片仔癀(600436.SH):獲片仔癀錠劑《藥品註冊補充申請受理通知書》
格隆匯3月2日丨片仔癀(600436.SH)公佈,近日,公司收到國家藥品監督管理局核發的《受理通知書》,公司就片仔癀錠劑增加用於治療中晚期原發性肝癌功能主治提交的藥品註冊補充申請獲國家藥監局的審評受理。
片仔癀是由公司獨家生產的國家中藥一級保護品種,由麝香、牛黃、蛇膽、三七組成,具有清熱解毒、涼血化瘀、消腫止痛的功效,用於治療熱毒血瘀所致急慢性病毒性肝炎,癰疽疔瘡,無名腫毒,跌打損傷及各種炎症。
民間及臨牀多有將片仔癀用於抗腫瘤的案例。2015年版《中藥新藥治療惡性腫瘤臨牀研究技術指導原則》中指出片仔癀等傳統方藥在改善臨牀症狀、抑制腫瘤生長方面顯示出了一定療效。前期探索性臨牀試驗結果顯示,片仔癀用於治療中晚期原發性肝癌具有維護肝功能、減少患者癌症疼痛、改善中醫臨牀症狀,提高患者生存質量的作用,並具有延長總生存期、無進展生存期的趨勢。
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