Core Points - The first domestically produced nine-valent HPV vaccine "Xinkening®9" is priced at 499 yuan per dose, approximately 40% of the price of imported nine-valent HPV vaccines, marking the end of the "high-price era" for HPV vaccines [1] - The vaccine was developed by a team led by Academician Xia Ning Shao from Xiamen University and Wantai Biological Pharmacy, utilizing a novel prokaryotic expression system [2] - The development process took 18 years and involved over 1 million independent trials, showcasing a significant increase in complexity compared to the two-valent HPV vaccine [2][3] - Clinical trial results published in The Lancet Infectious Diseases indicate that "Xinkening®9" has similar immune response and safety profiles to imported vaccines, effectively preventing high-risk HPV infections [3] - The vaccine is the only one approved for a two-dose regimen for ages 9-17, which may significantly improve vaccination compliance among young girls in China [4] Industry Insights - The nine-valent HPV vaccine not only retains the protective effects against HPV16 and HPV18 but also covers additional high-risk types, achieving over 98% protection against related persistent infections [5] - The collaboration between Wantai Biological and Xiamen University represents a successful model of industry-academia integration, having completed numerous national-level research projects [6] - Wantai Biological has invested approximately 1 billion yuan in the development of the nine-valent HPV vaccine, reflecting a strong commitment to research and innovation [6][7] - The introduction of a cost-effective HPV vaccine is expected to enhance vaccination rates among eligible women in China, contributing to the global goal of cervical cancer elimination [7]

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].

Core Viewpoint - The launch of China's first domestically produced nine-valent HPV vaccine "Xinkening®9" at a price of 499 yuan per dose significantly undercuts the imported vaccine priced at 1300 yuan, marking the end of the "high-price era" for HPV vaccines [1] Group 1: Product Pricing and Market Impact - The domestic nine-valent HPV vaccine is priced at approximately 40% of the imported vaccine's market standard price [1] - The competitive pricing is expected to enhance the willingness of eligible women to get vaccinated, contributing to the establishment of a national immunity barrier and accelerating the goal of cervical cancer elimination [1] - The pricing strategy is projected to benefit over 100 million women in China and positively impact global cervical cancer prevention efforts [1] Group 2: Company Initiatives and Global Expansion - After the approval of the nine-valent HPV vaccine, the company is actively advancing the national bidding and procurement process as per its established plan [1] - The company is also working diligently on the WHOPQ certification process for the nine-valent HPV vaccine, leveraging its international achievements with the two-valent HPV vaccine, which has gained market access in over 20 countries and is included in the immunization programs of 8 countries [1] - The company expresses confidence in accelerating the overseas access and expansion of the nine-valent HPV vaccine through its established global network [1]

Core Viewpoint - The approval of the first domestic nine-valent HPV vaccine, Xinkening®9, by Wantai Biological Pharmacy, marks a significant breakthrough in China's vaccine industry, challenging Merck's long-standing monopoly in the market [1][26]. Summary by Sections R&D and Product Value - Wantai Biological invested approximately 1 billion yuan over 18 years to develop Xinkening®9, achieving three major breakthroughs in vaccine technology [3][12]. - The vaccine utilizes an innovative E. coli expression system, resulting in higher immunogenicity, cost-effectiveness, and complete proprietary intellectual property [5][6]. Efficacy and Safety - Xinkening®9 can prevent infections from nine HPV types, covering over 90% of HPV-related infections, with proven efficacy and safety comparable to imported vaccines [6][7]. - A head-to-head study published in The Lancet confirmed that both domestic and imported vaccines had a 100% seroconversion rate for neutralizing antibodies [7]. Administration and Accessibility - The vaccine offers flexible dosing schedules: a two-dose regimen for females aged 9-17 and a three-dose regimen for those aged 18-45, making it more accessible compared to imported alternatives [11][12]. Pricing Strategy - The market is keenly awaiting the pricing strategy for Xinkening®9, with current expectations based on the pricing of the only other available nine-valent HPV vaccine, Gardasil®9, which costs around 1300 yuan per dose [13][14]. - Two main pricing strategies are anticipated: an aggressive pricing approach or a price set at 50%-70% of the imported vaccine's cost [14][15]. Market Potential and Growth - If priced between 700 to 800 yuan per dose, Xinkening®9 could balance commercial viability and social responsibility, addressing the significant gap in HPV vaccination rates in China [16][17]. - The global demand for HPV vaccines is robust, with projections estimating Xinkening®9 could reach sales of 22.8 billion yuan [23]. Future Expansion - Wantai Biological plans to expand into the male market and pursue international opportunities, leveraging its WHO pre-certification and existing market access in various countries [25]. - The approval of Xinkening®9 signifies a shift in China's vaccine industry from catching up to leading in core product development [26].