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片仔癀(600436.SH):PZH2109膠囊的境內生產藥品註冊申請獲審評受理
格隆匯 08-14 17:05

格隆匯 8 月 14日丨片仔癀(600436.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)簽發的《受理通知書》(受理號:CXHL2000371國、CXHL2000372國),公司PZH2109膠囊的境內生產藥品註冊申請獲國家藥監局的審評受理。

PZH2109膠囊是公司具有自主知識產權的化學藥品1類創新藥。該藥品主要用於治療非酒精性脂肪性肝炎(Non-Alcoholic Fatty Liver DiseasesNASH)。根據化學藥品新註冊分類中1類創新藥的有關注冊法規,公司已經完成PZH2109膠囊原料藥以及製劑的藥學、藥理毒理、非臨牀安全性評價等方面的研究,研究結果表明PZH2109膠囊具有良好的安全性、成藥性及臨牀開發價值。

截至公告日,該藥品項目的研發投入累計約2500萬元。

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