3月27日，中国国家药监局药品审评中心(CDE)官网最新公示，阿斯利康(AZN.US)旗下专注于罕见病领域的Alexion公司申报的1类新药eneboparatide注射液获批临床，拟开发治疗慢性甲状旁腺功能减退症。公开资料显示，这是一款治疗性多肽，具有创新作用机制。2024年3月，阿斯利康宣布以10.5亿美元收购罕见内分泌疾病领域生物技术公司Amolyt Pharma，从而获得这款名为eneboparatide(AZP-3601)的3期临床阶段研发项目。

截图来源：CDE官网

Eneboparatide是一种甲状旁腺激素受体1(PTHR1)激动剂，它通过与PTHR1的特定构象结合，恢复PTH的功能，从而管理HypoPT患者的症状，同时保留肾功能和骨骼健康，旨在满足甲状旁腺功能减退症的治疗目标。该产品已获得美国FDA授予的快速通道资格和孤儿药资格，并获得欧洲药品管理局的孤儿药资格，用于治疗HypoPT。本次这款创新多肽药物在中国获批临床，意味着其即将在中国开展临床研究。

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