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九典制藥(300705.SZ):外用非甾體類抗炎藥PDX-02獲批臨牀
格隆匯 01-17 16:31

格隆匯1月17日丨九典制藥(300705.SZ)公佈,公司近日收到國家藥監局簽發的關於PDX-02的《藥物臨牀試驗批准通知書》,在完成相關準備工作後將開展臨牀試驗研究。經審查,2021年11月8日受理的PDX-02符合藥品註冊的有關要求,同意該藥品PDX-02按改良型新藥進行鎮痛、消炎的臨牀試驗。

PDX-02的適應症為下列疾病及症狀的鎮痛、消炎:骨關節炎、肩周炎、肌腱及腱鞘炎、腱鞘周圍炎、肱骨外上髁炎(網球肘)、肌肉痛、外傷所致腫脹、疼痛。

PDX-02為外用非甾體類抗炎藥物,目前國內外未有該產品處於臨牀試驗階段,國內外尚無該產品獲批上市,亦無相關銷售數據。

目前國內已上市外用非甾體抗炎藥包括雙氯芬酸鈉、吲哚美辛、洛索洛芬鈉、氟比洛芬、吡羅昔康等品種,外用劑型涵蓋凝膠貼膏、貼劑、凝膠、乳膏等劑型。

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