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 归还前次暂时补充流动资金的闲置募集资金并继续使用 部分闲置募集资金暂时补充流动资金的核查意见 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《证券发行上市保荐业务管理办法》《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 物使用部分闲置募集资金暂时补充流动资金的事项进行了审慎核查，核查情况 如下： 一、募集资金基本情况 根据中国证券监督管理委员会《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 8,996 万股，每股发行价格为人民币 20.50 元，共募集资 金 184,418.00 万元；扣除发行费用（不含增值税）12,688.99 万元后，募集资金净 额 171,729.01 万元。上述募集资金到位情况已经毕马威华振会 ...

Financial Performance - The company's operating revenue for the third quarter was RMB 72,218,787.01, a decrease of 5.44% compared to the same period last year[5] - The net profit attributable to shareholders was a loss of RMB 69,381,897.11, reflecting a significant decline[5] - The company achieved a year-to-date operating revenue of RMB 29,777,524.75, an increase of 25.25% year-on-year[5] - In the first three quarters of 2023, the company achieved operating revenue of CNY 72.22 million, a year-on-year increase of 25.25%[12] - Total operating revenue for the first three quarters of 2023 reached ¥72,218,787.01, an increase of 25.4% compared to ¥57,658,276.97 in the same period of 2022[23] - The net loss for the first three quarters of 2023 was ¥242,466,343.10, compared to a net loss of ¥226,508,768.06 in the same period of 2022, indicating a deterioration in performance[24] Research and Development - Research and development expenses for the quarter totaled RMB 49,492,247.37, down 39.66% year-on-year[5] - The ratio of R&D expenses to operating revenue decreased by 94.22% in the current quarter[5] - R&D investment for the first three quarters of 2023 was CNY 161.42 million, a year-on-year decrease of 1.02%[12] - Research and development expenses for the first three quarters of 2023 were ¥161,419,424.80, slightly down from ¥163,077,212.38 in the same period of 2022[23] - The company has submitted three invention patent applications and received one invention patent authorization during the reporting period[16] Assets and Liabilities - Total assets at the end of the reporting period were RMB 2,201,479,988.56, down 8.68% from the previous year[5] - The equity attributable to shareholders was RMB 1,671,449,391.84, a decrease of 14.49% compared to the previous year[5] - The company's total assets decreased to ¥2,201,479,988.56 in Q3 2023 from ¥2,410,859,210.09 in Q3 2022, a decline of 8.7%[20] - Total liabilities increased to ¥772,299,291.31 in Q3 2023 from ¥739,409,818.25 in Q3 2022, marking a rise of 4.0%[20] - The company’s equity attributable to shareholders decreased to ¥1,429,180,697.25 in Q3 2023 from ¥1,671,449,391.84 in Q3 2022, reflecting a decline of 14.5%[20] Cash Flow - The company's cash flow from operating activities showed a significant decline, with a net cash outflow reported for the first three quarters of 2023[26] - In the first three quarters of 2023, the cash inflow from operating activities was CNY 95,171,577.78, a decrease of 45.5% compared to CNY 174,853,420.03 in the same period of 2022[27] - The net cash outflow from operating activities was CNY -209,635,731.88, worsening from CNY -186,815,442.24 year-over-year[27] - The cash inflow from investment activities totaled CNY 3,573,274,904.05, an increase of 43.7% compared to CNY 2,486,956,022.78 in the previous year[27] - The net cash flow from investment activities was CNY 335,657,777.12, significantly improving from CNY 99,933,245.26 in the same quarter last year[28] - The cash inflow from financing activities was CNY 261,679,305.39, down from CNY 336,746,410.62 year-over-year[28] - The net cash flow from financing activities was CNY 49,622,820.31, a decrease of 82.6% compared to CNY 284,908,758.98 in the previous year[28] - The ending balance of cash and cash equivalents was CNY 726,238,538.79, down from CNY 995,003,191.23 in the same period last year[28] Product Development and Market Expansion - The company reported a basic earnings per share of -0.19 RMB, compared to -0.65 RMB in the same period last year[5] - Aikening has shown excellent clinical value in various treatment scenarios, leading to increased patient adherence to personalized antiviral treatment plans[12] - The company has expanded its coverage to over 280 HIV treatment hospitals and 180 DTP pharmacies across 28 provinces in China[15] - Aikening's clinical study results presented at the 19th European AIDS Conference demonstrated significant improvement in CD4+ T lymphocyte counts after 12 weeks of treatment[14] - The company received a No Action Indicated (NAI) result from the FDA for the pre-approval inspection of FB4001, paving the way for its ANDA application[16] - The average duration of medication for patients has increased due to the advocacy of long-term use of personalized treatment plans[12]

证券代码：688221 证券简称：前沿生物 公告编号：2023-031 前沿生物药业（南京）股份有限公司 关于召开 2023 年第三季度业绩说明会的公告 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：2023 年 11 月 13 日(星期一) 下午 15:00-16:00 1 （三） 会议召开方式：上证路演中心网络互动 三、 参加人员 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：上证路演中心网络互动 投资者可于 2023 年 11 月 06 日(星期一) 至 11 月 10 日(星期 五)16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通 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 2023 年 10 月 31 日发布公司 2023 年第三季度报告，为 便于广大 ...

证券代码：688221 证券简称：前沿生物 公告编号：2023-030 前沿生物药业（南京）股份有限公司 二、 对公司的影响 批准前现场检查（PAI）是ANDA获批的先决条件，本次通过FDA的现场检查，为FB4001 的ANDA申请奠定GMP合规基础，有利于推进FB4001在美国的ANDA审评工作进程。 自愿披露关于公司及子公司通过美国 FDA 现场检查的公告 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个别及连带责任。 前沿生物药业（南京）股份有限公司（以下简称"公司"）及下属全资子公司四川 前沿生物药业有限公司（以下简称"四川前沿"）于2023年8月接受了美国食品药品监督 管理局（以下简称"FDA"）对公司申报的FB4001（特立帕肽注射液）ANDA上市申请的批 准前现场检查(以下简称"PAI,Prior Approval Inspection")，PAI是药品上市审批的 先决条件。 近日，公司及四川前沿收到了FDA出具的现场检查报告（EIR，Establishment Inspection Report），检查结果为0-483通 ...

证券代码：688221 证券简称：前沿生物 公告编号：2023-029 前沿生物药业（南京）股份有限公司 首次公开发行部分限售股上市流通公告 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个别及连带责任。 重要内容提示 一、本次上市流通的限售股类型 根据中国证券监督管理委员会于2020年9月11日出具的《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），同意公司首次公开发行股票的注册申请。公司首次向社会公开发行人 民币普通股（A股）股票89,960,000股，并于2020年10月28日在上海证券交易所 科创板上市。公司首次公开发行前的总股本为269,800,000股，首次公开发行后 的总股本为359,760,000股，其中有限售条件流通股为277,134,220股，无限售条 件流通股为82,625,780股。 公司于2022年8月24日收到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）股份有限公司向特定对象发行股票注册的批复》（证监许可 [2022]1823号），同 ...

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 首次公开发行部分限售股上市流通的核查意见 中信证券股份有限公司（以下简称"保荐机构"）担任前沿生物药业（南京） 股份有限公司（以下简称"前沿生物"、"发行人"或"公司"）的持续督导机构， 根据《中华人民共和国公司法》《中华人民共和国证券法》《上海证券交易所科创 板股票上市规则》等有关规定，对公司首次公开发行部分限售股上市流通的事项 进行了审慎核查，核查情况如下： 一、本次上市流通的限售股类型 根据中国证券监督管理委员会于 2020 年 9 月 11 日出具的《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），同意公司首次公开发行股票的注册申请。公司首次向社会公开发行人 民币普通股（A 股）股票 89,960,000 股，并于 2020 年 10 月 28 日在上海证券交 易所科创板上市。公司首次公开发行前的总股本为 269,800,000 股，首次公开发 行后的总股本为 359,760,000 股，其中有限售条件流通股为 277,134,220 股，无限 售条件流通股为 82,625,780 ...

中信证券股份有限公司 2 | 序号 | 工作内容 | 实施情况 | | --- | --- | --- | | 14 | 发现以下情形之一的，督促上市公司做 | 2023 年上半年度，前沿生物未发生相 | | | 出说明并限期改正，同时向上海证券交 | | | | 易所报告：（一）涉嫌违反《上市规 | | | | 则》等相关业务规则；（二）证券服务 | | | | 机构及其签名人员出具的专业意见可能 | | | | 存在虚假记载、误导性陈述或重大遗漏 | | | | 等违法违规情形或其他不当情形； | 关情况。 | | | （三）公司出现《保荐办法》第七十一 | | | | 条、第七十二条规定的情形；（四）公 | | | | 司不配合持续督导工作；（五）上海证 | | | | 券交易所或保荐人认为需要报告的其他 | | | | 情形。 | | | 15 | 制定对上市公司的现场检查工作计划， 明确现场检查工作要求，确保现场检查 | 保荐机构已制定了现场检查的相关工作 计划，并明确了现场检查工作要求。 | | | 工作质量。 | | | 16 | 上市公司出现下列情形之一的，保荐机 道之日起 日内进行专项现场核 ...

Financial Performance - Frontier Biotechnologies reported a significant increase in revenue, achieving a total of $50 million for the first half of 2023, representing a 25% growth compared to the same period last year[14]. - The company has set a performance guidance of $100 million in revenue for the full year 2023, reflecting a 20% increase year-over-year[14]. - The company's operating revenue for the first half of 2023 was CNY 42.44 million, a year-on-year increase of 62.20%, primarily driven by the growth in the number of patients and duration of use for the innovative HIV drug Aikening[22]. - The net profit attributable to shareholders for the same period was a loss of CNY 173.08 million, which represents a 40.42% increase in loss compared to the previous year[22]. - The net cash flow from operating activities showed a net outflow of CNY 160.14 million, which is an increase of CNY 54.88 million compared to the same period last year[22]. - The company reported a significant increase in revenue, achieving a total of 1.5 billion in the first half of 2023, representing a 20% year-over-year growth[154]. - User data showed a growth in active users, reaching 10 million, which is a 15% increase compared to the previous year[155]. - The company provided an optimistic outlook for the second half of 2023, projecting a revenue growth of 25%[156]. Research and Development - The company has allocated $10 million for research and development in 2023, focusing on innovative therapies and technologies[14]. - Research and development expenses accounted for 263.72% of operating revenue, a decrease of 46.08 percentage points compared to the previous year[21]. - The total R&D investment increased by 38.08% to ¥111,927,177.43 compared to ¥81,061,414.45 in the same period last year[70]. - The number of R&D personnel increased to 95, accounting for 26.83% of the total workforce, up from 22.68% in the previous year[77]. - The company is actively expanding its product pipeline, including drugs for HIV, COVID-19, and pain management, with several products in various stages of clinical trials[28][29]. - The company has achieved significant progress in the development of FB2001, which has shown broad-spectrum inhibitory activity against major COVID-19 variants[62]. - The clinical trial plan for FB3001 (new transdermal analgesic patch) has been approved for Phase II/III trials[63]. Product Development and Pipeline - The company is actively developing several new products, including FB1002 for HIV treatment and FB3001, a novel transdermal patch for musculoskeletal pain[13]. - The company has initiated clinical trials for FB2001, a candidate drug for treating COVID-19, with expected results by Q4 2023[13]. - Aikening, the company's self-developed drug, is the world's first approved long-acting HIV fusion inhibitor, providing a new treatment option for patients[30]. - FB2001, an investigational drug for COVID-19, targets the 3CL protease of the virus and has completed part of the II/III clinical trial enrollment[37]. - FB3001, a new transdermal analgesic patch, has shown statistically significant efficacy in alleviating back pain in II phase clinical trials[39]. - FB6001, a long-acting lipid-lowering peptide vaccine, has completed phase I trials in Europe, demonstrating good safety and significant LDL-C reduction[40]. - FB4001, a teriparatide injection generic, targets osteoporosis treatment and has received an acceptance notice for its ANDA submission to the FDA[41]. Market Expansion and Strategy - Frontier Biotechnologies plans to expand its market presence by entering new regions, aiming for a 15% increase in market share by the end of 2024[14]. - The company is exploring potential mergers and acquisitions to enhance its product portfolio and accelerate growth, with a target completion date by mid-2024[14]. - Market expansion plans include entering three new international markets by Q4 2023, aiming for a 10% market share in each[154]. - The company is considering strategic acquisitions to bolster its market position, with potential targets identified in the tech sector[155]. - A new marketing strategy has been implemented, focusing on digital channels, which is expected to increase customer engagement by 40%[156]. Regulatory and Compliance - The company has identified key risks in its operations, including regulatory challenges and market competition, and has outlined strategies to mitigate these risks[5]. - The company emphasizes its commitment to maintaining high standards in manufacturing practices, adhering to GMP guidelines[12]. - The company received a GMP certificate from the Philippines FDA for its production base in Nanjing[67]. - The company has established an environmental protection mechanism and is compliant with relevant regulations[137]. Financial Management and Shareholder Relations - The company has committed to ensuring that the prospectus does not contain false statements or omissions, with legal liability for any losses incurred by investors[172]. - The company plans to distribute at least 30% of the average distributable profit in cash over the last three years, provided it is profitable[169]. - The company will reassess its dividend return plan every three years, allowing adjustments based on shareholder feedback[169]. - The company guarantees that if it has not made a profit, no dividends will be distributed[169]. - The company will propose a mid-term dividend based on its financial status[171]. Environmental Responsibility - The company actively promotes carbon neutrality policies and has focused on reducing greenhouse gas emissions through technical upgrades and daily management practices[149]. - The company has developed emergency response plans for environmental incidents, ensuring rapid and efficient response to emergencies[144]. - The company has implemented an environmental self-monitoring program, with real-time monitoring data supervised by environmental authorities[145]. - The company has a VOCs emission limit of 60 mg/m³ in compliance with local standards[140].

证券代码：688221 证券简称：前沿生物 公告编号：2023-024 前沿生物药业（南京）股份有限公司 关于第三届监事会第八次会议决议的公告 本公司监事会及全体监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、准确性和完整性依法承担法律责任。 一、监事会会议召开情况 监事会认为：公司 2023 年半年度募集资金存放与使用情况符合《上海证券 交易所科创板股票上市规则》《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》《公司募集资金管理制度》等法律法规和制度文件的规定，对 募集资金进行了专户存储和专户使用，并及时履行了相关信息披露义务，募集资 金具体使用情况与公司已披露情况一致，不存在变相改变募集资金用途和损害股 东利益的情况，不存在违规使用募集资金的情形。 经与会监事审议表决，形成的会议决议如下： 前沿生物药业（南京）股份有限公司（以下简称"公司"）第三届监事会第 八次会议通知于 2023 年 8 月 18 日以通讯方式送达全体监事。会议于 2023 年 8 月 28 日在公司会议室以现场结合通讯的方式召开。会议由监事会主席姜志忠先 生主持，会议应到监事 3 ...

前沿生物药业（南京）股份有限公司 关于召开 2023 年半年度业绩说明会的公告 证券代码：688221 证券简称：前沿生物 公告编号：2023-025 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： 公司已于 2023 年 8 月 30 日发布公司 2023 年半年度报告，为便 于广大投资者更全面深入地了解公司 2023 年半年度经营成果、财务 状况，公司计划于 2023 年 09 月 07 日下午 15:00-16:00 举行 2023 年 半年度业绩说明会，就投资者关心的问题进行交流。 一、说明会类型 本次投资者说明会以网络互动形式召开，公司将针对 2023 年半 年度的经营成果及财务指标的具体情况与投资者进行互动交流和沟 1 会议召开时间：2023 年 09 月 07 日(星期四)下午 15:00-16:00 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：上证路演中心网络互动 投资者可于 2023 ...