ASCLETIS-B (01672) rose nearly 5% in afternoon trading, reaching a high of HK$18.68, close to its historical peak of HK$18.75. At the time of writing, the stock was up 4.73% to HK$18.6, with a turnover of HK$49.0655 million. The increase follows a recent announcement by Ascletis that it has fully initiated clinical development for ASC30_39FDC, a fixed-dose oral combination of a small molecule GLP-1 receptor agonist and a small molecule amylin receptor agonist. The company plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) in the third quarter of 2026 for the use of this combination in treating obesity. Notably, this is the world's first publicly announced fixed-dose oral combination of a small molecule GLP-1 and a small molecule amylin, marking a key breakthrough in Ascletis' innovative strategy in the metabolic disease field. According to a research report from Soochow Securities, ASC30 is a dual-formulation small molecule GLP-1 agent developed in-house by the company, available in both oral and subcutaneous injection forms. In previously disclosed Phase II clinical data, the oral formulation showed a placebo-adjusted weight loss of up to 7.7% over 13 weeks. The once-monthly subcutaneous injection formulation achieved an average weight loss of 7.5% over 16 weeks. The oral formulation is set to have its Phase III clinical plan submitted to the FDA soon, with the company expecting to formally initiate the trial in Q3 2026. Based on current patient enrollment rates and treatment durations in obesity clinical trials, it is anticipated that data from this clinical study could be available in 2028.
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