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欣安立适(重组带状疱疹疫苗(CHO细胞)
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主力疫苗再破局:GSK欣安立适扩龄至风险增加成人,百亿市场迎新增量
21世纪经济报道· 2025-11-05 12:40
Core Viewpoint - The approval of the recombinant zoster vaccine (RZV) for adults aged 18 and above with increased risk of herpes zoster marks a significant expansion of its market potential in China, providing new growth momentum for GSK's vaccine sales [1][2][4]. Group 1: Vaccine Approval and Market Expansion - GSK's RZV has been approved by the National Medical Products Administration (NMPA) for use in adults aged 18 and above who are at increased risk of herpes zoster due to known diseases or treatments that cause immune deficiency [1][2]. - This approval expands the vaccine's protective range, which was initially limited to individuals aged 50 and above since its launch in June 2020 [1][3]. - The vaccine is the first and only one approved in China for this specific high-risk group, addressing a significant clinical gap in prevention [2][4]. Group 2: Disease Burden and Risk Factors - Herpes zoster, commonly known as "shingles," is a significant health burden in China, particularly among individuals aged 50 and above, with approximately 1.56 million new cases reported annually in this age group [2][3]. - The risk of developing herpes zoster increases with age, and certain conditions such as HIV infection and malignancies further elevate this risk, with affected individuals being 2.3 to 4.0 times more likely to contract the disease [3][6]. Group 3: Market Potential and Growth - The domestic herpes zoster vaccine market is projected to grow significantly, with a market size of 3.73 billion yuan in 2022 expected to reach 5.63 billion yuan by 2025, reflecting a compound annual growth rate (CAGR) of 16.4% [5]. - GSK's vaccine targets a population of 340 million people aged 50 and above in China, and with an estimated peak penetration rate of 10%, the market potential could reach approximately 65 billion yuan [5][6]. - The newly approved indication for high-risk adults represents an untapped market segment with substantial growth potential, driven by a large population base and a strong demand for preventive measures [5][6]. Group 4: Competitive Landscape - Currently, there are two approved herpes zoster vaccines in China: GSK's RZV and Baike Biological's "Ganwei," which utilize different technological approaches [8]. - GSK's RZV, as a recombinant vaccine, has established itself as a core growth engine for the company's vaccine business, demonstrating strong revenue stability and market competitiveness [8][9]. - Continuous investment in research and development is crucial for maintaining the competitive edge of RZV, with ongoing studies aimed at assessing its efficacy and safety in high-risk populations [9].