SHANGHAI , Oct. 21, 2024 /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, today announces that the Taiwan Food and Drug Administration (TFDA) has approved NEFECON® indicated "to reduce the loss of kidney function in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression[1]". There are no restrictions on initial proteinuria levels in the approved indication. This marks the expansion of NEFECON®, the world's first and only IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA), to more IgAN patients.
"The approval of NEFECON® in Taiwan, China is another milestone for NEFECON®, following approvals in Singapore, Hong Kong, and the commercial launch in Mainland China this year." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "IgAN is prevalent in the Asian population, which has 56% higher risk of progression to end-stage renal disease and faster disease progression, indicating a significant unmet clinical demand. In the future, we will continue to expand the access of NEFECON® across Asia to bring this first-in-disease therapy to more patients."
The global Phase 3 NefIgArd clinical trial showed that compared to placebo, NEFECON® not only brought about a sustained reduction in proteinuria and reduced the frequency of microscopic hematuria but also demonstrated clinically relevant and statistically significant treatment benefits in estimated glomerular filtration rate (eGFR) (p<0.0001), reducing the decline in kidney function by 50% and potentially delaying the progression to dialysis or kidney transplantation by 12.8 years.
Taiwan, China is the fifth region in Everest Medicines' authorized area to approve NEFECON® after Macau, Mainland China, Singapore, and Hong Kong. As the core product of Everest Medicines in the field of nephrology, NEFECON® was also submitted for new drug application in South Korea at the end of 2023 and successfully accepted. In May of this year, the first prescription was issued in Mainland China. In July this year, the China's National Medical Products Administration has accepted the submission of a supplemental new drug application seeking full approval of NEFECON® based on the complete clinical data from the global Phase 3 NeflgArd study, and NEFECON® is expected to become the first and only fully approved IgAN etiological treatment drug in China.
In addition, NEFECON® is expected to be included in the first Chinese IgAN guidelines, recommended as the 1L treatment for IgAN patients at risk of disease progression.
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 Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in Mainland China, Hong Kong, Macau, Taiwan, China and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.
About global Phase 3 NefIgArd clinical trial
The global Phase 3 NefIgArd clinical trial was a randomized, double-blind, multicenter study that evaluated the efficacy and safety of NEFECON® (16 mg/d, once daily) compared to placebo in adult patients with primary IgA nephropathy treated with optimized RAS inhibitors. The study lasted for 2 years, including a 9-month NEFECON® or placebo treatment period, followed by a 15-month drug withdrawal follow-up period.
The complete 2-year data of the NefIgArd study (n=364) further analyzed the potential differences in the response to NEFECON® treatment between Asians (n=83) and Caucasians (n=275). The results showed that compared to placebo, both Asians and Caucasians treated with NEFECON® for 9 months can significantly delay the decline of eGFR, protect kidney function, and bring about a sustained reduction in proteinuria and reduce the risk of microscopic hematuria.
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 .
Forward-Looking Statements:
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References
1. TFDA approved indication.