中国生物制药创新药研究获阳性结果 申请上市在即
财中社12月18日电中国生物制药（01177）发布公告，宣布其自主研发的1类创新药贝莫苏拜单抗注射液联合或不联合盐酸安罗替尼胶囊在非小细胞肺癌（NSCLC）放化疗后巩固治疗的III期研究取得阳性结果。该研究的期中分析显示，贝莫苏拜单抗的联合治疗显著延长了患者的无进展生存期（PFS），并降低了疾病进展或死亡风险。独立数据监查委员会已判定主要研究终点达到预设的优效界值。
此外，公司已与中国国家药品监督管理局药品审评中心（CDE）沟通，并获得书面同意提交上市申请。此次适应症将成为安罗替尼的第11个适应症和贝莫苏拜单抗的第4个适应症，预计将为局部晚期或不可切除的NSCLC患者提供新的治疗选择。公司计划在近期的国际权威学术大会上公布详细研究数据，进一步展示其在创新研发领域的成果。
（文章来源：财中社）
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