HighLight Pharma today announced that its independently developed oral, highly selective JAK1/TYK2 dual inhibitor, Genoxitenib (TLL-018), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of rheumatoid arthritis (RA).

This designation is based on positive topline data from the Phase III registrational study (TARA) of Genoxitenib. The CDE, following its review, determined that Genoxitenib meets the eligibility criteria for Breakthrough Therapy Designation, as it is intended to prevent or treat a serious, life-threatening, or quality-of-life-impairing disease, and demonstrates more significant or important therapeutic effects compared to existing treatment options.

The TARA study is the world's first RA Phase III clinical trial that uses an already-marketed JAK inhibitor, Xeljanz® (tofacitinib), as the active comparator and has successfully demonstrated superior efficacy. Data showed that Genoxitenib was significantly superior to tofacitinib across both the primary endpoint and all secondary efficacy endpoints (p < 0.0001), including: ACR50 response rate at 24 weeks; ACR20/ACR70 response rates; DAS28 disease activity score; and CDAI low disease activity.

Notably, patients in the tofacitinib group who did not achieve ACR50 showed marked efficacy improvement after switching to Genoxitenib, suggesting that Genoxitenib may remain effective in refractory patients who respond poorly to both biologics and JAK inhibitors. Currently, no drug is approved for refractory RA patients, representing an unmet clinical need. In terms of safety, Genoxitenib was generally well-tolerated, with no new safety signals observed.

Efung Capital participated in HighLight Pharma’s financing rounds in 2020 and 2021. Looking ahead, EF Capital will continue to uphold its original mission of "advancing the industrialization of biotech innovations through capital," and will stand alongside HighLight Pharma to accelerate the market launch of Genoxitenib and the global expansion of its broader pipeline, contributing to the life sciences sector and the development of a Healthy China.