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福森藥業(01652.HK):1.1類中藥創新藥"SY617"臨牀試驗申請獲得批准
格隆匯 09-19 21:27

格隆匯9月19日丨福森藥業(01652.HK)公吿,集團全資附屬公司嘉亨(珠海橫琴)醫藥科技有限公司所研發的"SY617"已獲中國國家藥品監督管理局批准進行臨牀試驗(批件號:2024LP02103)。SY617的功能主治為疏風解毒、清瘟除濕,用於流行性感冒辨證為風熱夾濕證的治療,症見發熱、頭重如裹、咽痛、惡風、咳嗽、肢體痠痛、胸悶、脘痞、舌質紅,苔白膩或黃膩、脈濡或滑或浮數。

據米內網數據顯示,2022年呼吸系統疾病用藥中成藥排名前三分別是清熱解毒類、止咳祛痰平喘用藥和感冒用藥,感冒用藥中成藥市場規模排在第三位。2022年感冒用藥中成藥在醫院渠道銷售額約為85億元人民幣,2023年上半年在醫院渠道銷售額超過45億元人民幣。

流行性感冒(簡稱流感)是一種由流感病毒引起的,有高度傳染性、高發病率、高變異性、反覆感染的急性呼吸道疾病。目前國際指南推薦及中國上市的主流藥物神經氨酸黴抑制劑具有一定的侷限性,且可能產生耐藥性,迫切需要尋找其他有效的治療措施。中醫藥在消除患者流感症狀、提高患者抗病康復能力以及防止併發症方面有着獨特優勢。

SY617是成都中醫藥大學附屬醫院(四川省中醫醫院)兩個具有多年使用歷史的院內製劑,在中醫藥理論指導下,經過有效加合而開展轉化研究,曾入選四川省中醫藥管理局中醫藥重大科技項目。本品屬於1.1類處方組成符合中醫藥理論、具有人用經驗的中藥創新藥。依據《中藥註冊管理專門規定》,SY617不需要開展I期臨牀試驗,直接申請II期臨牀試驗,已獲中國國家藥品監督管理局批准(批件號:2024LP02103),該申請的獲批具有里程碑意義。SY617在治療流行性感冒辨證為風熱夾濕證等方面展現了非常有利的前景。

SY617是繼雙黃連口服液和雙黃連注射液後的又一款重磅中藥抗感產品,進一步豐富了集團在抗感中成藥治療領域的產品管線。該產品上市後將會為流行性感冒辨證為風熱夾濕證患者提供更多的治療選擇。

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