PhytoHealth

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PHN013 (Orphan drug;ITP)

PhytoHealth PHN013 is an injection developed using extracted, isolated, and highly purified active polysaccharides of Astragalus (Huangqi), and is used in traditional Chinese medicine as an immunostimulant, which is known to be “yi qi bu xu” (beneficial to the energy flow and, and can cure deficiencies in the body). The results of animal testing showed that PhytoHealth PHN013 has the ability to promote the proliferation and maturation of megakaryocytes in bone marrow, leading to the production of platelets. Moreover, PhytoHealth PHN013 has two-way immunoregulatory function that can assist the balance between type 1 and type 2 T helper (Th) cells and regulate regulatory T cells. Hence, PhytoHealth PHN013 could be applied to the treatment of immune thrombocytopenic purpura.

Presently, Phase II trials have been completed, and the results have been submitted to the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare, and the US Food and Drug Administration (FDA). The product has been granted Orphan Drug Designation for the treatment of immune thrombocytopenic purpura, and will soon enter the priority review process, thereby reducing future development time and market launch procedures. In addition, the product has received patent approval in Singapore, the United States, mainland China, Japan, Malaysia, and Taiwan.


Notable achievements

01

Agreed by US FDA for the ITP Phase II clinical trial in 2009.

02

Patented for ITP in Singapore, the United States, China, Japan, Malaysia and Taiwan.

03

The patent application is under reviewed in Europe and South Korea .

04

Granted orphan drug designation by US FDA for treating ITP and it can be reviewed by "Fast Track" mechanism.