恒瑞医药：产品SHR - 4375注射液获美国FDA孤儿药资格认定

智通财经07-27

【恒瑞医药：产品SHR - 4375注射液获美国FDA孤儿药资格认定】恒瑞医药公告称，公司产品SHR - 4375注射液用于治疗胰腺癌适应症获美国FDA授予的孤儿药资格认定。该注射液是公司自主研发的抗体药物偶联物，国内临床试验已推进至Ⅱ期阶段，相关项目累计研发投入约5870万元。获认定后有望加快临床试验及上市注册进度，还可享政策支持，但后续能否获批上市及时间有不确定性，提醒投资者注意风险。

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