Nefecon receives green light for clinical use
Everest Medicines, a Hong Kong-listed Chinese biopharmaceutical company, announced on Monday that the Hainan Medical Products Administration has approved the clinical use of Nefecon, the first-in-disease treatment for primary immunoglobulin A nephropathy, in the Hainan subsidiary of Shanghai Ruijin Hospital.
The capsule was approved and marketed in the United States and the European Union in December 2021 and July 2022 respectively.
Nefeconhas been granted a 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, according to Everest Medicines.
The therapy ushers in a new era in etiological treatment, said medical experts.
China has the world's highest prevalence of primary glomerular diseases. Presently, there is an estimated 5 million IgA nephropathy patients in the country.
Up to half of such patients with disease progression are at risk of kidney failure within one to two decades and may require dialysis or kidney transplant. Experts said there is significant unmet medical need among IgA nephropathy patients in China and other Asian countries.
