Everest Medicines' NEFECON® Approval in China: A Catalyst for Dominance in IgAN Treatment

The recent full approval of NEFECON® (targeted-release budesonide) by China’s National Medical Products Administration (NMPA) on May 7, 2025, marks a transformative milestone for Everest Medicines (01952.HK) and its strategic position in the global nephrology market. This regulatory greenlight, combined with its inclusion in China’s clinical guidelines and National Reimbursement Drug List (NRDL), positions NEFECON® as the first-line treatment for immunoglobulin A nephropathy (IgAN), a disease affecting over 5 million patients in China. With robust clinical data and expanded market access, Everest is primed to capture a significant share of a critical unmet need, driving long-term growth and valuation.

Strategic Impact: A First-of-Its-Kind Therapy Dominates Early Treatment

NEFECON®’s NMPA approval removes the prior requirement for elevated proteinuria, broadening its use to all adult IgAN patients at risk of progression, regardless of disease severity. This expands the addressable market to millions of patients, including those previously ineligible. The drug’s mechanism—delivering budesonide directly to the ileum via TARGIT™ technology—targets the root cause of IgAN by suppressing pathogenic IgA1 (Gd-IgA1). This etiological approach distinguishes NEFECON® from symptomatic treatments, positioning it as a foundational therapy in the newly updated Clinical Practice Guidelines for IgAN in China (May 2025 draft).

The guidelines now recommend a 9-month course of NEFECON® to achieve durable kidney function preservation, with the goal of slowing eGFR decline to less than 1 mL/min/year. This endorsement by leading nephrology experts underscores NEFECON®’s role as a standard-of-care therapy, accelerating adoption in hospitals and clinics.

Reimbursement Access: 31 Provinces, 100,000+ New Patients Annually

The inclusion of NEFECON® in China’s NRDL (effective January 2025) ensures reimbursement across 31 provinces, eliminating cost barriers for patients. With over 100,000 new IgAN diagnoses annually in China and a 40% progression rate to end-stage renal disease (ESRD), the drug’s accessibility is critical.

The financial implications are profound. NEFECON®’s price, supported by the NRDL, will drive predictable revenue growth. Meanwhile, its 66% reduction in kidney function decline and 12.8-year delay in dialysis/transplantation (per Phase 3 trial data) reduce long-term healthcare costs, aligning with China’s push for cost-effective treatments.

Market Penetration: Capturing Asia’s Largest IgAN Population

China accounts for 40–50% of global IgAN cases, and NEFECON®’s NMPA approval now positions Everest to dominate this market. Key catalysts include:

1. Expanded Eligibility: The removal of proteinuria thresholds increases the target patient pool from ~2 million to ~5 million.
2. Guideline-Backed Prescribing: The “Treat the cause, Treat early” strategy in clinical guidelines ensures NEFECON® is prescribed at diagnosis, locking in long-term patient adherence.
3. Global Validation: Prior FDA and EMA approvals bolster trust in the drug’s safety and efficacy, accelerating adoption in Asia.

Future launches in Taiwan and South Korea (2025) will further expand its footprint in a region with 200 million at-risk patients.

Long-Term Valuation: A Decade-Long Growth Engine

NEFECON®’s total addressable market (TAM) in China alone exceeds $2 billion annually, assuming a 20% penetration rate. With a 9-month treatment course priced at ~$15,000–$20,000, Everest stands to generate sustained revenue. Additionally, the drug’s mechanism of action—targeting Gd-IgA1—creates a high barrier to competition, protecting margins.

The drug’s impact extends beyond IgAN. Preclinical data suggests its gut-kidney axis targeting could address other autoimmune renal diseases, unlocking new markets. Meanwhile, Everest’s partnership with Chiesi Farmaceutici for European distribution and its U.S. commercial team (post-FDA approval in 2023) ensure global scalability.

Risks and Considerations

• Pricing Pressure: While the NRDL provides reimbursement, potential negotiations could affect margins.
• Competitor Entry: No approved etiological IgAN therapies exist globally, but future rivals (e.g., gene therapies) pose long-term risks.
• Real-World Data: Long-term safety and efficacy in China’s diverse patient population will need monitoring.

Conclusion: A Must-Own Position in Healthcare

Everest Medicines’ NEFECON® is a once-in-a-decade drug addressing a massive unmet need in China’s IgAN market. With regulatory approvals, guideline endorsements, and NRDL access, the company is poised to capture a dominant market share while delivering life-altering outcomes for patients. Investors should view this as a buy-and-hold opportunity, with a multiyear growth trajectory fueled by expanding indications, geographic launches, and a first-mover advantage in etiological renal therapies.

The time to act is now—before the market fully recognizes the scale of this opportunity.