(function(){ var content_array=["

关于重度哮喘<\/u><\/b><\/p> \n

哮喘是一种异质性疾病，据估计影响全球约3.39亿人23<\/sup>。其中，高达10%的哮喘患者为重度哮喘24,25<\/sup>。尽管已使用吸入糖皮质激素（ICS）、现有的生物制剂及口服糖皮质激素（OCS）等药物治疗，仍有许多重度哮喘患者的病情未能得到有效控制24-26<\/sup>。由于重度哮喘的复杂性，许多患者的炎症驱动因素不明确或存在多种诱因，这可能导致其不符合现有生物制剂的适用条件，或对其治疗反应不佳25-28<\/sup>。<\/p> \n

由于频繁的急性发作、肺功能严重受限以及生活质量的下降，患者面临沉重的疾病负担24,25,29<\/sup>。同时，重度哮喘患者死亡风险更高，且哮喘相关住院风险是持续性哮喘患者的2倍30-32<\/sup>。此外，重度哮喘相关医疗费用约占哮喘患者医疗总成本的50%，为社会带来沉重的经济负担33<\/sup>。<\/p> \n

关于慢性鼻窦炎伴鼻息肉<\/u><\/b><\/p> \n

慢性鼻窦炎伴鼻息肉（CRSwNP）是以鼻腔黏膜持续性炎症伴良性息肉形成为特征的复杂炎症性疾病8,9<\/sup>。鼻息肉及其相关炎症可阻塞鼻腔通道，导致呼吸困难、嗅觉障碍、鼻分泌物增多、面部疼痛及睡眠障碍，严重影响生活质量34,35<\/sup>。<\/p> \n

上皮功能障碍和炎症是慢性鼻窦炎的重要特征，会损害上皮组织作为物理及免疫屏障抵御外界的能力36,37<\/sup>。胸腺基质淋巴细胞生成素（TSLP）是一种上皮细胞因子，通过作用于炎症级联反应上游，在重度哮喘及慢性鼻窦炎伴鼻息肉的共同发病机制中发挥关键作用36,37<\/sup>。<\/p> \n

现有慢性鼻窦炎伴鼻息肉（CRSwNP）治疗手段包括鼻内\/系统性糖皮质激素治疗、手术及生物制剂治疗9,35,38-43<\/sup>。<\/p> \n

关于<\/u><\/b>DIRECTION III<\/u><\/b>期研究<\/u><\/b><\/p> \n

DIRECTION研究是一项在亚洲进行的多中心、随机、双盲、安慰剂对照的III期临床研究，旨在评估特泽利尤单抗在重度哮喘控制不佳的成年受试者中的有效性和安全性1<\/sup>。该研究共纳入包含中国（65家医院）、韩国（8家医院）和菲律宾（3家医院），共计400例年龄在18~80岁范围内的重度、未控制哮喘患者（未限制基线生物标志物水平），按1:1比例随机分配，接受每4周皮下注射1次特泽利尤单抗210mg（n=201）或安慰剂（n=199）治疗，持续52周1<\/sup>。<\/p> \n

关于<\/u><\/b>WAYPOINT III<\/u><\/b>期研究<\/u><\/b><\/p> \n

WAYPOINT研究是一项双盲、多中心、随机、安慰剂对照、平行分组的III期临床研究，旨在评估特泽利尤单抗在重度慢性鼻窦炎伴鼻息肉（CRSwNP）成人患者中的疗效和安全性2,3,44<\/sup>。受试者通过皮下注射方式接受特泽利尤单抗或安慰剂治疗。完成52周治疗期的受试者还将进入12至24周的治疗后随访期2,44<\/sup>。<\/p> \n

该研究的共同主要终点为：通过内镜鼻息肉总评分评估的鼻息肉总体积较基线变化，以及通过患者鼻息肉症状日记中作为组成部分的患者自我报告鼻雍阻症状评分评估的双周鼻雍阻均值较基线变化2,44<\/sup>。关键次要终点包括：嗅觉丧失评分、评估疾病相关健康生活质量的SNOT-22评分、Lund-Mackay评分、鼻息肉手术决策时间、系统性糖皮质激素使用时间、症状日记总症状评分以及合并哮喘患者第52周支气管扩张前第一秒用力呼气量FEV12,44<\/sup>。<\/p> \n

关于特泽利尤单抗<\/u><\/b><\/p> \n

特泽利尤单抗是由阿斯利康与安进合作开发的全球首创（first-in-class）人源单克隆抗体，可抑制胸腺基质淋巴细胞生成素（TSLP）的活性。TSLP是一种位于多个炎症级联反应上游的关键上皮细胞因子，在重度哮喘、慢性鼻窦炎伴鼻息肉（CRSwNP）及其他炎症性疾病相关的过敏性、嗜酸细胞性及上皮驱动型炎症的启动和持续过程中具有核心作用36,37<\/sup>。<\/p> \n

多种与哮喘、慢性鼻窦炎伴鼻息肉（CRSwNP）、慢性阻塞性肺疾病（COPD）、嗜酸性粒细胞性食管炎（EoE）等疾病相关的环境触发因素（包括过敏原、病毒和其他大气颗粒物等）会刺激上皮细胞释放TSLP37,45<\/sup>。此类患者体内TSLP表达水平升高，且与疾病严重程度相关22,35<\/sup>。<\/p> \n

特泽利尤单抗一次性预充注射器和自动注射器已获美国、欧盟批准，供患者自我给药20-22<\/sup>。自2021年起，逾10万名重度哮喘患者已使用特泽利尤单抗治疗46<\/sup>。<\/p> \n

除重度哮喘、慢性鼻窦炎伴鼻息肉（CRSwNP）以外，特泽利尤单抗还在开发用于慢性阻塞性肺疾病（COPD）和嗜酸性粒细胞性食管炎（EoE）47,48<\/sup>。2021年10月，特泽利尤单抗获美国食品药品监督管理局（FDA）授予治疗嗜酸性粒细胞性食管炎（EoE）的孤儿药资格认定（Orphan Drug Designation）49<\/sup>。<\/p> \n

阿斯利康与安进的合作<\/u><\/b><\/p> \n

2012年安进与阿斯利康签署的特泽利尤单抗合作协议目前已经进行修订。根据协议，阿斯利康在向安进支付中度个位数百分比专利费后，双方将继续平摊成本与利润。阿斯利康负责药物全球开发，安进负责生产管理。所有合作事项由联合治理机构监督执行。根据协议，安进和阿斯利康在美国共同商业化特泽利尤单抗。美国市场销售额计入安进报表，阿斯利康则将其在美国的利润分成记入合作收入项。在美国以外地区，阿斯利康记录产品销售额，安进则将利润分成记入其他\/合作收入项。<\/p> \n

关于阿斯利康呼吸及自体免疫治疗领域<\/u><\/b><\/p> \n

呼吸与自体免疫是阿斯利康生物制药业务的重要组成部分，是公司聚焦的关键疾病领域和业务增长的主要驱动力。<\/p> \n

阿斯利康是呼吸领域的领先企业，深耕呼吸领域50多年，在免疫疾病领域也拥有日益丰富的产品线。公司致力于通过对吸入制剂、生物制剂和针对全新靶点的新疗法的管线开发和产品组合，来满足慢性且具有衰竭性特征的疾病领域的巨大未满足需求。我们的目标是提供改变患者生命的药物，帮助消除慢性阻塞性肺病这一主要死亡原因，消除哮喘发作，并实现免疫介导疾病的临床缓解。<\/p> \n

关于阿斯利康<\/u><\/b><\/p> \n

阿斯利康（LSE\/STO\/NYSE: AZN）是一家科学至上的全球生物制药企业，专注于研发、生产及营销处方类药品，重点关注肿瘤、罕见病以及包括心血管肾脏及代谢、呼吸及免疫在内的生物制药等领域。阿斯利康全球总部位于英国剑桥，业务遍布超过125个国家，创新药物惠及全球数百万患者。更多信息，请访问www.astrazeneca.com<\/a>或在社交平台关注@AstraZeneca。<\/p> \n

参考文献：<\/b><\/p> \n

    \n
  1. Yang X, Wang L, Huang K, et al. Efficacy and Safety of Tezepelumab in Adults With Severe, Uncontrolled Asthma in Asia: Results From the Phase 3 DIRECTION Study. J Allergy Clin Immunol Pract. 2025;13(11):3011-3020.e9. doi:10.1016\/j.jaip.2025.07.046<\/li> \n
  2. Lipworth, BJ, Han JK, et al. Tezepelumab in adults with severe, uncontrolled CRSwNP. N Engl J Med. 2025.<\/li> \n
  3. Lipworth, BJ, Han JK, et al. Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps: results from the Phase 3 WAYPOINT Study. [Late breaking oral presentation]. Presented at the American Academy of Allergy, Asthma & Immunology \/World Allergy Organization Joint Congress 2025 (28 February – 03 March).<\/li> \n
  4. Chinese Guidelines for the Prevention and Management of Bronchial Asthma (2024 Edition)<\/li> \n
  5. Chinese Journal of Tuberculosis and Respiratory Diseases. 2025;48(3):208-248<\/li> \n
  6. Zhonghua Nei Ke Za Zhi. 2017;56(7):481-482. doi:10.3760\/cma.j.issn.0578-1426.2017.07.001<\/li> \n
  7. Zhang Q, Fu X, Wang C, et al. Severe eosinophilic asthma in Chinese C‑BIOPRED asthma cohort[J]. Clin Transl Med, 2022, 12(2):e710. DOI: 10.1002\/ctm2.710.<\/li> \n
  8. Bachert C, et al. Phenotypes and Emerging Endotypes of Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2016;4(4):621-628.<\/li> \n
  9. Del Toro E, Portela J. Nasal Polyps. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. Available at: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK560746\/<\/a>. Accessed October 2025.<\/li> \n
  10. Zhu, D D et al. Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery vol. 60,11 (2025): 1389-1398. doi:10.3760\/cma.j.cn115330-20250527-00295<\/li> \n
  11. Bhattacharyya N, Villeneuve S, Joish VN, Amand C, Mannent L, Amin N, Rowe P, Maroni J, Eckert L, Yang T, Khan A. Cost burden and resource utilization in patients with chronic rhinosinusitis and nasal polyps. Laryngoscope. 2019 Sep;129(9):1969-1975. doi: 10.1002\/lary.27852. Epub 2019 Feb 5. PMID: 30720213; PMCID: PMC6767455.<\/li> \n
  12. Denton E, et al. The journal of allergy and clinical immunology. In practice vol. 9,7 (2021): 2680-2688.e7.<\/li> \n
  13. Hao D, Wu Y, Li P, et al. An Integrated Analysis of Inflammatory Endotypes and Clinical Characteristics in Chronic Rhinosinusitis with Nasal Polyps. J Inflamm Res. 2022 Sep 24;15:5557-5565.<\/li> \n
  14. Håkansson, Kåre et al. "A comparative and descriptive study of asthma in chronic rhinosinusitis with nasal polyps." American journal of rhinology & allergy vol. 28,5 (2014): 383-7. doi:10.2500\/ajra.2014.28.4076.<\/li> \n
  15. Global Initiative for Asthma. [Online]. Global strategy for asthma management and prevention, 2025. Available at: https:\/\/ginasthma.org\/wp-content\/uploads\/2025\/11\/GINA-2025-Update-25_11_08-WMS.pdf<\/a>. Accessed March 2026.<\/li> \n
  16. Chinese Education Association of Chronic Airway Diseases. Natl Med J China. 2024;104(20):1759-1789<\/li> \n
  17. AstraZeneca news release. Tezspire approved in the US for chronic rhinosinusitis with nasal polyps. Available at: https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2025\/us-fda-approves-tezspire-in-crswnp.html<\/a>. Accessed March 2026.<\/li> \n
  18. AstraZeneca news release. Tezspire approved in the EU for chronic rhinosinusitis with nasal polyps. Available at: https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2025\/tezspire-approved-in-eu-for-crswnp.html<\/a>. Accessed March 2026.<\/li> \n
  19. AstraZeneca news release. Tezspire 210mg pre-filled syringe and auto-injector approved in Japan for CRSwNP. Available at: https:\/\/www.astrazeneca.co.jp\/content\/az-jp\/media\/press-releases1\/2026\/202602191.html<\/a>. Accessed March 2026.<\/li> \n
  20. TEZSPIRE (tezepelumab) US prescribing information. Available at: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/761224s003lbl.pdf<\/a>. Accessed March 2026.<\/li> \n
  21. TEZSPIRE (tezepelumab) Summary of Product Characteristics. Available at: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/tezspire-epar-product-information_en.pdf<\/a>. Accessed March 2026.<\/li> \n
  22. AstraZeneca news release. TEZSPIRE approved in Japan for the treatment of severe asthma. Available at: https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2022\/tezspire-approved-in-japan-for-severe-asthma.html<\/a>. Accessed March 2026.<\/li> \n
  23. The Global Asthma Report 2018. [Online]. Available at: http:\/\/globalasthmareport.org\/resources\/Global_Asthma_Report_2018.pdf<\/a>. [Last accessed: February 2026].<\/li> \n
  24. Chung KF, et al. International ERS\/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43 (2): 343-373.<\/li> \n
  25. Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med. 2005; 172: 149-160.<\/li> \n
  26. Peters SP, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med 2006: 100 (7): 1139-51.<\/li> \n
  27. Hyland ME, et al. A Possible Explanation for Non-responders, Responders and Super-responders to Biologics in Severe Asthma. Explor Res Hypothesis Med. 2019; 4: 35–38.<\/li> \n
  28. Tran TN, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016; 116: 37–42.<\/li> \n
  29. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40: 364-372.<\/li> \n
  30. Chastek B, et al. Economic Burden of Illness Among Patients with Severe Asthma in a Managed Care Setting. J Manag Care Spec Pharm. 2016;22: 848–861.<\/li> \n
  31. Hartert TV, et al. Risk factors for recurrent asthma hospital visits and death among a population of indigent older adults with asthma. Ann Allergy Asthma Immunol. 2002;89: 467–73.<\/li> \n
  32. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009.<\/li> \n
  33. World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at: https:\/\/www.worldallergy.org\/educational_programs\/world_allergy_forum\/anaheim2005\/blaiss.php<\/a> [Last accessed: March 2026].<\/li> \n
  34. Stevens WW, et al. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016; 4(4):565-572.<\/li> \n
  35. Chen S, et al. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911.<\/li> \n
  36. Corren J, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377:936-946.  <\/li> \n
  37. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595.<\/li> \n
  38. Xolair (omalizumab) Summary of Product Characteristics; Available at: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/xolair-epar-product-information_en.pdf<\/a>. [Last accessed: February 2025].<\/li> \n
  39. Xolair (omalizumab) US prescribing information; Available at: https:\/\/www.gene.com\/download\/pdf\/xolair_prescribing.pdf<\/a> [Last accessed: February 2025].<\/li> \n
  40. Nucala (mepolizumab) Summary of Product Characteristics. Available at: https:\/\/ www.ema.europa.eu\/en\/documents\/product-information\/nucala-epar-product-information_en.pdf<\/a>. [Last accessed: February 2025].<\/li> \n
  41. Nucala (mepolizumab) US prescribing information; Available at: https:\/\/ www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761122s006,125526s018lbl.pdf<\/a>. [Last accessed: February 2025].<\/li> \n
  42. Dupixent (dupilumab) Summary of Product Characteristics. Available at: https:\/\/ www.ema.europa.eu\/en\/documents\/product-information\/dupixent-epar-product-information_en.pdf<\/a>. [Last accessed: February 2025].<\/li> \n
  43. Dupixent (dupilumab) US prescribing information; Available at: https:\/\/www.regeneron.com\/downloads\/dupixent_fpi.pdf<\/a>. [Last accessed: February 2025].<\/li> \n
  44. Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04851964<\/a>. Accessed March 2026.<\/li> \n
  45. Zhang M, et al. Hypoxia induces the production of epithelial-derived cytokines in eosinophilic chronic rhinosinusitis with nasal polyps. Int Immunopharmacol. 2023;121:110559.<\/li> \n
  46. AstraZeneca Data on file. 2025. REF-278452.<\/li> \n
  47. Clinicaltrials.gov. Tezepelumab COPD Exacerbation Study (COURSE) [Online]. Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04039113<\/a>. Accessed March 2026.<\/li> \n
  48. Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING). Available at: https:\/\/clinicaltrials.gov\/study\/NCT05583227<\/a>. Accessed March 2026.<\/li> \n
  49. AstraZeneca news release. Tezepelumab granted Orphan Drug Designation in the US for eosinophilic esophagitis. Available at: https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2021\/tezepelumab-granted-orphan-drug-designation-in-the-us-for-eosinophilic-esophagitis.html<\/a>. Accessed March 2026.<\/li> \n<\/ol>"]; $("#dvExtra").html(content_array[0]);})();