Everest Medicines Announces NMPA Full Approval of NEFECON® for the Treatment of Primary Immunoglobulin A nephropathy (IgAN) in Adults at Risk of Disease Progression

Everest Medicines a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the supplemental New Drug Application for NEFECON® has been granted full approval by the China National Medical Products Administration (NMPA). NEFECON® is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, irrespective of proteinuria levels. This approval marks NEFECON® as the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China. NEFECON® was first approved in November 2023 through NMPA’s priority review for the treatment of primary IgAN in adults at risk of disease progression.

""The full approval of NEFECON® in China marks a significant milestone, providing a foundational first-line treatment for IgAN patients, regardless of proteinuria levels, and addressing critical unmet clinical needs. As the first and only etiological treatment for IgAN in China to receive full approval from the NMPA, this further reinforces NEFECON®’s proven clinical efficacy and safety, providing a solid foundation for treatment decision-making,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “With over 5 million IgAN patients and more than 100,000 new cases diagnosed annually in China, there is a substantial unmet medical need. This approval allows NEFECON® to play a critical role in reducing the loss of kidney function in IgAN patients. NEFECON® has been included in the National Reimbursement Drug List (NRDL) and is now reimbursed across 31 provinces and cities. We remain committed to improving the accessibility and affordability of NEFECON® to benefit more IgAN patients.”

The full approval by the NMPA is based on data from the global Phase 3 NefIgArd clinical trial. The global Phase 3 NefIgArd clinical trial was a randomized, double-blind, multicenter study that evaluated the efficacy and safety of NEFECON® at a once-daily dose of 16 mg, compared to placebo in adult patients with primary IgAN on optimized RASi therapy. In the global study, NEFECON® demonstrated a statistically significant and clinically relevant benefit compared to placebo in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with NEFECON® and 15-months of follow-up off drug. The reduction in urine protein creatinine ratio (UPCR) observed with NEFECON® treatment was also durable and the proportion of patients with microhematuria in the NEFECON® group declined. Results from Phase 3 clinical study NefIgArd 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.

As the first IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), NEFECON® has been approved across all Everest Medicines’ territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan, China, as well as Singapore and South Korea. It is now commercially available in mainland China, Hong Kong, Macau, and Singapore, with anticipated launches in Taiwan, China and South Korea later this year, benefiting IgAN patients in all authorized regions.

About NEFECON®

NEFECON® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in mainland China, Hong Kong, Macau, Taiwan, China and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicines’ territories.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders.

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