恆瑞醫藥(600276.SH):HR011408注射液獲批開展用於治療成人糖尿病的臨牀試驗
格隆匯10月20日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發關於 HR011408注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
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,2021年7月19日受理的HR011408注射液符合藥品註冊的有關要求,同意開展用於治療成人糖尿病的臨牀試驗。
HR011408 注射液是一種速效胰島素的改良性新藥,皮下注射後具有更快的胰島素吸收和降血糖速度,可以更好地模擬生理狀態下餐時胰島素的分泌,臨牀擬皮下注射用於治療成人糖尿病。目前已有2 種同類藥物被美國和歐洲批准用於治療糖尿病,分別為諾和諾德公司的Fiasp®和禮來公司的Lyumjev®,國內尚無超速效胰島素注射液獲批上市。經查詢EvaluatePharma 數據庫,2020 年諾和諾德公司的 Fiasp®全球銷售額為2.12億美元,暫未查詢到2020 年禮來公司的Lyumjev®全球銷售額。
截至目前,HR011408相關研發項目累計已投入研發費用約4052萬元。
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