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新进展｜每年仅两针超长效，德莫奇单抗双适应症获批，重度哮喘合并鼻息肉患者或将迎来一体化治疗新方案

2026-04-08 小药说药 网络 发表于上海

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慢性鼻窦炎伴鼻息肉患者的症状持续影响日常生活，患者对于新型治疗方案有迫切的需求。德莫奇单抗在缩小鼻息肉及改善鼻塞症状方面实现了具有临床意义且具有统计学意义的显著改善。

葛兰素史克（LSE/NYSE: GSK）今日宣布，中国国家药品监督管理局（NMPA）批准易适来® （德莫奇单抗）与鼻用糖皮质激素联合使用，治疗系统性糖皮质激素和/或手术治疗无法充分控制疾病的慢性鼻窦炎伴鼻息肉（CRSwNP）成人患者。这些患者在接受系统性糖皮质激素和/或手术后，病情仍未得到充分控制。中国国家药品监督管理局近期还批准易适来®用于成人和12岁及以上青少年重度嗜酸性粒细胞性哮喘的维持治疗1。

易适来® 用于CRSwNP的获批是基于ANCHOR-1与ANCHOR-2两项III期临床试验数据。数据显示，治疗52周时，患者内窥镜息肉总评分（0-8分制）较基线改善（降低）[治疗差异（95%置信区间）及p值：ANCHOR-1为-0.7（-1.1, -0.3），p<0.001；ANCHOR-2为-0.6（-1.0, -0.2），p=0.004]；在治疗第49至52周，鼻塞语言应答量表（0-3分制）亦改善[治疗差异（95%置信区间）及p值：ANCHOR-1为-0.23（-0.46, <0.00），p=0.047；ANCHOR-2为-0.25（-0.46, -0.03），p=0.025]。两项试验中，德莫奇单抗整体耐受性良好，患者不良反应发生率及严重程度与安慰剂组相似2。

葛兰素史克高级副总裁，全球呼吸、免疫与炎症领域研发负责人及转化与开发科学负责人Kaivan Khavandi表示：“鉴于慢性鼻窦炎伴鼻息肉的患者存在未被满足的持续治疗需求，此次易适来® 的获批有望重新定义其治疗标准——每年仅需两针，可以帮助患者改善疾病带来的症状。此前易适来® 在中国还获批用于重度哮喘的治疗，这意味着更多中国患者将可获得这款全球首个且目前唯一超长效的生物制剂。”

近半数慢性鼻窦炎伴鼻息肉患者病情仍未得到控制，其中高达85%的患者存在2型炎症基础，而2型炎症与更严重的疾病表型相关3-5。一种能够持续抑制2型炎症的超长效治疗方案，可为这些仍受日常症状困扰的患者提供支持。 

GSK副总裁、中国总经理余慧明表示：“此次易适来® 在中国获批用于治疗慢性鼻窦炎伴鼻息肉的成人患者，是继其获批用于治疗重度哮喘之后，又一重要新增适应症。GSK期待通过易适来® ，为更多受2型炎症相关疾病困扰的患者，提供超长效的创新治疗选择。与此同时，我们将一如既往响应国家号召，持续提升创新药物的可及性与可负担性，以实际行动践行GSK心系患者、守护公众健康的企业社会责任。”

易适来® 已在美国和中国获批用于治疗重度哮喘，同时也在日本、欧盟及英国获批，用于治疗重度哮喘和慢性鼻窦炎伴鼻息肉1,6-9。

关于慢性鼻窦炎伴鼻息肉（CRSwNP）

慢性鼻窦炎伴鼻息肉（CRSwNP）是由鼻黏膜炎症引发，可导致软组织增生，即鼻息肉3,10。CRSwNP患者会出现鼻塞、嗅觉减退、面部疼痛、睡眠障碍、感染及流涕等症状，严重影响其身心健康3,10。与哮喘类似，大多数CRSwNP由慢性2型炎症驱动，且与合并症、严重病情、症状反复及组织重塑密切相关3,5,10-13。

关于易适来®  (德莫奇单抗)

易适来® 是首款针对基于2型炎症的特定呼吸系统疾病开展研究的超长效生物制剂。兼具与白介素-5（IL-5）的高亲和力和高结合力，且半衰期延长，可实现每年两次给药。白介素-5是2型炎症中的关键细胞因子2。

关于ANCHOR III期临床试验

ANCHOR研究结果已在2025年美国过敏、哮喘与免疫学会（AAAAI）及世界过敏组织（WAO）联合大会上公布，并发表于《柳叶刀》2,14。

ANCHOR-1研究中，德莫奇单抗联合标准治疗组纳入143例患者，安慰剂联合标准治疗组纳入128例患者；ANCHOR-2研究中，德莫奇单抗联合标准治疗组纳入129例患者，安慰剂联合标准治疗组纳入128例患者。全部528例患者均为控制不佳的慢性鼻窦炎伴鼻息肉（CRSwNP），包括双侧鼻腔息肉（内镜下双侧鼻息肉评分≥5），且既往接受过CRSwNP手术、全身糖皮质激素（SCS）治疗或对SCS不耐受。患者除接受标准治疗（维持性鼻内糖皮质激素）外，每6个月（26周）接受一次德莫奇单抗或安慰剂治疗2。

关于德莫奇单抗研发

德莫奇单抗目前正处于Ⅲ期临床试验阶段，评估用于治疗其他以2型炎症为病理基础的疾病，其中包括针对嗜酸性肉芽肿性多血管炎的OCEAN试验，以及针对高嗜酸性粒细胞综合征的DESTINY试验15,16。GSK也已启动ENDURA-1、ENDURA-2和VIGILANT三项Ⅲ期临床试验，评估德莫奇单抗作为附加治疗，用于伴2型炎症的未控制中重度慢性阻塞性肺疾病患者的疗效与安全性17-19。

参考资料

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2. Gevaert, P, et al. “Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): Phase 3, randomised, double-blind, Parallel Trials.” The Lancet, vol. 405, no. 10482, Mar. 2025, pp. 911–926, https://doi.org/10.1016/s0140-6736(25)00197-7. 

3. Bachert, C, et al. “Burden of disease in chronic rhinosinusitis with nasal polyps.” Journal of Asthma and Allergy, Volume 14, Feb. 2021, pp. 127–134, https://doi.org/10.2147/jaa.s290424.

4. Seys, S, et al. “Real-life assessment of chronic rhinosinusitis patients using mobile technology: The mysinusitiscoach project by Euforea.” Allergy, vol. 75, no. 11, 19 June 2020, pp. 2867–2878, https://doi.org/10.1111/all.14408.

5. Bernstein, J. “Use of patient-reported outcome measures and inflammatory biomarkers to differentiate chronic rhinosinusitis with nasal polyp endotypes: Is it feasible?” Annals of Allergy, Asthma & Immunology, vol. 130, no. 4, Apr. 2023, pp. 409–410, https://doi.org/10.1016/j.anai.2023.01.004

6. “Exdensur (Depemokimab) Approved by US FDA for the Treatment of Severe Asthma.” GSK, 16 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/

7. “Exdensur (depemokimab) approved in Japan for severe asthma and chronic rhinosinusitis with nasal polyps.” GSK, 6 Jan. 2026, https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/

8. “Exdensur (Depemokimab) Approved by the European Commission for Severe Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps.” GSK, 17 Feb. 2026, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-the-european-commission/.

9. “Exdensur (Depemokimab) Approved in the UK for Treatment of Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps.” GSK, 15 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-the-uk-for-treatment-of-asthma-with-type-2-inflammation-and-chronic-rhinosinusitis-with-nasal-polyps/

10. Bachert, C, et al. “EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and Biologics: Definitions and management.” Journal of Allergy and Clinical Immunology, vol. 147, no. 1, Jan. 2021, pp. 29–36, https://doi.org/10.1016/j.jaci.2020.11.013.

11. Laidlaw, T, et al. “Chronic rhinosinusitis with nasal polyps and asthma.” The Journal of Allergy and Clinical Immunology: In Practice, vol. 9, no. 3, Mar. 2021, pp. 1133–1141, https://doi.org/10.1016/j.jaip.2020.09.063.

12. De Corso, E, et al. “How to manage recurrences after surgery in CRSWNP patients in the biologic era: A narrative review.” Acta Otorhinolaryngologica Italica, vol. 43, no. 2 (Suppl. 1), Apr. 2023, https://doi.org/10.14639/0392-100x-suppl.1-43-2023-01

13. Chen, S, et al. “Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis.” Current Medical Research and Opinion, vol. 36, no. 11, 25 Sept. 2020, pp. 1897–1911, https://doi.org/10.1080/03007995.2020.1815682.  

14. Han, J, et al. Efficacy and Safety of Twice-Yearly Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP): The Phase III Randomized, Double-Blind, Placebo-Controlled Replicate ANCHOR-1/2 Trials. Journal of Allergy and Clinical Immunology, Volume 155, Issue 2, AB443. www.jacionline.org.  

15. “Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) (OCEAN).” Clinicaltrials.Gov, GlaxoSmithKline, www.clinicaltrials.gov/study/NCT05263934. Accessed 23 Jan 2026.

16. “Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (DESTINY).” Clinicaltrials.Gov, GlaxoSmithKline, www.clinicaltrials.gov/study/NCT05334368. Accessed 23 Jan 2026.

17. “Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1) (ENDURA -1).” ClinicalTrials.Gov, GlaxoSmithKline, www.clinicaltrials.gov/study/NCT06959095. Accessed 23 Jan 2026.

18. “Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2) (ENDURA-2).” Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06961214. Accessed 23 Jan 2026.

19. “eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation (VIGILANT).” Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT07177339. Accessed 23 Jan 2026.

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