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 ...

2023 年半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）》（证监会公告[2022]15 号）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 年半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 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 ...

关于第三届董事会第九次会议相关事项的独立意见 根据《上市公司独立董事规则》《上海证券交易所科创板股票上市规则》等 规范制度以及《前沿生物药业（南京）股份有限公司章程》（以下简称"《公司章 程》"）、《独立董事工作细则》的要求，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，我们本着认真负责、实事求是的态度，对公 司第三届董事会第九次会议相关事项进行了认真的了解和查验并发表如下独立 意见： 一、关于公司 2023 年半年度募集资金存放与使用情况的独立意见 前沿生物药业（南京）股份有限公司独立董事 (以下无正文) 独立董事：CHI KIT NG（吴智杰）、王广基、KAI CHEN（陈凯） 2023 年 8 月 28 日 经审阅《2023 年半年度募集资金存放与使用情况的专项报告》，我们认为： 公司 2023 年半年度募集资金的存放和使用符合中国证监会、上海证券交易所关 于上市公司募集资金存放和使用的相关监管要求和管理办法，不存在变相改变募 集资金用途和损害股东利益的情形，不存在募集资金存放和使用违规的情形。公 司所披露的募集资金存放和使用情况信息与实际情况一致，如实履行了信息披露 义务。 综 ...

前沿生物药业（南京）股份有限公司（以下简称"公司"）于2023年8月8日 收到保荐机构中信证券股份有限公司（以下简称"中信证券"）出具的《关于更 换保荐代表人的函》。 中信证券作为公司 2022 年度以简易程序向特定对象发行 A 股股票项目（以 下简称"再融资项目"）的保荐机构，原委派周游先生和罗耸先生为再融资项目 及持续督导期间的保荐代表人，现因罗耸先生工作变动，不再继续担任公司持续 督导期间的保荐代表人。为保证持续督导工作的有序进行，中信证券现委派徐磊 先生（简历见附件）接替罗耸先生担任公司的保荐代表人，继续履行持续督导职 责。 证券代码：688221 证券简称：前沿生物 公告编号：2023-022 前沿生物药业（南京）股份有限公司 关于更换保荐代表人的公告 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。 2 本次更换后，公司再融资项目持续督导期间的保荐代表人由周游先生、徐磊 先生担任，持续督导期至中国证券监督管理委员会和上海证券交易所规定的持续 督导义务结束为止。 1 附件： 徐磊先生简历 徐磊先生，保荐代表人，现 ...

Financial Performance - The company's revenue for Q1 2023 was ¥11,911,271, representing a 110.06% increase compared to the same period last year[5]. - The net profit attributable to shareholders was -¥75,708,310, with a basic and diluted earnings per share of -¥0.20[5]. - Net loss for Q1 2023 was ¥75,708,310.01, compared to a net loss of ¥59,241,597.75 in Q1 2022, indicating a deterioration in financial performance[24]. - Comprehensive loss for Q1 2023 totaled ¥75,720,718.28, compared to a comprehensive loss of ¥59,246,518.93 in Q1 2022[24]. - Basic and diluted earnings per share for Q1 2023 were both -¥0.20, compared to -¥0.16 in Q1 2022[24]. Revenue and Sales - The company achieved a revenue of RMB 11.91 million in Q1 2023, representing a year-on-year growth of 110%, primarily driven by sales of its core product, Aikening[14]. - Total operating revenue for Q1 2023 reached ¥11,911,271, an increase of 110.5% compared to ¥5,670,338.94 in Q1 2022[22]. - Cash received from sales of goods and services in Q1 2023 was ¥12,457,781.93, a decrease from ¥13,412,566.02 in Q1 2022[27]. Operating Costs and Expenses - The company experienced a 60.14% increase in operating costs, primarily due to increased sales volume[9]. - Total operating costs for Q1 2023 were ¥93,802,116.07, up from ¥73,476,784.35 in Q1 2022, representing a 27.7% increase[23]. - Research and development expenses totaled ¥44,347,571, accounting for 372.32% of revenue, a decrease of 259.48 percentage points year-on-year[6]. - Research and development expenses for Q1 2023 amounted to ¥44,347,571.68, an increase of 23.6% from ¥35,825,300.07 in Q1 2022[23]. Cash Flow - Cash flow from operating activities was -¥68,647,762.96[5]. - The net cash flow from operating activities was -68,647,762.96, compared to -34,410,228.06 in the previous year, indicating a significant decline in operational cash generation[28]. - Total cash outflow from operating activities was 103,800,954.73, compared to 94,833,107.17, showing an increase in operational expenses[28]. - Cash received from other operating activities was 16,967,529.79, compared to 32,298,557.04, indicating a decline in operational cash inflows[28]. Assets and Liabilities - Total assets at the end of the reporting period were ¥2,333,847,061, a decrease of 3.19% from the end of the previous year[6]. - Total liabilities as of Q1 2023 were ¥737,928,067.87, slightly down from ¥739,409,818.25 in Q1 2022[19]. - Total equity attributable to shareholders of the parent company was ¥1,595,918,993.14, down from ¥1,671,449,391.84 in Q1 2022[19]. - Non-current liabilities totaled ¥469,997,166.21 in Q1 2023, an increase from ¥462,179,699.47 in Q1 2022[19]. Shareholder Information - The number of ordinary shareholders at the end of the reporting period was 15,931[11]. - The top shareholder, Jianmu Pharmaceutical Co., Ltd., holds 18.86% of the shares, totaling 70,638,750 shares[11]. Product and Market Development - The company has established coverage in over 280 HIV treatment hospitals and more than 150 DTP pharmacies across 28 provinces in China by the end of the reporting period[14]. - The company hosted a national academic seminar on "Personalized Antiviral Treatment," where over 70 experts shared clinical applications and patient benefits of Aikening[15]. - Aikening's invention patent received the "China Patent Gold Award," recognizing its significance in the field of AIDS prevention and control in China[15]. - The company is actively promoting Aikening for outpatient treatment reimbursement to enhance long-term medication affordability[14]. Cash and Inventory - The company's cash and cash equivalents stood at RMB 592.18 million, an increase from RMB 550.89 million at the end of 2022[17]. - The company's inventory increased to RMB 71.50 million from RMB 55.61 million at the end of 2022[18]. - Short-term borrowings rose to RMB 175.16 million from RMB 110.64 million at the end of 2022[18]. - Short-term borrowings increased by 58.32%, attributed to additional borrowing[9].

Financial Performance - The company achieved a revenue of 84.74 million yuan in 2022, representing a year-on-year increase of 109.22%[4] - The net profit attributable to shareholders of the listed company for 2022 was a loss of RMB 356.76 million, representing a 37.19% increase in loss compared to the previous year [24] - The net cash flow from operating activities in 2022 was a negative RMB 289.04 million, an increase in cash outflow compared to RMB 243.07 million in 2021 [24] - By the end of 2022, the net assets attributable to shareholders of the listed company decreased by 8.68% to RMB 1.67 billion [24] - The total assets of the company at the end of 2022 were RMB 2.41 billion, a decrease of 4.81% compared to the previous year [23] - The company reported a weighted average return on equity of -20.96% in 2022, a decrease of 7.94 percentage points from the previous year [23] - The company plans to not distribute cash dividends or issue bonus shares for the 2022 fiscal year[7] Research and Development - Research and development expenses for 2022 amounted to 274.33 million yuan, an increase of 59.39% compared to the previous year[4] - The company's R&D expenditure accounted for 323.73% of operating revenue in 2022, a decrease of 101.20 percentage points from 2021 [23] - The company has filed 10 patent applications during the reporting period, strengthening its intellectual property framework[55] - The number of R&D personnel increased to 94, representing 23.97% of the total workforce, with an average salary of RMB 50.37 thousand[128] - The company reported a 59.39% increase in R&D expenses, totaling CNY 274.33 million, which represents 323.73% of its operating revenue[111] - The R&D investment capitalized ratio was 0%, indicating all R&D expenses were expensed[180] Product Development and Pipeline - The core product, Aikening, continues to advance in the commercialization process[4] - The company is focusing on the development of multiple new drugs in clinical trials to enrich its product pipeline[4] - The company is engaged in the development of several new products, including FB1002 for HIV treatment and FB2001 for COVID-19[14] - The company has made significant progress in overseas registration, obtaining drug registration in four countries and submitting applications in eight others[45] - The company is advancing multiple projects, including FB2001 for treating COVID-19 patients, with a total expected investment of ¥60 million and ongoing clinical trials[125] - The company is focusing on unmet clinical needs in HIV drug development, targeting a blue ocean market with differentiated product strategies[132] Market and Sales Strategy - The company aims to expand its market presence by covering over 250 HIV treatment hospitals and 130 DTP pharmacies nationwide[130] - The company plans to expand into overseas markets, collaborating with local partners to navigate regulatory environments[141] - The company aims to increase its international sales proportion and expand into emerging pharmaceutical markets[189] - The company will continue to expand its marketing network in the domestic market, accelerating the integration of Aikening into medical insurance and enhancing its accessibility[190] Clinical Trials and Approvals - The company completed Phase I clinical trials for the injectable FB2001 in China and the US, and initiated a Phase II/III trial for hospitalized moderate to severe COVID-19 patients, currently in the subject enrollment stage[47] - The company has received approval for the intravenous administration of Aikening, enhancing its delivery methods[111] - Aikening transitioned from conditional approval to regular approval, confirming its clinical efficacy, safety, and quality control[178] - The company has received CGT designation for FB4001 from the FDA, which allows for expedited approval and a 180-day market exclusivity period, significantly advancing the drug's market entry[52] Operational Challenges and Risks - The company experienced a significant increase in operating expenses, primarily due to rising employee compensation and various operational costs [24] - The company faces risks related to its reliance on Aikening for revenue, as other products are still in clinical trials, making it vulnerable to market changes[138] - The company is currently in a significant R&D investment phase, with multiple products in clinical trials, which may prolong the path to profitability[133] Awards and Recognition - The company received multiple awards in 2022, including recognition as a "Top 30 Innovative Small Molecule Drug Company" and "Top 10 Most Growth-Oriented Small Molecule Innovative Drug Companies" in China[60] Production and Manufacturing - The company has established three industrialization bases in Nanjing, Sichuan, and Shandong, enhancing its production capacity for commercialized drugs[131] - The company achieved a 100% product pass rate at its Nanjing production base, which has passed GMP compliance inspections, facilitating international registration efforts[53] - The company’s production capabilities include self-built production bases and contracted manufacturing organizations (CMOs), ensuring compliance with GMP standards[83][84]

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： 公司已于 2023 年 3 月 31 日发布公司 2022 年度报告，为便于广 大投资者更全面深入地了解公司 2022 年度经营成果、财务状况，公 司计划于 2023 年 04 月 24 日下午 15:00-16:00 举行 2022 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 2022 年度 会议召开时间：2023 年 04 月 24 日(星期一)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 ： http://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 04 月 17 日(星期一)至 04 月 21 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@frontie ...