Core Viewpoint - The company, Gilead Sciences-B (01672), has seen a stock increase of over 4% following the announcement of its new drug application progress for ASC40, aimed at treating moderate to severe acne [1] Group 1: New Drug Application - Gilead Sciences has completed pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration of China regarding ASC40 for treating moderate to severe acne [1] - The Pre-NDA communication took place from June 2025 to October 2025, with plans to submit the new drug application soon [1] Group 2: Clinical Development Candidates - Gilead Sciences has selected ASC35, a GLP-1R/GIPR dual agonist peptide, as a clinical development candidate, which is expected to be a best-in-class monthly subcutaneous injection [1] - The company plans to submit an Investigational New Drug (IND) application to the FDA for ASC35 in the second quarter of 2026, targeting obesity treatment [1] - ASC35 is being developed as both a monotherapy and combination therapy for treating cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH) [1]
港股异动 | 歌礼制药-B(01672)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