Everest Medicines Announces Hong Kong Department of Health Approval of Nefecon® for the Treatment for Primary IgA Nephropathy in Adult Patients

SHANGHAI, May 2, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company") announced that the Hong Kong Department of Health had approved Nefecon^® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. Hong Kong marks the fourth region in Everest territories that Nefecon^® received New Drug Application (NDA) approval after Singapore, Macau and mainland China. Nefecon^® received full U.S. Food and Drug Administration (FDA) approval in December 2023.

"IgAN is prevalent in the Asian population, which has 53% higher risks of progression to end-stage renal disease and faster disease progression," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "With the NDA approval of Nefecon^® in Hong Kong, we will continue to expand its access across Asian territories, including actively promoting the commercial launch of Nefecon^® in mainland China, and securing approvals in South Korea and Taiwan, China, to bring this first-in-disease therapy to more patients."

In the global Phase 3 NefIgArd clinical trial, Nefecon^® demonstrated a highly statistically significant and clinically meaningful benefit compared to placebo in estimated glomerular filtration rate (eGFR) over the two-year period. The reduction in UPCR observed with Nefecon^® treatment was also durable and the proportion of patients with microhematuria in the Nefecon group declined. Nefecon^® was also generally well-tolerated in the Phase 3 clinical trial.

Further subpopulation analysis from the NefIgArd clinical trial showed a numerically greater treatment effect in kidney function prevention, proteinuria reduction and microhematuria improvement in the Chinese subpopulation compared to the global population. The mean absolute change from baseline in eGFR at 24 months showed approximately 66% less deterioration in kidney function with 9-month Nefecon^® treatment compared with a smaller preservation of kidney function (50%) in the global population. Patients treated with Nefecon^® in China showed a 43% greater reduction (95% CI 8%, 65%) in UPCR compared with placebo at 24 months and a 31% greater reduction (95% CI 0, 53) at 9 months.  In the global population, Nefecon^® treatment provided an approximately 30% greater reduction in UPCR at both 24 months and 9 months compared to placebo. The proportion of Chinese patients without microhematuria in the Nefecon^® group increased from 26.9% at baseline to 57.7% during observational follow-up, while it was maintained at 14.3% in the placebo group.

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.

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon^® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's 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.