智通财经APP获悉,歌礼制药-B(01672)再涨超18%,截至发稿,涨16.1%,报10.96港元,成交额7990.7万港元。
消息面上,歌礼制药近日公布,同类首创、每日一次口服小分子脂肪酸合成酶(FASN)抑制剂地尼法司他(ASC40)治疗中重度寻常性痤疮的III期临床试验(NCT06192264)达到所有主要、关键次要及次要终点。东吴证券指出,目前痤疮疗法治标不治本,而地尼法司他III期临床达到所有终点,疗效数据优秀,未来有望成为疗效显著、患者依从性高、安全性好的BIC痤疮药物。随着地尼法司他III临床期顺利结束,公司预计将在2025年提交药监局申报上市,2026年贡献收入。
此外,歌礼制药将在美国芝加哥举行的美国糖尿病协会(ADA)第85届科学会议上,以壁报形式报告口服小分子GLP-1受体(GLP-1R)激动剂ASC30,以及脂肪靶向、减重不减肌候选药物ASC47的早期研究数据。东吴证券指出,ASC30是目前唯一一款既可每天口服,也可每月一次皮下注射的GLP-1小分子,满足了不同市场人群的需求,具备稀缺性;ASC47是靶向脂肪细胞THRβ靶点的小分子药物,每月一次皮下注射,有减脂不减肌潜力,是首个THRβ靶点的小分子减肥药。目前I期SAD研究数据已读出,在美国联合司美格鲁肽临床研究已经完成首例患者给药。
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