中信证券股份有限公司 关于前沿生物药业（南京）股份有限公司 2023 年度持续督导工作现场检查报告 根据《上海证券交易所上市公司自律监管指引第 11 号——持续督导》等有 关法律、法规的规定，中信证券股份有限公司（以下简称"中信证券"或"保荐 人"）作为正在对前沿生物药业（南京）股份有限公司（以下简称"前沿生物"、 "上市公司"、"公司"）进行持续督导工作的保荐人，对 2023 年度（以下简称"本 持续督导期间"）的规范运作情况进行了现场检查，现就现场检查的有关情况报 告如下： 一、本次现场检查的基本情况 （一）保荐人 中信证券股份有限公司 （二）保荐代表人 2024 年 3 月 28 日 周游、徐磊 （五）现场检查内容 （三）现场检查人员 现场检查人员对本持续督导期内发行人公司治理和内部控制情况、信息披露 情况、公司的独立性以及与控股股东、实际控制人及其他关联方资金往来情况、 募集资金使用情况、关联交易、对外担保、重大对外投资情况、经营状况等方面 进行了现场检查，具体检查内容详见本报告"二、本次现场检查主要事项及意见"。 周游、李铮、温志洋 1 （六）现场检查手段 本次现场检查的手段主要包括资料查阅、访谈、 ...

证券代码：688221 证券简称：前沿生物 公告编号：2024-016 前沿生物药业（南京）股份有限公司 关于参加 2023 年度制药专场集体业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： 会议召开时间：2024 年 4 月 17 日(星期三) 下午 15:00-17:00 会议 召开地点： 上海证券 交易所 上证路演 中心（ 网址 ： https://roadshow.sseinfo.com/） 会议召开方式：网络文字互动 投资者可于 2024 年 4 月 16 日（星期二）16:00 前通过前沿生物 药 业 （ 南 京 ） 股 份 有 限 公 司 （ 以 下 简 称 " 公 司 "） 邮 箱 invest@frontierbiotech.com 进行提问。公司将在说明会上对投资 者普遍关注的问题进行回答。 公司已于 2024 年 3 月 30 日发布公司 2023 年年度报告，为便于 广大投资者更全面深入地了解公司 2023 年年度经营成果、财务状况， 公司参与了由上海证券交易所主办的 2 ...

Investment Rating - The report maintains a "Buy" rating for the company [4][5]. Core Views - The company has successfully transitioned its product, Aikening, from conditional approval to regular approval, expanding its coverage to over 280 HIV treatment hospitals and 180 DTP pharmacies across 28 provinces and municipalities in China [3]. - The company achieved a sales revenue of 114 million yuan in 2023, marking a year-on-year growth of 34.82%, making Aikening the first domestically produced anti-HIV drug to surpass 100 million yuan in annual revenue [14]. - The company has a rich pipeline of new drug products, with FB1002 in Phase II clinical trials and FB4001 having passed FDA inspections, indicating strong potential for future growth [14]. Financial Forecast and Valuation - Revenue projections for 2024-2026 are estimated at 316 million yuan, 513 million yuan, and 641 million yuan, representing year-on-year growth rates of 177.0%, 62.0%, and 25.0% respectively [4][15]. - The net profit attributable to shareholders is forecasted to be -75 million yuan, -36 million yuan, and -6 million yuan for the same period, indicating a gradual reduction in losses [4][15]. - The earnings per share (EPS) are projected to be -0.20 yuan, -0.10 yuan, and -0.02 yuan for 2024-2026 [4][15].

地址：北京市西城区金融大街 35 号国际企业大厦 A 座 8 楼 邮编：100033 地址：重庆市江北区金沙门路 32 号西南证券总部大楼 21 楼 邮编：400025 请务必阅读正文后的重要声明部分 [ T able_StockInfo] 2024 年 03 月 30 日 证券研究报告•2023 年年报点评 当前价：6.85 元 前沿生物（688221）医药生物 目标价：——元（6 个月） 艾可宁用药人数+用药时长双增长，为首个实现年销售破亿元大关的国产抗 HIV 创新药。公司 2023年营业收入增长主要为艾可宁销售收入的增长。基于艾可宁 "巩固前期治疗成果+改善后续免疫恢复"的显著临床获益，积累了良好产品口 碑，更多住院患者出院后选择基于艾可宁的序贯治疗方案，长期用药人数增加， 用药粘性提高，平均用药时长延长。此外，艾可宁静脉推注在门诊场景逐步应 用，相比静脉滴注给药时间显著缩短，便利性大幅提高。截至 2023年底，公司 已实现全国 28个省及直辖市的 280余家 HIV 定点治疗医院及 180余家 DTP 药 房的覆盖，已被 29 个省份及直辖市纳入医保"双通道"及门慢门特目录。 盈利预测与投资建议：预 ...

Financial Performance - In 2023, the company achieved a sales revenue of 114 million yuan, representing a year-on-year growth of 34.82%, primarily driven by the sales of its core product, Aikening [4]. - The net loss attributable to shareholders for 2023 was 329 million yuan, a reduction in loss of 27.8 million yuan year-on-year, indicating improved financial performance despite still being unprofitable [4]. - The net profit attributable to shareholders was CNY -328.96 million, showing an improvement from CNY -356.76 million in 2022 [24]. - The net cash flow from operating activities showed a reduced outflow of CNY -267.17 million, a decrease of CNY 21.87 million compared to the previous year [25]. - The company's total assets decreased by 11.23% to CNY 2.14 billion at the end of 2023, down from CNY 2.41 billion in 2022 [24]. - The net assets attributable to shareholders decreased by 19.67% to CNY 1.34 billion, primarily due to losses incurred in 2023 [25]. - The basic earnings per share for 2023 was CNY -0.88, compared to CNY -0.98 in 2022 [24]. - The net cash flow from investment activities was CNY 172,697,179.21, a significant increase of CNY 28,996,530.00 year-on-year, attributed to reduced expenditures on cash management [135]. - The net cash flow from financing activities decreased by 55.92% to CNY 70,293,676.69, mainly due to last year's investment receipts [135]. Research and Development - The company invested 214 million yuan in R&D expenses in 2023, a decrease of 21.91% compared to the previous year [4]. - Research and development expenses accounted for 187.51% of operating revenue, a decrease of 136.22 percentage points from the previous year [24]. - The total R&D investment for the year was approximately ¥214.23 million, a decrease of 21.91% compared to the previous year's ¥274.33 million [113]. - The company has several ongoing R&D projects, including Aikening for HIV maintenance therapy, which is in the process of applying for Phase II clinical trials [163]. - The company is actively pursuing international patents for its drug compositions and preparation processes to enhance its market position [159]. - The company has established a stable and professional talent team with over 20 years of experience in antiviral drug development [121]. - The company is primarily adopting an independent research and development model, covering the entire process from drug selection to clinical trials and regulatory approval [81]. Product Development and Market Position - Aikening became the first domestically produced anti-HIV drug to exceed 100 million yuan in annual revenue, indicating strong clinical value and market recognition [4]. - The company is focused on the development of innovative drugs in the antiviral and chronic disease sectors, with a competitive edge in the anti-HIV market [4]. - The company is developing several new products, including FB1002 for HIV treatment and FB3001 for musculoskeletal pain [16]. - Aikening's clinical value has been recognized widely, leading to an increase in patient adherence and average treatment duration [38]. - Aikening has received drug registration approval in five overseas countries, including Ecuador and Cambodia, and has submitted applications in seven additional countries [44]. - The company has diversified its operations by expanding into HIV viral load and drug resistance testing, achieving sales revenue from these initiatives [45]. - Aikening has been included in the National Medical Insurance Directory since 2020, covering over 280 HIV treatment hospitals and 180 DTP pharmacies across 28 provinces and municipalities in China [73]. - Aikening's long-acting injectable HIV innovative drugs align with global market trends, addressing the need for reduced medication frequency and improved patient adherence [109]. Operational Strategies - The company emphasizes risk management and has outlined potential operational risks and mitigation strategies in its report [5]. - The company has implemented strategies to reduce employee compensation expenses, contributing to the decrease in cash outflows [25]. - The company is focused on optimizing corporate governance and enhancing operational efficiency to support sustainable long-term growth [34]. - The company has established self-built production bases that comply with GMP standards, ensuring quality and capacity for its products [83]. - The company is committed to reducing costs and increasing efficiency, linking employee incentives to key performance indicators [62]. - The company is currently in a significant R&D investment phase, with multiple products in clinical development, which may lead to continued losses in the near future [124]. Market Trends and Competitive Landscape - The global HIV market is projected to grow from $38 billion in 2021 to $57.5 billion by 2030, with a compound annual growth rate of 6.0% from 2021 to 2025 [92]. - The long-acting injectable HIV drug market is anticipated to expand rapidly due to the increasing demand for safe and convenient medication options among patients [94]. - The introduction of nine HIV drugs into the national medical insurance directory has significantly improved drug affordability and accessibility for patients [102]. - The company is positioned as a leading innovator in the domestic HIV drug market, with a competitive edge in research, production, and commercialization [107]. - The company aims to enhance its international sales proportion and expand into emerging pharmaceutical markets, aligning with the "14th Five-Year" plan for the pharmaceutical industry [176]. Governance and Compliance - The company held a total of 5 board meetings during the reporting period, all in compliance with legal regulations and the company's articles of association [185]. - The board consists of 7 members, including 3 independent directors, ensuring compliance with legal requirements [185]. - The company maintained independence in financial, personnel, asset, business, and institutional aspects, with no related party transactions reported [186]. - The company disclosed its periodic reports and announcements in a timely manner, ensuring transparency and accuracy in information dissemination [186]. - The company has established a comprehensive insider information management system to prevent leaks and insider trading [186].

中信证券股份有限公司关于 前沿生物药业（南京）股份有限公司 2023 年度募集资金存放与使用情况的专项核查意见 中信证券股份有限公司（以下简称"中信证券"或"保荐机构"）作为正在履行 前沿生物药业（南京）股份有限公司（以下简称"前沿生物"或"公司"）持续督导 工作的保荐机构，根据《上海证券交易所科创板股票上市规则》《上市公司监管 指引第 2 号——上市公司募集资金管理和使用的监管要求》《上海证券交易所科 创板上市公司自律监管指引第 1 号——规范运作》等有关规定，对前沿生物 2023 年度募集资金的存放和使用情况进行了专项核查，核查情况如下： 一、实际募集资金基本情况 （一）募集资金基本情况 根据中国证券监督管理委员会出具的《关于同意前沿生物药业（南京）股份 有限公司首次公开发行股票注册的批复》（证监许可[2020]2232 号文），公司获 准向社会公开发行人民币普通股 89,960,000 股，每股发行价格为人民币 20.50 元， 共募集资金 1,844,180,000.00 元；扣除发行费用（不含增值税）126,889,920.46 元 后，募集资金净额为 1,717,290,079.54 元。上述募集 ...

前沿生物药业(南京)股份有限公司 审计 报 告 众环审字(2024)0600007 号 目 录 审计报告 | 财务报表 | | | --- | --- | | 合并资产负债表 | | | 合并利润表 | 3 | | 合并现金流量表 | ব | | 合并股东权益变动表 | 5 | | 资产负债表 | 7 | | 利润表 | 9 | | 现金流量表 | 10 | | 股东权益变动表 | 11 | | 财务报表附注 | 13 | | 财务报表附注补充资料 | 98 | 起始页码 审计报告 众环审字(2024)0600007 号 前沿生物药业(南京)股份有限公司全体股东: 一、审计意见 我们审计了前沿生物药业(南京)股份有限公司(以下简称"前沿生物")财务报表,包 括 2023年 12月 31日的合并及公司资产负债表,2023年度的合并及公司利润表、合并及公 司现金流量表、合并及公司股东权益变动表以及相关财务报表附注。 我们认为,后附的财务报表在所有重大方面按照企业会计准则的规定编制,公允反映了 前沿生物 2023年12月31日合并及公司的财务状况以及 2023年度合并及公司的经营成果和 现金流量。 二、形成审计意见 ...

现将 2023 年度主要工作情况报告如下： 前沿生物药业（南京）股份有限公司 2023 年度独立董事述职报告 本人作为前沿生物药业（南京）股份有限公司(以下简称"公司")的独立董 事,在 2023 年度履职期间，我严格按照《公司法》《证券法》《上市公司独立董事 管理办法》《上海证券交易所科创板股票上市规则》和《前沿生物药业（南京） 股份有限公司章程》（以下简称"《公司章程》"）《独立董事工作制度》的有关 规定，在工作中谨慎、认真、忠实、勤勉地履行法律法规及《公司章程》赋予的 职责，积极参与公司重大事项决策，客观、公正、审慎地发表意见，充分发挥了 独立董事的作用，维护公司整体利益和全体股东尤其是中小股东的合法权益。 （一）会议出席情况 报告期内，公司共召开了 5 次董事会和 1 次股东大会。我本着勤勉尽责的态 度，依法认真履行独立董事的职责，认真审阅会议材料，与相关人员进行沟通， 最大限度发挥专业知识和工作经验优势，提出合理的意见和建议，同时独立、客 观地行使权力。 2023 年度，我出席会议的情况如下： | 独立董事姓名 | | | 参加董事会情况 | | | 参加股东大 会情况 | | --- | --- ...

证券代码：688221 证券简称：前沿生物 公告编号：2024-014 前沿生物药业（南京）股份有限公司 2023 年度募集资金存放与使用情况的专项报告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 根据中国证券监督管理委员会印发的《上市公司监管指引第 2 号——上市公司募集 资金管理和使用的监管要求（2022 修订）》和上海证券交易所发布的《上海证券交易所 科创板上市公司自律监管指引第 1 号——规范运作（2023 年 12 月修订）》等相关法律 法规的规定及要求，前沿生物药业（南京）股份有限公司（以下简称"公司"、"前沿 生物"）董事会将公司 2023 年度募集资金存放与实际使用情况专项说明如下： 一、实际募集资金基本情况 1． 募集资金基本情况 公司分别在华泰证券股份有限公司及上海浦东发展银行南京江宁开发区支行开立 了募集资金理财产品专用结算账户，专用于暂时闲置募集资金购买理财产品的结算，不 会用于存放非募集资金或用作其他用途。根据《上市公司监管指引第 2 号——上市公司 募集资金管理和使用的监管要求（2022 ...

关于前沿生物药业（南京）股份有限公司 募集资金年度存放与实际使用情况 的鉴证报告 众环专字(2024)0600024号 目 景 起始页码 鉴证报告 募集资金专项报告 关于募集资金年度存放与实际使用情况的专项报告 1 前沿生物药业(南京)股份有限公司 年度存放与实际使用情况的鉴证报告 众环专字(2024)0600024 号 前沿生物药业(南京)股份有限公司全体股东: 我们接受委托,对后附的前沿生物药业(南京)股份有限公司(以下简称"前沿生物") 截至 2023 年 12 月 31 日止的《公司募集资金年度存放与实际使用情况的专项报告》进行了 鉴证工作。 按照中国证监会发布的《上市公司监管指引第2号 -- 上市公司募集资金管理和使用的 监管要求》和上海证券交易所发布的《上海证券交易所科创板上市公司自律监管指引第 1 号 -- 规范运作》等有关规定,编制《董事会关于公司募集资金年度存放与实际使用情况的 专项报告》,提供真实、合法、完整的实物证据、原始书面材料、副本材料、口头证言以及 我们认为必要的其他证据,是前沿生物董事会的责任。我们的责任是在执行鉴证工作的基础 上,对《董事会关于公司募集资金年度存放与实际使用情况 ...