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中国生物制药(01177.HK):治疗胃酸相关性疾病药物“艾司奥美拉唑镁肠溶胶囊”获药品注册证书
格隆汇 02-08 16:59

格隆汇 2 月 8日丨中国生物制药(01177.HK)发布公告,集团开发的治疗胃酸相关性疾病药物“艾司奥美拉唑镁肠溶胶囊”(规格:20mg及40mg)已获中国国家药品监督管理局颁发药品注册证书。该产品按照化学药品注册分类新3类申报并获批上市,且视同通过仿制药质量和疗效一致性评价。

根据披露,艾司奥美拉唑通过其特异性的质子泵抑制作用,可减少胃酸分泌,进而达到治疗胃酸相关性疾病的目的。此外,艾司奥美拉唑对根除幽门螺杆菌有效。此次获批上市的艾司奥美拉唑产品剂型为肠溶微丸充填胶囊,易于吞咽,可大幅提高患者的顺应性,而且给药方式更为灵活(可采用与苹果酱同服或鼻胃管方式给药),便利儿童、老年人、精神病患者、吞咽困难患者服用,具有明显的临床使用优势。

公司表示,胃酸相关性疾病的发病率在国内有逐渐上升的趋势,其复发率亦较高,且治疗费用高昂,给患者带来了沉重的经济压力。目前国内仅有片剂的原研药进口,胶囊剂和片剂的仿制产品为数不多,因此集团开发的艾司奥美拉唑镁肠溶胶囊的市场容量大、发展空间可观。

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