白云山(600332.SH):分公司苯磺酸氨氯地平片通过一致性评价
格隆汇3月8日丨白云山(600332.SH)宣布,2021年3月8日,公司分公司广州白云山医药集团股份有限公司白云山制药总厂(“白云山制药总厂”)收到国家药品监督管理局签发的《药品补充申请批准通知书》(通知书编号:2021B00498),苯磺酸氨氯地平片已通过仿制药质量和疗效一致性评价。
苯磺酸氨氯地平是二氢吡啶类钙拮抗剂,用于治疗原发性高血压、慢性稳定性心绞痛及变异型心绞痛。
白云山制药总厂苯磺酸氨氯地平片于2007年10月在国内正式上市,并于2019年9月26日向国家药品监督管理局递交一致性评价申请,于2019年10月25日获得受理。
目前中国境内上市的苯磺酸氨氯地平片的生产厂家还包括辉瑞制药有限公司、华润赛科药业有限责任公司、扬子江药业集团上海海尼药业有限公司、浙江尖峰药业有限公司、昆明赛诺制药股份有限公司等。根据米内网数据显示,2019年苯磺酸氨氯地平片在中国公立医院和城市零售药店的销售收入分别为人民币37.31亿元和人民币21.95亿元。
截至公告日,白云山制药总厂针对该药品一致性评价已投入研发费用约人民币437.88万元(未经审计)。2019年度白云山制药总厂该药品的销售收入为人民币129万元,约占白云山制药总厂2019年度的营业收入的0.0335%,约占公司2019年度的营业收入的0.0020%。
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