片仔癀(600436.SH):新藥PZH2108片獲批臨牀試驗
格隆匯12月1日丨片仔癀(600436.SH)宣佈,近日,公司收到國家藥監局簽發的有關新藥PZH2108片的《藥物臨牀試驗批准通知書》。截至公告日,該藥品項目的研發投入累計約2800萬元。
PZH2108片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癌性疼痛。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PZH2108片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PZH2108片具有良好的安全性、成藥性及臨牀開發價值。
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