Core Viewpoint - Frontier Biotech reported a revenue of 129 million yuan for 2024, marking a year-on-year growth of 13.32%, and a revenue of 28.33 million yuan for Q1 2025, with a growth of 14.93% compared to the previous year, indicating a sustained growth trend [1] Group 1: Business Performance - The company achieved a net cash outflow from operating activities of 94.66 million yuan, a reduction compared to the previous year, due to efforts in cost reduction and efficiency enhancement [1] - The core product, Aikening®, has generated over 100 million yuan in sales for two consecutive years since 2023, demonstrating successful commercialization [2] Group 2: R&D and Market Strategy - Frontier Biotech is enhancing its new drug R&D, production, and commercialization capabilities, solidifying its competitive edge in the new drug development sector [3] - The company is focusing on targeted patient education and product promotion in outpatient settings, particularly among high-viral-load populations and those with inadequate antiviral treatment [3] Group 3: Innovation and Technology - The company is actively expanding into the chronic disease market with small nucleic acid drugs and high-end generic drugs, leveraging its technical strengths and R&D experience from Aikening® [4] - Frontier Biotech has initiated clinical trial applications for its candidate small nucleic acid drug FB7013, aimed at treating IgA nephropathy, and has filed nine patent applications related to its small nucleic acid products [4] Group 4: Diversification Strategy - The company is pursuing a diversified business strategy, including acquiring commercialization rights for Veklury® in China and expanding into HIV viral load and drug resistance testing [5] - Veklury® has been successfully listed for sale in 29 provinces across China, contributing to the company's performance [5]

Financial Performance - The company achieved total revenue of 129.47 million yuan in 2024, representing a year-on-year growth of 13.32%[5]. - The company reported a net loss attributable to shareholders of 201.38 million yuan in 2024, a reduction in loss by 127.58 million yuan compared to the previous year[13]. - The net cash flow from operating activities improved, with a net outflow of CNY 172.52 million, a reduction of CNY 9.47 million from the previous year, due to cost reduction and efficiency enhancement efforts[36]. - The basic earnings per share for 2024 was -CNY 0.54, an improvement from -CNY 0.88 in 2023[34]. - The company achieved a revenue of RMB 129.47 million in the reporting period, but reported a net loss of RMB 201.38 million attributable to shareholders[142]. - The company reported a significant non-recurring gain of CNY 125.93 million, primarily from the disposal of a 70% stake in Qianyan Jianling and government subsidies[39]. - The quarterly revenue for Q4 2024 was CNY 37.83 million, contributing to the overall annual growth[38]. - The company has set a performance guidance of achieving RMB 600 million in revenue for the next quarter, reflecting a 20% growth target[32]. Research and Development - Research and development expenses for 2024 amounted to 137.21 million yuan, primarily focused on post-marketing studies of Aikening® and advancing pipeline product development[13]. - The company has established a value-driven R&D management system to prioritize innovative projects with significant clinical advantages[9]. - The company is committed to strengthening its new drug R&D and production capabilities to maintain competitiveness in the pharmaceutical industry[45]. - The company is focusing on optimizing its R&D pipeline, with new projects currently in early development stages[127]. - The total R&D expenditure for the year was ¥137,205,648.06, a decrease of 35.95% compared to the previous year[126]. - The company’s R&D investment accounted for 105.97% of its revenue during the reporting period, significantly higher than the industry average[191]. - The R&D investment for small nucleic acid drugs was 26.65 million RMB, accounting for 20.59% of operating revenue, with no applicable year-on-year comparison[195]. - The company has established a comprehensive patent management system to protect its innovative products, creating a patent moat in the long-acting HIV drug and small nucleic acid drug fields[138]. Product Development and Pipeline - The core product, Aikening®, has seen sales exceed 100 million yuan for two consecutive years since 2023, indicating successful commercialization[14]. - Aikening® is currently undergoing Phase II clinical trials for two additional indications, which have been approved by the National Medical Products Administration[14]. - The company is advancing the clinical development of FB7013, a candidate drug for IgA nephropathy, which is in the preclinical research stage and has First-in-Class potential[8]. - The company is focusing on developing long-acting HIV drugs and new small nucleic acid drugs, with a pipeline that includes innovative and high-end generic drugs to meet market demands[55][56]. - The company is actively developing multiple new drugs, including FB1002 for HIV treatment and FB2001 for COVID-19, with clinical trials progressing as planned[24]. - The company is exploring the application of Aikening® in post-exposure prophylaxis, with successful implementations in private clinics in cities like Shanghai, Nanjing, and Guangzhou[52]. - The company is developing high-end generic drugs in the chronic disease treatment field, including FB4001 for osteoporosis and FB3002 for musculoskeletal pain, to strengthen its competitive advantage[135]. Market Strategy and Expansion - The company aims to enhance operational efficiency and marketing network construction to drive high-quality development and value growth in 2025[10]. - Frontier Biotechnologies aims to expand its market presence, targeting a 15% increase in market share over the next fiscal year[32]. - The company is focusing on building a comprehensive long-acting anti-HIV product matrix while also exploring opportunities in the chronic disease market with small nucleic acid drugs and high-end generics[14]. - The company has expanded its product coverage to over 300 HIV treatment hospitals and 200 DTP pharmacies across 30 provinces and municipalities in China, with the product included in the national medical insurance directory for 2024[47]. - The company is committed to increasing R&D investment and advancing the development of small nucleic acid products across various therapeutic areas[90]. - The company employs a dual sales model, utilizing both distributor and direct supply methods to enhance market reach and patient access[95][96]. Regulatory and Compliance - The company is exposed to regulatory risks in the pharmaceutical industry, which could hinder market expansion or increase compliance costs if strategic adjustments are not made in response to policy changes[149]. - The company has successfully renewed the inclusion of Aikening® in the National Medical Insurance Directory, maintaining the original payment standards and scope, which supports further commercialization in local markets[47]. - The company has submitted an ANDA for the osteoporosis treatment FB4001 to the FDA, which is currently under review, aiming for commercialization in the U.S. by 2025[62]. Financial Position and Risks - Total assets decreased by 15.33% year-on-year to CNY 1.81 billion, while equity attributable to shareholders decreased by 15.00% to CNY 1.14 billion, mainly due to the sale of a 70% stake in Qianyan Jianling[36]. - The company faces significant risks related to the rapid technological changes in the pharmaceutical industry, which could affect its business operations and financial status if competitors develop superior products[145]. - The company is still heavily reliant on Aikening® for revenue, and any significant changes in the HIV drug market could adversely impact its business performance[146]. - The company is facing risks related to potential significant declines in performance or losses, particularly if the market performance of Aikening® does not meet expectations[144].

Financial Performance - The company's revenue for Q1 2025 was CNY 28,328,182.53, representing a 14.93% increase compared to CNY 24,648,130.00 in the same period last year[3]. - Total operating revenue for Q1 2025 was CNY 28,328,182.53, an increase of 14.3% compared to CNY 24,648,130.00 in Q1 2024[14]. - The net profit attributable to shareholders was a loss of CNY 44,121,517.41, an improvement from a loss of CNY 55,706,177.98 year-over-year[3]. - Net loss for Q1 2025 was CNY 44,121,517.41, an improvement from a net loss of CNY 55,706,177.98 in Q1 2024, representing a 20.5% reduction in losses[15]. - The company reported a total comprehensive loss of CNY 44,099,957.95 for Q1 2025, an improvement from CNY 55,705,964.26 in Q1 2024[15]. Research and Development - R&D expenses totaled CNY 16,803,233.38, a significant decrease of 50.68% from CNY 34,071,674.17 in the previous year, with R&D investment accounting for 59.32% of revenue, down 78.91 percentage points[3]. - Research and development expenses significantly decreased to CNY 16,803,233.38 from CNY 34,071,674.17, a decline of 50.7%[14]. Cash Flow and Assets - The net cash flow from operating activities was -CNY 48,669,328.08, compared to -CNY 43,749,418.44 in the previous year[3]. - Cash flow from operating activities showed a net outflow of CNY 48,669,328.08, compared to a net outflow of CNY 43,749,418.44 in the same period last year[16]. - The company's total current assets decreased from CNY 1,222.62 million as of December 31, 2024, to CNY 1,130.07 million as of March 31, 2025[11]. - The company's cash and cash equivalents decreased from CNY 248.98 million to CNY 221.97 million during the same period[11]. - Cash and cash equivalents at the end of Q1 2025 were CNY 218,010,949.55, down from CNY 526,400,496.91 at the beginning of the period[18]. - The company's total assets at the end of the reporting period were CNY 1,723,742,799.34, a decrease of 4.88% from CNY 1,812,138,179.73 at the end of the previous year[4]. - The company's total assets decreased from CNY 1,812.14 million to CNY 1,723.74 million during the same period[12]. - The company's total liabilities decreased from CNY 670.83 million to CNY 626.53 million from December 31, 2024, to March 31, 2025[13]. Shareholder Information - The number of ordinary shareholders at the end of the reporting period was 11,392[7]. - The largest shareholder, Jianmu Pharmaceutical Co., Ltd., holds 70,638,750 shares, representing 18.86% of the total shares[8]. Operational Highlights - The company has seen a significant increase in accounts payable, which rose by 96.80%, indicating increased operational activity[5]. - In Q1 2025, the company achieved revenue of CNY 28.33 million, a year-on-year increase of 14.93%, primarily driven by the sales growth of its core product, Aikening®[9]. - The company has focused on three outpatient groups: high viral load patients, those with suboptimal antiviral treatment, and patients with incomplete immune reconstitution, enhancing clinical application in outpatient settings to boost sales[9]. - As of March 2025, the company has successfully introduced the antiviral drug Veklury® in 29 provinces across the country, generating stable revenue[10]. - The company continues to advance its diversified business strategy, focusing on enhancing the clinical promotion of Aikening® in both inpatient and outpatient settings[9]. Investment Activities - Investment activities generated a net cash inflow of CNY 62,384,367.43, contrasting with a net cash outflow of CNY 307,550,372.78 in Q1 2024[17]. Earnings and Returns - The weighted average return on equity was -3.94%, an improvement from -4.24% in the same period last year[3]. - Basic and diluted earnings per share improved to CNY -0.12 from CNY -0.15 year-over-year[15]. - The company's net loss increased from CNY 1.96 billion to CNY 2.00 billion in retained earnings[13]. Operating Costs - Total operating costs decreased to CNY 74,909,155.77 from CNY 86,698,546.20, a reduction of 13.6% year-over-year[14].

1、 专项审计报告 2、 附表 委托单位：前沿生物药业（南京）股份有限公司 审计单位：中审众环会计师事务所（特殊普通合伙） 联系电话：（027） 86791215 讨沿生物药业(南京)股份有限公司 金占用及其他关联资金往来情况汇总表 的专项审核报告 关于前沿生物药业（南京）股份有限公司 非经营性资金占用及其他关联资金往来情况 汇总表的专项审计报告 目 录 众环专字(2025)0600076 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,在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") 2024年12月31 日合并及公司的资产负债表,2024年度合并及公司的利润表、合并及公司 的现金流量表和合并及公司的股东权益变动表以及财务报表附注的基础上,对后附的《上市 公司 2024年度非经营性资金占用及其他关联资金往来的情况汇总表》(以下简称"汇总表") 进行了专项审核。按照中国证券监督管理委员会印发的《上市公司监管指引第8号 -- 上市 公司资金往来、对外担保的监管要求》的规定,编制和披露汇总表、提供真实、合法、完整 的审核证据是前沿生物管理层的责任,我们的责任是在执行审核工作的基础上对 ...

前沿生物药业（南京）股份有限公司 内部控制审计报告 内部控制审计报告 众环审字(2025)0600263 号 前沿生物药业(南京)股份有限公司全体股东: 按照《企业内部控制审计指引》及中国注册会计师执业准则的相关要求,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")2024年12月31日的财务报告 内部控制的有效性。 众环审字(2025)0600263号 一、前沿生物对内部控制的责任 按照《企业内部控制基本规范》、《企业内部控制应用指引》、《企业内部控制评价指引》 的规定,建立健全和有效实施内部控制,并评价其有效性是前沿生物董事会的责任。 二、注册会计师的责任 我们的责任是在实施审计工作的基础上,对财务报告内部控制的有效性发表审计意见, 并对注意到的非财务报告内部控制的重大缺陷进行披露。 三、内部控制的固有局限性 内部控制具有固有局限性,存在不能防止和发现错报的可能性。此外,由于情况的变化 可能导致内部控制变得不恰当,或对控制政策和程序遵循的程度降低,根据内部控制审计结 果推测未来内部控制的有效性具有一定风险。 四、财务报告内部控制审计意见 我们认为,前沿生物药业(南京)股份有限公司于 2 ...

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 2024 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（2022 修订）》《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）》等有关规定，对前沿生物 2024 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 ...

关于前沿生物药业(南京) 股份有限公司 2024年度营业收入扣除情况表 的专项核查报告 众环专字(2025)0600078号 目 录 起始页码 专项核查报告 营业收入扣除情况表 营业收入扣除情况表 l 众环专字(2025)0600078 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,在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") 2024年12月31日的合并及公司的资产负债表,2024年度合并及公司的利润表、合并及公 司的现金流量表和合并及公司的股东权益变动表以及财务报表附注(以下简称"2024年度 财务报表")的基础上,对后附的《前沿生物药业(南京)股份有限公司 2024年度营业收入 扣除情况表》(以下简称"营业收入扣除表")进行了专项核查。 按照《上海证券交易所股票上市规则》及《上海证券交易所科创板股票上市规则》及《科 创板上市公司自律监管指南第9号 -- 财务类退市指标:营业收入扣除》的规定,编制和披 露营业收入扣除表,提供真实、合法、完整的核查证据,是前沿生物管理层的责任。我们的 责任是在执行核查工作的基础上对营业收入扣除表发表专项核查意见。 我们按照中国注册会计师审 ...

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(2025)0600077号 目 景 起始页码 鉴证报告 募集资金专项报告 前沿生物药业(南京)股份有限公司 金年度存放与实际使用情况的鉴证报告 众环专字(2025)0600077 号 关于募集资金年度存放与实际使用情况的专项报告 l 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 2024年12月31 日止的《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》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 ...

Core Insights - Frontline Bio (688221.SH) reported a revenue of 129.47 million yuan for 2024, marking a year-on-year growth of 13.32%, primarily driven by the sales growth of its innovative HIV drug, Aikening®, and diversified sales strategies [1] - The company is focusing on expanding the market for Aikening® through differentiated marketing strategies and exploring new indications to maximize its commercial potential [1] - Frontline Bio is also strategically positioning itself in the high-end generic drug market to create a second growth curve, which is essential for maintaining cash stability and funding innovation [1] Revenue Growth and Product Development - The company achieved significant progress with two high-end generic drugs: FB4001 for osteoporosis, which is expected to be approved for sale in the U.S. by 2025, and FB3002, a hot melt adhesive generic drug, which has entered the registration review stage [2] - The global osteoporosis patient population exceeds 200 million, with projections suggesting it could surpass 450 million by 2030, indicating a strong demand for osteoporosis medications [2] - The U.S. osteoporosis drug market is projected to reach $6.5 billion in 2024 and could grow to between $9 billion and $11 billion by 2030, highlighting the market potential for FB4001 [2] Future Strategy - Frontline Bio plans to enhance its commercialization and self-sustaining capabilities, focusing on a market-oriented approach and a combined research and development strategy of innovation and generics [3] - The company aims to achieve sustainable development and high-quality growth by accelerating the clinical and commercial transformation of new drugs through stable cash flow [3]