World's first oral drug for CKD Anemia approved in China

FibroGen China announced Wednesday that it has received marketing authorisation from the National Medical Products Administration (NMPA) for its domestic class 1 innovative drug roxadustat, a first-in-class oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment of patients with anaemia in chronic kidney disease (CKD) who are dialysis-dependent (DD).

The medicine can be prescribed to patients who use haemodialysis or peritoneal dialysis. This first-in-world approval of a first-in-class medicine by China, for the first time in history, representing the achievement of "3-Firsts" innovation breakthroughs, is of milestone significance.

Roxadustat, a domestic Class 1 innovative drug supported by China's "Significant New Drugs Development" Program under the13th five-year plan, is co-developed by FibroGen China and AstraZeneca China.

FibroGen China sponsored the development and registration of roxadustat, and holds all the regulatory approvals issued by NMPA. Following this approval, FibroGen China will manage manufacturing, and medical affairs, and AstraZeneca China will manage commercialisation activities in China. FibroGen China and AstraZeneca China expect to launch roxadustat in China in the second half of 2019.

Thomas B. Neff, Chief Executive Officer, FibroGen, said: "We believe roxadustat will make a significant difference for patients in China by addressing a substantial unmet medical need in the treatment of anemia associated with chronic kidney disease. This is an exciting milestone, as we are realizing our decade-long commitment to bringing innovative medicine to people in China. We look forward to bringing roxadustat to patients worldwide."

Chris Chung, Managing Director, FibroGen China, said: "We are grateful to the patients and physicians in China who participated in our clinical studies. Almost ten years ago, FibroGen made the decision to develop Roxadustat, a first-in-class investigational candidate, in China as a Domestic Class 1.1 Innovative Drug. It arose out of a commitment to give Chinese patients accelerated access to critically needed innovative medicines. We believe the approval of roxadustat is not only the fruit of China's efforts in sharpening the reform on drug registration review and approval process and stimulation of innovative drugs, but also will hopefully be a catalyst of local innovation blossom in China's pharmaceutical industry, and is entirely consistent with China's course of gearing pharmaceutical R&D and registration to international conventions after its entry into the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)."

Anaemia commonly develops in association with CKD. Based on a large-scale cross-sectional survey performed between September 2009 and September 2010 published in the Lancet, there are an estimated 120 million CKD patients in China, with an estimated 0.5 million patients on dialysis who may be suffering from anaemia, a number that has been increasing significantly.

According to clinical data in China, roxadustat can effectively increase and maintain hemoglobin in dialysis patients with anemia caused by CKD.FibroGen China has also completed a roxadustat Phase III placebo-controlled trial in non-dialysis-dependent (NDD) CKD patients, we are anticipating the addition of NDD patients in the label. Professor Chen Nan, lead principal investigator in the Phase-III clinical trial of roxadustat in China and Professor of Shanghai Jiao Tong University School of Medicine, said: "Roxadustat is a first-in-class drug, with China being the first approval country, not only offers the Chinese nephrology community a chance to lead the world, but also brings an effective and well tolerated new therapy to the Chinese CKD patients with anemia, which is potentially a paradigm shift in the treatment of anemia in CKD, and trigger the second revolution in the treatment of anemia in CKD. "