Everest Medicines Announces Approval of Nefecon’s Clinical Trial Application by the China National Medical Products Administration

Dec  2019

Everest Medicines entered into a license agreement with Calliditas Therapeutics to develop and commercialize Nefecon in June 2019

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  Ocer of Everest   Medicines. “In only  six  months we  have  made signicant 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  signicant 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.


For further information, please contact:


Everest  Medicines

Media in US and Europe: Mark Corbae

Senior Vice President

Westwicke PR (203) 682-8288 mark.corbae@icrinc.com



Media in China: Edmond  Lococo Senior Vice President ICR Asia

+86 (10) 6583-7510

edmond.lococo@icrinc.com


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