2026.01.09 本文字数：1088，阅读时长大约2分钟 作者 |第一财经 林志吟 锐康迪罕见病 2026年1月9日 12:23 北京 1月9日，锐康迪（北京）医药有限公司在公众号发布消息称，根据公司唯一股东的正式决议，公司已于 2025年12月11日依法完成清算组备案，并进入清算程序。基于此，公司全部业务活动将于近期内逐步、 有序地全面终止。未来，公司将无法继续提供任何形式的产品、服务或业务支持。 锐康迪原本是意大利制药集团Recordati于2021年在北京设立的分公司，核心定位是从全球引进最好的罕 见病药物，惠及中国的罕见病患者。 锐康迪入华的这些年，在中国已获批三款罕见病药物，按照时间顺序分别是治疗甲基丙二酸血症、异戊 酸血症、丙酸血症、N-乙酰谷氨酸合成酶缺乏症引起的高氨血症的卡谷氨酸分散片、治疗库欣综合征 的磷酸奥唑司他和治疗肢端肥大的长效注射用双羟萘酸帕瑞肽微球。而公司在华开展这些药物的商业化 时间，总体进行不久。 随着锐康迪突然终止在华业务，在中国获批的这些罕见病药物将何去何从？ 锐康迪罕见病 ♥ 61 1 音 第一财经记者致电锐康迪的公开电话，但接电话的工作人员称"不了解后续安排"。 6 ...

2026.01. 09 本文字数：1088，阅读时长大约2分钟 作者 | 第一财经 林志吟 1月9日，锐康迪（北京）医药有限公司在公众号发布消息称，根据公司唯一股东的正式决议，公司 已于2025年12月11日依法完成清算组备案，并进入清算程序。基于此，公司全部业务活动将于近期 内逐步、有序地全面终止。未来，公司将无法继续提供任何形式的产品、服务或业务支持。 锐康迪原本是意大利制药集团Recordati于2021年在北京设立的分公司，核心定位是从全球引进最 好的罕见病药物，惠及中国的罕见病患者。 在此向大家告知一项关于公司未来 发展的重要决定:根据本公司唯一 股东的正式决议,公司已于2025 年12月11日依法完成清算组备案, 并进入清算程序。基于此,公司全 锐康迪入华的这些年，在中国已获批三款罕见病药物，按照时间顺序分别是治疗甲基丙二酸血症、异 戊酸血症、丙酸血症、N-乙酰谷氨酸合成酶缺乏症引起的高氨血症的卡谷氨酸分散片、治疗库欣综 合征的磷酸奥唑司他和治疗肢端肥大的长效注射用双羟萘酸帕瑞肽微球。而公司在华开展这些药物的 商业化时间，总体进行不久。 随着锐康迪突然终止在华业务，在中国获批的这些罕见病药物将何去 ...

有两款药物还未有国产仿制药上市。 1月9日，锐康迪（北京）医药有限公司在公众号发布消息称，根据公司唯一股东的正式决议，公司已于 2025年12月11日依法完成清算组备案，并进入清算程序。基于此，公司全部业务活动将于近期内逐步、 有序地全面终止。未来，公司将无法继续提供任何形式的产品、服务或业务支持。 锐康迪原本是意大利制药集团Recordati于2021年在北京设立的分公司，核心定位是从全球引进最好的罕 见病药物，惠及中国的罕见病患者。 锐康迪入华的这些年，在中国已获批三款罕见病药物，按照时间顺序分别是治疗甲基丙二酸血症、异戊 酸血症、丙酸血症、N-乙酰谷氨酸合成酶缺乏症引起的高氨血症的卡谷氨酸分散片、治疗库欣综合征 的磷酸奥唑司他和治疗肢端肥大的长效注射用双羟萘酸帕瑞肽微球。而公司在华开展这些药物的商业化 时间，总体进行不久。 随着锐康迪突然终止在华业务，在中国获批的这些罕见病药物将何去何从？ "我们一开始就知道做罕见病很难，但真正对此有感知是最近两年有产品开始陆续上市以后。坦白讲， 这个挑战比我们最初想象的要大得多。首要挑战在于中国患者和医生对于罕见病的认知仍然较为有限。 对于填补临床空白的药物，我们需要 ...

Core Viewpoint - The announcement by the company regarding the approval of a new specification for its pulmonary arterial hypertension (PAH) treatment product, Treprostinil injection, highlights its commitment to providing precise treatment options for patients [1][2] Group 1: Product Approval and Specifications - The new specification of Treprostinil injection (20ml:50mg) has received drug registration certification from the National Medical Products Administration, complementing the previously approved specification (20ml:20mg) in March 2023 [1] - Treprostinil is a synthetic prostacyclin analog that promotes vasodilation and inhibits platelet aggregation, making it a first-line treatment for PAH and a foundational drug in targeted therapy combinations [1] Group 2: Company’s Focus and Product Pipeline - The cardiovascular emergency sector is a key focus area for the company, which has nearly 30 products in this segment, with 14 included in the national emergency rescue drug list and 16 in the shortage drug list, positioning the company among the industry leaders in product pipeline quantity [1] - The company has over 20 products under research in the cardiovascular emergency sector, including treatments for rare diseases, with recent approvals for drugs addressing high ammonia levels and Cushing's disease, and ongoing development for other rare disease medications [2]

Core Viewpoint - The introduction of a new specification for the first-line treatment of pulmonary arterial hypertension (PAH) in China will provide rare disease patients with more clinical medication options [1][2]. Group 1: Product Development and Market Potential - The new specification of 20ml:50mg for the drug Treprostinil injection has been approved by the National Medical Products Administration, complementing the existing 20ml:20mg specification approved in March 2023 [1][7]. - The global PAH market is projected to reach approximately $8.06 billion in 2024, with a compound annual growth rate (CAGR) of 5.3%, and the Asia-Pacific region expected to grow at a CAGR of 13.3% [5]. - Treprostinil, a synthetic prostacyclin analog, has shown significant efficacy and safety in clinical studies, with one-year and four-year survival rates of 88% and 70% respectively [5][6]. Group 2: Company Strategy and Collaborations - The company has entered into a strategic investment and product cooperation agreement with Shanghai Zhongqiang Pharmaceutical, acquiring exclusive commercialization rights for Treprostinil inhalation formulations and injection globally, excluding certain regions [7]. - The company is expanding its product matrix to address unmet clinical needs, focusing on both common and rare diseases, thereby enhancing its market position in the cardiovascular emergency sector [8][9]. Group 3: Clinical and Epidemiological Insights - PAH is characterized by high pulmonary vascular resistance and pressure, leading to severe symptoms and a poor prognosis, with a median survival of only 2.8 years in the absence of targeted therapies [2]. - The incidence of adult PAH is approximately 2.4 per million person-years, with a prevalence of about 15 per million, indicating a significant clinical need for effective treatments [2].

Group 1: Product Development and Regulatory Approvals - The company has received a drug registration certificate from the National Medical Products Administration of China for a new specification (20ml:50mg) of its product, Treprostinil injection, used for treating pulmonary arterial hypertension (PAH) [1] - The existing specification (20ml:20mg) was approved for market launch in March 2023, and both specifications are included in the medical insurance catalog, allowing for more precise treatment options for clinicians [1] - The company has reached an equity investment and product cooperation agreement with Shanghai Zhongqiang Pharmaceutical Co., Ltd., which includes acquiring approximately 14.42% equity and exclusive commercialization rights for Treprostinil inhalation formulation in Greater China [2] Group 2: Market Potential and Epidemiology - PAH is a rare cardiovascular disease with an incidence rate of approximately 2.4 per million person-years and a prevalence of about 15 per million, leading to high mortality and disability rates [3] - The global PAH market is projected to reach approximately $8.06 billion in 2024, with a compound annual growth rate (CAGR) of 5.3%, and the Asia-Pacific region expected to grow at a CAGR of 13.3% [3] Group 3: Clinical Efficacy and Treatment Landscape - Treprostinil is a synthetic prostacyclin analog that promotes vasodilation and inhibits platelet aggregation, with clinical studies showing significant long-term efficacy and safety [4] - The one-year and four-year survival rates for patients on Treprostinil monotherapy are 88% and 70%, respectively, indicating a substantial improvement in patient prognosis [4] - The approval of Treprostinil injection has altered the market landscape by reducing the monopoly of single products in the domestic market, potentially lowering the medical burden on PAH patients [4] Group 4: Commitment to Rare Diseases and Innovation - The company is focused on developing treatments for rare diseases, with over 20 products in the pipeline, including those for conditions like N-acetylglutamate synthase deficiency and hyperammonemia [5] - The company aims to address the clinical needs in the rare disease sector, responding to government and societal calls, and is committed to increasing the development of effective treatments for rare diseases [5] - The company emphasizes innovation and advanced technology in product development, aiming to create a global sales network and enhance its international presence [6][7]

Core Viewpoint - The company has made significant progress in the treatment of pulmonary arterial hypertension (PAH) with the approval of a new specification for its drug, which will enhance treatment options for patients [1][4]. Group 1: Product Development and Approval - The company received a drug registration certificate from the National Medical Products Administration for a new specification (20ml: 50mg) of its drug for PAH treatment, complementing the previously approved 20ml: 20mg specification [1]. - The new specifications will allow clinicians to provide more precise treatment plans based on patient needs, marking a major advancement in the rare disease sector of cardiovascular emergency care [1]. - The company has also entered into an equity investment and product cooperation agreement with Shanghai Zhongqiang Pharmaceutical, acquiring approximately 14.42% equity and exclusive commercialization rights for various formulations of its PAH treatment [2]. Group 2: Market Potential and Epidemiology - PAH is a rare cardiovascular disease with an incidence rate of approximately 2.4 per million person-years and a prevalence of about 15 per million, indicating a significant unmet medical need [3]. - The global PAH market is projected to reach approximately $8.06 billion in 2024, with a compound annual growth rate (CAGR) of 5.3%, and the Asia-Pacific region expected to grow at a CAGR of 13.3% [3]. Group 3: Clinical Efficacy and Treatment Landscape - The drug, a synthetic prostacyclin analog, has demonstrated long-term efficacy and safety in clinical studies, with survival rates of 88% and 70% at one and four years, respectively [4]. - The approval of the injection solution has altered the market dynamics, potentially reducing the financial burden on PAH patients [4]. Group 4: Commitment to Rare Diseases - The company is focused on developing treatments for rare diseases, with over 20 products in the pipeline, including those for conditions like N-acetylglutamate synthase deficiency and Cushing's disease [5]. - The company aims to address the significant challenges faced by rare disease patients, where only 5% of such diseases have effective treatments available [5]. Group 5: Innovation and Global Strategy - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and enhance its product pipeline [6][7]. - A strategy of global operational layout and dual-circulation development is being adopted to promote domestic and international growth [6][7].