CHINA – Everest Medicines, a biopharmaceutical company listed in Hong Kong, has launched Nefecon, an innovative treatment for IgA nephropathy (IgAN) in China, marking a significant advancement in patient care.
Nefecon, an oral medication, is specifically designed to address primary IgAN in adults at risk of disease progression, offering new hope to those battling this condition.
Nefecon contains budesonide, a corticosteroid renowned for its potent glucocorticoid effects and minimal mineralocorticoid activity.
Its innovative delayed-release formulation targets mucosal B-cells in the distal ileum, a crucial aspect in the pathogenesis of IgAN.
Nefecon ensures targeted delivery in an enteric-coated capsule by releasing its active components only upon reaching the intended site in the intestine.
“The commercialization of Nefecon in the Chinese market represents a significant milestone for Everest and a breakthrough for IgAN patients in China,” said Rogers Yongqing Luo, CEO of Everest Medicines.
“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-ever treatment for IgAN to receive full approval from the US Food and Drug Administration (FDA).”
The China National Medical Products Administration (NMPA) approved Nefecon in November 2023, recognizing its potential to address the urgent medical needs of IgAN patients.
With China boasting the highest prevalence of primary glomerular diseases globally, where IgAN accounts for 35% to 50% of cases, the introduction of Nefecon holds profound significance.
Studies reveal that a majority of IgAN patients face the risk of progressing to end-stage renal disease, highlighting the critical need for effective treatments.
“IgAN is the most common primary glomerular disease, occurring at a young age with a high likelihood of progression to end-stage renal disease,” stated Professor Zhang Hong of Peking University First Hospital.
“Compared to European and American populations, Chinese IgAN patients experience faster disease progression, poorer prognosis, and impose a heavy burden on patients and society.”
Clinical trials and real-world data attest to Nefecon’s efficacy in stabilizing renal function, reducing proteinuria and hematuria, and improving patients’ quality of life.
Recent analyses presented at the World Congress of Nephrology 2024 further support its potential in delaying kidney function decline, offering hope for those with rapidly progressing disease.
Everest Medicines’ commitment to accessibility and affordability is exemplified through various initiatives, including patient assistance programs and partnerships to enhance medication accessibility.
With the commercial launch of Nefecon in mainland China, the company is poised to address the unmet medical needs of IgAN patients, paving the way for improved disease management and better outcomes.
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