奥赛康(002755.SZ):子公司注射用奈达铂首家通过仿制药一致性评价
格隆汇 1 月 25日丨奥赛康(002755.SZ)公布,公司的全资子公司江苏奥赛康药业有限公司(“子公司”)于近日收到国家药品监督管理局(“药监局”)核准签发的注射用奈达铂《药品补充申请批准通知书》,批准该药品首家通过仿制药质量和疗效一致性评价。
奈达铂是一种烷化剂类抗肿瘤药,进入细胞水解后与DNA结合,通过阻碍DNA的复制发挥抗肿瘤作用。奈达铂由日本盐野制药公司研发,于1995年在日本上市,规格为10mg、50mg和100mg。子公司研制的注射用奈达铂(奥先达®)于2004年9月在国内首批上市,商品名:奥先达®,规格有10mg、20mg、50mg和100mg;2019年4月子公司首家向CDE提交注射用奈达铂10mg、注射用奈达铂50mg质量一致性评价补充申请,近期首家获得注射用奈达铂10mg、注射用奈达铂50mg药品补充注册批件。
铂类抗癌药物是当今恶性肿瘤化疗的基石,奈达铂是新型第二代铂类抗癌药物,可用于治疗头颈部癌、小细胞肺癌、非小细胞肺癌、食管癌、膀胱癌、精巢(睾丸)肿瘤、卵巢癌、宫颈癌等实体瘤。由于奈达铂与顺铂没有完全交叉耐药,可以有效治疗对铂类耐药的肿瘤患者;奈达铂的毒性与顺铂不一样,它的剂量限制性毒性为骨髓抑制所引起的血小板降低,肾毒性与胃肠道不良反应比顺铂稍轻。PDB数据库显示2019年中国样本医院销售额达2亿元,有较好的临床需求和市场潜力。
据国家相关政策,通过一致性评价的药品品种,质量和疗效等同原研产品,在医保支付及医疗机构采购方面将予以适当支持。在国家鼓励优先采购和使用通过一致性评价的产品的政策背景下,注射用奈达铂通过仿制药一致性评价有利于进一步增强该药品的技术优势,提升市场竞争力,扩大市场份额。
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