礼来(LLY.US)减重新药在中国获批关键3期临床

智通财经
Mar 05

智通财经APP获悉,近期,礼来(LLY.US)宣布,新型长效胰淀素受体激动剂eloralintide获中国国家药品监督管理局药品审评中心(CDE)批准,同步在中国开展3项全球关键3期临床研究,用于支持未来该产品在体重管理等多个适应症在中国的注册,以满足肥胖或超重患者及其相关合并症患者的临床需求,提供更多有效且耐受性良好的治疗方案。

Eloralintide是一种强效、选择性、长效胰淀素受体(AMYR)激动剂,能以高亲和力与人胰淀素1型受体(AMY1R)结合,同时保持对人降钙素受体(hCTR)的选择性,在维持体重减轻效果的同时也改善了胃肠道反应,从而实现疗效和耐受性的平衡。Eloralintide对胰淀素受体的选择性可降低与降钙素受体活性相关的潜在风险。因其血浆半衰期较长(约14天),该产品适用于每周一次皮下(SC)给药。

Eloralintide正在被开发用于以下适应症:作为饮食控制和运动的辅助治疗,单独用于肥胖或超重(合并至少1种体重相关合并症)的成人的长期体重管理;为联合治疗,用于已使用稳定剂量肠促胰岛素类药物但未达到治疗目标的成人患者的长期体重管理。

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