Beijing Shenogen Pharma Group Ltd just received a notification letter fromUS Food and Drug Administration (FDA) to confirm that the Company has beenapproved to start clinical trials in the United States with SNG1153, which was developed to treatpatients with advanced cancer.In addition to Icaritin, SNG1153is another innovative antitumordrug with fully independent intellectual property rights.

SNG1153 is a chemicallysynthesized derivative of Icaritin, which can directly kill cancer cells. In vitro studies havedemonstrated that SNG1153 could inhibit the proliferation of various cancer cells that werederived from liver cancer, lung cancer, melanoma and multiple myeloma(MM). In animal studies, it was observed that SNG1153 inhibited tumor growth in nude mice orthotopicxenograft model with human hepatocellular carcinoma HepG2 liver cellsand nude mice subcutaneous xenograft model with human non-small cell lungcancer (NSCLC) Spc-A-1 cells. Moreover, SNG1153 has significant immune-modulating effect. Itcould inhibit tumor growth in murine melanoma B16/F10 homologous subcutaneoustumor model and down-regulate the expression of PD-L1 and other molecules, and provideadditional possibilities for tumor immunotherapy.

Asa product with Shenogen’s global independent IP rights, SNG1153 receivedIND approval from the former China Food and Drug Administration(CFDA) in May 2018. Now, the approval to conduct clinical trials in USsymbolizes that Shenogen has moved into the fast-track to internationalize thecompany’s anti-tumor drug research. Shenogen will launch a new R&D centerin Boston, US recently to initiate the related clinical trials and push the furtherinternationalization of the innovative immune modulatory small molecule drugSNG1153, and to make new discoveries in combinedimmunotherapy.