Everest Medicines gets NMPA approval to expand NEFECON® production in China

CHINA—Everest Medicines has announced that China’s National Medical Products Administration (NMPA) has officially approved a supplemental application to expand the production capacity of NEFECON®.

This approval will allow the company to increase supply and better meet the rising clinical demand for the drug in China and across Asia.

NEFECON® is the first and only treatment that targets the cause of IgA nephropathy (IgAN) to receive full approval in China, the United States, and Europe.

 It serves as a foundational first-line therapy for patients with this chronic kidney disease.

Since its initial approval in China in November 2023, NEFECON® was added to the National Reimbursement Drug List in November 2024 and granted full NMPA approval in May 2025 without restrictions based on proteinuria levels.

This makes the treatment accessible to most people living with IgAN in China.

The drug works by modulating the gut’s mucosal immune system to reduce the production of galactose-deficient IgA1 (Gd-IgA1), a key factor that triggers IgAN.

Clinical results from the Phase 3 NefIgArd study demonstrate that NEFECON® cuts the decline in kidney function by 50% overall.

Specifically among the Chinese population, the study showed a 66% reduction in kidney function decline and delayed progression to dialysis or kidney transplantation by an average of 12.8 years.

Rogers Yongqing Luo, CEO of Everest Medicines, commented that expanding NEFECON® production will help address the urgent treatment needs of IgAN patients in China.

He noted that China has one of the highest rates of primary glomerular diseases globally, with over 5 million people living with IgAN and more than 100,000 new cases every year.

 Furthermore, Chinese patients tend to experience faster disease progression and worse outcomes, creating a significant unmet medical need.

Luo emphasized that NEFECON® is the only etiological treatment currently recommended by both international and Chinese guidelines.

Increasing production capacity will accelerate the adoption of such targeted therapies, enabling patients to receive standardised care sooner.

This early intervention can slow disease progression and protect kidney function.

He also reaffirmed the company’s commitment to making NEFECON® more affordable and accessible, aiming to shift the treatment landscape and ultimately redefine the standard of care for IgAN.

NEFECON® is the only IgAN-specific treatment included in the KDIGO 2024 Clinical Practice Guideline for the Management of IgAN and related conditions.

Its approvals extend across all Everest Medicines’ territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan, Singapore, and South Korea.

As production and supply capacities improve, NEFECON® is expected to benefit a growing number of patients by expanding access to effective etiological treatment, thereby preserving kidney function and delaying disease progression.

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