加利福尼亚州圣迭戈, Dec. 06, 2025 (GLOBE NEWSWIRE) -- Sapu Nano 今日公布了最新的药代动力学 (PK) 和组织分布研究结果，证实基于该公司 Deciparticle™ 专利技术的依维莫司静脉注射 (IV) 制剂 Sapu003 可显著减少药物在胃肠道的蓄积，从而解决了口服依维莫司（Afinitor®）最显著且广为人知的局限性之一。 数据显示，Sapu003 能提供更高的耐受性，同时保留该药物固有的代谢特性，并能提升不同患者之间全身暴露量的一致性。 相较于口服给药，静脉注射的 Sapu003 可将胃肠道部位的依维莫司暴露量降低 67 倍 新的组织分布数据显示，通过静脉给药的 Sapu003 消除了依维莫司口服给药特有的胃肠道部位极端药物蓄积现象。口服给药后，依维莫司的药物浓度在胃部达到血浆浓度的 2,448 倍，在小肠达到血浆浓度的 750 倍，在大肠则达到了血浆浓度的 323 倍，这证实了肠道是依维莫司口服制剂的主要暴露部位。 相比之下，静脉注射的 Sapu003 在相同的胃肠道部位的药物浓度仅为血浆浓度的 36 至 48 倍，这意味着胃部暴露量降低了 67 倍，小 ...

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]

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]

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]