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On September 2, China Biopharmaceuticals announced that TDI01, an innovative drug for fibrosis developed by the group, had submitted and accepted a clinical trial application from the Drug Review Center (CDE) of the State Drug Administration of China.
the application was filed by Beijing Ted Pharmaceuticals, according to CDE's official website.
, TDI01 has been approved for FDA clinical trials in the United States, the product is currently in the United States to launch phase 1 clinical administration trials.
TDI01 is a new target, highly selective Rhho/Rho-related curling helical protein kinase 2 (ROCK2) inhibitor.
, the product is currently being clinically adapted to non-alcoholic fatty hepatitis (NASH) and pulmonary fibrosis.
fibrosis is a fibrous connective tissue or generalized tissue formed by damage or long-term inflammation.
in liver, lung and kidney fibrosis, the loss of tissue can gradually lead to structural damage and functional decline, and even failure.
the body's response to damage involves the recombination of the kinetic protein cytoskeletes of a variety of cells (e.g. endocrine cells, fibroblasts, etc.), while the assembly of the amyoglobulin and the contraction of the myoglobulin are regulated by rock family proteins (including ROCK1 and ROCK2).
TDI01 can inhibit ROCK2, and at the same time has inhibited the fibrosis process, anti-inflammatory and immunomodulation effect, the development of fibrosis in all aspects of the therapeutic role.
: Voluntary Announcement - "TDI01" clinical trial application accepted by CDE. Retrieved Sep 2,2020, from s.2 self-announcement - "TDI01" to the U.S. FDA to submit a new application for acceptance. Retrieved Feb 3,2020, from.