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锐康迪退出中国市场,罕见病患者陷“断供”危机
Guo Ji Jin Rong Bao· 2026-01-15 14:01
Group 1 - Recordati's subsidiary in China, Ruikangdi, has officially exited the Chinese market, ceasing the supply of three rare disease drugs, which may disrupt treatment for patients [1][2] - The drug with the most significant impact from the exit is the innovative drug Shireza, which has no domestic generic alternatives, potentially leaving Cushing's syndrome patients without medication [1][2] - Approximately 40,000 to 50,000 patients in China suffer from Cushing's syndrome, with only about 3,000 requiring drug treatment [1] Group 2 - Ruikangdi, a small enterprise focused on rare diseases, is a subsidiary of Recordati, which operates in around 150 countries and has been involved in the rare disease sector since 1990 [2] - The direct reason for the market exit was a failure in health insurance negotiations, as two of its drugs did not make it into the 2025 health insurance directory [2] - The challenges faced by rare disease drug companies in China include high investment costs with low returns, as the development cost for a single orphan drug is approximately 260 million yuan, while the rare disease drug market in China accounts for only 3% of the global market [3] Group 3 - The Chinese rare disease patient population exceeds 20 million, with over 200,000 new patients added each year [3] - The industry is facing insufficient health insurance coverage, with 83% of rare disease drugs having annual treatment costs exceeding 300,000 yuan, and only 50% being included in health insurance [3] - Policy initiatives are being explored to address these challenges, such as the Boao Lecheng Pilot Zone allowing expedited approval for unapproved drugs and encouraging local innovation in the rare disease sector [3]