PLBIO(SZ:000403) Shang Hai Zheng Quan Bao·2025-10-28 23:30Core Viewpoint - The company has decided to terminate the development of prothrombin complex concentrate and shift focus to the more advantageous development of human coagulation factor IX, due to market demand, competitive landscape, and cost-effectiveness considerations [1][2]. Market Demand and Competitive Landscape - The domestic market for prothrombin complex concentrate has seen stable issuance volumes with limited new market space, while the market for human factor IX has fewer competitors and significant growth potential [1]. - Human factor IX is considered a better option for treating hemophilia B due to its lower risk of thrombotic side effects compared to prothrombin complex concentrate [1][2]. Product Comparison Analysis - Prothrombin complex concentrate contains various vitamin K-dependent factors and may pose risks of thrombosis with repeated high-dose use, while human factor IX is purer and has a higher specific activity, making it a safer treatment option [1][2]. Cost-Effectiveness Analysis - The clinical trial approval for prothrombin complex concentrate was obtained in 2008, but the regulatory requirements for production site changes and the need for extensive research have made it less economically viable compared to human factor IX, which has a higher sales price and greater market growth potential [2][4]. Project Background and Investment Plan - The genomic DNA length of human factor IX is approximately 34,000 bp, and the project is expected to complete development and obtain production approval by the end of 2030 [2][4]. - The estimated investment for the development of human factor IX is 60 million yuan, with funding sourced from both raised capital and the company's own funds [4]. Project Benefits and Feasibility - The human factor IX product is aimed at treating patients with factor IX deficiency (hemophilia B), and the limited number of competitors in this market suggests significant future growth opportunities [5]. - The project aligns with market trends and the company's operational needs, enhancing resource allocation and economic benefits, thereby improving profitability and market competitiveness [5][7]. Implementation Timeline - The implementation timeline for the new product development is expected to be completed by the end of 2030, with the associated production line construction already finished [6][4]. Impact of Changes on the Company - The termination of the prothrombin complex concentrate project will reduce the current year's net profit but is expected to enhance the company's future product development and sales capabilities [7]. - The board and supervisory committee have approved the change in fundraising purposes, emphasizing the alignment with the company's operational needs and long-term interests [8][10].