SBP GROUP (01177) announced that its wholly-owned subsidiary, Hangzhou Hejiya Biopharmaceutical Co., Ltd. (Hejiya), presented Phase I clinical data for its self-developed Class 1 innovative drug, Kylo-0603, a THR-β small molecule agonist, at the 2026 European Association for the Study of the Liver (EASL) annual meeting. The data, from a first-in-human study in healthy subjects, demonstrated favorable safety and lipid-lowering effects for Kylo-0603.
The pharmacokinetic profile indicated non-linear exposure. Blood concentrations in the 1.2–16 mg dose groups were below the lower limit of quantitation within 8 hours after dosing on Day 1 or Day 14 (with one exception in the 16 mg group), and no accumulation was observed following multiple doses. The half-life of Kylo-0603 ranged from 0.5 to 1.5 hours.
In this study, Kylo-0603 exhibited a good safety and tolerability profile. Adverse events (AEs) showed no treatment- or dose-related trends, and no serious adverse events occurred. Most AEs and all treatment-related AEs (TRAEs) were Grade 1. No gastrointestinal adverse events were reported in the Kylo-0603 group. In the 1.2–16 mg dose groups, elevations in alanine aminotransferase did not exceed 1.5 times the upper limit of normal.
Mean levels of thyroid hormones, including thyroid-stimulating hormone, free triiodothyronine (T3), total T3, free thyroxine (T4), and total T4, fluctuated mostly within normal reference ranges across dose groups, with no symptoms or signs of thyroid dysfunction observed.
On Day 15, clinically meaningful, placebo-corrected reductions in serum low-density lipoprotein cholesterol (LDL-C) levels were observed in the 8mg, 12mg, and 16mg dose groups (p < 0.05). The 12 mg group showed the greatest reduction, reaching 28.5%. Significant reductions in total cholesterol, apolipoprotein B, and triglycerides were also noted.
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