药代动力学

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歌礼制药-B在第61届欧洲糖尿病研究协会年会上报告其ASC30口服小分子GLP-1R激动剂 28天多剂量递增研究队列1和队列2的结果
Zhi Tong Cai Jing· 2025-09-17 07:35
Core Insights - The company reported results from its ASC30 oral small molecule GLP-1 receptor agonist study at the 61st EASD Annual Meeting, indicating promising weight loss outcomes in obese subjects [1][5] Study Results - The Ib phase MAD study was randomized, double-blind, and placebo-controlled, assessing the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ASC30 in obese participants (BMI: 30-40 kg/m²) [1] - In MAD cohort 2, ASC30 showed a 6.5% average weight reduction after 28 days of treatment, while cohort 1 showed a 4.5% reduction, both adjusted for placebo [1] - No signs of weight loss plateau were observed by day 29 [1] Pharmacokinetics - ASC30 at 20 mg and 40 mg demonstrated superior oral PK characteristics at steady state, with a positive correlation between higher drug exposure (AUC) and significant weight loss [2] - Key PK metrics for MAD cohorts are summarized, showing differences in Tmax, Cmax, AUCo-24h, and half-life (T1/2) between the two cohorts [3] Safety and Tolerability - ASC30 exhibited good safety and tolerability, with only mild to moderate gastrointestinal adverse events reported [5] - No vomiting was reported in cohort 1, while cohort 2 experienced vomiting primarily during the 10 mg dose escalation week [5] - No serious adverse events (SAE) were reported, and liver enzymes remained stable throughout the study [5]
歌礼制药:ASC30在美国Ib期研究中展现出良好且具差异化的药代动力学特征
Zheng Quan Shi Bao Wang· 2025-08-27 23:53
Core Insights - The core point of the article is that Gilead Sciences-B (01672.HK) announced positive results for its ASC30 oral tablet in a Phase Ib multi-dose escalation study in the U.S., demonstrating favorable pharmacokinetic characteristics compared to orforglipron [1] Group 1: Drug Performance - ASC30 shows a drug exposure level approximately 2.3 to 3.3 times higher than orforglipron, indicating a significant advantage in pharmacokinetics [1] - The higher drug exposure and good tolerability of ASC30 suggest it may be more effective than orforglipron [1] Group 2: Future Research - Gilead plans to conduct a Phase IIa study of ASC30 in overweight or obese subjects, with top-line data expected in the fourth quarter of 2025 [1]
阿斯利康(AZN.US)凡舒卓 新适应症在华获批 用于儿童重度嗜酸粒细胞性哮喘的维持治疗
Zhi Tong Cai Jing· 2025-08-07 07:40
Core Insights - AstraZeneca (AZN.US) announced the approval of its first respiratory biologic, Fasenra (benralizumab), for a new indication in China, specifically for the maintenance treatment of severe eosinophilic asthma (SEA) in children aged 6 to under 12 years [1] Group 1: Approval and Clinical Trials - The approval is based on positive results from the global multicenter, open-label TATE Phase III clinical trial [1] - This trial was conducted in the United States and Japan to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and long-term safety of benralizumab in SEA pediatric patients aged 6-11 years [1] Group 2: Sales Performance - Since its initial approval, benralizumab has shown steady sales growth, entering the $1 billion sales club in 2021 [1] - Global sales are projected to reach $1.689 billion in 2024, reflecting an 8.76% year-over-year growth [1] - According to the semi-annual report disclosed for 2025, the drug's sales for the first half of the year reached $920 million, marking an 18% year-over-year increase [1]