GSK Achieves Landmark NMPA Approval for Shingrix as First Shingles Vaccine for Immunosuppressed Patients in China

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GSK Achieves Landmark NMPA Approval for Shingrix as First Shingles Vaccine for Immunosuppressed Patients in China

(IN BRIEF) GSK’s Shingrix vaccine has been approved by China’s NMPA for adults aged 18 and over who are immunocompromised or immunosuppressed, marking the first shingles vaccine available for this group in the country. Affecting about six million people annually in China, shingles is especially severe among patients with weakened immune systems. The approval is based on six clinical studies showing strong immune responses across multiple patient groups. By expanding Shingrix’s indication beyond adults over 50, GSK aims to improve protection for at-risk populations and strengthen its global vaccine leadership.

(PRESS RELEASE) LONDON, 14-Oct-2025 — /EuropaWire/ — GSK plc (LSE/NYSE: GSK) has secured regulatory approval in China for its shingles vaccine, Shingrix (Recombinant Zoster Vaccine, RZV), to be used in adults aged 18 and over who are immunocompromised or immunosuppressed. The authorisation from the National Medical Products Administration (NMPA) makes Shingrix the first and only shingles vaccine approved for individuals with weakened immune systems in the country — a group particularly vulnerable to the disease’s painful and potentially long-lasting effects.

Each year, an estimated six million people in China are affected by shingles, a viral infection that can cause severe nerve pain and lasting complications. While older age remains a primary risk factor, people with compromised immune systems face a far greater chance of developing shingles and related conditions. Until now, no approved vaccine in China offered protection for these high-risk patients.

The NMPA’s decision expands the existing indication for Shingrix, which was already authorised for adults aged 50 and above. It is supported by data from six clinical studies involving immunocompromised adults — including patients who have undergone stem cell or kidney transplants, or who are living with HIV, blood cancers, or solid tumours. These studies demonstrated that Shingrix could provide strong and durable immune protection even in those with weakened immunity.

Sanjay Gurunathan, Senior Vice President of Vaccines and Infectious Diseases R&D at GSK, said: “This marks a major milestone in widening protection against shingles for patients who need it most. By expanding access to Shingrix in China, we’re enabling earlier and broader disease prevention for those facing elevated risks due to immune-related conditions or treatments.”

Shingles, caused by reactivation of the varicella-zoster virus, can trigger intense pain described as stabbing or burning, often interfering with sleep, work, and daily activities. The extended approval means that physicians in China will now be able to offer protection to younger adults at higher risk, helping to reduce the overall burden of the disease and its impact on quality of life.

With this latest approval, GSK continues to advance its vaccine strategy globally, focusing on protecting vulnerable populations through innovation and preventive health solutions.

About shingles

Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox.4 Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face.14 Following the rash, a person can also experience post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years.4 PHN is the most common complication of shingles, occurring in 5–30% of all shingles cases15.

About Shingrix

Shingrix (Recombinant Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over and in several countries and regions. RZV is also approved for adults aged 18 years or over at increased risk for shingles. It combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunisation that contributes to the challenge of protecting adults aged 50 and over from shingles. RZV is not indicated to prevent primary varicella infection (chickenpox). The use of RZV should be in accordance with official recommendations and local product label.

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

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 gsk.com.

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 2024, and GSK’s Q2 Results for 2025.

References

  1. Zhang, Z., et al. The incidence of herpes zoster in China: A meta-analysis and evidence quality assessment. Human vaccines & immunotherapeutics. 2023;19(2):2228169.
  2. Zhenwei L, et al. Study on the risk of recurrence of herpes zoster in adults based on a retrospective cohort design. Zhejiang University of Traditional Chinese Medicine Conference.
  3. Chen, S.Y., et al. Incidence of herpes zoster in patients with altered immune function. Infection. 2014;42(2):325-34.
  4. Harpaz, R., et al. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008;57(Rr-5):1-30; .
  5. van Oorschot, D.A.M., et al. A Cross-Sectional Concept Elicitation Study to Understand the Impact of Herpes Zoster on Patients’ Health-Related Quality of Life. Infectious diseases and therapy. 2022;11:501 – 16.
  6. Gater, A., et al. The humanistic, economic and societal burden of herpes zoster in Europe: a critical review. BMC public health. 2015;15:193.
  7. Panatto, D., et al. Evaluation of the economic burden of Herpes Zoster (HZ) infection. Human vaccines & immunotherapeutics. 2015;11(1):245-62.
  8. Bastidas, A., et al. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2019;322(2):123-33.
  9. Vink, P., et al. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial. Cancer. 2019;125(8):1301-12.
  10. Dagnew, A.F., et al. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. The Lancet Infectious Diseases. 2019;19(9):988-1000.
  11. Stadtmauer, E.A., et al. A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 2014;124 (19):2921–9.
  12. Berkowitz, E.M., et al. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. The Journal of infectious diseases. 2015;211(8):1279-87.
  13. GSK. Abstract on file.
  14. Mueller, N.H., et al. Varicella zoster virus infection: clinical features, molecular pathogenesis of disease, and latency. Neurologic clinics. 2008;26(3):675-97.
  15. Kawai, K., et al. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ open. 2014;4(6).

Media contact:
Email: corporate.media@gsk.com
Phone: +44 (0)20 8047 5502

SOURCE: GlaxoSmithKline plc

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