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Everest Medicines Announces China NMPA Recommends Priority Review for Nefecon for the Treatment of Primary IgA Nephropathy

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Press release content from PR Newswire. The AP news staff was not involved in its creation.
December 30, 2022 GMT

--Further regulatory support for accelerated approval of Nefecon following NMPA’s NDA acceptance with Breakthrough Therapy Designation—

SHANGHAI, Dec. 29, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines in Greater China and other parts of Asia, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review for the New Drug Application (NDA) of Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression. It marks another important advancement following the NMPA’s acceptance of the NDA in November 2022. Nefecon has also been granted Breakthrough Therapy Designation for IgAN.

“We are very pleased to see the NMPA’s recommendation of Priority Review for Nefecon, which is expected to further accelerate the review process for this first-in-disease therapy,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “We will work closely with the agency and try our best to bring this innovative treatment to Chinese patients as quickly as possible.”

Renal disease is a key focus area for Everest Medicines with Nefecon as the leading product. The company believes there is significant unmet medical need in the renal space and is developing a promising pipeline with the potential to treat glomerular diseases.

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 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 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:

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.

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SOURCE Everest Medicines