Everest Medicines Announces Major Regulatory Updates in Taiwan and South Korea for Nefecon for the Treatment of Primary IgA Nephropathy

— Taiwan Food and Drug Administration Grants Accelerated Approval Designation (AAD) to Nefecon —

— Ministry of Food and Pharmaceutical Safety of South Korea grants ODD to Nefecon —

— Nefecon is a first disease treatment for IgAN patients and has been approved in the US and EU —

SHANGHAI, November 27, 2022 /PRNewswire/ — Everest Medicines (HKEX: 1952.HK), a biopharmaceutical company focused on the development and commercialization of transformative pharmaceutical products that address the critical unmet medical needs of patients in Greater China and other parts of Asiatoday announced the Taiwan Food and Drug Administration and the Ministry of Food and Drug Safety in South Korea granted an expedited approval process to Nefecon^®. Nefecon is our lead product in the kidney disease portfolio as the first disease treatment for Primary Immunoglobulin A (IgAN) Nephropathy and a New Drug Application (NDA) has been accepted on the continent China.

“We are very pleased to receive an expedited review and approval process for Nefecon in Taiwan and South Koreawhich will help bring this treatment option to patients Asia faster,” said Rogers Yongqing Luo, CEO of Everest Medicines. “While primary IgAN has a much higher prevalence in Asia that elsewhere in the world, there are no established treatments for patients with this chronic disease, underscoring the significant and urgent unmet need for this innovative drug.”

The Taiwan Food and Drug Administration has granted Accelerated Approval Designation (AAD) to Nefecon, which will allow submission of an NDA and priority review of Nefecon based on the key results of Part A of NefIgArd, the pivotal Phase 3 global clinical trial. Meanwhile, the Department of Food and Drug Safety of South Korea granted SDG^I for Nefecon, which will significantly speed up NDA filing and approval with an increased likelihood of priority review designation. Earlier this month, China’s National Medical Products Administration (NMPA) accepted Everest Medicines’ NDA for Nefecon on the mainland. China, bringing Nefecon one step closer to becoming the first-ever indicated treatment option for approximately 5 million IgAN patients nationwide. The NMPA has recommended Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgAN in December 2020.

The story continues

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

Kidney disease is a key focus area for Everest Medicines. In addition to Nefecon, Everest’s renal portfolio also includes EVER001, a next-generation reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor in development for the treatment of glomerular diseases, and several preclinical programs targeting glomerular nephropathy, most advanced program to enter the clinic in two years.

Nefecon is approved and marketed in the United States as TARPEYO^® and in the EU as Kinpeygo^®.

About Nefecon

Nefecon is a patented delayed-release oral formulation of budesonide, a corticosteroid with potent glucocorticoid activity and low mineralocorticoid activity that undergoes extensive first-pass metabolism. The formulation is designed as a delayed release capsule which is enteric coated so that it remains intact until it reaches the Peyer’s patch region of the lower small intestine. Each capsule contains budesonide-coated beads that target mucosal B-lymphocytes present in the ileum where the disease originates, according to predominant patterns of pathogenesis.

In June 2019Everest Medicines has entered into an exclusive, royalty-based license agreement with Calliditas, which grants 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 include South Korea as part of the Everest Medicine territories.

About drugs Everest

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address the critical unmet medical needs of patients in Asian markets. Everest Medicines’ management team has deep expertise and extensive experience with 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 world-first 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 diseases and infectious diseases. For more information, please visit their website at www.everestmedicines.com.

Forward-looking statements:

This press release may contain statements that constitute forward-looking statements, including descriptions regarding the current intention, belief or expectations of the Company or its officers with respect to the Company’s business activities and financial condition. , which can be identified by terminology such as “will”, “expect”, “anticipate”, “future”, “intend”, “plan”, “believe”, “estimate”, ” trust” and similar statements. These forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the Company’s control and cannot be predicted. Therefore, actual results may differ from those in forward-looking statements due to various factors and assumptions, such as future changes and developments in our business, the competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives is under no obligation and does not undertake to revise any forward-looking statements to reflect new information, future events or circumstances after the date of this press release, except as required by law. .

^I ODD stands for Orphan Drug Designation

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SOURCE Everest Medicines