Sevoflurane

关键词：中国制剂出口 全球格局 随着国内集采（带量采购）常态化、医保谈判控费以及审评标准全面与国际接轨（加入 ICH），中国医药产业已全面进入「大出海时代」。中国制剂出口已从早期的低端原料药（API）和低附加值代工，彻底蜕变为「高壁垒制剂、创新生物药、高端复杂制剂」的全球化布局。 目前，中国制剂出口呈现出清晰的三分天下（三大核心市场）格局：                     ┌─── 规范市场 (美、欧、日) ─── 高壁垒、高利润 (PIV专利挑战、生物类似药)                     │ 中国制剂出口全球格局 ├─── 新兴市场 (东盟、拉美、中东) ─ 政策红利期 (集采平台拓展、本土合资)                     │                     └─── 国际组织采购 (UN、全球基金) ─ 稳定跑量 (WHO-PQ认证、抗疟/抗结核) 1. 监管规范市场（美、欧、日）：以美国 ANDA（仿制药）和欧洲互认程序（MRP/DCP）为目标，进入主流高利润医保市场。核心策略已从常规仿制药，升级为挑战原研专利（Paragraph IV）、抢占首仿、以及复杂注射剂、生物类似药（Biosimilars）的注册突围。 2. 新兴市场（东盟、拉丁美洲、中东、中亚）：这是目前增长最快的区域。中资企业深度依赖政策红利，例如利用中国—东盟区域医药交易（集采）平台、中亚「中心药房」等国家级信道，跳过海外传统中间商，直接切入当地本国医保及医院网络。 3. 国际组织援助采购市场（WHO/UN 招标）：依赖 WHO-PQ（资格预审） 认证，常年向联合国儿童基金会（UNICEF）、全球基金（The Global Fund）等公益组织稳定供应抗疟、抗结核、抗艾滋病等基本药物。 🏆 代表性企业与核心出海产品 在不同的出海赛道和市场中，中国已经涌现出一批极具国际公信力的龙头制剂企业和重磅产品： 1. 创新生物药 / 生物类似药（出海最高壁垒） 这类企业代表了中国制剂转型创新的最高水平，直接在欧美和全球市场与跨国药企正面硬刚： • 百济神州 (Beigene)：其自研的 泽布替尼 (Brukinsa) 堪称中国医药出海的「天花板」级产品。通过多中心临床试验（MRCT）直接在「头对头」试验中击败琼森/艾伯维的原研药，全球年销售额已突破 10 亿乃至数十亿美元，成功控盘欧美主流血液瘤分销市场。 • 复宏汉霖 (Henlius)：其研发的 汉曲优 (曲妥珠单抗，欧洲商品名：Zercepac) 是中国首个自主研发、并在中、欧、美三地均获批上市的生物类似药。该产品通过与海外大牌分销商（如 Accord Healthcare）合作，成功切入欧洲和北美发达国家的公立医保采购。 • 百奥泰 (Bio-Thera) / 迈威生物：其阿达木单抗、托珠单抗等生物类似药，相继通过 FDA 和 EMA 审评，在欧美市场与全球巨头瓜分生物制剂红利。 2. 高壁垒无菌注射剂与仿制药巨头（深耕欧美 ANDA） 这类企业在过去十几年中建立了解析欧美法规的「特种部队」，通过高难度剂型和复杂供应链突围： • 健友股份 (Nanjing Jianyou) / 普利制药 (Hainan Poly)：中国无菌注射剂出口美国的绝对领头羊。健友股份在美国拥有数十个获批的注射剂 ANDA 批文，涵盖抗肿瘤、抗感染等领域，并在美国建立了极为灵敏的短缺药快速响应分销机制。 • 齐鲁制药 (Qilu Pharmaceutical)：其顺铂注射液、鲍曼海因等抗肿瘤制剂，在美国面临严重药品短缺时，获美国 FDA 特批直接以「中国包装和中文标签」紧急出口美国支持一线临床，树立了极高的国际合规和供应链声誉。 • 恒瑞医药 (Hengrui)：其吸入用七氟烷、奥沙利铂注射液等重磅制剂，在美、欧、日全线获批。近年更是将其 GLP-1 减肥产品组合通过 NewCo（海外合资） 模式授权给美国 Hercules CM 公司，实现了「管线+国际资本」的轻资产高阶出海。 3. 国际公认基本药物与多边采购先锋（WHO-PQ 与非洲市场） 这类企业在细分领域做到全球前三，深度切入全球公益和公共卫生供应链： • 复星医药 (Fosun Pharma) / 桂林南药：自主研发的 注射用青蒿琥酯 (Artesun) 是全球抗击重症疟疾的金标准。复星医药控股了西非第三大分销商 Tridem Pharma，在非洲建立起了完全中资控股的「自产+自销」直营网络，累计挽救了全球数千万疟疾患者的生命。 • 人福医药 (Humanwell)：其芬太尼系列麻醉制剂在非洲多国实现本地化注册与合资建厂，在西非（如马里）建立了极具统治力的本地化分销壁垒。

Choice of general anaesthetic for major surgery can continue to be based on patient and clinician preference, according to the largest ever trial comparing the two main techniques used in the NHS. The VITAL trial, led by the University of Warwick and The Royal Marsden NHS Foundational Trust involved 2,507 patients across 49 NHS hospitals, and compared total intravenous anaesthesia (TIVA), delivered through a continuous infusion of the drug propofol, with the more traditional method of using volatile anaesthetic gases, such as sevoflurane or isoflurane, inhaled through a mask during surgery. The findings are published in the journal JAMA. Both approaches are used routinely to keep patients unconscious during the more than 1.5 million major non-cardiac operations carried out in the UK each year. Some anaesthetists have argued that TIVA offers a smoother recovery, with less sickness and pain, while others have pointed to rare risks such as a patient briefly regaining awareness during surgery. Until now, no large-scale UK trial had settled which technique, if either, was better for patients or the health service. Key findings Patients aged 50 and over undergoing major planned surgery were randomly allocated to receive either TIVA or inhalational anaesthesia for major planned operations. The results found no meaningful difference between the two groups in the number of days patients were alive and out of hospital 30 days after surgery, the trial's main measure of recovery. Rates of major complications, delirium and death at 30 days, 90 days and six months were also similar between the groups. However, patients who received TIVA reported lower rates of thirst, hoarseness, nausea and vomiting on the day after their operation, suggesting a modest improvement in early postoperative recovery and comfort. A separate economic evaluation, published in the journal Anaesthesia, found the two techniques cost the NHS a similar amount and delivered similar quality of life for patients over a six-month period. What this means Together, the two studies indicate that TIVA and inhalational anaesthesia are clinically and economically equivalent for adults having major non-cardiac surgery. The research team says this supports continuing to let clinicians choose the technique best suited to individual patients, based on factors such as patient preference, clinical expertise and what is available locally, rather than mandating a single approach across the NHS. Professor Joyce Yeung of Warwick Clinical Trials Unit and chief investigator of the VITAL trial, said: "For years anaesthetists have debated which technique gives patients the best start to their recovery. What our trial shows is that, for most patients having major surgery, the two methods are equally viable. That's reassuring for patients, and it means doctors can keep making that decision based on what's right for the person in front of them, not on pressure to switch to a newer or supposedly superior technique." The researchers note some limitations: the trial was not blinded, which could affect patient-reported outcomes such as pain and nausea; participants were all treated within the NHS, so findings may not transfer directly to other health systems; and the study did not examine longer-term cancer outcomes or the environmental impact of the different techniques, an area of growing interest given that volatile anaesthetic gases are potent greenhouse gases. ENDS Notes to Editors The trial was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme and coordinated by Warwick Clinical Trials Unit, part of Warwick Medical School. The paper 'Total Intravenous vs Volatile Inhalational Anesthesia for Major Noncardiac Surgery' is published in the October 13th issue of JAMA. DOI: 10.1001/jama.2026.11065 For more information please contact: Matt Higgs, PhD | Media & Communications Manager (Warwick Press Office) Email: Matt.Higgs@warwick.ac.uk | Phone: +44(0)7880 175403 About the University of Warwick Founded in 1965, the University of Warwick is a world-leading institution known for its commitment to era-defining innovation across research and education. A connected ecosystem of staff, students and alumni, the University fosters transformative learning, interdisciplinary collaboration and bold industry partnerships across state-of-the-art facilities in the UK and global satellite hubs. Here, spirited thinkers push boundaries, experiment and challenge convention to create a better world.