Everest Medicines Announces NEFECON® Inclusion in China's Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)
SHANGHAI,May 23, 2025/PRNewswire/ -- Everest Medicines (HKEX 1952.HK,"Everest", or the"Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics,announcedthat NEFECON®has been included in the"Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)"(hereinafter referred to as the"Guideline (Draft)")onMay 21, recommending the etiological treatment with a 9-month course of NEFECON®for all primary immunoglobulin A nephropathy (IgAN) patients who are at risk for disease progression, irrespective of proteinuria levels (2B).
The Guideline (Draft) was presented by ProfessorHong Zhangand ProfessorJicheng Lvfrom Peking University First Hospital, during the IgA Nephropathy Forum and IIgANN-China Annual Meeting. It aims to provide crucial guidance for the standardization and optimization of IgA nephropathy diagnosis and treatment. The Guideline (Draft) emphasizes a new disease management strategy of Treat the cause, Treat early, Treat comprehensively.
The Guideline (Draft) recommends that patients with proteinuria ≥ 0.5g/day (or equivalent levels) undergo a renal biopsy and initiate treatment. The treatment goal is to slow the estimated glomerular filtration rate (eGFR) loss to less than 1 ml/min per year. In addition to the two core indicators of proteinuria and eGFR, the Guideline (Draft) also emphasizes routine monitoring of hematuria.
For the first time, the guideline introduces interventions targeting immune-mediated injury, particularly the formation of pathogenic IgA (Gd-IgA1), a key driver of pathogenesis to IgAN. For patients at risk of disease progression, the guideline proposes addressing both symptoms of renal function decline, and initiating therapies targeting immune-mediated injury and CKD progression. NEFECON®is recommended as the preferred treatment to reduce Gd-IgA1. Once short-term treatment goals, namely proteinuria remission (defined as proteinuria< 0.5 g/day, ideally< 0.3 g/day) and stable renal function, are achieved, low-dose maintenance or repeated safe and effective immunotherapy can be considered together with supportive care to ensure that eGFR declines by less than 1 ml/min per year.
"Compared to European and American populations,Chinahas a large IgAN patient population. Chinese IgAN patients experience more rapid disease progression and poorer prognosis. A majority of IgAN patients face the risk of progressing to end-stage renal disease during their lifetime, placing a heavy burden on patients and society."SaidProfessorZhang Hongwith Peking University First Hospital, a member of the global steering committee for the Phase 3 clinical trial NefIgArd, chairman of the Chinese Collaborative Group of the International IgAN Federation."Therefore, IgAN patients require early diagnosis, and a comprehensive treatment approach that spans early intervention, initial therapy, and maintenance therapy. The Guideline (Draft) offers important guidance for clinical practice of IgA nephropathy treatment inChina."
"IgA nephropathy is the most common form of chronic glomerulonephritis worldwide, affecting 40% to 50%[1,2]of kidney biopsy patients in Asian populations, particularly inChina. Fifteen years after diagnosis, the kidney survival rate can drop to as low as 40%[1].This makes the development of guidelines tailored to the Chinese population particularly important."saidProfessorJicheng Lvfrom Peking University First Hospital."The Guideline (Draft) updates the treatment strategies and medications for IgAN inChina, further standardizing its diagnosis and treatment. It establishes a novel care strategy for Chinese IgAN patients, emphasizing the principles of Treat the cause, Treat early, Treat comprehensively. It recommends treatment with a 9-month course of NEFECON®for IgAN patients at risk of disease progression (2B)."
"We are delighted to see NEFECON®included in the Guideline (Draft), marking a milestone that not only provides Chinese physicians a scientific and precise treatment option but also promises greater benefits and improved quality of life for Chinese IgAN patients."saidRogersYongqing Luo, Chief Executive Officer of Everest Medicines."As the first and only etiological treatment for IgAN fully approved inChina,the United States, andEurope, NEFECON®significantly slows eGFR decline, reduces proteinuria, and preserves kidney function. NEFECON®has established itself as a first-line cornerstone therapy for IgAN. Its inclusion in the draft guideline further validates its outstanding clinical advantages, redefining treatment standards and entering a new era of standardized care."
NEFECON®, as the only in-disease IgA nephropathy (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), recommending treatment with a 9-month course of NEFECON®for patients who are at risk of progressive kidney function loss with IgAN (2B).
Results from the 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. During the 2-year treatment and observation period, NEFECON®also demonstrated clinically significant kidney function protection. With the Phase 3 clinical study and real-world evidence, NEFECON®not only fills the gap in etiological treatment for IgAN both domestically and internationally, but also provides clinicians with more compelling treatment options, giving patients a valuable treatment window.
SinceMay 2025, NEFECON® is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, irrespective of proteinuria levels. This approval marks NEFECON® as the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China. NEFECON®was also included in the National Reimbursement Drug List inNovember 2024.
About NEFECON®
NEFECON® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.
InJune 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in mainlandChina,Hong Kong,Macau,Taiwan(China) andSingapore. The agreement was extended inMarch 2022to includeSouth Koreaas part of Everest Medicines' territories.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.
Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as"will,""expects,""anticipates,""future,""intends,""plans,""believes,""estimates,""confident"and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
References:
1. Shen X, et al. Nephrol Dial Transplant. 2024 Nov 19: gfae252.
2. Li G, et al. J Nephrol . 2025 Mar 26. doi: 10.1007/s40620-025-02261-1. Online ahead of print.
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