NEFECON receives Chinese approval for expanded IgA nephropathy treatment
China’s National Medical Products Administration has approved expanded production capacity for NEFECON®, the only etiological treatment for IgA nephropathy. The regulatory milestone addresses growing clinical demand across Asia, where over 5 million patients live with this progressive kidney disease requiring targeted therapeutic intervention.
Everest Medicines has secured regulatory approval from China’s National Medical Products Administration (NMPA) to expand production capacity for NEFECON®, marking a critical milestone in addressing the substantial unmet medical need for IgA nephropathy (IgAN) treatment across Asian populations.
The approval represents a strategic response to escalating clinical demand for the first and only etiological therapy approved for IgAN in China, the United States, and Europe. NEFECON functions as a targeted immunomodulatory treatment, specifically addressing the underlying pathophysiology of IgAN through selective intervention in mucosal immune pathways.
Addressing Asia’s IgAN treatment gap
China demonstrates one of the highest global rates of primary glomerular disease, with epidemiological data indicating over 5 million patients currently living with IgAN and approximately 100,000 new diagnoses annually. Chinese IgAN patients typically experience accelerated disease progression and compromised prognosis compared to Western populations, creating a significant therapeutic challenge.
“China has one of the highest rates of primary glomerular disease in the world, with more than 5 million patients estimated to be living with IgAN and over 100,000 new cases diagnosed each year,” stated Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Chinese IgAN patients generally experience faster disease progression and poorer prognosis, highlighting a significant unmet medical need.”
The production expansion directly addresses this clinical reality, positioning NEFECON to serve broader patient populations across mainland China, Hong Kong SAR, Macau SAR, Taiwan region, Singapore, and South Korea.
Mechanism of action and clinical efficacy
NEFECON operates through a sophisticated immunomodulatory mechanism, specifically targeting the mucosal immune system within the gastrointestinal tract. The treatment reduces formation of pathogenic galactose-deficient IgA1 (Gd-IgA1), the key molecular trigger driving IgAN pathogenesis.
Clinical validation stems from the Phase 3 NefIgArd trial, which demonstrated NEFECON’s capacity to reduce kidney function decline by 50% in the overall study population. Notably, results from the Chinese population subset showed even more pronounced therapeutic benefit, with kidney function decline reduced by 66% and disease progression to dialysis or kidney transplantation delayed by 12.8 years.
These clinical outcomes establish NEFECON as a disease-modifying therapy capable of altering the natural history of IgAN, moving beyond symptomatic management to address underlying pathophysiological mechanisms.
Regulatory pathway and guideline recognition
NEFECON’s regulatory journey in China began with initial approval in November 2023, followed by inclusion in the National Reimbursement Drug List (NRDL) in November 2024. The NMPA granted full approval in May 2025, notably removing proteinuria level restrictions and thereby expanding treatment eligibility to encompass most individuals living with IgAN.
The treatment has achieved distinctive recognition within international clinical guidelines. NEFECON represents the only targeted therapy included in the KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) public review draft, earning endorsement from both international and Chinese clinical practice standards.
Strategic implications for IgAN management
The production expansion facilitates a paradigm shift in IgAN treatment approaches, transitioning from reactive symptomatic management towards proactive etiological intervention. This strategic positioning enables earlier therapeutic intervention, potentially preventing irreversible kidney damage and reducing long-term healthcare burden.
“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 standardised treatment earlier to delay disease progression and protect kidney function,” Luo explained.
The expanded manufacturing capacity supports Everest Medicines’ broader strategic objective of advancing NEFECON from ‘changing the treatment landscape’ to ‘redefining the standard of care’ for IgAN management across Asian markets.
Future therapeutic landscape
Enhanced production capabilities position NEFECON to address the substantial treatment gap in IgAN management, particularly within Asian populations demonstrating aggressive disease progression patterns. The regulatory approval enables accelerated treatment uptake, facilitating earlier therapeutic intervention when kidney function preservation opportunities remain optimal.
The expanded availability of etiological IgAN treatment represents a fundamental shift in nephrology practice, moving beyond traditional immunosuppressive approaches towards targeted pathophysiology-based intervention strategies.
