Everest Medicines, a biopharmaceutical company dedicated to the development, manufacturing, and commercialization of innovative medicines and vaccines, is making significant progress in the global fight against primary immunoglobulin A nephropathy (IgAN).
Following the successful NDA filing in Mainland China in November 2022, the Singapore Health Sciences Authority (HSA) has now accepted their New Drug Application (NDA) for Nefecon, a first-in-disease treatment therapy. Everest is set to receive NDA approval in Singapore in 2023, further cementing the company’s leading position in the development of treatments for this rare condition.
Everest Medicines is proud to have reached a major milestone with the approval of their first-in-disease drug candidate, Nefecon, in the Asia-Pacific region. This achievement is a testament to their commitment to bring critical treatment options to patients in need as quickly as possible. What’s more, Everest is planning to submit NDAs for Nefecon in South Korea, Hong Kong and Taiwan this year.
Renal disease is a major focus area of theirs and they are diligently working to develop promising drug candidates to address the huge unmet medical needs in this area, especially in Asia, where prevalence of the disease is much higher compared to other parts of the world.
Nefecon is making waves in the medical world, as it is the first non-oncology medicine to receive Breakthrough Therapy Designation in China. This has been further reinforced by its Priority Review status in mainland China, with approval expected in the second half of this year.
The potential impact of Nefecon is even more significant in light of the approximately five million IgAN patients in China. Nefecon has also been granted Global Innovative product on Fast Track (GIFT) designation by South Korea’s Ministry of Food and Drug Safety (MFDS) and Accelerated Approval Designation (AAD) by the Taiwan Food and Drug Administration, allowing for a 25% faster regulatory review time with the rolling review process. All in all, Nefecon stands to revolutionize treatment options for IgAN patients in the region.
Nefecon is an innovative oral, delayed-release formulation of the potent corticosteroid budesonide. Unlike other medications, Nefecon’s enteric-coated capsules remain intact until they reach the Peyer’s patch region of the lower small intestine.
This targeted delivery method allows Nefecon to directly target the mucosal B-cells present in the ileum, where the disease originates, according to the predominant pathogenesis models.
In June 2019, Everest Medicines and Calliditas entered into a groundbreaking agreement that granted Everest exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan, Singapore, and South Korea. The royalty-bearing license agreement looks set to revolutionize the drug development and commercialization industry in these territories.
About Everest Medicines
Everest Medicines is a biopharmaceutical powerhouse, dedicated to developing and commercializing revolutionary pharmaceuticals and vaccines that can tackle some of the most serious unmet medical needs in Asian markets.
Our experienced management team, which draws upon expertise from both top-tier global pharmaceutical organizations and local Chinese pharmaceuticals, excels in drug discovery, clinical development, regulatory affairs, CMC, business development and operations.
Many of our potentially groundbreaking first-in-class or best-in-class molecules are in late-stage clinical development, and our therapeutic areas of concentration include cardio-renal diseases, autoimmune disorders, and infectious diseases.