Everest Medicine launches first oral chronic kidney disease treatment in China

The official launch of Nefecon in mainland China represents a groundbreaking development in the field of patient care, particularly for those suffering from IgA nephropathy (IgAN). This chronic kidney disease, predominantly affecting young adults, is characterized by the entrapment of immunoglobulin A (IgA) in the kidney's glomeruli, resulting in damage and eventual scarring of the organ.

China reports the highest prevalence of primary glomerular diseases worldwide, with IgAN comprising approximately 35% to 50% of these cases. The majority of individuals with IgAN are at risk of progressing to end-stage renal disease, a condition that often necessitates dialysis or kidney transplantation. Despite the availability of current treatments, such as renin-angiotensin system (RAS) inhibitors, these do not sufficiently address the disease's progression, underlining a significant unmet medical need.

Rogers Yongqing Luo, the CEO of Everest Medicines, highlighted that the commercialization of Nefecon in China marks a significant milestone, both for the company and IgAN patients. Nefecon has been in development for 20 years and is the first non-oncology drug to receive Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA). Additionally, it is the first IgAN treatment to gain full approval from the U.S. Food and Drug Administration (FDA).

In China, there are approximately 5 million IgAN patients, with over 100,000 new diagnoses each year. Luo expressed his gratitude to all parties involved in Nefecon's approval, particularly the clinical investigators and the 62 Chinese patients who participated in the global phase 3 clinical trials. This significant unmet clinical demand underscores the urgent need for effective treatment options.

Professor Zhang Hong from Peking University First Hospital, part of the global steering committee for the NefIgArd phase 3 clinical study, emphasized the importance of making Nefecon accessible and affordable. He noted that improving diagnosis, treatment, and disease management for nephropathy can ultimately benefit a larger patient population. As the commercialization of Nefecon progresses in China and Asia, there is also a push to develop other innovative nephropathy treatments.

IgAN, the most common primary glomerular disease, often progresses to end-stage renal disease at a young age. Among Chinese patients, the disease progresses more rapidly and with a poorer prognosis compared to European and American populations, placing a considerable burden on patients and society. The results of the NefIgArd study indicate that Nefecon can protect renal function, delay the need for dialysis or transplantation, and significantly reduce urinary protein and hematuria. It is also safe and well-tolerated by patients.

Data analysis of the Chinese population shows that Nefecon can reduce the decline in kidney function by 66% and delay disease progression to dialysis or transplantation by 12.8 years. This approval fills a critical gap in targeted therapy for IgAN in China, offering new treatment options and improving disease prognosis for patients.

Recent analyses presented at the World Congress of Nephrology 2024 further suggest that Nefecon can significantly delay kidney function decline in Chinese patients with rapidly progressing disease without affecting their quality of life. Positive outcomes from the global Open Label Extension (OLE) study, based on the NefIgArd phase 3 trial, support the efficacy and safety of re-treatment with Nefecon, laying a solid foundation for future long-term maintenance regimens.

Professor Xie Jingyuan of Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine emphasized the urgent need for targeted treatments for IgAN, a leading cause of kidney failure in young Chinese adults. He noted that Nefecon, as the world's first-in-disease therapy for IgAN, had shown promising results in stabilizing renal function and reducing proteinuria and hematuria during its early-access program in Boao. The official commercialization of Nefecon in mainland China is a significant step forward, enabling early treatment initiation for IgAN patients.

Nefecon received approval from the China NMPA in November 2023 for treating primary IgAN in adults at risk of disease progression. It has also been approved in multiple countries across Europe, the US, and Asia.