SHANGHAI, Feb. 10, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines in Greater China and other parts of Asia, announced today that South Korea's Ministry of Food and Drug Safety (MFDS) has granted Global Innovative product on Fast Track (GIFT) designation to Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN). This demonstrates the urgent unmet medical needs for Nefecon, as Everest also received Priority Review status for the New Drug Application (NDA) of Nefecon in China from the National Medical Products Administration (NMPA).
Nefecon is the second product and the first non-oncology product included in MFDS' GIFT program. Inclusion in the GIFT program is expected to accelerate regulatory review time by 25% and allow for rolling review.
"We are excited to see South Korea MFDS' designation of GIFT for Nefecon, which will significantly accelerate the review process for this first-in-disease therapy in Asia's third-largest pharmaceutical market," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "IgAN has much higher prevalence in East Asia than the rest of the world and we hope to bring this novel therapy to this region and address unmet patient needs as soon as possible."
South Korea's MFDS also granted ODD[i] status for Nefecon in November 2022 while the Taiwan Food and Drug Administration awarded Accelerated Approval Designation (AAD) to Nefecon in the same month.
Renal disease is one of the core therapeutic areas for Everest Medicines with Nefecon as the leading product. The company is also developing a promising pipeline with the potential to treat glomerular diseases.
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 reaches the Peyer's patch region of the lower small intestine. 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 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 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, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include cardio-renal diseases, autoimmune disorders, and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
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[i] ODD refers to Orphan Drug Designation |