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打破默沙东“一家独大”格局 首个国产九价HPV疫苗获批上市
Zheng Quan Ri Bao· 2025-06-05 16:40
Core Viewpoint - The approval of the first domestically produced nine-valent HPV vaccine by Wantai Biological Pharmacy is expected to disrupt the market dominance previously held by Merck's Gardasil 9, enhancing the company's competitive edge and product line [2][4]. Group 1: Market Dynamics - The nine-valent HPV vaccine, named "Xinkening 9," is approved for use in females aged 9 to 45, with different dosing schedules based on age [2][4]. - Currently, there are six HPV vaccines available in the domestic market, including two-valent and four-valent vaccines from GSK and Merck, as well as two-valent vaccines from Watson Bio and Wantai Biological [3][4]. - Merck's Gardasil 9 has maintained a monopoly in the market since its approval in 2018, with an estimated issuance of approximately 31.14 million doses in 2024 [3]. Group 2: Competitive Landscape - The introduction of Wantai's nine-valent HPV vaccine may accelerate market changes, as domestic vaccine companies are rapidly advancing through technological upgrades and product iterations [4]. - Analysts suggest that the pricing of Wantai's nine-valent HPV vaccine will be a focal point, with expectations of a potential price war due to the lower production costs and high capacity of domestic vaccines [4][5]. - Other domestic companies, such as Yunnan Watson Bio, are also progressing in the development of nine-valent HPV vaccines, indicating a competitive environment [4][5]. Group 3: Low-Cost Vaccine Market - The approval of Wantai's nine-valent HPV vaccine raises questions about the future of low-cost HPV vaccines, which are still relevant for price-sensitive populations [5][6]. - Companies like Kanglao Weishi are also entering the market with a three-valent HPV vaccine aimed at cost-sensitive consumers, indicating a strategy to capture both government procurement and self-pay markets [5]. - The low-cost vaccines are expected to maintain their market position in economically underdeveloped regions, serving as a complement to higher-priced vaccines [5][6].
HPV疫苗企业一季度业绩集体失速
Core Viewpoint - The performance of major Chinese vaccine companies, including Wantai Biological Pharmacy (万泰生物), Zhifei Biological Products (智飞生物), and Watson Bio (沃森生物), has significantly declined in Q1 2025, primarily due to a shrinking self-paid market for HPV vaccines amid economic pressures [1] Group 1: Company Performance - Wantai Biological reported a revenue of 401 million yuan in Q1 2025, a year-on-year decrease of 46.76%, with a net loss of 52.78 million yuan [1] - Zhifei Biological's revenue fell to 2.374 billion yuan, down 79.16% year-on-year, resulting in a net loss of 305 million yuan [1] - Watson Bio achieved a revenue of 462 million yuan, a decline of 22.93%, with a net profit of 2.65 million yuan, down 81.27% [1] Group 2: Market Dynamics - The HPV vaccine market is experiencing a significant contraction, with a 61.57% year-on-year drop in the total number of HPV vaccine batches approved for sale in 2024 [3] - The two-valent HPV vaccine's sales revenue for Wantai Biological plummeted by 84.69% to 606 million yuan in 2024, influenced by price reductions and increased competition from the nine-valent HPV vaccine [3][4] - The price of HPV vaccines has drastically decreased, with the two-valent vaccine's procurement price dropping from over 300 yuan to 27.5 yuan in Shandong province, reflecting a nearly 90% decline [7] Group 3: Competitive Landscape - The introduction of the nine-valent HPV vaccine has intensified competition, with consumers favoring higher-priced vaccines, leading to a sharp decline in demand for the two-valent vaccine [4] - Zhifei Biological, as the exclusive agent for Merck's HPV vaccines, faced a 95.49% drop in the issuance of four-valent HPV vaccines in 2024, exacerbated by Merck's suspension of supplies to China [4][5] - The price war in the HPV vaccine market has severely compressed profit margins, with Wantai Biological's vaccine segment gross margin falling from 91.6% in 2022 to 70.4% in 2024 [7] Group 4: Future Outlook - The development of domestic nine-valent HPV vaccines is accelerating, with several companies, including Wantai Biological, advancing their clinical trials [8] - The potential introduction of male-targeted HPV vaccines may open new growth avenues, as Merck's four-valent HPV vaccine has been approved for male use [9]