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北京创新药临床试验审批缩至30日
Bei Jing Qing Nian Bao· 2025-10-17 00:39
Group 1 - The core viewpoint of the articles is that regulatory reforms in Beijing are significantly enhancing the pharmaceutical and healthcare industry, aiming for a market value exceeding one trillion yuan through various supportive policies [1][2][3]. Group 2 - The approval time for clinical trials of innovative drugs has been reduced from 60 days to 30 days, with some projects being approved in as little as 18 working days [2][3]. - A total of 26 drug varieties have been approved, including 21 for rare diseases, benefiting approximately 4,900 patients [2]. - The Beijing model includes measures such as bonded stockpiling and multiple uses of a single customs clearance to expedite access to urgently needed drugs [2][3]. Group 3 - The overall time for initiating clinical trial projects is targeted to be reduced from 28 weeks to under 20 weeks by 2024, with some hospitals already achieving a reduction to around 7 weeks [3][4]. - A green channel has been established for innovative drugs, allowing for simultaneous reviews of project initiation, ethical review, and contract review, significantly shortening approval times [4]. Group 4 - The National Medical Insurance Bureau has implemented a dynamic adjustment mechanism for the medical insurance catalog, adding 835 new drugs over seven years, including 149 innovative drugs [5]. - Approximately 80% of innovative drugs are expected to be included in the medical insurance catalog within two years of their market launch [5][6]. - In the first seven months of 2025, 13.05 million patients purchased national negotiated drugs, totaling 3.95 billion yuan in expenses [5]. Group 5 - A dual-channel supply mechanism for national negotiated drugs has been established to ensure accessibility and address issues related to slow and difficult hospital entry [5][6]. - The Beijing Medical Insurance Fund will separately pay 4.5 billion yuan for national negotiated drugs in 2024, ensuring that these drugs are not subject to DRG payment limits [6][7]. Group 6 - The establishment of a drug and medical device review center in the Beijing-Tianjin-Hebei region aims to accelerate the approval process for innovative drugs and medical devices [8]. - The center will provide comprehensive technical services, including guidance and consultation for drug and device registration, focusing on clinical needs [8].
70万一针救命药进医保 罕见病男孩上学了
Yang Shi Xin Wen· 2025-09-27 22:45
Core Viewpoint - The story highlights the journey of a child with spinal muscular atrophy (SMA) and the impact of national healthcare policies on access to life-saving treatments, showcasing the importance of medical advancements and insurance negotiations in improving patient outcomes [1][14]. Group 1: Medical Condition and Treatment - The child, known as Little Stone, was diagnosed with SMA at eight months old, with initial medical advice suggesting a grim prognosis and no available treatments in China [3][5]. - A special drug, Nusinersen, was introduced in China in early 2019, but its high cost of approximately 700,000 yuan per injection posed a significant financial burden for the family [5][10]. - In 2020, the drug's price was reduced to 550,000 yuan per injection, and the company offered a buy-one-get-five-free deal, improving the child's condition through ongoing rehabilitation and treatment [8][12]. Group 2: Healthcare Policy and Insurance Negotiations - The first round of national healthcare negotiations in 2021 saw the drug's price drop dramatically from 550,000 yuan to around 30,000 yuan, making it accessible for more patients [10][12]. - The negotiations aimed to balance the interests of patients, pharmaceutical companies, and the healthcare fund, reflecting a significant shift in the availability of rare disease treatments in China [10][14]. - Following the successful negotiations, the number of patients using Nusinersen in 2022 increased significantly, with a reported 2.6 times growth in sales compared to the previous year [12]. Group 3: Social Integration and Support - Little Stone successfully enrolled in elementary school, with the institution making special accommodations to support his learning needs, demonstrating a positive societal response to children with disabilities [16][18]. - The family continues to face challenges, including ongoing rehabilitation sessions and the aging of family members who provide support [20]. - The narrative emphasizes the importance of community support, family involvement, and healthcare policies in enabling children with rare diseases to integrate into society and pursue education [21].