華潤雙鶴(600062.SH):厄貝沙坦分散片國內首家通過一致性評價
格隆匯6月4日丨華潤雙鶴(600062.SH)宣佈,近日,公司全資子公司雙鶴利民收到了國家藥監局核准簽發的厄貝沙坦分散片《藥品補充申請批准通知書》(通知書編號:2021B01604),該藥品通過仿製藥質量和療效一致性評價。該藥品主要用於原發性高血壓以及合併高血壓的2型糖尿病腎病的治療。
雙鶴利民自2018年啟動該藥品的一致性評價工作,於2020年5月8日向國家藥監局提交一致性評價申請,2020年5月14日獲得受理通知書,並於2021年5月24日獲得國家藥監局批准通過一致性評價,也是作為分散片劑型首家通過。
截至該公吿日,雙鶴利民就該藥品開展一致性評價累計研發投入人民幣673.05萬元(未經審計)。
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