— Taiwan Food and Drug Administration Grants Nefecon Accelerated Approval Designation (AAD) —
— Ministry of Food and Drug Safety Korea Give ODD to Nefecon —
— Nefecon is the first treatment for IgAN patients and is approved in the US and EU —
Shanghai, November 27, 2022 /PRNewswire/ — Everest Medicines (HKEX: 1952.HK) is a biopharmaceutical company focused on developing and commercializing innovative medicines that address critical unmet medical needs of patients. Greater China and other parts Asiaannounced today by the Taiwan Food and Drug Administration and the Ministry of Food and Drug Safety Korea Allowed Nefecon for expedited approval process®Nefecon is a leading product in the renal disease portfolio and has been New Drug Application (NDA) approved in the mainland as the first treatment for primary immunoglobulin A nephropathy (IgAN). China.
“We are very pleased with the accelerated Nefecon review and approval process. Taiwan When Koreacan help bring this treatment option to patients Asia Rogers Yongqing Luo, CEO of Everest Medicines, said: Asia More than anywhere else in the world, there is no established treatment for patients with chronic diseases, highlighting the critical and urgent unmet need for this innovative medicine. “
The Taiwan Food and Drug Administration has granted Nefecon Accelerated Approval Designation (AAD). This will enable Nefecon’s NDA submission and priority review based on the topline results of Part A of NefIgArd, a pivotal global Phase 3 clinical trial.On the other hand, the Ministry of Food and Drug Safety Korea Granted ODDMe This increases the likelihood of a priority review designation and significantly accelerates NDA filing and approval. Earlier this month, China’s National Medicines Administration (NMPA) accepted Everest Medicines’ NDA for his Nefecon on the mainland. ChinaWith this, Nefecon takes an important step towards becoming the first treatment option indicated for the approximately 5 million IgAN patients in the country. The NMPA recommended Breakthrough Therapy Designation (BTD) for treatment of her IgAN on Nefecon. December 2020.
Published in Everest Medicines April 2022 The reduction in proteinuria and stabilization of eGFR in the 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. November 2020The results of Part A of the NeflgArd study were published in Kidney International. October 2022 This was associated with a 27% lower urinary protein-to-creatinine ratio (UPCR) in the Nefecon group at 9 months of treatment compared to placebo, corresponding to a difference of 3.87 ml/min/1.73 m2 compared to placebo for eGFR preservation. showed benefits.Nefecon was also well tolerated.
Kidney disease is a key area of focus for Everest Medicines. In addition to Nefecon, Everest’s kidney portfolio includes EVER001, a next-generation covalent reversible Bruton’s Tyrosine Kinase (BTK) inhibitor being developed for the treatment of glomerular disease, and glomerulonephropathy. It includes several preclinical programs to target, the most advanced program being a two-year clinic.
Nefecon is approved and marketed in the United States under the name TARPEYO.® and in the EU as Kinpeygo®.
About Nefecon
Nefecone is a patented oral delayed-release formulation of budesonide, a corticosteroid with strong glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first-pass metabolism. The formulation is designed as an enteric-coated delayed-release capsule, so it remains intact until it reaches the Peyer’s patch area in the lower small intestine. Each capsule contains budesonide-coated beads that target mucosal B cells residing in the diseased ileum according to the primary etiologic model.
of June 2019Everest Medicines has entered into an exclusive royalty-bearing license agreement with Calliditas. Hong Kong, macau, Taiwan When Singaporethe agreement was extended March 2022 include Korea As part of the Everest Medicine territory.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing innovative medicines that address critical unmet medical needs of patients in the Asian market. Everest Medicines management team has deep expertise and extensive experience in high-quality clinical development, regulatory affairs, CMC, business development and operations from both major global pharmaceutical companies and local Chinese pharmaceutical companies. I’m here. 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. Our therapeutic areas of interest include cardiorenal diseases, autoimmune diseases, and infectious diseases. For more information, visit his website at: www.everestmedicines.com.
Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements. This includes statements regarding the intentions, beliefs or current expectations of the Company or its officers regarding the Company’s business operations and financial condition. “will”, “expect”, “expect”, “future”, “intend”, “plan”, “believe”, “estimate”, “believe” and similar statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors. Some of which are beyond our control and unpredictable. Accordingly, actual results may differ from forward-looking statements as a result of various factors and assumptions, including future changes and developments in our business, the competitive environment, political, economic, legal and social conditions. may vary. The Company or its affiliates, directors, officers, advisors or representatives make no forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. does not undertake any obligation or promise to revise any forward-looking statements. .
Me ODD refers to Orphan Drug Designation
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