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探访首个国产九价HPV疫苗诞生地:从“0”到“1”的创新破局 定价499元/支

Core Viewpoint - The approval of the domestic nine-valent HPV vaccine "Xinkening®9" marks a significant shift in the market, breaking the long-standing monopoly of imported vaccines and enhancing China's capability to independently supply high-priced HPV vaccines [2][11]. Group 1: Vaccine Development and Approval - The domestic nine-valent HPV vaccine was developed by a collaboration between Xiamen University and Wantai Vaccine, and it is the first of its kind approved in China [2][4]. - The vaccine development began in 2002, with a focus on preventing cervical cancer caused by high-risk HPV infections [3][4]. - The vaccine has undergone five clinical trials since 2019, involving over 11,000 healthy volunteers, demonstrating good safety and immune response comparable to imported vaccines [7][11]. Group 2: Technological Innovation - The vaccine utilizes a novel prokaryotic expression system based on E. coli, which allows for high yield and stable production, overcoming patent barriers associated with traditional eukaryotic systems [4][5][8]. - The development process took 18 years, with significant breakthroughs in using E. coli to produce virus-like particles [5][6]. - The vaccine covers more high-risk HPV types, achieving over 98% protection against related infections, thus reaching international leading levels in HPV vaccine development [8][12]. Group 3: Market Impact and Accessibility - The price of the domestic nine-valent HPV vaccine is set at 499 yuan per dose, approximately 40% lower than imported alternatives, which is expected to improve accessibility [12][13]. - The production capacity is designed to reach approximately 20 million doses per year, with plans for further expansion to meet domestic demand [11][12]. - The introduction of this vaccine aligns with global health initiatives aimed at eliminating cervical cancer by 2030, reflecting China's evolving role in global health governance [13].