{"id":21452,"date":"2023-08-25T00:15:00","date_gmt":"2023-08-25T00:15:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4192889_AE92889_0"},"modified":"2023-08-25T00:15:00","modified_gmt":"2023-08-25T00:15:00","slug":"everest-medicines-announces-new-drug-application-acceptance-by-the-pharmaceutical-administration-bureau-of-macao-for-nefecon-for-the-treatment-of-primary-iga-nephropathy","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=21452","title":{"rendered":"Everest Medicines Announces New Drug Application Acceptance by the Pharmaceutical Administration Bureau of Macao for Nefecon\u00ae for the Treatment of Primary IgA Nephropathy"},"content":{"rendered":"

SHANGHAI<\/span>, Aug. 25, 2023<\/span> \/PRNewswire\/ — Everest Medicines<\/a> (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China<\/span> has accepted its New Drug Application (NDA) for Nefecon\u00ae for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. The Company expects to receive NDA approval in Macao<\/span> in 2023. The NDA acceptance in Macao<\/span> marks the third region, after Mainland China in November 2022<\/span> and Singapore<\/span> in April 2023<\/span>, in which Everest has successfully filed Nefecon\u00ae as a first-in-disease treatment therapy.<\/p>\n

“Everest stays committed to bringing this first-in-disease, critical therapy to as many patients as possible in Asia<\/span> to address the significant unmet needs as this region has much higher prevalence of IgAN than the rest of the world,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Approval in Macau<\/span> will allow us to cover more patients in the Greater Bay area. Our successful filing of Nefecon\u00ae in Macao<\/span> will be followed by South Korea<\/span> and Taiwan<\/span> to further expand our patient base on top of the estimated 5 million patients in mainland China<\/span>. “<\/p>\n

Nefecon\u00ae has already been approved and marketed in the United States<\/span>, the European Union and the UK. The NDA for Nefecon\u00ae in mainland China<\/span> is currently under Priority Review and is expected to be approved in the second half of this year. It was the first non-oncology medicine to receive Breakthrough Therapy Designation in China<\/span>, reinforcing the urgent need of Nefecon\u00ae as a first-in-disease therapeutic option in the nation. Nefecon\u00ae has been available for clinical use in Shanghai Ruijin Hospital’s Hainan<\/span> subsidiary through an early-access program since April.<\/p>\n

About Nefecon\u00ae <\/b><\/p>\n

Nefecon\u00ae 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.<\/p>\n

In June 2019<\/span>, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon\u00ae in Mainland China, Hong Kong<\/span>, Macau<\/span>, Taiwan<\/span> and Singapore<\/span>. The agreement was extended in March 2022<\/span> to include South Korea<\/span> as part of Everest Medicine’s territories.<\/p>\n

About Everest Medicines<\/b><\/p>\n

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 discovery, 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 renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com<\/a>.<\/p>\n

Forward-Looking Statements:<\/b><\/p>\n

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.<\/p>\n","protected":false},"excerpt":{"rendered":"

SHANGHAI, Aug. 25, 2023 \/PRNewswire\/ — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China has accepted its New Drug Application (NDA) for Nefecon\u00ae for the treatment […]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-21452","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"\nEverest Medicines Announces New Drug Application Acceptance by the Pharmaceutical Administration Bureau of Macao for Nefecon\u00ae for the Treatment of Primary IgA Nephropathy - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=21452\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Everest Medicines Announces New Drug Application Acceptance by the Pharmaceutical Administration Bureau of Macao for Nefecon\u00ae for the Treatment of Primary IgA Nephropathy - 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