高磷血症药!百美特生物「醋酸钙片」首家通过一致性评价

2020-10-15 医药魔方 医药魔方

10月14日,百美特生物的醋酸钙片通过一致性评价,为国内首家。

10月14日,百美特生物的醋酸钙片通过一致性评价,为国内首家。

醋酸钙片是一种磷结合剂,主要用于预防和治疗终末期肾病高磷血症。高磷血症是慢性肾脏病的常见并发症,患者因为肾功能衰竭而出现排磷困难,从而导致高磷血症。如果高磷血症持续过久,体内过高的磷会造成钙质流失,使血液中血钙降低,进而表现为低钙血症。目前中国成人慢性肾病的患病率为10.8%,总数高达1.2亿人,其中终末期肾病患者约为200万人。

国内目前上市的终末期肾病透析患者高磷血症治疗药物主要有司维拉姆、碳酸镧和醋酸钙等。IQVIA数据显示,2018年司维拉姆和碳酸镧在中国境内的销售额约为3.53亿元,这两款药物国内已经均有首仿获批。

医药魔方数据库PharmaGo显示,国内生产销售醋酸钙片的厂家有6家,此前尚未有企业通过一致性评价。除百美特生物外,正在申请或视同申请该药一致性评价的厂家还有5家。

正在申请/视同申请醋酸钙片一致性评价厂家

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    2021-03-04 luwei00
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    2021-09-09 zhanfl
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    2020-10-17 huagfeg

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