Everest Medicines Announces New Drug Application Acceptance by China NMPA for Nefecon for the Treatment of Primary IgA Nephropathy

-- NDA acceptance takes Everest closer to making this first-in-disease treatment available for primary IgAN patients in China

-- China is home to the largest patient base for IgAN with estimated 5 million people with the disease and currently there is no approved treatment in the country

-- Nefecon is approved in the U.S. and E.U., and received Breakthrough Therapy Designation (BTD) in China

SHANGHAI, Nov. 14, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression. The acceptance brings Nefecon, approved and marketed in the U.S. under the name TARPEYO® and in the E.U. as Kinpeygo®, an important step closer to becoming the first-ever therapeutic option indicated for IgAN treatment in China. The NMPA recommended Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgAN in December 2020.

"Chronic kidney disease is one of the most serious public health problems in China, where IgAN affects around five million people," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Nefecon's NDA acceptance marks a significant milestone in bringing this first-in-disease treatment to IgAN patients in China. Nefecon, which leads our renal disease portfolio, will be the next focus of commercialization for Everest, and we look forward to working closely with the regulatory authority to bring this innovative treatment to patients in China as quickly as possible."

Everest Medicines announced in April 2022 that reduction in proteinuria and stabilization of eGFR in a Chinese subpopulation after 9 months of treatment with Nefecon were consistent with topline results from Part A of the pivotal global Phase 3 clinical trial NefIgArd, which were reported by our partner Calliditas Therapeutics AB in November 2020. Results from Part A of the NeflgArd study were published in Kidney International in October 2022 which showed urine protein-to-creatinine ratio (UPCR) was 27% lower in the Nefecon group at nine months of treatment compared with placebo, along with a benefit in eGFR preservation corresponding to a 3.87 ml/min/1.73 m² difference versus placebo. Nefecon was also well-tolerated.

Renal disease is a key focus area for Everest Medicines going forward, where the Company believes patients have significant unmet needs. Besides Nefecon as a leading late-stage product candidate, Everest has also received approval from the China NMPA on an Investigational New Drug (IND) application for a Phase 1b study of EVER001 in September. EVER001 is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor in development for the treatment of glomerular diseases. The Company's internal research team continues to discover and develop renal drug candidates. Everest has several programs at discovery stage with the most advanced candidate targeting glomerular nephropathy expected to enter IND filing over the next two years.

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 IgA Nephropathy

IgA nephropathy (IgAN), is a chronic autoimmune disease associated with progressive renal impairment. IgAN is the most common primary glomerular disease in China and a leading cause of chronic kidney disease (CKD) and renal failure. A central finding in patients with lgAN is the presence of circulating and glomerular immune complexes comprised of galactose-deficient IgA1, an IgG autoantibody directed against the hinge region O-glycans, and C3. Glomerular sclerosis, renal interstitial fibrosis, renal dysfunction, proteinuria and hypertension are associated with disease progression. 50% of IgAN patients will develop end stage renal disease within 30 years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a material impact on patients' quality of life. Currently, there are no approved treatments for IgAN in China.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products 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. 

Forward-Looking Statements:

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SOURCE Everest Medicines