Calliditas Therapeutics (Nasdaq: CALT) announced that its partner, Everest Medicines, has launched Nefecon® in China. China has up to 5 million patients with IgA nephropathy (IgAN), a progressive autoimmune disease. IgAN accounts for 35% to 50% of primary glomerular diseases, with over 100,000 new cases yearly. The Phase 3 NefIgArd trial showed a 66% reduction in kidney function loss in Chinese patients treated with Nefecon, outperforming global results.
Nefecon received conditional approval from China’s National Medical Products Administration (NMPA) in November 2023 and has since been launched in Macau, Hong Kong, and Singapore. The drug is also under review in Taiwan and South Korea.
Calliditas Therapeutics AB (CALT) announced positive results from a Phase 2 trial of setanaxib in combination with pembrolizumab for head and neck cancer treatment. The trial demonstrated significant improvements in progression-free survival and overall survival compared to placebo, with a positive impact on tumor biology. The treatment was well-tolerated, showing an increase in CD8+ T-cells in tumor tissue, indicating enhanced immunological activity. The company plans to present more data at an upcoming R&D day in Stockholm.
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