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健康元(600380.SH):“吸入用異丙託溴銨溶液”獲得藥品註冊證書
格隆匯 09-03 19:00

格隆匯 9 月 3日丨健康元(600380.SH)公告,近日,公司收到國家藥品監督管理局核准簽發的《藥品註冊證書》。

一、藥品註冊證書主要內容

藥品通用名稱:吸入用異丙託溴銨溶液

英文名/拉丁名:IpratropiumBromideSolutionforInhalation

劑型:吸入用溶液劑

規格:2ml:0.25mg(按C20H30BrNO3計)、2ml:0.5mg(按C20H30BrNO3計)

申請事項:藥品註冊(境內生產)

註冊分類:化學藥品4類

上市許可持有人:健康元藥業集團股份有限公司

生產企業:深圳太太藥業有限公司

藥品批准文號:國藥準字H20203453、國藥準字H20203454

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。

二、藥品研發及相關情況

公司首次提交吸入用異丙託溴銨溶液註冊獲得受理時間為2019年03月12日,受理號為CYHS1900195、CYHS1900196。本品可與吸入性β-受體激動劑聯合用於治療急性或慢性哮喘引起的可逆性氣道阻塞。本品為本公司自主研發產品。異丙託溴銨為抗膽鹼能藥物,具有較強的支氣管平滑肌鬆弛作用,可明顯改善慢性阻塞性肺疾病(COPD)患者的肺功能和運動耐量,緩解患者呼吸困難的症狀,改善睡眠及生活質量,是治療COPD的主要藥物之一。異丙託溴銨與吸入性β受體激動劑合用,廣泛用於治療哮喘急性發作。

截止本公告日,本公司累計直接投入吸入用異丙託溴銨溶液的研發費用約人民幣1186.98萬元。

目前,公司已完成本品投產前的準備工作,取得藥物註冊批件後即可進行生產和銷售。製劑產品銷售業務易受到國內醫藥行業政策變動、招標採購、市場環境變化等因素影響,存在不確定性,敬請廣大投資者謹慎決策,注意投資風險

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