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阿尔茨海默病创新药长期随访结果如何?是否安全?最新数据公布
第一财经· 2025-08-02 06:33
Core Viewpoint - Recent innovations in Alzheimer's disease drugs have shown promising results in clinical trials, particularly the long-term efficacy of therapies like donanemab, but concerns about long-term effects and safety remain [3][4]. Group 1: Clinical Trial Results - Eli Lilly's donanemab has demonstrated a significant slowing of disease progression in Alzheimer's patients over a three-year follow-up, with early treatment showing a 27% reduced risk of advancing to the next disease stage compared to delayed treatment [3][4]. - Over 75% of early-treated patients achieved amyloid clearance within 76 weeks, and the rate of amyloid plaque re-deposition was slow at approximately 2.4 CL/year during the longest observation period of 2.5 years [3][4]. Group 2: Safety and Side Effects - No new safety signals were observed during the long-term extension phase of the study, but previously noted issues related to amyloid-targeting treatments, such as ARIA (Amyloid-related imaging abnormalities), remain a concern [4]. - ARIA-related symptoms, including edema and bleeding, primarily occur within the first six months of treatment, and patients with the ApoE4 allele are at higher risk for these complications [4]. Group 3: Market Context and Patient Demographics - Donanemab was recently introduced in China, but the long-term efficacy in the Chinese patient population is yet to be validated due to the timing of its market entry [4][5]. - The earlier launched drug, lecanemab, has also shown a 34% reduction in cognitive decline over four years, with no new safety issues reported, although this data does not include Chinese patients [5]. - China has approximately 9.83 million Alzheimer's patients, with an estimated 20% being in the early stages of the disease, indicating a significant potential market for innovative treatments [5].
21调查|谁在收割阿尔茨海默病患者钱包?
2 1 Shi Ji Jing Ji Bao Dao· 2025-06-24 10:10
Core Viewpoint - The market for GV-971 (also known as "Jiuyiqi"), a drug for Alzheimer's disease, is experiencing disruptions due to reports of its production halt, leading to a surge in demand for alternative products labeled as "GV-971" in the market [1][5][8]. Group 1: Market Dynamics - Reports indicate that the production of GV-971 has been temporarily halted, causing a supply shortage in pharmacies across the country [5][6]. - The price of GV-971 on e-commerce platforms has skyrocketed from its original price of 296 yuan per box to around 1000 yuan, with many listings having purchase limits [5][6]. - There is a growing trend of individuals attempting to sell their remaining stock of GV-971 at high prices on social media, reflecting the urgent demand from families of Alzheimer's patients [5][6]. Group 2: Product Misrepresentation - A number of products claiming to be "GV-971" are being marketed as food and health products, which do not have the same therapeutic effects as the actual drug [3][8]. - Many of these products are sold under the guise of "medicine-food homology," which is misleading as these products do not possess the same medicinal properties as GV-971 [8][11]. - Some sellers are using terms like "Beijing Tongrentang" to enhance credibility, despite these products not being officially authorized by the brand [3][8]. Group 3: Regulatory Concerns - The sale of GV-971 as a prescription drug is regulated, and any unauthorized resale is illegal, posing risks of counterfeit or substandard products entering the market [5][11]. - The distinction between actual pharmaceuticals and food products is critical, as the latter cannot replace the therapeutic functions of prescribed medications [11][12]. - The active ingredient in GV-971, derived from marine brown algae, is not included in the list of substances that can be classified as "medicine-food homology," further complicating the market situation [11][12].
谁在收割阿尔茨海默病患者钱包?
21世纪经济报道· 2025-06-24 10:02
Core Viewpoint - The article discusses the market dynamics surrounding the Alzheimer's disease treatment drug GV-971 (甘露特钠胶囊), which has reportedly been suspended, leading to a surge in demand for both legitimate and illegitimate products claiming to be similar or related [1][4]. Group 1: Market Response to Drug Suspension - Since June, there have been ongoing reports about the suspension of GV-971, with the manufacturer,绿谷制药, confirming temporary adjustments in production but not clarifying if it will be permanently discontinued [1]. - The suspension has led to a nationwide shortage of GV-971, with prices on e-commerce platforms skyrocketing from approximately 296 yuan to around 1000 yuan per box, often with purchase limits [4]. - Many families of Alzheimer's patients are actively seeking to purchase GV-971 at high prices, indicating a strong demand despite the legal restrictions on resale of prescription drugs [4]. Group 2: Emergence of Alternative Products - A variety of products labeled as "甘露特钠胶囊" have emerged in the market, often marketed as "药食同源" (food and medicine from the same source), which are not officially recognized as drugs and may mislead consumers [3][8]. - Some sellers are using the name "北京同仁堂" to enhance credibility, although these products are not officially authorized by the brand [3]. - The concept of "药食同源" is being exploited by sellers to bypass drug regulations, with products being marketed under misleading names that suggest medicinal benefits [8][9]. Group 3: Regulatory and Safety Concerns - The sale of GV-971 without a prescription is illegal, and private transactions pose risks of counterfeit or substandard products, jeopardizing patient safety [4]. - Experts emphasize that while GV-971 offers a new approach to Alzheimer's treatment, it is not the only option available, and patients should not panic about the temporary suspension [5][6]. - The article highlights that the active ingredient in GV-971, derived from marine brown algae, does not meet the criteria for inclusion in the "药食同源" category, reinforcing the distinction between legitimate drugs and food products [10].