Everest Medicines, China-based biopharmaceutical startup focused on the development, manufacturing and commercialisation of innovative medicines and vaccines, has announced that Nefecon, the first-in-disease treatment for primary immunoglobulin A nephropathy (IgAN), has been approved by the Hainan Medical Products Administration for clinical use in Shanghai Ruijin Hospital's Hainan subsidiary.

The launch of this early-access programme in Hainan marks the beginning of a new treatment era for IgA nephropathy in China, where Everest can now offer patients a targeted therapy that could fundamentally change their disease progression.

China has the highest prevalence of primary glomerular diseases in the world with an estimated 5 million IgAN patients. There are no approved therapies in the country, and while non-targeted options such as RAS inhibitors are used to treat IgAN, they do not fundamentally alter disease progression. Up to 50% of IgAN patients with disease progression are at the risk of kidney failure within 10-20 years, which may require dialysis or kidney transplant. There is a very significant unmet medical need among IgAN patients in China and other Asian countries.

Nefecon has already been approved and marketed in the United States, the European Union and the UK. It was granted Breakthrough Therapy Designation and Priority Review status in China, and a decision from the National Medical Products Administration is expected in the second half of this year.