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SINO BIOPHARM: The new indication for TDI01 suspension has been included in the breakthrough therapy drug program by CDE.

Breakings ·  Jun 16 18:13

SINO BIOPHARM (01177.HK) Board of Directors announced that the group’s developed innovative Class 1 drug TDI01 suspension "ROCK2 inhibitor" has been included in the breakthrough therapy drug program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, for the treatment of moderate to severe chronic graft-versus-host disease (cGVHD) in patients previously treated with no more than five lines of systemic therapy. The results of the Ib/II clinical study showed that TDI01 demonstrated significant efficacy potential and good safety in moderate to severe cGVHD patients who had undergone 1-5 lines of prior treatment. These results have been presented in a verbal report at the 51st Annual Meeting of the European Society for Blood and Marrow Transplantation.

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