SHANGHAI, China, Dec. 18, 2019 (GLOBE NEWSWIRE) -- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced it has received Clinical Trial Application (CTA) approval from the China National Medical Products Administration to conduct clinical trials for Nefecon in China. Nefecon is being developed in collaboration with Calliditas Therapeutics for the treatment of patients with IgA nephropathy (IgAN).
“This is an important step forward for Nefecon in China, where the unmet need in IgA nephropathy is particularly acute,” said Ian Woo, President and Chief Financial Officer of Everest Medicines. “In only six months we have made significant operational and regulatory progress in our territory and look forward to further clinical updates.”
Under the licensing agreement between Calliditas and Everest Medicines, which was announced in June 2019, Everest Medicines received exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. This CTA approval will allow Everest Medicine to include China clinical sites in Callidita’s ongoing global Phase 3 NefIgArd trial.
While IgAN is an orphan disease in the US and Europe, the prevalence is much higher in China, where IgAN is the most common primary glomerulonephritis, accounting for about 40% of primary glomerular diseases. China is the world’s largest market in terms of the number of IgAN patients, which extracts a significant economic and social impact. To date, there are no approved therapies for IgAN in China.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. For more information, please visit its website at www.everestmedicines.com.
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Everest Medicines
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