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: This email address is being protected from spambots. You need JavaScript enabled to view it.
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:
Macau Approval Eng |
| Last Trade: | US$40.00 |
| Daily Volume: | 0 |
| Market Cap: | US$1.080B |
August 13, 2024 July 26, 2024 June 18, 2024 | |
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
CLICK TO LEARN MORE
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
CLICK TO LEARN MORE
