NEFECON(R) Receives NMPA Approval for Production Expansion in China,as Everest Medicines Accelerates Accessibility and Capacity Efforts

By: Everest Medicines Limited via ACN Newswire

August 04, 2025 at 21:21 PM EDT

HONG KONG, Aug 5, 2025 - (ACN Newswire) - Everest Medicines (HKEX 1952.HK) today announced that the supplemental application for the production expansion of NEFECON® has been officially approved by China’s National Medical Products Administration (NMPA). This approval for production expansion will further boost capacity and increase product supply, enabling a more efficient response to the growing clinical demand in China and across Asia.

NEFECON® is the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China, the United States, and Europe, serving as a foundational first-line therapy for patients with IgAN. Since its initial approval in China in November 2023, NEFECON® was subsequently included in the National Reimbursement Drug List (NRDL) in November 2024, and received full approval from the NMPA in May 2025, irrespective of proteinuria levels, benefiting most individuals living with IgAN.

NEFECON® specifically modulates the mucosal immune system in the gut to reduce the formation of pathogenic galactose-deficient IgA1 (Gd-IgA1) that trigger IgAN. Results from the Phase 3 clinical study NefIgArd demonstrated that NEFECON® reduces the decline in kidney function by 50%. 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.

“The expansion of our NEFECON® production capacity will help better meet the growing clinical treatment needs of IgAN patients in China.” Said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “China has one of the highest rates of primary glomerular disease in the world, with more than 5â€¯million patients estimated to be living with IgAN and over 100,000 new cases diagnosed each year. Chinese IgAN patients generally experience faster disease progression and poorer prognosis, highlighting a significant unmet medical need.

As the only etiological treatment for IgAN currently recommended by both international and Chinese guidelines, the expansion of NEFECON® production will further accelerate the uptake of etiological treatment, enabling more patients to access standardized treatment earlier to delay disease progression and protect kidney function. We will continue to enhance the accessibility and affordability of NEFECON®, supporting its advancement from ‘changing the treatment landscape’ to ‘redefining the standard of care’.”

NEFECON®, as the only in-disease IgAN treatment has been included in the KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (public review draft), making it the only targeted therapy endorsed by both international and Chinese guidelines. NEFECON® has been approved across all Everest Medicines’ territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan region, China, as well as Singapore and South Korea, and continues to expand its therapeutic impact across Asia.

As production capacity continues to grow and supply capabilities improve, NEFECON® is well positioned to benefit a broader patient population by accelerating the uptake of etiological treatment, enabling more patients to access standardized care earlier to delay disease progression and preserve kidney function.

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NEFECON(R) Receives NMPA Approval for Production Expansion in China,as Everest Medicines Accelerates Accessibility and Capacity Efforts

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