众生药业(002317.SZ)：利巴韦林片通过仿制药质量和疗效一致性评价
格隆汇 11 月 27日丨众生药业(002317.SZ)公布，近日，公司全资子公司广东华南药业集团有限公司(“华南药业”)收到国家药品监督管理局批准签发的《药品补充申请批准通知书》，通知书编号：2020B04997。华南药业为国内通过利巴韦林片仿制药质量和疗效一致性评价的前三家企业。
利巴韦林适用于呼吸道合胞病毒引起的病毒性肺炎与支气管炎；皮肤疱疹病毒感染。与干扰素α联合使用，治疗成人慢性丙型肝炎。
利巴韦林为人工合成的核苷类药物，具有广谱抗病毒作用，对20多种DNA和RNA病毒都有明显的抑制作用，多年来一直是用于治疗病毒性感染疾病的首选药，临床常用于呼吸道合胞病毒引起的病毒性肺炎、支气管炎，以及联合干扰素用于各型肝炎的治疗。
利巴韦林作为一种广谱抗病毒药，适应症较广泛，是多年来用于治疗病毒性感染疾病的首选药。利巴韦林片是我国国家基本药物目录药物，同是也是医保目录甲类药物。米内网中国城市公立医院化学药终端竞争格局数据库显示，利巴韦林片2017至2019年销售额分别为人民币4873万元，4228万元，4652万元。
公司积极顺应国家仿制药质量和疗效一致性评价政策，公司已开展一致性评价品种十多个，除已通过仿制药一致性评价的盐酸二甲双胍片、异烟肼片、头孢拉定胶囊、氢溴酸右美沙芬片、盐酸乙胺丁醇片、格列齐特片、吡嗪酰胺片和利巴韦林片以外，还有盐酸小檗碱片、格列吡嗪片等4个品种已获得仿制药一致性评价CDE受理，处于审评审批中，目前研发进度符合预期。本次利巴韦林片仿制药质量和疗效一致性评价的通过，是公司及华南药业研发能力、生产及质量管理体系等综合实力的体现，也是国家药品监管部门对上述综合能力和产品质量的认可。对公司有积极影响，有利于提升产品市场竞争力，扩大产品的市场份额及夯实公司在抗病毒药品领域的市场地位。
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