据悉,替恩戈替尼是一款自主研发、注册性临床阶段的创新多靶点小分子激酶抑制剂,通过靶向肿瘤细胞和改善肿瘤微环境发挥抗肿瘤作用。目前,替恩戈替尼已经在中美两地开展了多项针对胆管癌、前列腺癌、乳腺癌等实体瘤的临床试验,并获得了美国FDA授予的用于治疗胆管癌的“孤儿药认证”(Orphan Drug Designation, ODD)、“快速通道资格认证”(Fast Track Designation),以及用于治疗前列腺癌的“快速通道资格认证”,中国NMPA批准纳入突破性治疗品种名单,欧洲EMA授予的用于治疗胆道癌的孤儿药认证(ODD)。
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