司拉德帕(Seladelpar)
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罕见病创新药司拉德帕中国内地首方从顺义开出
Xin Jing Bao· 2026-01-07 01:48
在北京友谊医院顺义院区,患者刘丽(化名)拿到了中国内地开出的第一盒司拉德帕。刘丽已经确诊原 发性胆汁性胆管炎多年,选择目前一线治疗药物后,相关指标没有显著好转,经充分沟通后,决定试用 罕见病创新药司拉德帕。"希望这款创新药能够改善我的情况,同时希望此类药物早日纳入医保,惠及 更多患者。"刘丽说。 原发性胆汁性胆管炎是一种慢性胆汁淤积性肝病,以肝内小胆管的进行性破坏为特征。这类患者疾病进 展风险高,可逐渐进展至肝纤维化、肝硬化,并出现消化道出血、腹水、肝性脑病等并发症。目前,约 30%至40%患者对目前该领域一线用药疗效欠佳,亟需更有效的创新治疗方案。 新京报讯 据"北京顺义"微信公众号消息,1月6日上午,北京友谊医院顺义院区开出罕见病创新药司拉 德帕(Seladelpar)的中国内地首张处方,这款药物专治原发性胆汁性胆管炎。这不仅标志着我国罕见 病治疗领域迈出重要一步,也为更多创新药物的引进提供了可借鉴范式。 在北京市临床急需药品临时进口政策东风以及科园信海(北京)医疗用品贸易有限公司的高效协作下, 司拉德帕仅历时两个多月便快速获批,为罕见病患者带来福音。 2025年9月,48盒司拉德帕已经在天竺综保区内保税 ...
直击进博会 | 创新药迎来历史性一刻
盐财经· 2025-11-07 09:48
Core Viewpoint - The China International Import Expo (CIIE) is significantly accelerating the speed at which innovative drugs enter the Chinese market, transforming the landscape for multinational pharmaceutical companies and benefiting countless patients [3][8]. Group 1: Innovative Drug Launches - A groundbreaking drug for delaying the progression of type 1 diabetes, Trelagliptin, made its Asian debut at the CIIE and received approval for market entry in September [10]. - Sanofi's innovative cardiovascular drugs and Gilead Sciences' long-acting HIV prevention drug, Lenacapavir, were showcased at the CIIE, indicating a trend of faster access to top-tier medications for Chinese patients [6][18]. - The "CIIE speed" is exemplified by Sanofi's drug Dupixent, which received approval in China ahead of the U.S. FDA, showcasing a record time for innovative drugs to benefit Chinese patients [11]. Group 2: Market Strategy and Investment - Multinational pharmaceutical companies are shifting from merely introducing products to deeper, full-industry chain strategies in China, with Sanofi establishing China as an independent strategic market unit [20][22]. - Novartis has conducted over 100 clinical trials in China and aims for 90% of new drug registrations to align with global timelines within the next two years [28]. - Gilead Sciences is focusing on synchronizing its research and development projects in China with global efforts, emphasizing the importance of the Chinese market [23][26]. Group 3: CIIE's Spillover Effect - The CIIE is not only expediting drug launches but also creating a "spillover effect" that enhances the overall healthcare landscape in China, allowing for broader access to innovative treatments [15][17]. - Since its inception, Novartis has had over 40 innovative drugs and indications approved in China, accounting for 40% of its total approvals in the country since 1987 [15]. - The CIIE serves as a high-level open platform that fosters consensus, innovation, and collaboration among pharmaceutical companies, ultimately changing the lives of Chinese patients [17].