REG - GSK PLC - Exdensur approved for CRSwNP in China

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RNS Number : 5394Z  GSK PLC  08 April 2026

Issued: 8 April 2026, London UK

 

Exdensur (depemokimab) approved in China for the treatment of chronic
rhinosinusitis with nasal polyps (CRSwNP)

 

·   Exdensur is the first and only ultra-long-acting biologic in China for
CRSwNP

·   Approval based on ANCHOR trials showing clinically meaningful and
statistically significant improvements in nasal polyp size and nasal
obstruction

·   Patients with CRSwNP continue to face debilitating daily symptoms,
underscoring need for novel treatments

 

 

 

GSK plc (LSE/NYSE: GSK) today announced that China's National Medical Products
Administration (NMPA) has approved Exdensur (depemokimab) as an add-on therapy
with intranasal corticosteroids for the treatment of adult patients with
CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not
provide adequate disease control. This follows the NMPA's recent approval for
Exdensur as an add-on maintenance treatment of severe asthma characterised by
an eosinophilic phenotype in adult and paediatric patients aged 12 years and
older.(1)

 

The approval of Exdensur in CRSwNP is based on data from the ANCHOR-1 and
ANCHOR-2 phase III trials, which showed an improvement (reduction) from
baseline in nasal polyp score (scale: 0-8) at 52 weeks [treatment difference
(95% confidence interval) p-value: ANCHOR-1 -0.7 (-1.1, -0.3) p<0.001 and
ANCHOR-2 -0.6 (-1.0, -0.2) p=0.004] and in nasal obstruction verbal response
scale (scale: 0-3) over weeks 49-52 [ANCHOR-1 -0.23 (-0.46, <0.00) p=0.047
and ANCHOR-2 -0.25 (-0.46, -0.03) p=0.025].(4) Across these trials,
depemokimab was well-tolerated, with patients experiencing a similar rate and
severity of side effects as those receiving placebo plus standard of care.(2)

 

Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation
(RI&I), and Head of Translational & Development Sciences, GSK, said:
"Given the continued unmet need amongst patients with CRSwNP, today's approval
of Exdensur could redefine care by protecting from the debilitating symptoms
of this disease in just two doses a year. This builds on Exdensur's recent
approval in severe asthma, which means more patients in China could have
access to this first and only ultra-long-acting biologic."

 

Almost half of all patients with CRSwNP remain uncontrolled and up to 85% have
underlying type 2 inflammation, which is associated with more severe
disease.(3-5) An ultra-long-acting therapeutic option that provides sustained
suppression of type 2 inflammation could support these patients who continue
to face daily symptoms.

 

Exdensur has also been approved in the US and China for the treatment of
severe asthma, as well as in Japan, the EU, and UK for the treatment of severe
asthma and CRSwNP.(1,6-9)

 

About CRSwNP

CRSwNP is caused by inflammation of the nasal lining that can lead to soft
tissue growths, known as nasal polyps.(3,10) People with CRSwNP experience
symptoms such as nasal obstruction, loss of smell, facial pain, sleep
disturbance, infections and nasal discharge that can significantly affect
their emotional and physical well-being.(3,10) Similar to asthma, the majority
of cases of CRSwNP are driven by chronic type 2 inflammation, which is
strongly associated with comorbidities, more severe disease, recurring
symptoms and tissue remodelling.(3,5,10-13)

 

About Exdensur (depemokimab)

Exdensur is the first ultra-long-acting biologic being evaluated for certain
respiratory diseases with underlying type 2 inflammation. It combines high
interleukin-5 (IL-5) binding affinity and high potency with an extended
half-life to enable twice-yearly dosing. IL-5 is a key cytokine in type 2
inflammation.(2)

 

For product and important safety information please consult the country's
relevant summary of product characteristics.

 

The EU product information is available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur
(https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur)

 

The US product information is available at: EXDENSUR-PI-PIL.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Exdensur/pdf/EXDENSUR-PI-PIL.PDF)

 

About the ANCHOR phase III trials

Full results from the ANCHOR trials were presented at the 2025 American
Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy
Organization (WAO) Joint Congress
(https://www.jacionline.org/article/S0091-6749(24)02307-8/fulltext)  and
published in The Lancet
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00197-7/abstract)
.(2,14)

ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and 128 in the
placebo plus SOC arm; in ANCHOR-2, 129 patients were included in the
depemokimab plus SOC arm and 128 in the placebo plus SOC arm. All 528 patients
had inadequately controlled CRSwNP, including nasal polyps in both nasal
cavities (an endoscopic bilateral NPS ≥5), and had either undergone previous
surgery for CRSwNP, had received previous treatment with SCS or were
intolerant to SCS. Patients received depemokimab or placebo at six-monthly
intervals (26 weeks) in addition to SOC (maintenance intranasal
corticosteroids).(2)

About the depemokimab development programme

Depemokimab is currently being evaluated in phase III trials for the treatment
of other diseases with underlying type 2 inflammation, including OCEAN for
eosinophilic granulomatosis with polyangiitis (EGPA) and DESTINY for hyper
eosinophilic syndrome (HES).(15,16) GSK has also initiated the ENDURA-1,
ENDURA-2 and VIGILANT phase III trials assessing the efficacy and safety of
depemokimab as an add-on therapy in patients with uncontrolled moderate to
severe COPD with type 2 inflammation.(17-19)

 

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious
treatment goals, develop the next generation standard of care, and redefine
the future of respiratory medicine for hundreds of millions of people with
respiratory diseases. With an industry-leading respiratory portfolio and
pipeline of vaccines, targeted biologics, and inhaled medicines, GSK is
focused on improving outcomes and the lives of people living with all types of
asthma and COPD along with less understood refractory chronic cough or rarer
conditions like systemic sclerosis with interstitial lung disease. GSK is
harnessing the latest science and technology with the aim of modifying the
underlying disease dysfunction and preventing progression.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at www.gsk.com
(https://www.gsk.com) .

 

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2025.

 

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References

1.     "Exdensur (depemokimab) approved in China for the treatment of
severe asthma." GSK, 30 Mar. 2026,
https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-china-for-the-treatment-of-severe-asthma/
(https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-china-for-the-treatment-of-severe-asthma/)

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
(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
(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 (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
(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/
(https://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/
(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/
(http://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/
(https://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
(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
(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-supp
(https://doi.org/10.14639/0392-100x-supp) l.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
(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 (http://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
(https://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
(https://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
(https://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
(https://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
(https://www.clinicaltrials.gov/study/NCT07177339) . Accessed 23 Jan 2026.

 

 

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