GSK has received China National Medical Products Administration (NMPA) approval for its Shingrix recombinant zoster vaccine in adults aged 18 years and older with increased risk of herpes zoster due to immunodeficiency or immunosuppression from conditions including hematopoietic stem cell transplantation. The approval expands protection for vulnerable populations where no alternative vaccines are currently approved, addressing a significant disease burden with approximately six million annual shingles cases in China. Clinical data supporting the application derived from six trials involving patients post-transplantation, with haematologic malignancies, solid tumours or HIV infection.
GSK senior vice president Sanjay Gurunathan highlighted the milestone in expanding access for high-risk populations who may experience more severe shingles complications. The recombinant vaccine uses a CHO cell expression system, avoiding live attenuated virus limitations in immunocompromised patients.
PharmCube's NextBiopharm® database shows that Shingrix is the only recombinant zoster vaccine approved globally among 22 projects under development. Click here to request a free trial for NextBiopharm®.
