WANTAI BIOLOGICAL(SH:603392) 格隆汇APP·2025-06-08 10:17Core 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].