨科倫藥業(002422.SZ)公佈,公司近日獲悉,公司控股子公司四川科倫博泰生物醫藥股份有限公司開發的KL130008膠囊(JAK1/2抑制劑)獲得國家藥品監督管理局(NMPA)增加新適應症的臨牀試驗通知書。經審查,2021年12月30日受理的KL130008膠囊符合藥品註冊的有關要求,同意開展臨牀試驗。
KL130008膠囊是四川科倫博泰生物醫藥股份有限公司開發的具有全球自主知識產權的1類創新藥,靶向JAK1和JAK2激酶的選擇性抑制劑。目前,KL130008膠囊已在中國開展4項臨牀試驗,本次申請為KL130008膠囊增加新適應症,用於重度斑禿患者的治療。
目前,國內外尚無針對該適應症的同類產品獲批上市,2022年1月31日,禮來宣佈Baricitinib在美國遞交的新適應症(斑禿)上市申請處於監管審查階段。
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