China’s NMPA approves GSK’s Exdensur (depemokimab) as add-on therapy for chronic rhinosinusitis with nasal polyps, supported by phase III ANCHOR trial data showing improved nasal polyp and obstruction scores.
Written by: Mennatullah Mansour, PharmD
Reviewed By: Pharmacally Editorial Team
China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as an add-on therapy to intranasal corticosteroids for adults with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease remains inadequately controlled with systemic corticosteroids and/or surgery. The decision expands availability of the ultra-long-acting biologic following the regulator’s recent approval of Exdensur for add-on maintenance treatment of severe asthma with an eosinophilic phenotype in patients aged 12 years and older.
Phase III ANCHOR Trials Supported Approval
The approval in CRSwNP was based on results from the phase III ANCHOR-1 (NCT05274750) and ANCHOR-2 trials (NCT05281523), which evaluated depemokimab administered every 26 weeks in addition to standard of care intranasal corticosteroids.
At 52 weeks, depemokimab demonstrated improvement from baseline in nasal polyp score compared with placebo. Treatment differences were −0.7 (95% CI: −1.1, −0.3; p<0.001) in ANCHOR-1 and −0.6 (95% CI: −1.0, −0.2; p=0.004) in ANCHOR-2. Improvements were also observed in nasal obstruction verbal response scale scores during weeks 49–52, with treatment differences of −0.23 (p=0.047) and −0.25 (p=0.025), respectively.
Across both trials, depemokimab was well tolerated, with similar rates and severity of adverse events compared with placebo plus standard of care.
ANCHOR-1 enrolled 143 patients in the depemokimab arm and 128 in the placebo arm, while ANCHOR-2 included 129 and 128 patients, respectively. All participants had inadequately controlled CRSwNP with bilateral nasal polyps and prior exposure to surgery or systemic corticosteroids, or intolerance to corticosteroids. Results from the ANCHOR trials were published in The Lancet.
Company Statement Highlights Unmet Need
Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation (RI&I) noted that many patients with CRSwNP remain uncontrolled despite current treatments. The company indicated that the approval introduces a twice-yearly biologic option that could help reduce symptoms and address underlying type 2 inflammation. The statement also highlighted that the CRSwNP authorization builds on the therapy’s recent approval in severe asthma, expanding access for patients in China.
About CRSwNP
CRSwNP results from inflammation of the nasal lining that leads to soft tissue growths called nasal polyps. Patients commonly experience nasal obstruction, reduced sense of smell, facial pressure, sleep disturbance, infections, and nasal discharge. The condition is frequently driven by chronic type 2 inflammation, which is associated with more severe disease, recurrence, and comorbidities. Nearly half of patients remain uncontrolled, and up to 85% have underlying type 2 inflammatory biology.
About Exdensur (Depemokimab)
Exdensur is an ultra-long-acting biologic targeting interleukin-5 (IL-5), a key cytokine involved in type 2 inflammation. The therapy combines high IL-5 binding affinity with an extended half-life, enabling dosing every six months.
Exdensur has also received approvals in multiple regions. The therapy is approved in the United States and China for severe asthma, and in Japan, the European Union, and the United Kingdom for both severe asthma and CRSwNP.
Ongoing Development Program
Depemokimab continues to be evaluated in additional phase III studies targeting diseases driven by type 2 inflammation. These include the OCEAN trial in eosinophilic granulomatosis with polyangiitis and DESTINY in hypereosinophilic syndrome. GSK has also initiated ENDURA-1, ENDURA-2, and VIGILANT trials assessing depemokimab as add-on therapy in patients with uncontrolled moderate to severe COPD associated with type 2 inflammation.
References
Exdensur (depemokimab) approved in China for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), 08 April 2026, Exdensur (depemokimab) approved in China for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) | GSK
Efficacy and Safety of Depemokimab (GSK3511294) in Participants with Chronic Rhinosinusitis with Nasal Polyps (ANCHOR-1), ClinicalTrials.gov ID NCT05274750, https://clinicaltrials.gov/study/%20NCT05274750
Efficacy and Safety of Depemokimab (GSK3511294) in Participants with Chronic Rhinosinusitis with Nasal Polyps (ANCHOR-2) (ANCHOR-2), ClinicalTrials.gov ID NCT05281523, https://clinicaltrials.gov/study/NCT05281523
Gevaert P, Desrosiers M, Cornet M 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, Volume 405, Issue 10482 p911-926 2025, https://doi.org/10.1016/S0140-6736(25)00197-7
About the Writer
Mennatullah Mansour is pursuing a PharmD and is based in Alexandria, Egypt. She is driven by a strong passion for continuous learning and professional development, with a focus on pharmaceutical care, patient health, and medication safety. Her interests include prescription processing, patient counseling, and interpreting clinical information. She brings a detail-oriented approach and a strong ability to translate medical knowledge into clear, accurate, and reliable content for healthcare audiences.