November 13, 2026
Source: drugdu
22

recently announced that the National Medical Products Administration (NMPA) of China has formally accepted its marketing application for Shingrix (recombinant herpes zoster vaccine [CHO cell], abbreviated as RZV) pre-filled syringe (PFS) formulation, which is used to prevent shingles. The active ingredient in the pre-filled syringe formulation is completely identical to that of the existing lyophilized formulation (lyophilized antigen + liquid adjuvant), simplifying the vaccination preparation process for medical personnel by eliminating the need for reconstitution of the lyophilized antigen before use.
A GSK press release stated that during the 9th China International Import Expo, it showcased the latest progress in the deployment of its innovative vaccines and drugs in China, with Shingrix, the shingles vaccine that continues to expand its beneficiary population, being one of the highlights of its booth. Following approval for expanded indications in China, Shingrix has achieved new progress in dosage form innovation.
GSK's pre-filled syringe formulation of its shingles vaccine received FDA approval in July 2025 and EMA approval in January 2026. Shingrix was approved in China in 2025 for the prevention of shingles in adults aged 18 and older with increased risk due to immunodeficiency or immunosuppression caused by known diseases or treatments (such as autologous hematopoietic stem cell transplantation). This approval builds upon previous expansion of the target population for adults aged 50 and older. A GSK press release stated that the acceptance of this new formulation application marks a key step in expanding the methods of administration, and further updates will be provided upon completion of regulatory review.
Shingles is a disease characterized by painful, vesicular rash that can last for several weeks. According to real-world data from China (2014–2021), the incidence of shingles increases with age, even in high-risk groups, and approximately 5% of people may experience a recurrence, a rate approaching 10% in the elderly. Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. Most people aged 50 and older have latent VZV5 in their bodies, which can be reactivated with age. The body's immune system's ability to fight infection gradually declines with age, increasing the risk of developing shingles.
Shingrix consists primarily of the varicella-zoster virus glycoprotein E antigen and the AS01B adjuvant system, helping to prevent shingles in adults aged 50 and older. RZV is not indicated for the prevention of primary varicella infection (i.e., chickenpox). In some countries, this vaccine has also been approved for use in adults aged 18 and older at increased risk of shingles.
Source: https://cj.sina.com.cn/articles/view/5953189932/162d6782c067053qdy?froms=ggmp
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