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泰恩康(301263.SZ):博創園將在申請獲批後儘快開展白癜風適應症II期臨牀試驗
格隆匯 07-04 08:50

格隆匯7月4日丨泰恩康(301263.SZ)近期在接待機構調研時表示,公司控股子公司江蘇博創園生物醫藥科技有限公司(以下簡稱“博創園”)已於今年5月取得國家藥品監督管理局簽發的受理通知書,同意受理CKBA軟膏白癜風適應症開展II期臨牀試驗申請,公司目前已做了大量臨牀前期準備工作,博創園將在申請獲批後儘快開展白癜風適應症II期臨牀試驗。

基於對白癜風治療新藥的迫切的臨牀需求和較大的患者基數,公司對CKBA白癜風適應症的臨牀進度相對樂觀,同時公司將集中資源加快推進相關臨牀研究工作,並將根據白癜風適應症Ⅱ期臨牀的進展情況,計劃提交突破性療法認定申請,以進一步加快CKBA治療白癜風適應症1類新藥的上市進度。

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