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Recently, at the 23rd Asia Pacific Congress of Nephrology (APCN 2025), Everest Medicines' core product Nefecon® (budesonide enteric-coated capsules) showcased 11 latest clinical research findings from multiple top hospitals across China, providing additional evidence-based medical support for the treatment of IgA nephropathy.
IgA nephropathy is a chronic kidney disease with high prevalence in Asia; China has approximately 5 million patients, with over 120,000 newly diagnosed cases each year. Characterized by "high incidence and high progression rate," there is an urgent clinical need for precise treatment. Since the world's first disease-modifying therapy, Nefecon®, was included in China's national reimbursement drug list (NRDL), clinicians have gradually shifted their focus from "reducing proteinuria" to "protecting renal function" as treatment duration accumulates, aiming to provide important references for long-term management of IgA nephropathy patients.
Multiple studies presented at this congress enriched the efficacy and safety evidence for Nefecon® from various clinical scenarios and long-term treatment perspectives, reinforcing its position as a cornerstone of first-line therapy for IgA nephropathy and offering valuable guidance for clinical practice.
Validating Disease-Modifying Value Across Multiple Scenarios
In clinical practice, some IgA nephropathy patients show poor response or intolerance to conventional treatments, urgently requiring more effective regimens. Three combination therapy studies presented at the congress focused on Nefecon® combination strategies, offering novel disease-modifying options for different clinical settings.
A study by the First Affiliated Hospital of Xi'an Jiaotong University targeted IgA nephropathy patients who continued to progress despite optimized supportive care. Results confirmed the importance of full-course disease-modifying therapy for renal function protection. Although supportive care improved proteinuria, its effect on renal function protection was limited; hence, combining "disease-modifying therapy + supportive care" per guideline recommendations may achieve better disease control.
A case study from the First Affiliated Hospital of Xinjiang Medical University focused on IgA nephropathy patients unresponsive or intolerant to multiple conventional therapies. For patients intolerant to systemic glucocorticoids, Nefecon® combined with finerenone improved eGFR and reduced proteinuria. Moreover, during the 9-month Nefecon® treatment period, no typical adverse events (e.g., weight gain, edema, suboptimal glycemic/blood pressure control, gastrointestinal discomfort) were reported. This suggests Nefecon®'s unique formulation reduces systemic drug exposure risk while maintaining clinical efficacy, offering a safe and effective renal protection option for patients intolerant to conventional therapy.
A study by the First Affiliated Hospital of Nanchang University explored the effect of Nefecon® combined with hydroxychloroquine. This provided a new idea for immunomodulatory combination therapy in IgA nephropathy, indicating that long-term co-administration of Nefecon® and hydroxychloroquine can synergistically reduce proteinuria and improve renal function with good safety, expanding treatment choices for patients with varying baseline renal function levels.
Long-Term Treatment Benefits Confirmed
To address uncertainties regarding efficacy and safety of Nefecon® beyond 9 months of extended treatment, Kiang Wu Hospital Macau conducted a retrospective real-world study. Twelve IgA nephropathy patients receiving continuous Nefecon® 16 mg/day for 12 months were enrolled, matched with 36 controls receiving conventional therapy; baseline characteristics (age, sex, Scr, eGFR, proteinuria) were balanced between groups.
Results showed Nefecon® had significant advantages in proteinuria control, renal function protection, and tolerability. Proteinuria in the Nefecon® group decreased from 1016 mg/day to 114 mg/day, versus 1074 mg to 291 mg in controls - a significantly greater reduction, with final levels markedly lower in the Nefecon® group. Regarding renal function, the annual eGFR slope was +5.4 ml/min/1.73 m²/year (improving trend) in the Nefecon® group, compared with –3.4 ml/min/1.73 m²/year (declining trend) in controls. In terms of tolerability, no severe infections occurred in the Nefecon® group, which showed better tolerance than the conventional immunosuppressive therapy in controls.
This study not only provided empirical evidence for the value of disease-modifying therapy in protecting renal function in IgA nephropathy patients, but also added evidence for Chinese patients receiving budesonide enteric-coated capsules for up to 12 months of extended treatment. It confirmed that long-term therapy can further strengthen proteinuria control, stabilize and improve renal function, with manageable safety, supporting extension of treatment duration beyond 9 months for more durable renal protection benefits.
Clinical Value Continues to Unfold
Industry experts noted that the multiple studies presented at APCN 2025 validated Nefecon®'s core value in "disease modification" and enriched its long-term treatment evidence, offering new treatment ideas for IgA nephropathy patients in diverse clinical scenarios. They also provided evidence-based support for the clinical strategy of "disease-modifying treatment, early initiation, and long-term treatment," positively impacting standardized management of IgA nephropathy.
With clear efficacy, controllable safety, and abundant clinical evidence, Nefecon® has now been recommended by both the 2025 KDIGO Clinical Practice Guideline for the Management of IgA Nephropathy and IgA Vasculitisand the Chinese Clinical Practice Guideline for Adult IgA Nephropathy and IgA Vasculitis (2025), making it the only disease-modifying therapy for IgA nephropathy endorsed jointly by international and domestic guidelines.
The continuously improving clinical evidence lays a solid foundation for Nefecon®'s commercialization, while NRDL implementation has accelerated its market penetration. As a newly added product in the 2024 National Reimbursement Drug List, Nefecon®'s reimbursement policy took effect on January 1, 2025, effectively unleashing clinical demand.
Data show that cumulative sales revenue from January to September 2025 reached nearly RMB 1 billion, prompting Everest Medicines to raise its full-year sales guidance to RMB 1.2–1.4 billion, making it one of the fastest-growing innovative chronic disease drugs in recent years.
