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]

Core Viewpoint - Recordati's subsidiary, Recondi, unexpectedly announced its exit from the Chinese market, citing recent market and regulatory dynamics, including the rejection of its drug Ozagrel for inclusion in the national medical insurance drug list [1][2]. Company Overview - Recondi, established in 2021, focused on rare diseases and had three approved drugs in China, with two commercialized. The company experienced rapid expansion but faced challenges in achieving profitability [3][16]. - The company had been actively hiring and promoting its products for inclusion in medical insurance while conducting education for doctors and patients [2][3]. Market Dynamics - The National Healthcare Security Administration has been increasing support for rare diseases, with approximately 100 rare disease drugs included in the national medical insurance drug list since 2018 [3]. - Despite the growing support for rare diseases, Recondi's products, including Ozagrel, did not make it into the insurance list, leading to their withdrawal from the market [3][7]. Product Details - Ozagrel, a key product for treating Cushing's syndrome, was priced at 8,008 yuan per box, significantly lower than global prices but still high for patients [6][7]. - The other product, Karglutan, had limited sales due to the availability of generic alternatives and high costs, making it unaffordable for many patients [6][10]. Patient Impact - The exit of Recondi has left many patients without access to critical medications, with some patients expressing regret and concern over the lack of alternatives [2][11]. - The high cost of Ozagrel and the absence of insurance coverage have made it difficult for patients to afford the treatment, with many waiting for it to be included in the insurance list [10][11]. Industry Challenges - The rare disease sector faces significant challenges, including high research and development costs, limited patient populations, and the need for extensive education and market cultivation [16][18]. - Recondi's experience reflects broader industry difficulties, as companies specializing in rare diseases often struggle to achieve sustainable business models without the support of insurance coverage [17][18].

经济观察报 记者 张铃 "我非常遗憾，我的很多病人没药可用了。"2026年1月13日，看到意大利制药集团Recordati旗下锐康迪（北京）医药有限公司（下称"锐康迪"）宣布退出中 国市场的消息后，中山大学附属第一医院内分泌科主任医师廖志红对经济观察报说。 锐康迪在2026年1月9日宣布，其已于2025年12月11日完成清算组备案，并进入清算程序，全部业务活动将于近期全面终止，未来将无法继续提供任何形式的 产品、服务或业务支持。 这是一家成立五年、专注罕见病的跨国药企中国商业子公司，旗下有三款罕见病药物在中国获批，其中两款实现商业化。近两年，锐康迪招兵买马，推动产 品进医保，同时开展医生和患者教育。 接受经济观察报采访的患者、医生、锐康迪前员工和罕见病企业人士，都对锐康迪的离开感到意外和遗憾。 关于退出中国市场的原因，锐康迪官方在1月13日向经济观察报出示的声明中提到："这一决定是基于近期的市场和监管动态，包括奥唑司他申请2025年国家 医保药品目录的否决结果。" 事实上，国家医保局一直在加大对罕见病的保障力度，2018年至今，已有约100种罕见病用药被纳入国家医保药品目录。 锐康迪有过一段激进扩张的时期，在 ...