STOCKHOLM, Nov. 24,
2023 /PRNewswire/ -- Calliditas Therapeutics
AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas')
today announced that its partner Everest Medicines (HKEX:
1952.HK) ('Everest') announced that China's National Medical Products
Administration (NMPA) has approved Nefecon® for the treatment of
primary immunoglobulin A nephropathy (IgAN) in adults at risk of
disease progression.
China has the highest
prevalence of primary glomerular diseases in the world with an
estimated five million IgAN patients. There is a very
significant unmet medical need for novel therapies among IgAN
patients in China and other Asian
countries. Everest also announced that, in addition to Nefecon's
approval in mainland China and
Macau, it expects a decision on
New Drug Application (NDA) approval in Singapore and Hong
Kong in the near term.
"We are very excited about Nefecon's approval in China. There is clearly a very significant
need amongst IgAN patients in China to have access to an approved medication
specifically designed to target the origin of the disease and which
provides hope of disease modification," says CEO Renée
Aguiar-Lucander.
Results from the Chinese subpopulation analysis of the Phase 3
NefIgArd trial, presented at the American Society of Nephrology
(ASN) Kidney Week 2023, provided evidence that the treatment effect
of Nefecon in the Chinese cohort was greater than in the global
data set with regards to kidney function, proteinuria and
microhematuria. In the Chinese cohort, the mean absolute change
from baseline in eGFR at 24 months showed an approximately 66%
reduction in loss of this measure of kidney function with Nefecon
compared with a 50% reduction in loss of eGFR in the global data
set.
This approval triggers a milestone payment of five million USD to Calliditas, which will be
included as revenue in the fourth quarter.
CONTACT:
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com
The information was sent for publication, through the agency
of the contact person set out above, on November 24, 2023 at 08:45
a.m. CET.
The following files are available for download:
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https://mb.cision.com/Main/16574/3882049/2452102.pdf
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China
Approval_PR_ENG
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content:https://www.prnewswire.com/news-releases/calliditas-partner-everest-medicines-announces-china-nmpas-approval-of-nefecon-for-the-treatment-of-primary-iga-nephropathy-301997025.html
SOURCE Calliditas Therapeutics