HONG KONG, Could 7, 2025 – (ACN Newswire) – Everest Medicines (HKEX: 1952.HK) in the present day introduced that the supplemental New Drug Software (sNDA) for NEFECON has obtained full approval from the China Nationwide Medical Merchandise Administration (NMPA). This regulatory milestone considerably broadens the therapy inhabitants, permitting NEFECON for use to cut back the lack of kidney operate in grownup sufferers with major immunoglobulin A nephropathy (IgAN) liable to illness development, no matter proteinuria ranges. The prior limitation requiring elevated proteinuria has now been eliminated.
With this newest approval, NEFECON turns into the primary and solely etiological therapy for IgAN to obtain full approval in China, reaffirming its place as a foundational first-line remedy and marking a significant development in the usual of look after IgAN sufferers.
“The complete approval of NEFECON in China marks a big milestone, offering a foundational first-line therapy for IgAN sufferers, no matter proteinuria ranges, and addressing vital unmet scientific wants,” mentioned Rogers Yongqing Luo, Chief Government Officer of Everest Medicines. “As the primary and solely etiological therapy for IgAN in China to obtain full approval from the NMPA, this additional reinforces NEFECON’s confirmed scientific efficacy and security, offering a stable basis for therapy decision-making. With over 100,000 new instances identified yearly in China, there’s a substantial unmet medical want. NEFECON’s inclusion within the Nationwide Reimbursement Drug Listing (NRDL), with reimbursement now obtainable in 31 provinces and cities, is essential to enhancing accessibility and affordability for sufferers.”
The NMPA’s full approval is supported by sturdy efficacy and security information from the worldwide Section 3 NefIgArd scientific trial, a randomized, double-blind, multicenter research evaluating NEFECON (16 mg as soon as every day) in contrast with placebo in sufferers on optimized RASi remedy. Within the international cohort, NEFECON demonstrated a statistically vital and clinically significant profit in preserving estimated glomerular filtration price (eGFR) over a two-year period-comprising 9 months of therapy and 15 months of follow-up off drug. NEFECON additionally confirmed sturdy reductions in urine protein creatinine ratio (UPCR) and a decline in microhematuria, additional supporting its scientific utility.
Within the China subpopulation of the International Section 3 NefIgArd Medical Trial, NEFECON lowered the speed of kidney operate decline by 66% and delayed the necessity for dialysis or kidney transplantation by 12.8 years, reinforcing its transformative potential for long-term illness administration in Chinese language sufferers.
As the primary IgAN etiological therapy drug totally accredited by the U.S. Meals and Drug Administration (FDA) and the European Medicines Company (EMA), NEFECON has been accredited throughout all Everest Medicines territories, together with mainland China, Hong Kong SAR, Macau SAR, Taiwan(China), in addition to Singapore and South Korea. It’s now commercially obtainable in mainland China, Hong Kong, Macau, and Singapore, with anticipated launches in Taiwan(China), and South Korea later this yr, benefiting IgAN sufferers in all licensed areas.
The complete approval of NEFECON not solely broadens its scientific applicability, permitting extra IgAN sufferers to profit from focused remedy earlier of their illness development, but additionally represents a big development in Everest Medicines management within the renal illness sector. This milestone additional demonstrates Everest’s dedication to accelerating entry to revolutionary remedies that tackle vital unmet medical wants and supply long-term worth for sufferers, healthcare techniques, and society.
Subject: Press launch abstract
Supply: Everest Medicines Restricted
Sectors: BioTech, Healthcare & Pharm
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