Calliditas' partner Everest Medicines announces China NMPA's approval of Nefecon® for the treatment of primary IgA nephropathy

Rhea-AI Summary

Calliditas Therapeutics AB (CALT) and Everest Medicines (1952.HK) have announced the approval of Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression by China's National Medical Products Administration (NMPA). This approval addresses a significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries, with an estimated five million IgAN patients in China alone.

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:

https://mb.cision.com/Main/16574/3882049/2452102.pdf

China Approval_PR_ENG

 

 

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SOURCE Calliditas Therapeutics

What is the recent announcement from Calliditas Therapeutics AB (CALT) and Everest Medicines (1952.HK)?

The recent announcement is the approval of Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression by China's National Medical Products Administration (NMPA).

What is the significance of Nefecon®'s approval in China?

The approval of Nefecon® in China addresses a significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries, with an estimated five million IgAN patients in China alone.

What other regions are expected to approve Nefecon®?

In addition to Nefecon's approval in mainland China and Macau, Everest Medicines expects a decision on New Drug Application (NDA) approval in Singapore and Hong Kong in the near term.