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前沿生物: 前沿生物关于2024年年度报告的信息披露监管问询函的回复公告

Core Viewpoint - Frontier Biopharmaceuticals (Nanjing) Co., Ltd. reported a revenue of 129 million yuan for 2024, marking a 13.32% year-on-year increase, with the core product Aikening® generating 114 million yuan in sales, a 4.05% increase [1][2][3]. Group 1: Main Business and Financial Performance - The company achieved a revenue of 129 million yuan in 2024, with a year-on-year growth of 13.32% [1]. - Aikening® sold 271,400 units, contributing 114 million yuan to the revenue, reflecting a 4.05% increase [1]. - The gross profit margin for Aikening® was reported at 20.18% [7]. - The company has initiated the first phase of a 10 million unit HIV fusion inhibitor project at its production base in Nanjing [1]. Group 2: Customer and Sales Analysis - The top five customers accounted for 56.81% of total sales, with a total sales amount of 73.55 million yuan [4]. - There were no signs of inventory pressure or post-sale returns from major distributors, and all accounts receivable were fully collected by the end of the reporting period [4][7]. - The company confirmed that revenue recognition policies comply with relevant accounting standards [5][6]. Group 3: Production and Cost Structure - The company reported a sales revenue of 68.36 million yuan from self-manufactured products, a 36.63% increase from the previous year, while production costs rose by 47.53% to 54.57 million yuan, resulting in a gross margin of 20.18% [7][8]. - The commissioned production revenue decreased by 23.26% to 45.80 million yuan, with production costs dropping by 39.60% [7]. - The production capacity at the Nanjing base is currently underutilized at approximately 11%, with a production and sales rate of 85% [12][13]. Group 4: Research and Development Progress - The company terminated several R&D projects, including FB3001 and FB6001, and recognized a full impairment of 36.21 million yuan for related patent licenses [27]. - Currently, only two products, FB3002 and FB4001, are in the drug approval stages in China and the U.S. respectively, with total R&D expenses for the year amounting to 137.21 million yuan [27][28]. Group 5: Market Opportunities and Competitive Landscape - The market for pain relief patches is expected to grow significantly due to an aging population, with the market size for external patches reaching 18 billion yuan in 2021, growing at 17.81% [29][30]. - FB3002, a high-end generic drug, is positioned to capture market share as it is the first of its kind in China, with 11 companies having submitted applications for approval [30][31]. - The global osteoporosis drug market is also expanding, with FB4001 targeting a significant patient base, as the number of osteoporosis patients is projected to rise to 450 million by 2050 [32][33].