REG - GSK PLC - Exdensur approved for severe asthma in China

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RNS Number : 5380Y  GSK PLC  30 March 2026

Issued: 30 March 2026, London UK

 

Exdensur (depemokimab) approved in China for the treatment of severe asthma

 

·   Exdensur is the first and only ultra-long-acting biologic in China for
the treatment of severe asthma with an eosinophilic phenotype

·   Approval based on SWIFT trials showing significantly lower rates of
exacerbations in patients receiving depemokimab versus placebo

·   More than 2 million people in China are affected by severe asthma and
experience increased risk of exacerbations requiring hospitalisation

 

 

GSK plc (LSE/NYSE: GSK) today announced that China's National Medical Products
Administration (NMPA) has approved Exdensur (depemokimab) as add-on
maintenance treatment of severe asthma characterised by an eosinophilic
phenotype in adult and paediatric patients aged 12 years and older.

 

The approval of Exdensur in severe asthma is based on data from the SWIFT-1
and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated
sustained exacerbation reduction with two doses per year versus placebo, both
plus standard of care.(1)

( )

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology &
Inflammation R&D, GSK, said: "Today's approval for Exdensur in China
represents an important advance for patients with severe asthma with an
eosinophilic phenotype. By providing sustained suppression of type 2
inflammation, an underlying driver of exacerbations and disease progression,
Exdensur could redefine care in just two doses a year. With Exdensur now
approved in several major markets, we are focused on transforming the
treatment paradigm in severe asthma."

 

Asthma is a major health burden in China affecting an estimated 46 million
adults.(2) Of those, approximately 6% experience severe asthma, which is
associated with an increased risk of exacerbations requiring hospitalisation,
and higher likelihood of potentially fatal asthma attacks.(2-6) In China,
around 15% of people with asthma have experienced an exacerbation requiring a
hospital visit in the preceding 12 months.(2)

 

In the SWIFT-1 and SWIFT-2 trials, treatment with depemokimab resulted in a
significant 58% and 48% reduction in the rate of annualised asthma
exacerbations (asthma attacks) over 52 weeks, respectively [rate ratio (95%
confidence interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2
0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus placebo: SWIFT-1 0.46
vs. 1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per year). In addition,
efficacy and safety results from Chinese patients participating in SWIFT-1
were consistent with the overall population analysis (n=58).(1)

 

In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated with
depemokimab experienced numerically fewer exacerbations requiring
hospitalisation and/or emergency department visits (1% and 4%) compared with
placebo (8% and 10%), respectively. A pre-specified pooled analysis of the two
trials showed there was a 72% reduction in the annualised rate of clinically
significant exacerbations requiring hospitalisation and/or ED visits over 52
weeks for depemokimab compared with placebo [rate ratio 0.28, 95% CI (0.13,
0.61), nominal p=0.002] (AER depemokimab 0.02 versus placebo 0.09).(1) Across
these trials, depemokimab was well-tolerated, with patients experiencing a
similar rate and severity of side effects as those receiving placebo.(1) The
full results from the SWIFT trials were presented at the 2024 European
Respiratory Society International Conference
(https://publications.ersnet.org/content/erj/64/suppl68/rct3718)  and
published in the New England Journal of Medicine.
(https://www.nejm.org/doi/10.1056/NEJMoa2406673?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed)
(1,7)

 

The NMPA is also reviewing Exdensur as an add-on therapy with intranasal
corticosteroids for the treatment of adult patients with severe chronic
rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic
corticosteroids and/or surgery does not provide adequate disease control.
Exdensur has been approved in the US for the treatment of severe asthma, as
well as in Japan, the EU, and UK for the treatment of severe asthma and
CRSwNP.(8-11)

 

About asthma

Asthma affects more than 260 million people globally, many of whom continue to
experience symptoms and exacerbations despite treatment.(12,13) Severe asthma
is defined as asthma that requires treatment with medium- to high-dose inhaled
corticosteroids plus a second therapy (i.e., systemic corticosteroid or
biologic) to prevent it from becoming uncontrolled, or which remains
uncontrolled despite therapy.(14) Type 2 inflammation is the underlying cause
of pathology in more than 80% of patients with severe asthma, in which
patients exhibit elevated levels of eosinophils (a type of white blood
cell).(14)

 

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.(1)

 

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 SWIFT phase III trials

The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and safety of
depemokimab adjunctive therapy in 382 and 380 participants with severe asthma
who were randomised to receive depemokimab or a placebo, respectively, in
addition to their standard of care (SOC) treatment with medium to high-dose
inhaled corticosteroids plus at least one additional controller. The full
analysis set in SWIFT-1 included 250 patients in the depemokimab plus SOC arm
and 132 in the placebo plus SOC arm; in SWIFT-2, 252 patients were included in
the depemokimab plus SOC arm and 128 in the placebo plus SOC arm.(1)

 

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.     Jackson D., et al. Twice-Yearly Depemokimab in Severe Asthma with
an Eosinophilic Phenotype. NEJM. September 2024. Vol. 391 No.
24.DOI: 10.1056/NEJMoa2406673
(https://www.nejm.org/doi/pdf/10.1056/NEJMoa2406673) .

2.     Huang, Kewu, et al. "Prevalence, risk factors, and management of
asthma in China: A national cross-sectional study." The Lancet, vol. 394, no.
10196, Aug. 2019, pp. 407-418, https://doi.org/10.1016/s0140-6736(19)31147-x
(https://doi.org/10.1016/s0140-6736(19)31147-x) .

3.     Ding, Bo, and Mark Small. "Disease burden of mild asthma in China."
Respirology, vol. 23, no. 4, 20 Oct. 2017, pp. 369-377,
https://doi.org/10.1111/resp.13189 (https://doi.org/10.1111/resp.13189) .

4.     National Heart, Lung, and Blood Institute. Guidelines for the
Diagnosis and Management of Asthma (EPR-3).  Online . Available at:
https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma
(https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma)
. Accessed January 2025.

5.     Ambrosino, Nicolino, and Pierluigi Paggiaro. "The management of
asthma and chronic obstructive pulmonary disease: Current status and future
perspectives." Expert Review of Respiratory Medicine, vol. 6, no. 1, Feb.
2012, pp. 117-127, https://doi.org/10.1586/ers.12.2
(https://doi.org/10.1586/ers.12.2) .

6.     Antonicelli, L et al. "Asthma severity and medical resource
utilisation." The European respiratory journal vol. 23,5 (2004): 723-9.
https://pubmed.ncbi.nlm.nih.gov/15176687/
(https://pubmed.ncbi.nlm.nih.gov/15176687/)

7.     Jackson, D, et al. "Late breaking abstract - depemokimab
efficacy/safety in patients with asthma on medium/high-dose ICS: The phase
IIIA randomised SWIFT-1/2 studies." European Respiratory Journal 2024, vol.
64, no. 68, 14 Sept.
2024, https://doi.org/10.1183/13993003.congress-2024.rct3718
(https://doi.org/10.1183/13993003.congress-2024.rct3718) .

8.     "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/)

9.     "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/)

10.    "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/)
.

11.    "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/)

12.    World Health Organisation. Asthma Key Facts. Available
at: https://www.who.int/news-room/fact-sheets/detail/asthma
(https://www.who.int/news-room/fact-sheets/detail/asthma) .
(https://www.who.int/news-room/fact-sheets/detail/asthma)
(https://www.who.int/news-room/fact-sheets/detail/asthma) Accessed February
2025. (https://www.who.int/news-room/fact-sheets/detail/asthma)

13.    Wang E, et al. Characterization of Severe Asthma Worldwide: Data
From the International Severe Asthma Registry. CHEST, Volume 157, Issue 4,
790 - 804. https://doi.org/10.1016/j.chest.2019.10.053
(https://doi.org/10.1016/j.chest.2019.10.053) .
(https://doi.org/10.1016/j.chest.2019.10.053)

14.    Heaney, L, et al. "Eosinophilic and noneosinophilic asthma." CHEST,
vol. 160, no. 3, Sept. 2021, pp.
814-830, https://doi.org/10.1016/j.chest.2021.04.013.
(https://doi.org/10.1016/j.chest.2021.04.013)

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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