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北京时间·🕒 发布 08-03 19:00:33时区推断·⟳ 抓取 08-03 19:01:03·⚡ 决策 08-04 03:24:43 +8h23m·84.6 天前
歌礼制药启动ASC30全球肥胖适应症III期关键试验并披露2028年读数计划
ASC30启动两项全球III期试验、合计约4600名受试者，是口服GLP-1慢性体重管理项目的明确推进。
📄 原文Investing.com↗ 原文
Ascletis initiates global phase III trials for obesity drug ASC30
Oil falls over 4% as Trump calls off Iran strike, announces fresh talks HONG KONG - Ascletis Pharma Inc. (HKEX:1672) an…
不做 歌礼制药（01672.HK）
查重命中08-03 19:02 UTC已处理的同一ASC30全球III期启动催化；当前条目不重复推卡，risk_signals保持为空。
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研究档案
🔎 新鲜度:最早出现 2026-08-03 · 扩散 medium · price-in 风险 medium ↗
关键理由
- ASC30启动两项全球III期试验、合计约4600名受试者，是口服GLP-1慢性体重管理项目的明确推进。
- 公司称现金可支持运营至2029年，覆盖ASC30预计2028年底FDA申报和2029年初EMA申报窗口。
- 但本批当前条目与已处理库08-03 19:02 UTC“歌礼制药ASC30获FDA III期许可并启动全球肥胖关键试验”为同一具体催化，按查重纪律不重复出交易卡。
主要风险
- 已处理库显示同一催化已经决策；当前再次输出交易会造成重复推卡。
反向证据
- 做多前查反向 · 来源 search_processed_events · 日期 2026-08-03 · 影响 invalidates
命中同一具体催化已经在08-03 19:02 UTC决策为值得做，当前条目不重复出交易。
检索:search_processed_events hours=72 limit=200 tickers=01672.HK
工具调用 · 历史记录,结果未知(3 种)
- normalize_ticker · 结果未知
- stock_quote · 结果未知
- search_processed_events · 结果未知
原文全文
展开原文 · 2,101 字
Oil falls over 4% as Trump calls off Iran strike, announces fresh talks
HONG KONG - Ascletis Pharma Inc. (HKEX:1672) announced today it has initiated a global Phase III program for ASC30, an oral small molecule GLP-1 drug for chronic weight management, according to a press release statement.
The program consists of two pivotal trials, AURORA-1 and AURORA-2, which will enroll approximately 4,600 participants with obesity or overweight across the U.S., Europe, and Canada. AURORA-1 will study participants without type 2 diabetes, while AURORA-2 will include participants with type 2 diabetes.
Both trials are multicenter, randomized, double-blind, placebo-controlled studies that will investigate three maintenance doses of once-daily oral ASC30 (20 mg, 40 mg, and 60 mg) compared with placebo. The treatment duration for both studies is 72 weeks, with titration periods ranging from 12 to 20 weeks depending on the dose cohort.
The company expects to announce topline data from the Phase III program in the third quarter of 2028. A New Drug Application filing with the U.S. FDA is expected by the end of 2028, with a Marketing Authorisation Application filing with the European Medicines Agency expected in early 2029.
Ascletis also reported preclinical data for its oral small molecule GLP-1/GIP/amylin triple agonist fixed-dose combination, designated ASC30_48_39FDC. In non-human primates, the triple agonist demonstrated up to 15.2% body weight reduction after seven days of treatment, representing up to 120% greater relative body weight reduction compared to a dual agonist combination.
The company stated it has sufficient cash on hand to support operations into 2029, beyond the expected regulatory submissions for ASC30.
Ascletis is developing a portfolio of five oral small molecule programs spanning GLP-1, GIP, and amylin targets, alone and in fixed-dose combinations, for obesity and metabolic diseases. The company plans IND filings for several candidates throughout 2026.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
HONG KONG - Ascletis Pharma Inc. (HKEX:1672) announced today it has initiated a global Phase III program for ASC30, an oral small molecule GLP-1 drug for chronic weight management, according to a press release statement.
The program consists of two pivotal trials, AURORA-1 and AURORA-2, which will enroll approximately 4,600 participants with obesity or overweight across the U.S., Europe, and Canada. AURORA-1 will study participants without type 2 diabetes, while AURORA-2 will include participants with type 2 diabetes.
Both trials are multicenter, randomized, double-blind, placebo-controlled studies that will investigate three maintenance doses of once-daily oral ASC30 (20 mg, 40 mg, and 60 mg) compared with placebo. The treatment duration for both studies is 72 weeks, with titration periods ranging from 12 to 20 weeks depending on the dose cohort.
The company expects to announce topline data from the Phase III program in the third quarter of 2028. A New Drug Application filing with the U.S. FDA is expected by the end of 2028, with a Marketing Authorisation Application filing with the European Medicines Agency expected in early 2029.
Ascletis also reported preclinical data for its oral small molecule GLP-1/GIP/amylin triple agonist fixed-dose combination, designated ASC30_48_39FDC. In non-human primates, the triple agonist demonstrated up to 15.2% body weight reduction after seven days of treatment, representing up to 120% greater relative body weight reduction compared to a dual agonist combination.
The company stated it has sufficient cash on hand to support operations into 2029, beyond the expected regulatory submissions for ASC30.
Ascletis is developing a portfolio of five oral small molecule programs spanning GLP-1, GIP, and amylin targets, alone and in fixed-dose combinations, for obesity and metabolic diseases. The company plans IND filings for several candidates throughout 2026.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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