记能达(多奈单抗注射液)

Search documents
礼来:记能达对早期症状性阿尔茨海默病显示出三年持续增强获益
Zheng Quan Shi Bao Wang· 2025-08-02 02:29
Core Insights - Eli Lilly announced long-term extension results from its TRAILBLAZER-ALZ2 Phase 3 clinical study, showing significant disease progression slowdown in participants treated with donanemab compared to an untreated cohort from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database [1] - The benefits of donanemab treatment continued to enhance over a three-year period, indicating sustained efficacy [1] - Participants who started treatment later still experienced benefits, but those who received early treatment had a significantly lower risk of progressing to the next stage of the disease compared to the delayed treatment group [1] - These findings were presented at the 2025 Alzheimer's Association International Conference (AAIC) held in Toronto [1]
多奈单抗注射液三年长期临床研究结果公布 创新疗法支持尽早干预
Zheng Quan Ri Bao Wang· 2025-08-02 01:41
Core Insights - The aging population in China is leading to an increased threat from Alzheimer's disease (AD), which has become the fifth leading cause of death in the country, following cardiovascular diseases, malignant tumors, chronic respiratory diseases, and diabetes [1] - There is a significant disease burden from Alzheimer's and other dementias in China, exceeding the global average, necessitating effective intervention measures to help patients capture the early intervention window [1] - Eli Lilly's TRAILBLAZER-ALZ2 long-term extension study results indicate that treatment with donanemab significantly slows disease progression, with benefits increasing over three years [1][2] Company Insights - Eli Lilly's TRAILBLAZER-ALZ2 study is a double-blind extension phase aimed at evaluating the long-term efficacy and safety of donanemab in early symptomatic Alzheimer's patients [2] - Participants originally receiving donanemab either continued treatment or switched to a placebo, while the placebo group began receiving donanemab under blind conditions [2] - The study included an external control group from the Alzheimer's Disease Neuroimaging Initiative (ADNI) to measure treatment outcomes [2] Study Results - Key preliminary results from the TRAILBLAZER-ALZ2 study show that participants receiving donanemab experienced sustained clinical benefits over three years, with a 0.6-point reduction in cognitive decline at 18 months and a 1.2-point reduction at 36 months on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [3] - Early use of donanemab reduced the risk of disease progression to the next stage by 27% compared to delayed treatment [3] - Over 75% of participants treated with donanemab achieved amyloid clearance within 76 weeks, and the rate of amyloid plaque re-deposition remained slow at approximately 2.4 CL/year over a maximum observation period of 2.5 years [3] - No new safety signals were observed during the long-term extension phase, confirming the existing safety profile of donanemab [3]
涉嫌使用“回流药”,武汉5家涉案医疗机构和人员已被立案调查 | 医药早参
Mei Ri Jing Ji Xin Wen· 2025-03-30 23:37
Group 1 - Five medical institutions and personnel in Wuhan have been investigated for allegedly using "reflow drugs," with the local medical insurance bureau suspending their insurance settlements and service agreements [1] - The Wuhan market supervision department will conduct a special rectification of pharmacies across the city, while the police have detained several drug dealers involved in the case [1] Group 2 - Eli Lilly's innovative drug for Alzheimer's disease, "Jinengda" (donanemab injection), has officially launched in China, targeting early-stage Alzheimer's and significantly slowing disease progression [2] - "Jinengda" was approved by the National Medical Products Administration on December 17, 2024, as a breakthrough therapy for treating mild cognitive impairment and mild dementia due to Alzheimer's disease [2] Group 3 - Heng Rui Medicine reported a 2024 net profit of 6.337 billion yuan, a year-on-year increase of 47.28%, with total revenue reaching 27.985 billion yuan, up 22.63% [3] - The company plans to distribute a cash dividend of 2 yuan per 10 shares (including tax), driven by significant growth in innovative drug revenue and successful overseas licensing [3] Group 4 - Hua Lan Biology disclosed a 2024 net profit of 1.088 billion yuan, down 26.57% year-on-year, with total revenue of 4.379 billion yuan, a decrease of 18.02% [4] - The company continues to upgrade production processes for existing blood products and increase investment in vaccine, innovative drug, and biosimilar development [4]