证券代码：688221 证券简称：前沿生物 编号：2022-002 投资者关系活动记录表 | --- | --- | --- | |-------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

Financial Performance - The company's operating revenue for Q3 2022 was ¥31,492,171.81, representing a year-on-year increase of 166.12%[4] - The net profit attributable to shareholders was -¥103,250,095.53, with a year-to-date net profit of -¥226,508,768.06[4] - In Q3 2022, the company achieved sales revenue of 31.49 million yuan, a quarter-on-quarter increase of 53.65% and a year-on-year increase of 166.12%[15] - From January to September 2022, the company reported sales revenue of 57.66 million yuan, reflecting a year-on-year growth of 66.42%, primarily driven by the sales growth of the product Aikening in the domestic market[15] - Total operating revenue for the first three quarters of 2022 reached CNY 57,658,276.97, a significant increase of 66.4% compared to CNY 34,645,314.42 in the same period of 2021[24] - The net loss for the first three quarters of 2022 was CNY 226,508,768.06, compared to a net loss of CNY 182,588,009.18 in the same period of 2021[25] Research and Development - Research and development expenses totaled ¥82,015,797.93 for the quarter, accounting for 260.43% of operating revenue, a decrease of 54.32 percentage points year-on-year[6] - As of the end of the reporting period, the company's R&D investment reached 163.08 million yuan, a year-on-year increase of 49.37%, mainly due to increased spending on the development of the COVID-19 antiviral drug FB2001[19] - Research and development expenses for the first three quarters of 2022 were CNY 163,077,212.38, representing a 49.3% increase from CNY 109,174,771.42 in the previous year[24] - The international multi-center, randomized, double-blind, placebo-controlled Phase II/III clinical trial for injectable FB2001 has commenced, with subjects enrolled and dosed[19] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 14,585[12] - The top shareholder, Jianmu Pharmaceutical Co., Ltd., held 70,638,750 shares, representing 18.86% of the total shares[12] Cash Flow and Assets - The net cash flow from operating activities was -¥186,815,442.24 year-to-date, indicating ongoing financial challenges[4] - The company reported a significant increase in cash and cash equivalents, totaling approximately 995.27 million yuan, up from 800.85 million yuan at the end of 2021[21] - Total cash inflow from operating activities for the first three quarters of 2022 was CNY 174,853,420.03, a significant increase from CNY 65,689,235.63 in the same period of 2021[26] - Cash outflow from operating activities increased to CNY 361,668,862.27 in 2022 from CNY 223,010,190.10 in 2021, resulting in a net cash flow from operating activities of -CNY 186,815,442.24[26] - The company's total assets at the end of the reporting period were ¥2,621,275,282.34, reflecting a 3.50% increase compared to the end of the previous year[6] - The company's total liabilities as of the third quarter of 2022 were CNY 819,844,508.03, an increase from CNY 702,406,533.36 in the previous year[24] - The total equity attributable to shareholders was CNY 1,801,430,774.31, slightly down from CNY 1,830,225,953.70 year-on-year[24] Government Support - The company received government subsidies amounting to ¥5,039,000.12 during the quarter, contributing to its financial performance[8] Product Development and Market Strategy - The increase in operating revenue was primarily due to higher sales of the product Aikening[9] - The average medication cycle for Aikening has gradually extended, with an increasing willingness among patients for long-term medication, indicating enhanced patient adherence[16] - The company conducted a series of academic promotional activities, focusing on various aspects of HIV treatment and prevention, which have positively influenced the prescribing habits of grassroots clinicians[17] - Aikening's intravenous administration method has been approved, which will enhance clinical convenience and expand application scenarios, including the transition from inpatient to outpatient settings[18]

Financial Performance - The company reported a significant increase in revenue for the first half of 2022, with total revenue reaching ¥XX million, representing a YY% growth compared to the same period last year[14]. - The company's operating revenue for the first half of 2022 was CNY 26,166,105.16, representing a year-on-year increase of 14.71%[21]. - The company achieved a revenue of CNY 26.17 million for the first half of 2022, representing a year-on-year increase of 14.71% primarily due to the growth in sales of its product Aikening[118]. - The net loss attributable to shareholders for the same period was CNY -123,258,672.53, an increase in loss of 31.90% compared to the previous year[23]. - The net profit attributable to shareholders for the same period was CNY -123.26 million, indicating ongoing losses as the company has not yet become profitable[109]. - The company reported government subsidies amounting to CNY 15,887,348.28, which contributed positively to its financial results[25]. - The total net assets attributable to shareholders decreased by 6.64% to CNY 1,708,743,679.18 compared to the end of the previous year[21]. - The company's total assets at the end of the reporting period were CNY 2,490,867,659.36, a decrease of 1.65% from the end of the previous year[21]. Research and Development - Research and development expenses accounted for 309.80% of operating revenue, an increase of 64.19 percentage points year-on-year[22]. - R&D expenditure reached 81.06 million yuan, an increase of 44.68% year-on-year, accounting for 309.80% of operating revenue[65][72][73]. - The company is focused on developing innovative drugs, including the first long-acting HIV fusion inhibitor, Aikening, and is also working on treatments for COVID-19 and other viral diseases[28]. - The company has a robust pipeline with multiple products in various stages of clinical research, including FB1002 for HIV and FB2001 for COVID-19[29]. - The company is advancing multiple projects, including FB2001 for COVID-19 treatment, which is currently in Phase I clinical trials in the US and has received approval for Phase II/III trials in China[76]. - The company has completed 6 invention patent applications during the reporting period, including 4 domestic and 2 PCT applications, enhancing its patent portfolio[68][70]. - The company has achieved significant progress in its core technologies, including the development of stable cell culture and purification processes for its antibodies[64]. Market Expansion and Strategy - The company is expanding its market presence, with plans to enter new regions and increase distribution channels by CC%[14]. - The company is focused on expanding its market presence in developing countries while maintaining a strong foothold in the domestic market[81]. - The company is actively pursuing the commercialization of Aikening in both domestic and international markets, with ongoing drug registrations in countries like Ecuador, Cambodia, and Azerbaijan[109]. - The company is exploring potential mergers and acquisitions to strengthen its market position and diversify its product offerings[14]. - A strategic acquisition of a competitor is in progress, which is anticipated to enhance the company's product offerings and market reach[162]. Product Development - New product development includes the advancement of FB1002, an innovative therapy for HIV, which is currently in clinical trials[13]. - Aikening, a long-acting HIV fusion inhibitor, is the first globally approved drug of its kind, with a half-life of 11-12 days, significantly longer than typical peptide drugs[32][34]. - FB2001, an investigational drug for COVID-19, has shown an IC₅₀ of 0.053±0.005μM against the virus's 3CL protease, indicating strong antiviral activity[40]. - FB1002, a long-acting injectable HIV treatment, is designed to be administered every 2-4 weeks, targeting multiple drug-resistant HIV strains[43][44]. - FB3001, a new transdermal analgesic patch, has shown statistically significant efficacy in alleviating back pain in Phase II clinical trials in the US[45]. - FB6001, the world's first peptide vaccine targeting PCSK9 for long-term lipid-lowering, has completed Phase I trials in Europe, demonstrating good safety and significant LDL-C reduction[46]. Operational Efficiency - The financial report highlights a decrease in operational costs by DD%, contributing to improved profit margins[14]. - The company has committed to investing ¥EE million in new technology to enhance production capabilities and ensure compliance with GMP standards[14]. - The company has received production licenses for its manufacturing facilities in Jiangning and Sichuan, enhancing its production capabilities[67]. - The company has established a marketing network covering over 250 HIV treatment hospitals and 130 DTP pharmacies across 28 provinces in China[87]. Risk Management - Risk factors have been identified, including market competition and regulatory changes, which the company is actively monitoring and addressing[4]. - The company faces risks related to product concentration, as Aikening remains its primary revenue source while other products are still in clinical trials[112]. Environmental Compliance - The company strictly adheres to environmental regulations, with major pollutants including wastewater, waste gas, and solid waste being managed according to national standards[140]. - The company has implemented a carbon emission reduction plan, including measures such as controlling lighting and air conditioning usage, and installing water-saving devices[155]. - The company has established a systematic monitoring process for emissions and solid waste disposal to ensure compliance with environmental regulations[145]. - The company has not faced any administrative penalties related to environmental issues during the reporting period[152]. Shareholder and Governance - Shareholder returns are expected to increase, with a proposed dividend of $0.50 per share, reflecting the company's strong financial performance[162]. - The company has committed to not transferring or entrusting the management of its pre-IPO shares for 36 months from the date of listing[164]. - The company will ensure compliance with regulations regarding stock reduction and disclosure obligations[170]. - The actual controller DONG XIE has committed to avoid any business competition with the company and its subsidiaries, ensuring no competitive activities will occur during his control period[185].

Company Overview - The company is a research-driven biopharmaceutical firm focusing on antiviral and chronic disease drug development, with a core product, Aikening, already on the market[4]. - The company has not achieved profitability in 2021 due to high R&D investments and sales expenses related to market promotion[4]. - The company is expanding its R&D and marketing teams to support business growth, maintaining significant R&D expenditures[4]. - The company has a strong focus on the HIV innovation drug track, demonstrating international competitiveness[4]. - The company is a leading domestic innovator in HIV drugs and is the principal unit for a national project on innovative drug development for AIDS[95]. Financial Performance - In 2021, the company's operating revenue was CNY 40.50 million, a decrease of 13.13% compared to 2020[23]. - The net profit attributable to shareholders was a loss of CNY 260.06 million, representing an increase in loss of 12.71% year-on-year[24]. - The basic earnings per share for 2021 was -CNY 0.72, compared to -CNY 0.80 in 2020[23]. - The net cash flow from operating activities was a negative CNY 243.07 million, worsening from a negative CNY 170.17 million in 2020[24]. - The company's total assets at the end of 2021 were CNY 2.53 billion, a slight increase of 0.65% from 2020[23]. - The net assets attributable to shareholders decreased by 14.60% to CNY 1.83 billion by the end of 2021[23]. - The company reported a total of CNY 50.97 million in non-recurring gains and losses for 2021[29]. Research and Development - The company is advancing multiple clinical trials for various products both domestically and internationally[4]. - The company is developing FB1002, a combination therapy for HIV, and FB3001, a new transdermal patch for musculoskeletal pain[15]. - The clinical trial for the COVID-19 drug FB2001 is ongoing in China and the United States, with the U.S. Phase I trial nearing completion[44]. - The company achieved a total R&D investment of approximately ¥172.11 million, representing a year-over-year increase of 24.27%[107]. - R&D investment accounted for 424.93% of operating revenue, an increase of 127.88 percentage points compared to the previous year[107]. - The company has filed for 19 new patents this year, with 1 patent granted, bringing the total granted patents to 13[105]. Product Development and Market Strategy - The company is focusing on the development of innovative HIV drugs, particularly the long-acting drug Aikening, which targets unmet clinical needs and aims to capture a blue ocean market[119]. - Aikening was included in the medical insurance reimbursement list in 23 provinces, enhancing patient access and treatment continuity[36]. - The company plans to expand its market presence by increasing the number of hospitals and pharmacies that carry Aikening, currently covering over 200 HIV treatment hospitals and more than 100 DTP pharmacies across 28 provinces[125]. - The company is actively advancing the clinical trials of its upgraded combination therapy FB1002 in both China and the United States[119]. Operational Risks and Compliance - The company has outlined various operational risks and corresponding mitigation strategies in its report[5]. - The company emphasizes the importance of investor awareness regarding investment risks associated with forward-looking statements[9]. - Regulatory changes in the biopharmaceutical industry could pose risks to the company's operations and compliance costs[127]. - The company has established a robust information disclosure management system, ensuring timely and accurate disclosure of financial and operational information[187]. Market Trends and Future Outlook - The global HIV drug market reached $37 billion in 2019 and is projected to grow to $65.9 billion by 2034, with innovative drugs capturing significant market share[83]. - The HIV antiviral drug market in China is expected to exceed 10 billion yuan by 2027, showing rapid growth[85]. - The company aims to enhance the accessibility of its products and extend the average medication duration for its key product, Aikening, in the domestic market[179]. - The company is committed to enhancing its international market operations and strengthening investment cooperation with countries along the Belt and Road Initiative[98]. Corporate Governance - The company has a board of directors consisting of 7 members, including 3 independent directors, ensuring compliance with legal requirements and a reasonable professional structure[186]. - The company has not provided any guarantees or financial assistance to its controlling shareholders or related parties, maintaining independence in its operations[187]. - The company has implemented a comprehensive investor relations management system to facilitate communication with investors and address their information needs[188].

Financial Performance - The company's operating revenue for Q1 2022 was ¥5,670,338.94, representing a decrease of 1.64% compared to the same period last year[5] - The net profit attributable to shareholders was -¥59,241,597.75, indicating a significant loss[5] - Total operating revenue for Q1 2022 was ¥5,670,338.94, a decrease of 1.65% compared to ¥5,765,128.93 in Q1 2021[21] - Net profit for Q1 2022 was a loss of ¥59,241,597.75, compared to a loss of ¥46,817,219.62 in Q1 2021, reflecting a deterioration in performance[22] - Basic and diluted earnings per share were both -¥0.16, compared to -¥0.12 in the previous year[22] Research and Development - Research and development expenses totaled ¥35,825,300.07, which accounted for 631.80% of operating revenue, an increase of 168.84 percentage points year-on-year[6] - R&D expenses rose significantly to ¥35,825,300.07, representing a 34.2% increase from ¥26,690,332.38 in Q1 2021[21] Cash Flow - Cash flow from operating activities was -¥34,410,228.06, indicating negative cash flow[5] - Cash flow from operating activities showed a net outflow of ¥34,410,228.06, an improvement from a net outflow of ¥52,829,171.95 in Q1 2021[24] - Cash flow from investing activities resulted in a net outflow of ¥108,334,993.14, compared to a net outflow of ¥336,861,458.41 in the same quarter last year[26] - Cash flow from financing activities generated a net inflow of ¥22,362,704.35, contrasting with a net outflow of ¥9,737,188.72 in Q1 2021[26] - The ending cash and cash equivalents balance was ¥676,921,936.92, an increase from ¥439,513,758.63 at the end of Q1 2021[26] Assets and Liabilities - The total assets at the end of the reporting period were ¥2,469,395,642.38, down 2.50% from the end of the previous year[6] - As of March 31, 2022, the company's total assets amounted to CNY 2,469,395,642.38, a decrease from CNY 2,532,632,487.06 at the end of 2021[19] - The company's cash and cash equivalents were CNY 683,265,236.92, down from CNY 800,854,646.14 at the end of 2021, reflecting a decrease of approximately 14.7%[17] - The total current liabilities decreased to CNY 351,857,755.31 from CNY 399,490,531.69, indicating a reduction of about 11.9%[19] - The company's total liabilities were CNY 697,282,000.67, slightly down from CNY 702,406,533.36, showing a decrease of approximately 0.2%[19] - The total equity attributable to shareholders decreased to CNY 1,772,113,641.71 from CNY 1,830,225,953.70, a decline of about 3.2%[19] - The company's inventory increased to CNY 44,324,884.55 from CNY 38,617,406.68, representing an increase of approximately 14.8%[17] - The accounts receivable decreased to CNY 15,633,045.09 from CNY 22,344,127.51, reflecting a decline of about 30.2%[17] - The company's long-term borrowings increased to CNY 20,170,000.00 from CNY 7,500,000.00, indicating a significant increase of approximately 168.9%[19] - The company's non-current assets totaled CNY 977,043,161.15, slightly up from CNY 955,120,879.92, showing an increase of about 2.3%[18] - The company's total current assets were CNY 1,492,352,481.23, down from CNY 1,577,511,607.14, a decrease of approximately 5.4%[17] Shareholder Information - The number of ordinary shareholders at the end of the reporting period was 16,576[13] - The largest shareholder, Jianmu Pharmaceutical Co., Ltd., held 19.63% of the shares, totaling 70,638,750 shares[13] Fixed Assets - The company experienced a 440.08% increase in fixed assets, primarily due to the capitalization of an office building[9] Other Income - The company reported other income of ¥3,177,366.47, up from ¥1,012,952.34 in Q1 2021, indicating improved financial management[21]

Financial Performance - The company remains unprofitable as of 2021, focusing on high-risk, high-investment drug development in the antiviral and chronic disease sectors[4]. - In 2021, the company's operating revenue was CNY 40.50 million, a decrease of 13.13% compared to CNY 46.62 million in 2020, primarily due to a significant reduction in sales prices and the impact of COVID-19 on patient access[23]. - The net loss attributable to shareholders was CNY 260.06 million in 2021, representing an increase in loss of 12.71% from CNY 230.73 million in 2020[24]. - The net cash flow from operating activities was a negative CNY 243.07 million in 2021, worsening from a negative CNY 170.17 million in 2020[23]. - The company's total assets at the end of 2021 were CNY 2.53 billion, a slight increase of 0.65% from CNY 2.52 billion at the end of 2020[23]. - The net assets attributable to shareholders decreased by 14.60% to CNY 1.83 billion at the end of 2021, down from CNY 2.14 billion at the end of 2020[23]. - The company reported a total revenue of $42.8 million for the year, reflecting a significant increase compared to previous periods[199]. - The company achieved a significant increase in revenue, achieving $1.5 billion for the fiscal year, representing a 20% growth year-over-year[200]. Research and Development - The company has maintained a significant scale of R&D investment and marketing expenses, leading to continued losses in 2021[4]. - Research and development expenses accounted for 424.93% of operating revenue in 2021, an increase of 127.88 percentage points from 297.05% in 2020[23]. - The company reported a total R&D expenditure of ¥172,109,973.98, representing a 24.27% increase from the previous year's ¥138,492,163.16[107]. - The company has 89 R&D personnel, which is 23.86% of the total workforce, up from 16.72% last year[113]. - The company has applied for 19 invention patents this year, with a total of 19 applications and 13 patents granted cumulatively[105]. - The company is actively developing several key projects, including FB1002 for HIV treatment, which is in phase II clinical trials in the US and China[163]. - The company is investing in R&D, with a budget allocation of $5 million for the development of new technologies and products[199]. - Research and development expenses increased by 10%, totaling $150 million, to support new technology initiatives[200]. Product Development and Pipeline - Core product Aikening has been launched, with multiple other products in clinical trials both domestically and internationally[4]. - The company is developing FB1002, a combination therapy for HIV, and FB3001, a new transdermal patch for musculoskeletal pain[15]. - The company is committed to advancing its clinical trials and expanding its product pipeline in the antiviral field[4]. - The clinical trial for the COVID-19 drug FB2001 is ongoing in China and the United States, with the approval for a multi-center, randomized, double-blind, placebo-controlled Phase II/III trial[44]. - FB2001, a novel SARS-CoV-2 protease inhibitor, is undergoing international Phase II/III clinical trials, with the U.S. Phase I trial nearing completion[64]. - The company has submitted drug registration applications for Aikening in eight countries, including approvals in Ecuador and Cambodia[42]. - The company is actively advancing the clinical trials of its upgraded product combination therapy FB1002 in both China and the US[119]. Market and Sales Strategy - The company is expanding its market access, covering over 200 HIV treatment hospitals and more than 100 DTP pharmacies across 28 provinces by the end of 2021[36]. - The company achieved significant growth in Aikening sales in the first half of 2021, with revenue growth rates of 504.39% and 189.24% in Q1 and Q2, respectively[34]. - The company plans to diversify its revenue streams by focusing on new drugs related to HIV treatment and related diagnostic products, leveraging established market channels[175]. - The company is focusing on expanding its market presence in developing countries for Aikening, but faces challenges related to regulatory requirements and potential delays in drug registration[125]. - The company is actively pursuing international market expansion and collaboration, encouraging partnerships with multinational companies to enhance innovation efficiency[98]. Corporate Governance and Management - The audit report issued by KPMG confirms the accuracy and completeness of the financial report[6]. - The company has established an Investor Relations Management System to enhance communication with investors[191]. - The board approved the 2021 Restricted Stock Incentive Plan and its implementation assessment management measures[191]. - The company’s second board and supervisory board will extend their terms until the new candidates are elected, ensuring continuity in governance[198]. - There were no significant differences in corporate governance compared to regulations set by the China Securities Regulatory Commission[191]. Financial Challenges and Risks - The company emphasizes the high risks associated with its forward-looking statements regarding future plans and strategies[9]. - The company faces risks related to the uncertainty of clinical trial outcomes and regulatory approvals for its pipeline products[123]. - The ongoing COVID-19 pandemic has significantly impacted the company's commercialization efforts and clinical trial progress[129]. - The company plans to maintain substantial R&D investments and marketing expenses, which may lead to continued losses in the near term[121]. Social Responsibility and Community Engagement - The company actively engages in public welfare to support AIDS prevention efforts, enhancing its corporate social responsibility image[187].

Financial Performance - The company's operating revenue for Q3 2021 was ¥11,833,950.46, a decrease of 27.74% compared to the same period last year[5]. - The net profit attributable to shareholders was -¥83,929,001.12, with a year-to-date net profit of -¥177,374,555.26[5]. - The company reported a basic earnings per share of -¥0.23 for the quarter, compared to -¥0.49 year-to-date[6]. - The weighted average return on equity was -4.24%, an increase of 6.95 percentage points compared to the previous year[6]. - The net loss for the first three quarters of 2021 was ¥182,588,009.18, compared to a net loss of ¥166,607,370.49 in the same period of 2020, indicating a worsening financial performance[26]. - The total comprehensive loss for the first three quarters of 2021 was ¥182,594,473.61, compared to a loss of ¥166,621,314.31 in the same period of 2020[26]. Research and Development - Research and development expenses totaled ¥53,147,864.40 for the quarter, representing 449.11% of operating revenue, an increase of 180.68 percentage points[6]. - The company invested a total of ¥109,174,771.42 in R&D from the beginning of the year to the end of the reporting period, an increase of 8.88% year-on-year[6]. - The company has invested ¥10,917.48 million in R&D from January to September 2021[13]. Assets and Liabilities - Total assets at the end of the reporting period were ¥2,465,528,798.73, a decrease of 2.02% from the end of the previous year[6]. - As of September 30, 2021, total current assets amounted to RMB 1,617,177,882.96, a decrease from RMB 1,848,172,697.84 as of December 31, 2020[22]. - The company reported a total liability of RMB 542,746,079.15 as of September 30, 2021, an increase from RMB 375,669,442.36 at the end of 2020[23]. - The company's total assets as of September 30, 2021, were RMB 2,465,528,798.73, compared to RMB 2,516,290,135.69 at the end of 2020[24]. - The company’s cash and cash equivalents as of September 30, 2021, were RMB 287,558,111.69, down from RMB 839,094,950.34 at the end of 2020[21]. - The company’s inventory as of September 30, 2021, was RMB 14,474,885.22, slightly up from RMB 13,529,745.60 at the end of 2020[21]. Cash Flow - The company recorded a net cash flow from operating activities of -¥157,320,954.47 year-to-date[5]. - Cash flow from operating activities showed a net outflow of ¥157,320,954.47 in 2021, compared to a net outflow of ¥114,618,845.70 in 2020, reflecting increased operational challenges[28]. - Investment activities resulted in a net cash outflow of ¥523,592,532.76 in 2021, compared to a smaller outflow of ¥13,282,942.16 in 2020, indicating significant investment expenditures[29]. - Cash and cash equivalents at the end of Q3 2021 totaled ¥287,558,111.69, down from ¥839,094,950.34 at the beginning of the year, showing a decrease in liquidity[29]. Clinical Trials and Product Development - The company is conducting multiple clinical trials for its pipeline products, including FB1002 and FB2001, with various stages of participant enrollment and safety evaluations ongoing in the U.S. and China[15]. - The company has received a notice from the National Medical Products Administration regarding the acceptance of a clinical trial supplement application for intravenous administration of Aikening, which will enhance clinical usability and compliance once approved[14]. - The storage conditions for the product Aikening have been approved to change from "light-proof, sealed, frozen" to "light-proof, sealed, refrigerated," which reduces transportation and storage requirements for distributors and hospitals, facilitating market promotion and lowering delivery costs[14]. Equity and Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 15,769[10]. - The company's equity attributable to shareholders was approximately $2.14 billion, with a decrease in undistributed profits of approximately $809.31 million[33].

Financial Performance - The company reported a significant increase in revenue for the first half of 2021, with total revenue reaching RMB 150 million, representing a 25% growth compared to the same period last year[13]. - The company's operating revenue for the first half of the year reached CNY 228.11 million, a significant increase of 233.14% compared to the same period last year[20]. - The company's revenue for the first half of 2021 was CNY 22.81 million, a 233.14% increase compared to CNY 6.85 million in the same period last year[82]. - The net profit attributable to shareholders was a loss of CNY 93.45 million, an improvement from a loss of CNY 101.94 million in the previous year[20]. - The net profit attributable to shareholders for the first half of 2021 was a loss of CNY 93.45 million, with a net loss of CNY 116.55 million after deducting non-recurring gains and losses[74]. - The basic earnings per share for the first half of the year was -CNY 0.26, an improvement from -CNY 0.38 in the same period last year[21]. - The company reported a net loss of CNY 902,760,472.42, widening from a loss of CNY 809,314,918.28[180]. - The total comprehensive income for the first half of 2021 was -¥97,989,935.72, an improvement from -¥103,427,166.96 in the previous year[187]. Research and Development - The company has allocated RMB 50 million for research and development in the upcoming year, focusing on innovative therapies and technologies[13]. - R&D expenditure accounted for 245.61% of operating revenue, a decrease of 576.74 percentage points due to the substantial increase in revenue[21]. - The total R&D investment for the period was ¥56,026,907.02, a decrease of 0.50% compared to the previous period's ¥56,309,263.7[52]. - The company invested 56.03 million yuan in R&D during the first half of 2021, with R&D expenses accounting for 245.61% of its revenue[68]. - The company has applied for 8 new invention patents during the reporting period, bringing the total number of applications to 9, with 12 patents granted[50]. - The company has initiated Phase II clinical trials for FB1002 in the United States, targeting long-term maintenance therapy for HIV-1 infected patients[56]. - The company is actively conducting Phase II clinical trials for its upgraded product FB1002 in both China and the United States[68]. - The company has established a comprehensive new drug R&D system, enhancing its core competitiveness in innovative drug development[59]. Product Development - New product development includes the launch of FB2001, a candidate drug for treating COVID-19, which is currently in the clinical trial phase[12]. - The company is focused on developing innovative drugs in the HIV treatment sector, with its product Aikening being a long-acting HIV fusion inhibitor[28]. - Aikening has been recognized as a significant advancement in HIV treatment, being the first long-acting fusion inhibitor approved globally[31]. - The in-development product FB1002, a long-acting injectable drug combination, aims to replace existing oral therapies and targets multiple indications including multi-drug resistance and maintenance therapy[36]. - FB2001, an investigational small molecule for COVID-19, shows an IC₅₀ of 0.053 ± 0.005 μM and EC₅₀ of 0.42 ± 0.08 μM, demonstrating high efficacy against SARS-CoV-2[37]. - FB3001, a new transdermal analgesic patch, has shown statistically significant efficacy in alleviating pain in patients with back pain during Phase II clinical trials in the U.S.[38]. Market Expansion and Strategy - The company is actively pursuing market expansion strategies, targeting new regions in Asia and Europe to increase its market share[13]. - The company has expanded its market access, covering over 160 HIV treatment hospitals and more than 80 DTP pharmacies across 27 provinces and municipalities in China[64]. - The company aims to create an international manufacturing system compliant with FDA, EMA, and NMPA standards to support large-scale production[61]. - The company has built a marketing system that covers a wide range of medical institutions, enhancing its commercialization capabilities[60]. Financial Position and Cash Flow - The company has maintained a strong cash position, with cash reserves amounting to RMB 200 million, ensuring liquidity for ongoing operations and investments[13]. - Cash and cash equivalents decreased by 47.70% to CNY 438.88 million, primarily due to idle funds being used for financial investments[85]. - Trading financial assets increased by 32.90% to CNY 1.25 billion, attributed to idle funds being utilized for financial investments[85]. - The company reported a net cash outflow from operating activities of CNY -89.04 million, reflecting increased employee compensation and operational expenses[83]. - The cash inflow from operating activities for the first half of 2021 was CNY 48,012,523.40, a significant increase from CNY 18,970,456.22 in the same period of 2020, representing a growth of approximately 153.5%[192]. Risks and Challenges - The management has identified potential risks, including regulatory changes and market competition, which could impact future performance[4]. - The company is facing risks related to the expiration of patents for its main product, Aikening, which is set to expire on September 23, 2023, potentially leading to increased market competition[77]. - The company is currently focused on the commercialization of Aikening, with other products still in the research and development phase, leading to a high concentration risk in revenue sources[76]. Environmental and Social Responsibility - The company has implemented a self-monitoring plan for environmental compliance, with all monitored pollutants meeting standards[109]. - The company emphasizes clean production and pollution reduction, aiming to achieve advanced domestic standards for energy consumption and pollutant emissions[111]. - The company is actively participating in public welfare activities related to AIDS treatment, including donations to support prevention efforts in China[71]. Shareholder and Governance - The actual controller of the company has committed to not interfere with management activities and to protect the interests of the company and its shareholders[132]. - The company has committed to distributing at least 30% of the average distributable profits over the last three years in cash dividends, provided it is profitable[133]. - The actual controller DONG XIE (谢东) has committed to reduce and regulate related party transactions with the company and will avoid voting in related board and shareholder meetings[142]. - The company will ensure that all financial disclosures are accurate and free from misleading statements, with legal responsibilities for any discrepancies[135].

2021 年第一季度报告 公司代码：688221 公司简称：前沿生物 一、 重要提示 1.1 公司董事会、监事会及董事、监事、高级管理人员保证季度报告内容的真实、准确、完整，不存 在虚假记载、误导性陈述或者重大遗漏，并承担个别和连带的法律责任。 1.2 公司全体董事出席董事会审议季度报告。 1.3 公司负责人 DONG XIE、主管会计工作负责人邵奇及会计机构负责人（会计主管人员）官鑫保证季 度报告中财务报表的真实、准确、完整。 1.4 本公司第一季度报告未经审计。 二、 公司基本情况 2.1 主要财务数据 前沿生物药业（南京）股份有限公司 2021 年第一季度报告 1 / 24 | 一、 | 重要提示 3 | | --- | --- | | 二、 | 公司基本情况 3 | | 三、 | 重要事项 6 | | 四、 | 附录 9 | 2021 年第一季度报告 | | 本报告期末 | 上年度末 | 本报告期末比上 年度末增减(%) | | --- | --- | --- | --- | | 总资产 | 2,487,108,775.77 | 2,516,290,135.69 | -1.16 | | 归属于上市公司 ...

Financial Performance - The company's operating revenue for 2020 was CNY 46,622,752.99, representing a year-on-year increase of 123.50%[21]. - The net profit attributable to shareholders was CNY -230,730,884.52, showing a decline compared to CNY -192,449,750.97 in 2019[21]. - The net cash flow from operating activities was CNY -170,174,582.20, a decrease of 596.32% compared to the previous year[21]. - The total assets at the end of 2020 were CNY 2,516,290,135.69, an increase of 167.83% from CNY 939,527,635.26 in 2019[21]. - The net assets attributable to shareholders increased to CNY 2,143,045,644.33, a growth of 255.50% compared to CNY 602,830,263.84 in 2019[21]. - The basic earnings per share for 2020 was CNY -0.80, compared to CNY -0.73 in 2019[22]. - The total revenue of 23.40 million RMB in Q4 2020, with a total annual revenue of approximately 46.62 million RMB[26]. - The total non-recurring gains and losses amounted to 9.48 million RMB in 2020, compared to -79.71 million RMB in 2019[27]. - The company achieved a sales revenue of 46.62 million yuan in 2020, representing a year-on-year growth of 123.50%[42]. - The sales volume of Aikening increased by 168.99%, with sales reaching 70,007 units[121]. Research and Development - The total R&D investment for the year was ¥138,492,163.16, representing a 62.13% increase from the previous year's ¥85,421,236.83[79]. - The R&D expenditure accounted for 297.05% of operating revenue, a decrease of 112.45 percentage points from 409.50% in 2019[22]. - The company has developed a series of innovative drugs in the anti-HIV field, including the marketed drug Aikening and the clinical trial project FB1002, which is currently undergoing Phase II trials in China and the U.S.[33]. - The company has established a long-term peptide technology platform and a new transdermal patch formulation technology platform to enhance its drug development capabilities[88]. - The company has a total of 12 granted invention patents, with 1 new application filed during the reporting period[77]. - The company is developing FB1002, a long-acting injectable HIV drug, which is currently in Phase II clinical trials for multiple indications, including multi-drug resistance and maintenance therapy[43][45]. - The company has initiated multiple Phase II clinical trials for its FB1002 project in both the U.S. and China, targeting various indications[97]. - The company has formed a collaboration with the Shanghai Institute of Materia Medica for the development of antiviral candidates, enhancing its R&D pipeline[98]. Market Strategy and Operations - The company enhanced market promotion efforts and increased the number of frontline marketing personnel to improve product coverage in target hospitals[21]. - The product Aikening's penetration rate in the target patient population improved due to its validated safety and efficacy in clinical applications[21]. - The company aims to enhance the accessibility of innovative drugs and has established a global commercial strategy to meet diverse patient needs[32]. - The company is actively pursuing drug registration for Aikening in 25 countries, with successful approvals in Ecuador as of March 2021[100]. - The company has established a marketing network covering over 120 HIV treatment hospitals and more than 60 DTP pharmacies across 26 provinces in China[91]. - The company plans to cover 30 key medical institutions across 30 provinces in China to enhance market penetration for its product Aikening[165]. Compliance and Governance - The company received a standard unqualified audit report from KPMG Huazhen[5]. - The board of directors confirmed the accuracy and completeness of the annual report, with no significant omissions or misleading statements[5]. - The company has not violated decision-making procedures for external guarantees[8]. - The company has not faced any issues with more than half of the directors being unable to guarantee the authenticity of the annual report[9]. - The company has maintained compliance with commitments related to the initial public offering and other related matters[186]. - There were no unresolved issues regarding related party transactions, ensuring transparency and adherence to regulations[186]. Dividend Policy - The company established a cash dividend policy that prioritizes cash dividends when conditions are met, aiming for a minimum cash dividend ratio of 80% during mature stages without major investment plans[175]. - For the fiscal year 2020, the company reported a net profit of -23,073.09 million RMB, resulting in no cash dividends or stock distributions[180]. - The company did not adjust its cash dividend policy during the reporting period, maintaining compliance with the established guidelines[179]. - The board of directors is responsible for proposing dividend plans, which must be approved by the shareholders' meeting, ensuring transparency and communication with minority shareholders[178]. Risks and Challenges - The company faces risks of continued losses due to high R&D expenses and potential delays in drug commercialization[105]. - The company has a risk of triggering delisting conditions if it fails to achieve a net profit or if its revenue falls below 100 million yuan in the fourth fiscal year post-IPO[115]. - The patents for Aikening are set to expire on September 23, 2023, which may lead to increased market competition from generics[111]. - The company is focusing on expanding its overseas market presence, particularly in developing countries, which may face regulatory challenges[114]. Future Outlook - The global HIV drug market is projected to grow from $34 billion in 2018 to $51.17 billion by 2027, indicating significant market potential for the company's FB1002 project[90]. - The HIV drug market in China is expected to exceed 10 billion yuan by 2027, showing rapid growth[160]. - The company is committed to building a strong capital market image and maintaining shareholder interests through effective communication with investors[170]. - The company is focused on becoming a globally competitive international innovative pharmaceutical enterprise, continuously improving its market position in the biopharmaceutical industry[197].