Today, Glorious Pharmaceuticals announced that its independently developed oral highly selective JAK1/TYK2 dual inhibitor, ganoxitinib (TLL-018), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration for the treatment of rheumatoid arthritis (RA).
This designation is based on positive topline data from the Ganoxitinib Phase III Registration Study (TARA). The CDE (Center for Drug Evaluation) has determined that Ganoxitinib meets the criteria for breakthrough therapy, indicating its use in the prevention and treatment of life-threatening or quality-of-life diseases, and demonstrating a more significant or important therapeutic effect compared to existing treatments.
The TARA study is the world's first Phase III clinical trial of RA using the marketed JAK inhibitor Shangjie® (tofacitinib) as a positive control and achieving the superiority endpoint. Data showed that ganoxitinib was significantly superior to tofacitinib in both the primary endpoint and all secondary efficacy endpoints (p < 0.0001): 24-week ACR50 response rate; ACR20/ACR70 response rate; DAS28 disease activity score; and CDAI low disease activity.
In particular, patients in the tofacitinib group who did not achieve an ACR50 showed significantly improved efficacy after switching to ganoxitinib, suggesting that ganoxitinib may still be effective for refractory patients who have not responded well to biologics and JAK inhibitors. Currently, no drugs are approved for the treatment of refractory RA patients, representing an unmet clinical need. Regarding safety, ganoxitinib was generally well-tolerated, and no new safety risk signals were observed.
Yifeng Capital participated in the investment of Gaoguang Pharmaceutical in 2020 and 2021. Looking to the future, Yifeng will continue to uphold its original intention of "using capital to promote the industrialization of biotechnology achievements", accompany Gaoguang Pharmaceutical to accelerate the listing process of Ganoxitinib and the global expansion of more innovative pipelines, and continue to contribute to the life science cause and the construction of a healthy China.

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