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东曜药业-B(01875.HK):醋酸甲地孕酮口服混悬液获国家药监局上市许可
格隆汇 05-13 12:14

格隆汇5月13日丨东曜药业-B(01875.HK)宣布,公司进口代理产品醋酸甲地孕酮口服混悬液(TOM218,于2014年在美国获批上市)(“该产品”)获得中国国家药品监督管理局批准,可在中国大陆上市,用于治疗获得性免疫缺陷综合征(“AIDS”)的厌食症,以及AIDS及癌症患者恶病质引起的体重明显减轻。该产品是从安成国际药业股份有限公司进口,规格为125mg╱mL(150mL╱瓶)。公司拥有该产品在中国大陆、香港和澳门的独家代理权,并拟使用商标名称“美适亚®”。

醋酸甲地孕酮口服混悬液主要成分为醋酸甲地孕酮(一种半合成孕激素衍生物),能够改善AIDS和癌症患者的恶病质状态,有效改善食欲、食物摄入量、体重以及有时出现的恶心和呕吐。口服混悬液相较于片剂药品,可以缓解患者吞咽不适感。该产品是目前中国大陆首个获批上市的高浓度醋酸甲地孕酮口服混悬液,其明确了针对治疗恶病质的口服剂量(推荐起始剂量为625mg╱天(5mL╱天))。高浓度醋酸甲地孕酮口服混悬液是在普通混悬剂工艺基础上采用纳米晶体工艺,提高患者治疗依从性,更易被人体吸收。

根据世界卫生组织国际癌症研究机构(IARC)发布的2020年全球最新癌症数据,2020年中国新发癌症病例457万例,癌症死亡病例300万例,而中国10大高发癌种中有6个常伴发恶病质,其中,胃食管及胰腺肿瘤恶病质的发生率超过65%。恶病质是导致肿瘤晚期患者高病死率和生存期缩短的一个重要因素。

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