东瑞制药(02348.HK)附属抗过敏药物通过一致性评价及抗感染药物获颁发药品注册批件
格隆汇7月15日丨东瑞制药(02348.HK)宣布,集团附属公司苏州东瑞的抗过敏药物"盐酸左西替利嗪片5毫克"(商品名"西可新")已获国家药品监督管理局批准通过仿制药质量和疗效一致性评价。
同时,苏州东瑞的抗感染药物"注射用头孢哌酮钠他唑巴坦钠(4:1)1.0g和2.0g"近期已获得国家药品监督管理局颁发药品注册批件。
盐酸左西替利嗪是一种临床常用的抗过敏药物,具有选择性拮抗组胺H1受体的作用。治疗下述疾病的过敏相关症状,如季节性过敏性鼻炎、常年性过敏性鼻炎、慢性特发性荨麻疹。该药无明显抗胆硷和抗5-羟色胺的作用,故对中枢抑制作用较小,是过敏性鼻炎、荨麻疹患者的一线用药。集团产品"西可新"自2006年上市以来,其优良质量得到临床医生和患者的高度认可。
注射用头孢哌酮钠他唑巴坦钠(4:1)是一种三代头孢药物头孢哌酮钠和β-内酰胺酶抑制剂药物他唑巴坦钠共同组成的抗感染复方制剂。与另一个β-内酰胺酶抑制剂药物舒巴坦钠相比,他唑巴坦钠对β-内酰胺酶的抑制作用更强。临床用于治疗由对头孢哌酮单药耐药、对该品敏感的产β-内酰胺酶细菌引起的中、重度感染。新获得一致性评价批件,不仅是对集团长期以来坚持"质量第一"的方针及产品的质量和疗效的进一步认可,同时也将进一步扩大市场,加速替代原研药进程,为患者提供优质优价的用药选择。
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