博濟醫藥(300404.SZ):“硝石甘膽顆粒”獲得臨牀試驗默示許可
格隆匯3月24日丨博濟醫藥(300404.SZ)公佈,近日,公司全資子公司廣州博濟新藥臨牀研究中心有限公司申報的“硝石甘膽顆粒”獲得國家藥品監督管理局藥品審評中心的臨牀試驗默示許可。
適應症:清熱利濕,利膽止痛。用於慢性膽囊炎屬肝膽濕熱證,症見右肋脹滿或腹痛,善太息,脘腹脹滿,食少納呆,厭食油膩,小便黃赤,舌紅苔黃膩,脈弦滑或弦細。
“硝石甘膽顆粒”處方來源於中醫臨牀應用多年的經驗方,屬於未在國內上市銷售的中藥、天然藥物複方製劑,具有清熱利濕,利膽止痛之功效,主要用於慢性膽囊炎的治療。
此次獲得“硝石甘膽顆粒”臨牀試驗默示許可是新藥研發的階段性成果,不會對公司近期業績產生重大影響。
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