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福森藥業(01652.HK):1.1類中藥創新藥“SY 617”臨牀試驗申請獲得受理
格隆匯 07-12 19:14

格隆匯7月12日丨福森藥業(01652.HK)公吿,集團全資附屬公司嘉亨(珠海橫琴)醫藥科技有限公司已就所研發的SY 617向中國國家藥品監督管理局提交臨牀試驗申請並獲受理。SY 617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,2023年上半年在醫院渠道銷售額超過45億元。

SY 617是成都中醫藥大學附屬醫院(四川省中醫醫院)兩個具有多年以上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》,SY 617毋須進行I期臨牀試驗。因此,其直接提出II期臨牀試驗申請,目前已獲中國國家藥品監督管理局藥品審評中心受理(受理號:CXZL2400038)。

SY 617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。SY 617是繼雙黃連口服液和雙黃連注射液之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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