翰宇药业(300199.SZ):HY3003注射液临床试验申请获受理

智通财经
Sep 10

智通财经APP讯,翰宇药业(300199.SZ)发布公告,公司于近日收到国家药品监督管理局(以下简称“国家药监局”)核准签发关于HY3003注射液临床试验申请的《受理通知书》。

HY3003是翰宇药业与深圳碳云智肽药物科技有限公司(以下简称“碳云智肽”)合作开发的一款新型GLP-1R/GIPR/GCGR三重受体激动剂。该项目通过人工智能结合多肽芯片技术筛选得到新型多肽分子,由翰宇药业负责临床前研究、IND申报及后续临床试验开发。HY3003拟用于减重、2型糖尿病、代谢相关脂肪性肝炎等适应症,是公司在代谢疾病领域布局的重磅创新药品种。本次申报的剂型为注射剂,拟用于减重适应症。

HY3003项目是翰宇药业与碳云智肽在“AI+多肽”领域深度合作的典范。双方基于技术与资源的深度互补——碳云智肽具备“硅基多肽芯片技术”和“AI算法” 优势,负责分子筛选;翰宇药业在多肽药物合成、纯化、制剂开发及临床转化方面积累深厚,负责临床前研究、IND申报、临床试验及产品注册申报,形成了“AI+多肽芯片筛选”与产业化开发相结合的协同路径。

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