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简称RZV)
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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].
扩展至18周岁以上人群!GSK带状疱疹疫苗在华获批新适应症
Core Insights - GSK's recombinant shingles vaccine, RZV, has been approved by China's NMPA for use in adults aged 18 and above who are at increased risk of shingles due to known diseases or treatments that cause immunodeficiency or immunosuppression [1][2] - The approval addresses a significant public health issue, as there are approximately 6 million cases of shingles in China each year, with factors like immunodeficiency increasing the risk of infection [1] - This is the first and only recombinant shingles vaccine approved for this high-risk population in China, filling a critical gap in disease prevention [2] Company Strategy - GSK aims to enhance the accessibility of RZV for high-risk groups, recognizing the severe impact shingles can have on their health and quality of life [2] - The company is committed to integrating disease prevention into its corporate strategy, supporting the development of a comprehensive "prevention-treatment" solution throughout the lifecycle of healthcare [2] - GSK's efforts align with China's vision for "Healthy China 2030," contributing to the advancement of immunization initiatives in the country [2] Clinical Evidence - The approval was based on data from six clinical trials conducted in patients aged 18 and older, including those who have recently undergone hematopoietic stem cell transplants, kidney transplants, or are living with blood cancers, solid tumors, or HIV [2]