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/YiXilai® (democizumab) is approved in China for the maintenance treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and above
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YiXilai® (democizumab) is approved in China for the maintenance treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and above

GSK China
2026/03/31

March 31, 2026

For Chinese media use only

• Yisilai ® is China's first and currently only ultra-long-acting biological agent for the treatment of severe asthma with eosinophilic phenotype. • The approval was based on results from the SWIFT clinical trial, which showed that patients treated with demokinumab had significantly lower asthma exacerbation rates than those in the placebo group. • More than 2 million people in China suffer from severe asthma, which puts them at a higher risk of acute attacks requiring hospitalization.

GSK China (LSE/NYSE: GSK) recently announced that China’s National Medical Products Administration (NMPA) has approved Insulin® (democizumab) for the maintenance treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and above.

The approval of Yixinlai ® for the treatment of severe asthma is based on the research data of two phase III clinical trials, SWIFT-1 and SWIFT-2. In both studies, which were combined with standard treatment, twice-yearly administration of demokinumab consistently reduced asthma exacerbations compared with placebo. 1

Kaivan Khavandi, Senior Vice President of GSK China and Head of Global Respiratory, Immunity and Inflammation R&D, said: "Today's approval of Yisela ® in China is an important milestone for patients with severe asthma with an eosinophilic phenotype. Type 2 inflammation is a key factor leading to the acute attack and progression of the disease, and Yisilai ® can sustainably control type 2 inflammation. Yisilai ® only needs to be administered twice a year and is expected to revolutionize existing treatment options. Currently Yisilai ® Already approved in several major markets, GSK is committed to revolutionizing the treatment of patients with severe asthma."

Asthma is one of the major health burdens in China, affecting approximately 46 million adults. 2 Approximately 6% of these patients have severe asthma, which puts them at higher risk for hospitalization-level exacerbations and a greater likelihood of fatal asthma exacerbations. 2-6 In China, 15% of asthma patients have visited the hospital due to an acute exacerbation in the past 12 months. 2

In two clinical trials, SWIFT-1 and SWIFT-2, during the 52-week study period, demokinumab treatment significantly reduced the annual asthma exacerbation rate by 58% in the SWIFT-1 trial and by 48% in the SWIFT-2 trial [rate ratio (95% confidence interval) and P value: SWIFT-1 was 0.42 (0.30, 0.59), P<0.001; SWIFT-2 was 0.52 (0.36, 0.73), P<0.001] (Comparison of annual acute exacerbation rates between the demokinumab group and the placebo group: SWIFT-1 was 0.46 times/year vs. 1.11 times/year, SWIFT-2 was 0.56 times/year vs. 1.08 times/year). In addition, among Chinese patients (n=58) participating in the SWIFT-1 study, demokinumab treatment reduced the annualized asthma exacerbation rate by 85% compared with placebo. 1

In the secondary endpoint of both SWIFT-1 and SWIFT-2 clinical trials, patients treated with demokinumab experienced fewer episodes requiring hospitalization and/or emergency department visits (1% and 4%, respectively) compared with 8% and 10% in the placebo group. A prespecified pooled analysis of the two trials showed that the annualized rate of clinically significant asthma exacerbations requiring hospitalization and/or emergency department visits over 52 weeks was 72% lower in the demokinumab group than in the placebo group [rate ratio 0.28, 95% confidence interval (0.13 to 0.61), nominal P value = 0.002] (annualized exacerbation rate 0.02 in the demokinumab group and 0.09 in the placebo group). 1 In both trials, demokinumab was well tolerated, with the incidence and severity of adverse events similar to those in the placebo group. 1 Full results from the SWIFT trial were presented at the 2024 European Respiratory Society International Conference and published in the New England Journal of Medicine. 1,7

Yu Huiming, vice president of GSK and general manager of China, said: "We are very pleased that Yisilai ® has been approved in China. We hope that Yisilai ® can provide more treatment options for suitable patients to meet their diverse health needs. At the same time, GSK will continue to improve the accessibility of innovative drugs and allow more Chinese patients to benefit from the results of medical innovation."

About asthma

Asthma affects more than 260 million people worldwide, and for many of these patients, their symptoms and flare-ups persist despite treatment. 8,9 Severe asthma is defined as asthma that requires the use of moderate to high doses of inhaled glucocorticoids combined with a second therapy (such as systemic glucocorticoids or biological agents) to prevent the condition from getting out of control, or that the condition remains uncontrollable despite the above treatments. 10 More than 80% of patients with severe asthma have type 2 inflammation as their pathological root cause. Such patients will have elevated levels of eosinophils (a type of white blood cell). 10

About YiXilai ® (Demoximab)

Xanax® is the first ultra-long-acting biologic studied for a specific respiratory disease based on type 2 inflammation. EasyLate ® has both high affinity and high binding capacity to interleukin-5 (IL-5), and has an extended half-life, allowing for twice-yearly administration. Interleukin-5 is a key cytokine in type 2 inflammation. 1

About the SWIFT series of phase III clinical trials

The SWIFT-1 and SWIFT-2 clinical trials respectively enrolled 382 and 380 patients with severe asthma to evaluate the efficacy and safety of adjuvant treatment with demokinumab. All subjects were randomly assigned to the demokinumab group or the placebo group on the basis of standard treatment of medium and high doses of inhaled glucocorticoids combined with at least one other control drug. The full analysis set of SWIFT-1 includes 250 patients in the demokinumab combined with standard treatment group and 132 patients in the placebo combined with standard treatment group; the full analysis set of SWIFT-2 includes 252 patients in the demokinumab combined with standard treatment group and 128 patients in the placebo combined with standard treatment group. 1

About the Demokinumab R&D Project

Demoqimab is currently in Phase III clinical trials evaluating its use in other diseases with type 2 inflammation as the pathological basis, including the OCEAN trial for eosinophilic granulomatosis with polyangiitis and the DESTINY trial for hypereosinophilic syndrome. 11,12 GSK has also initiated three phase III clinical trials, ENDURA-1, ENDURA-2 and VIGILANT, to evaluate the efficacy and safety of demokinumab as an add-on treatment for patients with uncontrolled moderate to severe chronic obstructive pulmonary disease with type 2 inflammation. 13-15

About GSK Breathing

Based on decades of pioneering work, GSK continues to help hundreds of millions of patients achieve higher treatment goals, develop a new generation of standardized treatment options, and redefine the future of respiratory disease treatment. With our industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled formulations, we are focused on improving outcomes and quality of life for patients with all types of asthma, chronic obstructive pulmonary disease, under-recognized refractory cough, or rare diseases such as systemic sclerosis with interstitial lung disease. GSK is applying the latest technologies to modify underlying disease dysfunction and prevent disease progression.

About GSK

GSK China (GSK) is a global biopharmaceutical company with the mission of "bringing together science, technology and talents to work together to transcend and overcome diseases". For more information, please visit www.gsk.com

References

  • 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.
  • 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.
  • 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 .
  • 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. Accessed January 2025.
  • 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.
  • 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/
  • Jackson, D, et al. "Late breaking abstract - depemokimab efficacy/safety in patients with asthma on medium/high-dose ICS: The phase IIIA randomized SWIFT-1/2 studies." European Respiratory Journal 2024, vol. 64, no. 68, 14 Sept. 2024, https://doi.org/10.1183/13993003.congress-2024.rct3718.
  • World Health Organization. Asthma Key Facts. Available at: https://www.who.int/news-room/fact-sheets/detail/asthma. Accessed February 2025.
  • 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.
  • 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.
  • “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.
  • “Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (DESTINY).” Clinicaltrials.Gov, GlaxoSmithKline, www.clinicaltrials.gov/study/NCT05334368. Accessed 23 Jan 2026.
  • "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.
  • "Depemokimab as an Extended treatmentNt 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.
  • "eValuating the Efficacy and Safety of InitiationG 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.