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又一款罕见病药将退出中国市场
Xin Lang Cai Jing· 2026-01-17 15:37
这对于库欣综合征患者而言,锐康迪的退出相当于断供了一款"救命药"。据媒体公开报道,一位服用了 四年奥唑司他的库欣综合征患者称,这几年下来,"吃掉了100万元"。 Recordati曾对奥唑司他在中国的销售抱有很高的期望。这款药物目前在国内尚无同类替代疗法,国内上 市后的价格约为8000元/盒,尽管中国国内售价为全球最低的市场之一,但一年下来平均治疗费用仍然 达到约20万元。 2025年8月,奥唑司他通过了2025年国家医保目录调整的初步形式审查目录。有专家称,该药物进入医 保目录的可能性很大,医保报销后,患者自费部分有望降到每月2000元以下。然而,最终的医保目录 中,该公司包括奥唑司他在内的三款药物均未成功纳入。 近日,意大利制药公司Recordati旗下100%控股的中国公司锐康迪正式进行注销备案,将彻底退出中国 市场。伴随着锐康迪的退出,该公司的几款罕见病药物也将停止对中国的供货,其中就包括中国仅有的 一款用于治疗库欣综合征的口服药物奥唑司他。 奥唑司他于2024年9月在中国国内获批,2025年4月正式在中国实现商业化,至今上市销售仅不到一年。 但自2021年起,该药物已经在博鳌乐城作为先行先试项目开始 ...
又一款罕见病药将退出中国市场,有患者称“吃掉100万”
第一财经· 2026-01-17 12:15
Core Viewpoint - Recordati's subsidiary in China, Ruikangdi, has officially filed for deregistration, marking its complete exit from the Chinese market, which will result in the discontinuation of several rare disease medications, including the only oral drug for Cushing's syndrome, Osilodrostat [3][5]. Group 1: Company Actions - Ruikangdi's exit signifies a significant loss for Cushing's syndrome patients, as it is considered a "lifesaving drug" [5]. - Osilodrostat was approved in China in September 2024 and commercialized in April 2025, but has been available since 2021 as part of a pilot program [5]. - Recordati had high sales expectations for Osilodrostat in China, where it was priced at approximately 8,000 yuan per box, with annual treatment costs averaging around 200,000 yuan [5]. Group 2: Market Challenges - The drug's potential inclusion in the national medical insurance directory was anticipated, which could have reduced out-of-pocket costs for patients to below 2,000 yuan per month, but it ultimately was not included [5]. - The high cost of rare disease drug development and the limited patient population make pricing and reimbursement a significant challenge, especially in China where commercial insurance is still developing [6]. - Only about 50 patients in China are estimated to have purchased Osilodrostat, highlighting the drug's limited market penetration due to affordability issues [6]. Group 3: Industry Context - Recordati's exit is not an isolated incident; BioMarin also withdrew a rare disease treatment from the Chinese market in 2024, leaving patients without available options [7]. - The challenges faced by rare disease pharmaceutical companies include lengthy and costly market education and the financial burden on patients, many of whom struggle economically [7]. - Even drugs that are included in insurance plans can face supply issues, as seen with the drug Nitisinone, which experienced shortages despite being on the market for two years [7].