甘李藥業(603087.SH):擬用於治療糖尿病的GZR101獲批臨牀試驗
格隆匯5月12日丨甘李藥業(603087.SH)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)下發的關於公司在研藥品GZR101《藥物臨牀試驗批准通知書》,受理號為CXSL2200110,通知書編號2022LP0784。
GZR101是甘李藥業在研的長效基礎胰島素GZR33與速效門冬胰島素混合製成的雙胰島素複方製劑,擬用於治療糖尿病。
目前,全球已上市的雙胰島素產品僅有諾和諾德旗下的德谷門冬雙胰島素注射液,該產品於2019年5月在中國獲批上市,在華商品名為諾和佳®。德谷門冬雙胰島素注射液是將長效德谷胰島素與速效門冬胰島素按7:3的比例混合而成的雙胰島素預混製劑。
截至2022年3月31日,甘李藥業在GZR101項目中累計投入研發費用1416萬元人民幣。
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