21世纪经济报道记者闫硕 医药产业链分工细化背景下，药品受托生产已成为行业资源优化配置的重要形式。近年来，越来越多持 有药品注册证书的企业(B证企业)选择将生产环节委托给具备生产资质的企业(C证企业)，通过轻资产运 营降低固定资产投入、提升市场响应速度。 然而，这一模式在快速发展中逐渐暴露出一些风险隐患。风云药谈创始人张廷杰向21世纪经济报道记者 举例道，生产线共线生产带来的污染风险、委托与受托双方责任界定模糊，均为质量管控埋下隐患。而 且，药品受托生产多涉及跨区域合作，如浙江企业委托江苏企业生产，需两地监管部门协同发力，此前 的监管机制尚需进一步完善。 1月6日，国家药监局发布《关于加强药品受托生产监督管理工作的公告》(以下简称《公告》)，剑指药 品受托生产中的突出矛盾，以强化质量监管和明确责任边界为核心，构建全链条规范管理体系。《公 告》自发布之日起执行。 具体而言，《公告》强调受托生产企业接受委托前应当对持有人及受托生产产品进行评估，在技术转 移、共线生产、变更管理等关键环节承担起实质性管控责任；明确委托和受托药品生产许可事项办理程 序及委托生产许可时限管理要求，并细化无菌药品等高风险产品委托生产、长期 ...

Core Viewpoint - The listing process of Jiangxi Shimei Pharmaceutical Co., Ltd. has attracted significant attention, particularly regarding its business focus and financial performance, as it primarily generates revenue from generic drugs while its innovative drugs are still in the research phase [1][2][3]. Business and Industry Situation - Jiangxi Shimei Pharmaceutical, established in November 2002, focuses on the research, development, production, and sales of generic drugs, improved innovative drugs, and innovative drugs, while also providing comprehensive services such as technology transfer and contract development and manufacturing (CDMO) [2][3]. - The company plans to raise 608 million yuan for projects related to the development and industrialization of chiral antihypertensive drugs, innovative drug research in Shandong, and the establishment of a formulation production base [2]. Performance Trends - The company reported significant revenue growth during the reporting period, with revenues of 81 million yuan, 148 million yuan, 184 million yuan, and 192 million yuan from 2020 to 2023, reflecting year-on-year growth rates of 81.72% and 24.53% in 2021 and 2022, respectively [4]. - Net profits also increased substantially, with figures of 19.31 million yuan, 51.54 million yuan, 75.58 million yuan, and 99.58 million yuan, showing year-on-year growth of 166.89% and 46.66% in 2021 and 2022, respectively [4]. Comparison with Peers - While Jiangxi Shimei Pharmaceutical's performance has improved, some of its peers, such as Boji Pharmaceutical and Baihua Pharmaceutical, have experienced declines in net profit, raising regulatory concerns about the reasons behind these contrasting trends [5]. - The company attributes its growth to favorable industry policies, strong market demand, and successful project registrations with large pharmaceutical enterprises, which have positively impacted its revenue [5]. Gross Margin Analysis - The gross margin of Jiangxi Shimei Pharmaceutical has consistently exceeded industry averages, with figures of 80.22%, 81.79%, 83.63%, and 88.28% during the reporting period [6]. - The gross margin for its pharmaceutical research and CDMO business was reported at 67.38%, 81.60%, 90.58%, and 91.84%, significantly higher than the average gross margins of comparable companies [6][7]. - The company’s gross margin is also notably higher than leading CRO firms like WuXi AppTec, which reported gross margins of 37.97% to 40.52% during the same period, indicating a strong competitive position [7].