By Fineline Cube 
China-based Sino Biopharmaceutical Limited (HKG: 1177) announced that its self-developed JAK/ROCK dual small molecule inhibitor, rovadicitinib tablets (TQ05105), has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). The drug is intended for the treatment of chronic graft-versus-host disease (cGVHD).
Global Innovation
Rovadicitinib is one of the globally leading JAK/ROCK dual-target inhibitors in development. A marketing application for the indication of intermediate-to-high-risk myelofibrosis (MF) was submitted and accepted in July 2024. The drug is currently in a Phase III clinical trial for cGVHD in China and has also received approval to conduct a Phase II trial in the U.S.
Clinical Trial Results
Previous results from an Ib/IIa study published in the journal Blood demonstrated promising outcomes. In 44 patients with moderate to severe glucocorticoid-refractory or -dependent cGVHD:
- No dose-limiting toxicities were observed.
- There were no drug-related discontinuations.
- The Best Overall Response (BOR) rate was 86.4%.
- The 12-month Failure-Free Survival (FFS) rate was 85.2%.
- 88.6% of subjects were able to reduce their steroid dose.
- 59.1% of subjects experienced symptom improvement.-Fineline Info & Tech