麗珠醫藥(01513.HK)旗下腸溶片獲批臨床試驗
麗珠醫藥(01513.HK)(000513.SZ)公布,全資子公司收到國家藥品監督管理局核準簽發的《藥物臨床試驗批准通知書》,批准公司自主研發的艾普拉唑微丸腸溶片開展臨床試驗。
該產品歷經五年研發,首次提交臨床試驗申請獲得受理的時間為今年8月19日。適應症包括治療十二指腸潰瘍及反流性食管炎;治療兒童十二指腸潰瘍及反流性食管炎;治療非糜爛性胃食管反流病;治療胃潰瘍;根除幽門螺桿菌;預防非甾體抗炎藥導致的胃潰瘍。
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