智通财经APP讯，和黄医药(00013)公布，赛沃替尼(savolitinib)用于经过至少2种治疗后失败的MET基因扩增的局部晚期或转移性胃癌或胃食道连接部腺癌成人患者的新药上市申请已获中国国家药品监督管理局受理，并获纳入优先审评。
该新药上市申请是基于一项在中国开展的赛沃替尼用于治疗伴有MET扩增的胃癌患者的单臂、多中心、开放标签的II期注册研究的数据。该研究已达到依据RECIST 1.1进行评估的客观缓解率(ORR)这一主要终点。该项研究的其他详情可登录clinicaltrials.gov，检索注册号NCT04923932查看。
赛沃替尼已于2023年获国家药监局纳入突破性治疗品种用于该潜在适应症。国家药监局将该创新疗法纳入突破性治疗品种，认可了其作为治疗严重疾病的新疗法，其临床证据表明较现有治疗手段的明显优势。
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