GSK plc has disclosed a new agreement with Chongqing Zhifei Biological Products, Ltd. (Zhifei) to modify the existing arrangement for Zhifei’s commercialisation of GSK’s Shingrix shingles vaccine within mainland China. This amended pact lengthens the initial 3-year timespan (2024-2026) granting Zhifei exclusive rights for importation, distribution, and co-promotion of the vaccine, extending through 2034, while adjusting anticipated volumes. Under the new terms, Zhifei also pledges exclusive collaboration talks with GSK about potentially commercialising a respiratory syncytial virus (RSV) vaccine in China, pending regulatory approval, with an introductory 10-year duration agreement.
Zhifei, the leading Chinese vaccine firm by revenue, boasts an extensive network encompassing more than 30,000 vaccination spots nationwide, and has a proven track record for facilitating access to novel vaccines in China.
Luke Miels, GSK’s Chief Commercial Officer, remarked, “This update with Zhifei stabilises our partnership, accommodating the macro environment’s near-term uncertainties, and aims to increase our innovative adult vaccine reach in China over the long haul.”
This amendment revises the previously communicated agreement from October 2023. Under the revised framework, Zhifei plans to sequentially procure Shingrix volumes estimated to potentially benefit GSK by £2.3 billion (at current exchange rates) from 2024-2029. Minimum purchase levels from prior contracts have been nulled.
Shingles, or herpes zoster, is a result of the reactivation of the varicella-zoster virus (VZV), which also causes chickenpox. Globally, individuals aged 50+ often harbor dormant VZV, making them susceptible to shingles, particularly as age-related immune decline intensifies infection risk. Immunocompromised individuals are equally at risk.
Symptoms typically manifest as blisters on the chest, abdomen, or face, described as aching, burning, stabbing, or sudden jabs. Post-rash, long-lasting nerve pain or post-herpetic neuralgia (PHN) can persist weeks or even years in 5-30% of cases, contingent on an individual’s age.
Shingrix was promptly approved by China’s National Medical Products Administration (NMPA) in May 2019 for preventing shingles in adults 50+ years old. Projections indicate 570 million people in this age group by 2030, despite just 1.2% urban population coverage among 50-74 year-olds for vaccination as of June 2023.
Shingrix (Recombinant Zoster Vaccine, RZV) is a non-live, recombinant subunit vaccine for shingles prevention in adults 50 or older. Featuring the glycoprotein E antigen combined with the AS01e adjuvant system, it counters the natural decline in immune response due to aging, providing essential protection. RZV is not indicated for primary varicella infection or chickenpox prevention, though some regions approve RZV for high-risk adults aged 18+. Vaccine usage should adhere to official guidelines.
RSV is a contagious virus impacting the lungs and airways. Adults with comorbidities, a compromised immune system, or advanced age face increased RSV disease risk. It can aggravate COPD, asthma, and chronic heart failure, potentially leading to severe outcomes like pneumonia and hospitalization. In seniors, RSV parallels flu complications severity. Approximately 297 million individuals aged 60+ live in China, where over 75% battle at least one chronic disease, underscoring the RSV burden.
The Respiratory Syncytial Virus Vaccine (recombinant), comprising stabilised recombinant RSV glycoprotein F (RSVPreF3), merges with GSK’s AS01E adjuvant.
As of May 2023, the US FDA approved GSK’s RSV vaccine for lower respiratory tract disease (LRTD) prevention caused by RSV in those 60+. By June 2024, FDA approval extended to individuals 50-59 at heightened RSV-LRTD risk. Approved in over 40 nations for individuals 60+, regulatory reviews for both age groups are ongoing globally. Proposed trade name awaits approval in other markets.
GSK pursues worldwide clinical trials to assess the safety and immune response of Arexvy in high-risk adults 18+. The proprietary AS01 adjuvant features Stimulon QS-21 from Antigenics LLC (Antigenics Inc.), under Agenus Inc., with Stimulon trademarked by SaponiQx Inc., a subsidiary of Agenus. Vaccine use should align with official recommendations, and protection may vary among recipients.
The vaccine awaits approval in China.
Chongqing Zhifei Biological Products Co., Ltd. is a holistic biotechnology enterprise specialising in vaccine research, development, production, sales, promotion, distribution, and import/export, committed to ‘disease prevention and health protection’.
GSK is a global biopharma entity focussed on integrating science, technology, and talent to proactively tackle diseases together.