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(Alliance News) - Hutchmed China Ltd announced on Wednesday it has received breakthrough therapy designation in China for its autoimmune bleeding disorder treatment.
The Hong Kong-based biopharmaceutical company said the Centre for Drug Evaluation of China's National Medical Products Administration has granted breakthrough therapy designation to HMPL-523, the company's investigational spleen tyrosine kinase inhibitor.
HMPL-523 is a treatment of chronic adult primary immune thrombocytopenia patients. Immune thrombocytopeniais is an autoimmune bleeding disorder characterized by the immunologic destruction of platelets and decreased platelet production.
The treatment is also being studied in non-Hodgkin's lymphoma and multiple subtypes of B-cell malignancies in China, the US and Europe.
China's National Medical Products Administration grants breakthrough therapy designation to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options and where clinical evidence demonstrates significant advantages over existing therapies, Hutchmed explained.
Drug candidates with breakthrough therapy designation may then be considered for conditional approval and priority review when submitting a new drug application.
Chief Executive Christian Hogg said: "The granting of breakthrough therapy designation to HMPL-523 in immune thrombocytopenia highlights the unmet need in this treatment setting and the promising clinical value of this novel oral spleen tyrosine kinase inhibitor. With this designation, we are hopeful that can accelerate the development of HMPL-523 in China."
Shares in Hutchmed were up 1.6% at 504.00 pence on Wednesday in London.
By Heather Rydings; heatherrydings@alliancenews.com
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