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联康生物科技集团(00690.HK):匹纳普®(伏立康唑片)通过NMPA生物等效性认证
格隆汇 12-09 18:48

格隆汇 12 月 9日丨联康生物科技集团(00690.HK)发布公告,集团匹纳普®(伏立康唑片)已通过国家药品监督管理局(“NMPA”)生物等效性(“BE”)认证,批准文号为H20055751(50mg)。为满足国家提高仿制药质量的要求,集团于2018年启动了质量进步和疗效测试。2019年8月,小组完成了所有BE实验,并将实验结果提交给NMPA。这项批准将有利于其医院招标和上市,特别是在国家采购方面,以在抗真菌感染药物市场取得更大的市场份额。本次批准非常及时,伏立康唑片已于2020年12月8日被列入国家采购公告,集团的匹纳普®将有资格参与。虽然有三家厂家通过了该产品的一致性评价,但只有两家厂家通过了50mg规格的认证,集团是其中之一。因此,该集团在迅速扩大其市场份额方面处于有利地位,在无需大幅降价的基础上提供高质量的伏立康唑片。

匹纳普®(伏立康唑片)是一种治疗严重真菌感染的主要药物。作为临床指南推荐的一线治疗,它通过阻止细胞壁的生长来发挥作用,广泛应用于肿瘤学、血液学、呼吸学、ICUs等免疫功能低下患者。

据IMS统计,2017年中国抗真菌药市场规模为49亿元,其中伏立康唑占比最大,约50%。2014-2017年,抗真菌药物的市场价值保持了两位数的增长,超过了中国医药市场4%-9%的增长水平。根据PDB和Menet的数据,2019年伏立康唑片剂在所有伏立康唑剂型中占比37%,而2017年为35%,口服剂型市场呈上升趋势。由于伏立康唑片作为维持疗法的使用,以及比注射剂型更方便的口服配方,在可预见的未来治疗模式将继续向口服伏立康唑转变。

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