New Drug Application Approval by the Pharmaceutical Administration Bureau of Macau for Nefecon® for the Treatment of Primary IgA Nephropathy

Rhea-AI Summary

Calliditas Therapeutics announces approval of Nefecon in Macau for the treatment of IgA nephropathy

Positive

• Everest Medicines, Calliditas' commercial partner, has received approval from the Pharmaceutical Administration Bureau of Macau for Nefecon, a treatment for primary IgA nephropathy. This marks the first approval in Everest territories and highlights the potential for Nefecon in the Chinese market. Nefecon is also under Priority Review for approval in mainland China and has received Breakthrough Therapy Designation.

Negative

• None.

STOCKHOLM, Oct. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that its commercial partner Everest Medicines (HKEX 1952.HK) ("Everest") received approval from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China. The approval for Nefecon is for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. Macau is the first region in Everest territories that received Nefecon approval.

The NDA for Nefecon in mainland China is under Priority Review and Nefecon was the first non-oncology medicine to receive Breakthrough Therapy Designation in China. Nefecon has been available for clinical use in Shanghai Ruijin Hospital's Hainan subsidiary through an early-access program since April 2023.

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 persons set out above, on October 27, 2023 at 09:15 a.m. CET.

The following files are available for download:

https://mb.cision.com/Main/16574/3864145/2390590.pdf

Macau Approval Eng

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SOURCE Calliditas Therapeutics

What is the recent announcement by Calliditas Therapeutics?

Calliditas Therapeutics has announced that its commercial partner, Everest Medicines, has received approval for Nefecon in Macau for the treatment of primary IgA nephropathy.

What is Nefecon?

Nefecon is a treatment for primary IgA nephropathy.

What is the significance of this approval?

This approval marks the first in Everest territories and highlights the potential for Nefecon in the Chinese market.

What other approvals is Nefecon seeking?

Nefecon is currently under Priority Review for approval in mainland China.

Has Nefecon received any special designations?

Yes, Nefecon was the first non-oncology medicine to receive Breakthrough Therapy Designation in China.