港股异动 | 歌礼制药-B(01672)涨超4% 1 类新药地尼法司他片上市申请获得受理

智通财经
Dec 08, 2025

智通财经APP获悉,歌礼制药-B(01672)涨超4%,截至发稿,涨4.25%,报14.23港元,成交额2682.71万港元。

消息面上,12月4日,CDE 官网显示,歌礼的1类新药地尼法司他片上市申请获得受理。根据该药的临床研究进度,Insight 数据库推测本次申请的适应症为用于治疗中重度寻常性痤疮。地尼法司他 (Denifanstat,ASC40) 是一款潜在 First-in-class、每日一次口服脂肪酸合成酶 (FASN) 抑制剂。该药最初由 Sagimet Biosciences 开发,歌礼拥有其在大中华区的独家权益。

兴业证券此前指出,歌礼制药在减重代谢领域持续投入,聚焦减重赛道核心痛点进行深度管线布局。随着小分子GLP-1R激动剂二期数据的潜在读出以及THRβ管线的进一步进展,公司在减重领域有望持续展现差异化竞争优势。公司引进的痤疮治疗药物ASC40也有望逐渐为公司贡献收入。

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