康緣藥業(600557.SH):獲得銀翹清熱片藥品註冊證書
格隆匯11月15日丨康緣藥業(600557.SH)公佈,公司於2021年11月15日收到國家藥品監督管理局簽發的《藥品註冊證書》。藥品通用名稱:銀翹清熱片。
適應症:辛涼解表,清熱解毒。用於外感風熱型普通感冒,症見發熱、咽痛、惡風、鼻塞、流涕、頭痛、全身痠痛、汗出、咳嗽、口乾,舌紅、脈數。
銀翹清熱片是 2020年7月1日新的中藥註冊分類實施以來首個獲批上市的1.1類中藥創新藥,其處方是中國工程院院士王永炎教授在温病名方“銀翹敗毒湯”基礎上,結合自身治療風熱感冒經驗化裁而來的臨牀經驗方,既具有祛風清熱,發表解肌,又具有清瀉肺熱,利咽止痛,瀉火解毒,止咳化痰的治療作用。
多中心、隨機、雙盲、安慰劑/陽性藥平行對照臨牀試驗結果顯示,治療3天后,銀翹清熱片組主症(發熱、咽痛、惡風、鼻塞、流涕)消失率為62.12%、銀翹解毒片陽性藥組為27.50%、安慰劑組為14.29%;銀翹清熱片組與安慰劑組主症消失率差值為47.83%,P<0.0001;銀翹清熱片組與銀翹解毒片組主症消失率差值為34.62%,P<0.0001,治療外感風熱型普通感冒具有較好的臨牀療效。
公司擁有該新藥獨立完整的知識產權。截至目前,公司對銀翹清熱片項目累計研發投入約3200.37萬元。
據米內網城市公立、誠市社區、縣級公立、鄉鎮衞生感冒藥中成藥數據顯示,2018年銷售額62.96億,2019年銷售額70.59億,2020年銷售額66.43億,2021年上半年度37.40億;同時,該類中成藥在藥店銷售遠超醫院銷售,市場潛力巨大。
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