This official launch marks a significant advancement in patient care in mainland China, introducing a new era in the treatment of IgA nephropathy (IgAN). IgA nephropathy (IgAN) is a common chronic kidney disease which mainly affects young adults. In IgAN a protein called immunoglobulin A (IgA) becomes trapped in the very fine filters of the kidney (glomeruli), causing damage and scarring to the whole kidney.
China has the highest prevalence of primary glomerular diseases globally, with IgAN accounting for about 35% to 50% of cases. Most IgAN patients risk progressing to end-stage renal disease during their lifetime, often requiring dialysis or kidney transplantation.
Current treatments, like renin-angiotensin system (RAS) inhibitors, fail to address the underlying disease progression, highlighting a significant unmet medical need.
Rogers Yongqing Luo, chief executive officer of Everest Medicines, said the commercialization of Nefecon in the Chinese market represents a significant milestone for Everest and a breakthrough for IgAN patients in China. Nefecon has undergone a 20-year research and development process, becoming the first non-oncology therapeutic to receive Breakthrough Therapy Designation in China by the China National Medical Products Administration (NMPA), and the first treatment for IgAN to receive full approval from the US Food and Drug Administration (FDA).
Five million IgAN patients in China
He said: “It is also the first approved medicine with an IgAN indication by the NMPA in China. On behalf of the company, I would like to extend my gratitude to all parties who have assisted in obtaining the approval for Nefecon’s market entry and clinical use in mainland China, especially the clinical investigators and the 62 Chinese patients who participated in the global phase 3 clinical trials. With approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand.
Professor Zhang Hong is from Peking University First Hospital, a member of the global steering committee for the phase 3 clinical study NefIgArd. He said: “We will actively engage with all stakeholders to improve the accessibility and affordability of this innovative therapy for IgAN. Moreover, we will contribute to improving nephropathy diagnosis, treatment, and disease management, ultimately benefiting more patients. As we advance the commercialization of Nefecon in China and Asia, we will also actively promote the development of other innovative drugs in the nephropathy field, extending benefits to more patients.”
“IgAN is the most common primary glomerular disease, occurring at a young age with a high possibility of progressing to end-stage renal disease. Compared to European and American populations, Chinese IgAN patients experience faster disease progression and poorer prognosis, imposing a heavy burden on patients and society. The full results of the NefIgArd study demonstrate that Nefecon can protect renal function, delay progression to dialysis or kidney transplantation, and significantly reduce urinary protein and hematuria. It is also safe and well-tolerated.”
“Data analysis of the Chinese population shows that Nefecon reduces kidney function decline by 66%, and delays disease progression to dialysis or kidney transplantation by 12.8 years. The approval of Nefecon fills the gap in targeted therapy for IgAN in China, benefiting Chinese patients, improving disease prognosis, and providing clinicians with new treatment options.”
Nefecon – even greater benefit in delaying kidney function decline
The company says the latest analysis, presented at the World Congress of Nephrology 2024, provides further evidence that Nefecon may offer even greater benefit in delaying kidney function decline in Chinese patients with more rapidly progressing disease, without compromising patients’ quality of life. Positive results from the global Open Label Extension (OLE) study based on the NefIgArd phase 3 study validated the efficacy and safety of re-treatment with Nefecon independent of prior treatment cycles, providing a solid scientific basis for future long-term maintenance regimens of Nefecon.
“IgAN is highly prevalent in Asia and is one of the main causes of kidney failure in young adults in China. Among IgAN patients, the risk of progressing to end-stage renal disease in Asian populations is 56% higher compared to other populations, and the disease progresses more rapidly, imposing a significant medical burden on patients, families, and society. Therefore, more proactive treatment is needed to intervene and control the risk of disease progression, delaying the need for dialysis or kidney transplantation.
“For a long time, this disease has lacked targeted treatment options, resulting in significant unmet clinical needs,” said Professor Xie Jingyuan, chief physician of the Department of Nephrology, Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine.
“Nefecon, as the world’s first-in-disease therapy for IgAN, has treated over one hundred patients in total through its early-access program in Boao last April. During the follow-up period, Nefecon was found to be effective in stabilizing renal function, reducing proteinuria and hematuria, and was well tolerated by the patients. It is of great significance for Nefecon to be officially commercialized in mainland China, helping patients with IgAN to initiate treatment as early as possible.”
Nefecon received approval from the China NMPA in November 2023 for the treatment of primary IgAN in adults at risk of disease progression. Additionally, Nefecon has been approved in multiple countries and territories across Europe, the US, and Asia.
