Everest Medicines Announces New Drug Application Acceptance by the Pharmaceutical Administration Bureau of Macao for Nefecon® for the Treatment of Primary IgA Nephropathy
Shanghai, China — August 25, 2023 — 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® 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 in 2023. The NDA acceptance in Macao marks the third region, after Mainland China in November 2022 and Singapore in April 2023, in which Everest has successfully filed Nefecon® as a first-in-disease treatment therapy.
“Everest stays committed to bringing this first-in-disease, critical therapy to as many patients as possible in Asia 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 will allow us to cover more patients in the Greater Bay area. Our successful filing of Nefecon® in Macao will be followed by South Korea and Taiwan to further expand our patient base on top of the estimated 5 million patients in mainland China. ”
Nefecon® has already been approved and marketed in the United States, the European Union and the UK. The NDA for Nefecon® in mainland China 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, reinforcing the urgent need of Nefecon® as a first-in-disease therapeutic option in the nation. Nefecon® has been available for clinical use in Shanghai Ruijin Hospital’s Hainan subsidiary through an early-access program since April.
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 Everest Medicines
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.
For further information, please contact:
Leah Liu, VP Corporate Affairs Everest Medicines
Media in Asia:
Jing Yang, Everest Medicines
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