新天地(301277.SZ):收到艾司奧美拉唑鈉、他達拉非的化學原料藥上市申請批准通知書
格隆匯9月25日丨新天地(301277.SZ)公佈,2024年9月24日,新天地藥業股份有限公司收到國家藥品監督管理局核准簽發的艾司奧美拉唑鈉原料藥、他達拉非原料藥《化學原料藥上市申請批准通知書》。
艾司奧美拉唑鈉為質子泵抑制藥,通過抑制胃壁細胞的H+/K+-ATP酶,對基礎胃酸分泌和受刺激後的胃酸分泌均產生抑制。可以治療由於胃酸分泌過多所導致的胃和食管反流疾病、胃潰瘍、十二指腸潰瘍等,還可以聯合抗菌藥物治療胃的幽門螺桿菌感染等,在治療胃酸相關疾病方面具有顯著的療效。
他達拉非為磷酸二酯酶抑制劑,通過抑制血管平滑肌上的PDE5,增加體內的環磷鳥苷含量,對男性勃起功能障礙有顯著治療效果;由於其同樣對心血管、肺動脈有一定的擴張作用,亦可用於肺動脈高壓的治療。
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