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全球首创:国产破伤风新药登上医学顶刊Nature Medicine
生物世界· 2025-07-10 03:24
Core Viewpoint - The article discusses the urgent need for a safe, effective, and more accessible alternative to current tetanus immunization therapies, highlighting the promising results of the recombinant monoclonal antibody Siltartoxatug compared to human tetanus immunoglobulin (HTIG) [3][15]. Group 1: Tetanus Overview - Tetanus is a life-threatening infection caused by the neurotoxin produced by Clostridium tetani, with an estimated 34,684 deaths globally in 2019 [1]. - Vaccination coverage for tetanus is inadequate, with 14.3 million infants not receiving the first dose of the DTP vaccine in 2022 [1]. Group 2: Current Treatments and Limitations - WHO recommends passive immunization for tetanus prevention and treatment, but current therapies like equine tetanus antitoxin are associated with allergic reactions occurring in 5%-30% of cases [2]. - HTIG, the replacement for equine antitoxin in developed countries, has issues such as supply shortages, high costs, and risks of infectious disease transmission [2]. Group 3: Siltartoxatug Development - Siltartoxatug, a recombinant fully human IgG1 monoclonal antibody, targets the AB fragment of tetanus toxin, blocking its transport and enzymatic activity [7]. - The monoclonal antibody can be produced on a large scale through standardized industrial processes, offering a viable alternative to plasma-derived therapies [6]. Group 4: Clinical Trial Results - A phase 3 clinical trial demonstrated that Siltartoxatug significantly outperformed HTIG in providing both short-term and long-term protection against tetanus [10][11]. - In the trial, 95.4% of participants receiving Siltartoxatug had a significant increase in neutralizing antibody titers within 12 hours compared to 53.2% for HTIG [10]. Group 5: Safety and Efficacy - The safety profile of Siltartoxatug was comparable to HTIG, with adverse event rates of 38.2% for Siltartoxatug and 33.9% for HTIG [14]. - Allergic reactions were lower in the Siltartoxatug group at 0.2% compared to 0.9% in the HTIG group [14]. Group 6: Regulatory Approval - Siltartoxatug received approval from the National Medical Products Administration (NMPA) in China in February for emergency prevention of tetanus in adults [16].
金融工程日报:A股午后放量下行,TMT全线回调、离境退税概念逆势大涨-20250610
Guoxin Securities· 2025-06-10 14:46
The provided content does not contain any specific quantitative models or factors, nor does it include their construction processes, formulas, evaluations, or backtesting results. The document primarily focuses on market performance, sector analysis, market sentiment, capital flows, ETF premiums/discounts, block trading, and institutional activities. These are descriptive analyses and statistics rather than quantitative models or factor-based methodologies. If you have another document or specific quantitative content, please provide it for analysis
来凯医药LAE102肥胖症I期试验启动皮下注射研究,预计年内完成单次剂量递增研究
IPO早知道· 2024-10-17 13:15
10月16日及17日,来凯医药股价涨幅分别为8.44%和16.21%。 已全面布局ActRII通路。 本文为IPO早知道原创 作者|罗宾 微信公众号|ipozaozhidao 据IPO早知道消息,10月16日,来凯医药(2105.HK)宣布其自主研发的LAE102(ActRIIA单克隆 抗体)针对超重/肥胖在中国开展的I期临床试验单次剂量递增(SAD)研究的皮下注射(SC)部分 已启动。 该I期临床系一项随机、双盲、安慰剂对照、单次和多次给药剂量递增研究,旨在通过静脉输注 (IV)和皮下注射(SC)两种给药方式,评价LAE102注射液在健康成年受试者及超重/肥胖受试者 中的安全性、耐受性及药代动力学。 截至2024年9月30日,已有过半数的静脉输注队列完成了给药,并在低剂量组中就观察到靶点结合 的早期迹象和预期的PD生物标志物变化。此次启动的为皮下注射研究部分,2024年底前有望完成单 次剂量递增研究。 LAE102是来凯医药自主研发、全球首创的一种单克隆抗体,针对参与调控肌肉再生和脂代谢的重要 靶点ActRIIA。临床前研究显示,可增加肌肉并减少脂肪 。 LAE102 与 GLP-1 受体激动剂联用,可 进 ...