來凱醫藥-B(02105.HK):LAE102針對肥胖症治療的IND臨牀方案修訂版已遞交美國FDA
格隆匯3月31日丨來凱醫藥-B(02105.HK)發佈公告,集團已就LAE102針對肥胖症治療適應症,向美國食品藥品監督管理局(“美國FDA”)提交新藥臨牀試驗申請(“IND”)臨牀方案修訂版。2024年4月,LAE102獲得美國FDA的IND批準,用於治療肥胖症患者。
2024年11月,集團與禮來公司(“禮來”)(NYSE:LLY)簽訂一項臨牀合作協議,旨在支持和加速LAE102針對肥胖症治療的全球臨牀開發。禮來將負責在美國執行一項I期研究(“美國I期臨牀試驗”)並承擔相關費用。集團保留LAE102的全球權益。美國I期臨牀試驗預計將於2025年第二季度啓動。集團致力於將這種精準治療帶給那些需要新型治療選擇以實現高質量體重控制的超重和肥胖症患者。
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