基石药业-B(02616.HK) 公布,已向欧洲药品管理局提交舒格利单抗的新适应症申请,用于治疗同步或序贯放化疗后未出现疾病进展的、不可切除的III期非小细胞肺癌(NSCLC)患者。
若顺利获批,舒格利单抗将填补III期非小细胞肺癌这一疾病领域的关键需求,成为欧洲第二款治疗该适应症的PD-(L)1抗体。同时,舒格利单抗在III期和IV期非小细胞肺癌中的双重应用,将进一步巩固其作为肺癌核心免疫疗法的地位。
基石药业首席执行官、研发总裁及执行董事杨建新表示,基于突出的疗效与良好的安全性,舒格利单抗有望解决III期NSCLC患者极待满足的临床需求。另外,公司将继续深化国际战略合作,并与监管机构紧密协作,以提高舒格利单抗在全球范围内的可及性。(js/da)(港股报价延迟最少十五分钟。)
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