Nefecon Receives Approval in China Offering New Hope to IgA Nephropathy Patients

In a groundbreaking development China's NMPA has approved Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN), a significant advancement for the five million Chinese suffering from this debilitating kidney disease. This approval marks a new era in targeted therapy, addressing a substantial unmet medical need.

Calliditas Therapeutics and partner Everest Medicines announced China's National Medical Products Administration (NMPA) approval of Nefecon for treating primary IgA nephropathy (IgAN). This marks a significant advancement in addressing the high prevalence of IgAN in China. The approval, based on the successful Phase 3 NefIgArd trial results, demonstrates Nefecon's efficacy in improving kidney function and reducing proteinuria, offering hope for millions of patients.

A Landmark in Kidney Health Care

Developed by Calliditas Therapeutics and commercialized in China by its partner Everest Medicines, Nefecon is the first medication in China specifically designed to target IgAN, a condition characterized by the buildup of IgA protein in the kidneys, leading to damage and, often, blood in the urine.

China holds the highest prevalence of primary glomerular diseases globally, with an estimated five million patients suffering from IgAN. This underscores a significant unmet medical need for innovative therapies among IgAN patients in China and other Asian countries. This milestone decision, which also includes Macau and anticipates approvals in Singapore and Hong Kong, has been met with widespread acclaim.

Renée Aguiar-Lucander, CEO of Calliditas, expressed excitement about the drug's potential, 

"We are very excited about Nefecon's approval in China. There is clearly a very significant need amongst IgAN patients in China to have access to an approved medication specifically designed to target the origin of the disease and which provides hope of disease modification."

Groundbreaking Clinical Results

Nefecon's approval follows impressive results from the Phase III NefIgArd trial. This study demonstrated the drug's efficacy in reducing estimated glomerular filtration rate (eGFR) decline and proteinuria, with the Chinese subgroup showing even more pronounced benefits. In this subgroup, Nefecon led to a 66% reduction in eGFR decline at 24 months, compared to 50% globally. These findings were recently presented at the American Society of Nephrology conference.

Commercialization and Global Impact

The drug's commercial launch in China is underway, with an early-access program initiated at the Hainan subsidiary of Ruijin Hospital. This is a crucial step in making Nefecon widely available to patients in need. Additionally, Calliditas is awaiting a decision from the U.S. FDA on converting the accelerated approval of Tarpeyo, the U.S. name for Nefecon, into a full approval, with a decision expected by December 20.

Financial Implications

This approval also triggers a milestone payment of $5 million to Calliditas, reflecting the commercial and therapeutic significance of Nefecon. Calliditas, a Sweden-based biopharma company, is known for its focus on renal and hepatic diseases.

A Beacon of Hope

Nefecon's approval in China is more than a regulatory milestone; it represents hope for millions of IgAN patients. By addressing the disease's root cause and offering potential disease modification, Nefecon stands as a beacon of hope in the fight against kidney diseases, promising to improve the lives of patients in China and, potentially, around the world.