理解市场 | 歌礼制药-B 现涨超 4% 公司已与国家药监局完成地尼法司他新药上市申请前沟通
ASCLETIS-B is currently up over 4%, as of the time of publication, up 4.29%, priced at HKD 9.49, with a transaction volume of HKD 23.5801 million. In terms of news, ASCLETIS announced that it has recently completed Pre-NDA communication with the National Medical Products Administration of China regarding the new drug application for the treatment of moderate to severe acne with the drug ASC40, and plans to submit the new drug application soon. The Pre-NDA communication began in June 2025 and ended in October 2025. Additionally, ASCLETIS recently announced that it has selected a candidate drug, ASC35, which is expected to become a best-in-class monthly subcutaneous injection GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual-target agonist peptide for clinical development. ASCLETIS expects to submit an IND application for ASC35 for the treatment of obesity to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026. ASC35 is being developed as both a monotherapy and combination therapy for the treatment of cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-associated steatotic liver disease (MASH)
According to the Zhitong Finance APP, ASCLETIS-B (01672) is currently up over 4%, with a rise of 4.29% as of the time of writing, priced at HKD 9.49, with a transaction volume of HKD 23.5801 million.
In terms of news, ASCLETIS announced that it has recently completed Pre-NDA communication with the National Medical Products Administration of China regarding the new drug application for the treatment of moderate to severe acne with Dapansutrile (ASC40), and plans to submit the new drug application soon. The Pre-NDA communication began in June 2025 and ended in October 2025.
Additionally, ASCLETIS recently announced that it has selected a candidate drug, ASC35, which is expected to become a best-in-class once-monthly subcutaneous GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual-target agonist peptide for clinical development. ASCLETIS expects to submit an IND application for ASC35 for the treatment of obesity to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026. ASC35 is being developed as both a monotherapy and combination therapy for the treatment of cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-associated steatotic liver disease (MASH)
