January 18, 2026 – HighLight Pharmaceutical Co., Ltd. announced positive topline data from a pre-specified interim analysis of its Phase III clinical trial (NCT06396026, hereinafter referred to as "the study") evaluating TLL-018 (generic name: Jinoxitinib), an oral small-molecule JAK1/TYK2 inhibitor, for the treatment of Chronic Spontaneous Urticaria (CSU). The interim analysis showed that TLL-018 met the primary endpoint, demonstrating statistically significant superiority over placebo in both primary and multiple secondary efficacy endpoints, along with a favorable safety and tolerability profile, supporting the continued advancement of the study per the established clinical protocol.

In this interim analysis, at Week 12, the TLL-018 treatment group showed significantly greater improvements in both UAS7 and ISS7 scores compared to the placebo group, with between-group differences achieving both statistical and clinical significance (p<0.0001). Additionally, efficacy was observed as early as two days after dosing and continued to strengthen throughout the follow-up period.

The interim analysis showed that the incidence rates of serious adverse events (SAEs) and adverse events requiring intervention were generally comparable between the TLL-018 and placebo groups. No major adverse cardiovascular events (MACE) or drug-related malignancies were observed. Regarding liver safety, the TLL-018 group showed lower elevations in ALT/AST compared to the placebo group, with no drug-induced liver injury observed. Treatment-related adverse events were primarily mild-to-moderate laboratory abnormalities and infectious events, consistent with the known pharmacological profile of JAK inhibitors.

As a highly selective oral small-molecule JAK1/TYK2 inhibitor, TLL-018 (Jinoxitinib) is designed to modulate key immuno-inflammatory signaling pathways for the treatment of various autoimmune and inflammatory diseases. To date, the drug has been evaluated in over 1,000 subjects cumulatively in China and the United States. Currently, TLL-018 is undergoing Phase III clinical trials in China for Chronic Spontaneous Urticaria (CSU) and Rheumatoid Arthritis (RA).