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恒瑞醫藥格隆溴銨注射液獲CFDA批臨床

6日,恒瑞醫藥發布公告稱,于近日收到CFDA核準簽發的格隆溴銨注射液的《藥物臨床試驗批件》。

格隆溴銨注射液由百特制藥首先研發,于 1975 年 2 月在美國上市,商品名為 Robinul®,其處方中含有防腐劑苯甲醇。格隆溴銨注射液可直接用于肌內或靜脈注射,用于胃腸道疾病或麻醉,目前已在美國、英國、加拿大、澳大利亞等國家上市,其上市規格為 0.2mg/mL。其中加拿大 Omega 公司的上市產品的處方中不含防腐劑苯甲醇。2016 年格隆溴銨注射液全球市場銷售額約為 2.35 億美元。

經查詢,目前國內已有湖南洞庭藥業的格隆溴銨片上市,暫無格隆溴銨注射液獲批上市。同時,國內已有成都苑東藥業、廣東嘉博制藥、成都天翼醫藥、江蘇恒瑞醫藥等 8 家企業提交格隆溴銨注射液的臨床注冊申請。

恒瑞醫藥于2013 年 8 月 29 日向江蘇省食品藥品監督管理局提交藥品注冊申請并獲受理。格隆溴銨注射液可用于在口服抗膽堿藥無法耐受或需要迅速產生抗膽堿作用時的胃腸道疾病治療并且可用作麻醉前抗毒蕈堿劑。截至目前,公司在格隆溴銨注射液研發項目上已投入研發費用約 280 萬元人民幣。

 

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