Xin Lang Cai Jing·2025-07-08 16:42Core Viewpoint - WanTai Biologics has officially launched its nine-valent HPV vaccine "Xinkening®9" at a price of 499 yuan per dose, significantly undercutting the imported vaccine price and marking the end of the "high-price era" for HPV vaccines in China [1][6]. Pricing and Market Impact - The imported nine-valent HPV vaccine "Gardasil 9" is priced at approximately 1318 yuan per dose, with a total cost of nearly 4000 yuan for three doses, while "Xinkening®9" costs about 1497 yuan for three doses [1]. - "Xinkening®9" is the only HPV vaccine approved for a two-dose regimen for ages 9-17, reducing the cost for this age group to 998 yuan, thereby enhancing accessibility and compliance [1]. Historical Context and Market Dynamics - Prior to the launch of "Xinkening®9", the nine-valent HPV vaccine market in China was monopolized by Merck's "Gardasil 9," which faced a dramatic shift from high demand and scarcity to excess inventory [2]. - In 2023, the batch issuance of "Gardasil 9" reached 36.55 million doses, a year-on-year increase of 136.16%, making Merck the highest-grossing multinational pharmaceutical company in China that year [2]. Sales Performance and Challenges - Merck's global sales of the HPV vaccine in 2024 were $8.583 billion, a 3% decline year-on-year, primarily due to weak performance in the Chinese market [3]. - To address high inventory levels, Merck announced a suspension of supply to China starting in early 2025, expected to last until at least mid-2025 [3]. Financial Performance of WanTai Biologics - WanTai Biologics reported a 59.25% year-on-year decline in revenue for 2024, totaling 2.245 billion yuan, with a net profit drop of 91.49% to 106 million yuan [3]. - The company faced significant challenges due to a price collapse in its two-valent vaccine, leading to a drastic reduction in government procurement prices [3]. Market Potential and Future Outlook - The potential market for HPV vaccines in China is substantial, with 70%-80% of the 300 million women aged 9-45 yet to be vaccinated [4]. - National Investment Securities predicts that WanTai's nine-valent HPV vaccine could reach a sales peak of 22.8 billion yuan, with projected revenues of 3.17 billion yuan, 11.4 billion yuan, and 28.63 billion yuan for 2025-2027 [4]. Competitive Landscape - Several domestic pharmaceutical companies are in the late clinical stages of developing their own nine-valent HPV vaccines, creating a competitive environment for WanTai [5]. - WanTai has initiated a Phase III clinical trial for a male indication, but competitors like Kanglaite have already started their trials earlier [5]. International Expansion - WanTai aims to become a leading global vaccine supplier by 2030, with plans to have 3 to 5 WHO pre-qualified products [5]. - Competitors are also pursuing international markets, with Kanglaite planning to submit for approval in Indonesia and Ruike Biologics exploring the Middle East [5]. Industry Trends - The World Health Organization has warned that global HPV vaccine supply may exceed demand from 2025 to 2030, potentially leading to a price war and industry reshuffling [5]. - The WHO's recommendation for a single-dose HPV vaccination regimen could further intensify market competition [5].