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康宁杰瑞制药-B(09966.HK)治疗胸腺上皮肿瘤新药获孤儿药资格认定
格隆汇 09-03 21:26

格隆汇 9 月 3日丨康宁杰瑞制药-B(09966.HK)宣布,美国食品药品监督管理局("FDA")已向KN046授予孤儿药资格。KN046为公司全资附属公司江苏康宁杰瑞生物制药有限公司("江苏康宁杰瑞")开发的一种重组人源化PD-L1/CTLA-4双特异性抗体,用于治疗胸腺上皮肿瘤("胸腺上皮肿瘤")。这是集团获得的第二个孤儿药资格。早在2020年1月,KN035(集团开发的一种重组人源化单域抗体)获美国FDA授予孤儿药资格,用于治疗胆道癌。

孤儿药资格认定源自1983年孤儿药法案,是美国FDA鼓励开发用于治疗在美国患病人数低于200,000人的罕见疾病的创新药措施。凡获得孤儿药资格认定的候选药物,有机会获得七年市场独占权,以及美国FDA提供的税收减免、生物制品许可证申报费减免、处方药用户费用减免、研发资助、方案协助和快速监管审批通道等一系列配套支持政策。

胸腺上皮肿瘤主要包括胸腺瘤和胸腺癌。胸腺癌不可以手术治疗且转移性胸腺癌预后差。对于铂基化疗治疗失败的患者,目前尚无获批的标准治疗。后线化疗或靶向治疗的客观缓解率不足20%,多线治疗复发的患者中位存活期不足12个月。亟需有效的药物改善患者治疗。KN046澳大利亚I期临床试验在胸腺上皮肿瘤患者中显示出了较高的响应率、持久的应答时间和良好安全性。公司已在美国和中国启动KN046治疗胸腺癌的II期注册临床试验。

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