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Icaritin Enters Fast Track Review for NDA
September 15th, 2015, Beijing, China
Icaritin, a Class I Natural Product sponsored by Beijing Shenogen Biomedical Co., Ltd, enters Fast Track Review process after the NDA was submitted to Beijing Food & Drug Administration (BFDA). Shenogen R&D team has been making great efforts in MOA study, biomarker study, extraction process, synthesis process and clinical indication of icaritin over the past nine years. Recently icaritin was cataloged as an immuno-modulator drug in a Nature review paper. Shenogen owns comprehensive domestic and international intellectual properties around icaritin. Icaritin’s development also attracts government funding support including National “Eleventh Five-year Plan”, “Twelfth Five-year Plan”, “Major Scientific and Technological Special Project for Significant New Drug Development” and other provincial and municipal projects. Clinical results show that icaritin safety and efficacy both reach expectation. There’s also breakthrough progress in icaritin mechanism and biomarker studies. Icaritin is a small molecule derived from a Traditional Chinese Medicine (TCM) with the purity above 98%. Experts regard icaritin as the next milestone of TCM modernization after artemisnin.
About Shenogen
Shenogen Pharma Group is a drug discovery and development company based in Beijing, China, that dedicated the development of first-in-class therapeutics for cancer treatment. We possess robust intellectual property rights around a novel membrane-bound estrogen receptor, ER-alpha 36, which is related to tumor metastasis. Under the motto of “Better Medicine, Better Life” and a seasoned management team, together with our partners, Shenogen has developed an impressive product pipeline. Our pipeline consists of novel small molecule and antibody therapeutics for cancer treatment which includes liver cancer, breast cancer, other solid tumors and leukemia. Our lead molecule, icaritin, is completing Ph II clinical trial for treatment of advanced hepatocellular carcinoma.