CFDA Granted Approval for Phase I/II/III Clinical Trials of Sihuan Pharmaceutical’s Fadanafil Drug
Thursday, December 15, 2016
Sihuan Pharmaceutical Holdings Group Ltd., a leading pharmaceutical company with the largest cardio-cerebral vascular drug franchise in China’s prescription market, announced that the China Food and Drug Administration (“CFDA”) has granted approval of Phase I/II/III clinical trials of Fadanafil, a Category 1.1 innovative patented drug, developed by Shandong XuanZhu Pharma Co., Ltd. (“Shandong XuanZhu”), a wholly-owned research and development arm of the Group.The intended indications for Fadanafil are benign prostatic hyperplasia-induced lower urinary tract symptoms (BPH-LUTS) and erectile dysfunction(ED).Such dual-purpose treatment that BPH-LUTS and ED can be treated with the same drug is currently not available in the China market, thus should enjoy extensive market prospect once marketed.
In recent years, BPH-LUTS and ED have been highly prevalent in aging men.There are huge unmet clinical needs for such dual-purpose treatment.Fadanafil is a new generation of PDE-5 inhibitor with high selectivity. Preclinical data suggest that Fadanafil possesses excellent intrinsic pharmacokinetics and pharmacodynamics properties, and also a large safety margin. Fadanafil combines merits of multiple drugsand can be used to treat BPH-LUTS and ED simultaneously. Fadanafil potentially obviates the adverse effects reported to be associated with other marketed PDE5 inhibitors.
Dr. Che Fengsheng, Chairman of Sihuan Pharmaceutical, said, “The approval for clinical trial of Fadanafil is another significant progress of Sihuan Phamaceutical’s patented new drug development. Such dual-purpose treatment that BPH-LUTS and ED can be treated with the same drug is currently not available in the China market.If Fadanafil can be marketed successfully in the future, it will fill in the blanks of clinical needs in this therapeutic area of the China market, hold extensive market prospect and significant social value and become a tremendous impetus for Sihuan Pharmaceutical’s future development in the therapeutic area.”
