orforglipron每日一次口服胶囊

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歌礼制药-B:ASC30每日一次口服片在美国Ib期多剂量递增研究中展现出良好且具差异化的药代动力学特征
Zhi Tong Cai Jing· 2025-08-27 23:53
Core Insights - The announcement from the company indicates positive topline pharmacokinetic (PK) data for ASC30, an oral tablet administered once daily, in a Phase Ib multiple ascending dose (MAD) study involving obese subjects [1][2][3] - The study demonstrated that higher drug exposure levels correlate with more significant weight loss, with a 4.5% reduction in the 20 mg cohort and a 6.5% reduction in the 40 mg cohort after 28 days of treatment [1][3] Group 1: Drug Exposure and Weight Loss - In the Phase Ib MAD study, ASC30 drug exposure levels (AUC0-24h) reached 3,560 ng.h/mL for the 20 mg cohort and 5,060 ng.h/mL for the 40 mg cohort, showing a direct relationship with weight loss outcomes [1] - Comparative analysis revealed that ASC30's drug exposure was approximately 2.3 times and 3.3 times higher than orforglipron's exposure at 24 mg, which resulted in a weight loss of only 3.6% [2] Group 2: Safety and Tolerability - The ASC30 oral tablet demonstrated good safety and tolerability, with no serious adverse events (SAEs) reported and no grade 3 or higher adverse events, including gastrointestinal issues [3] - Laboratory tests and vital signs showed no abnormalities, and there were no elevations in liver enzymes during the treatment period [3] Group 3: Competitive Positioning - The company believes that the higher drug exposure levels of ASC30 will lead to more significant weight loss effects compared to small molecule GLP-1 receptor agonists, including orforglipron [3] - The CEO expressed excitement over the data indicating ASC30's competitive and differentiated potential in treating obesity, based on its superior pharmacokinetic profile [3]
歌礼制药-B(01672):ASC30每日一次口服片在美国Ib期多剂量递增研究中展现出良好且具差异化的药代动力学特征
智通财经网· 2025-08-27 23:46
Core Insights - The announcement from the company indicates positive topline pharmacokinetic (PK) data for ASC30, an oral tablet administered once daily, in a Phase Ib multiple ascending dose (MAD) study involving obese subjects with a BMI of 30-40 kg/m² [1][2] - The study demonstrated that higher drug exposure levels correlate with more significant weight loss, with a 4.5% reduction in weight for the 20 mg cohort and a 6.5% reduction for the 40 mg cohort after 28 days of treatment [1][3] Group 1: Pharmacokinetics and Weight Loss - In the Phase Ib MAD study, the drug exposure levels (AUC0-24h) for the 20 mg and 40 mg cohorts were 3,560 ng.h/mL and 5,060 ng.h/mL, respectively [1] - The weight loss results were consistent with the drug exposure levels, indicating that higher exposure leads to more pronounced weight loss effects [1][3] Group 2: Comparison with Orforglipron - ASC30's drug exposure levels were approximately 2.3 times and 3.3 times higher than those of orforglipron (24 mg cohort), which had an AUC0-24h of 1,520 ng.h/mL [2] - The weight loss achieved with orforglipron after 28 days was only 3.6%, indicating that ASC30 may offer superior efficacy in weight reduction [2] Group 3: Safety and Tolerability - The ASC30 oral tablet demonstrated good safety and tolerability, with no serious adverse events (SAEs) reported and no grade 3 or higher adverse events observed [3] - No elevations in liver enzymes or other abnormalities were noted during the study, suggesting a favorable safety profile for ASC30 [3] Group 4: Competitive Positioning - The company believes that the higher drug exposure levels of ASC30 will lead to more significant weight loss compared to other small molecule GLP-1 receptor agonists, including orforglipron [3] - The data from non-human primate studies, which showed higher drug exposure for ASC30, has been successfully translated into human clinical research, enhancing the competitive and differentiated potential of ASC30 in treating obesity [3]
歌礼制药(01672) - 自愿性公告 - 歌礼宣布ASC30每日一次口服片在美国Ib期多剂量递增研...
2025-08-27 23:30
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Ascletis Pharma Inc. 歌禮製藥有限公司 (於開曼群島註冊成立的有限公司) (股份代號:1672) 「基於目前已公開的臨床數據,我們相信對於包括orforglipron在內的小分子GLP-1 受體(GLP-1R)激動劑而言,更高的藥物暴露量會產生更顯著的減重效果,」歌禮 創始人、董事會主席兼首席執行官吳勁梓博士表示,「在非人靈長類動物頭對頭研 究中,ASC30藥物暴露量高於orforglipron,這個數據進一步轉化到了人體臨床研 究中。跨試驗對比顯示,ASC30在人體中的藥物暴露量約為orforglipron的2.3倍至 3.3倍,我們對此感到非常激動。鑒於ASC30更高的藥物暴露量在肥胖受試者中產 生了更顯著的減重效果,我們相信,與orforglipron相比,ASC30每日一次口服片 治療肥胖症具有競爭性及差異化潛力。」 茲提述本公司日期為2025年8月5日的公告,本公司於該公告 ...