证券代码：688321 证券简称：微芯生物 公告编号：2023-028 深圳微芯生物科技股份有限公司 关于召开 2022 年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个别及连带责任。 重要内容提示： 会议召开时间：2023 年 04 月 24 日(星期一) 下午 15:00-16:30 会议召开地点：深圳市南山区西丽街道曙光社区南山智谷产业园 B 栋 22 楼多功能厅，上海证券交易所上证路演中心（网址： http://roadshow.sseinfo.com/）同步进行现场直播 会议召开方式：现场+上证路演中心视频直播和网络互动 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 或通过公司邮箱 ir@chipscreen.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。 本次投资者说明会以现场互动+视频直播结合网络互动召开，公 司将针对 2022 年度经营成果及财务指标的具体情况与投资者进行互 ...

Financial Performance - The company's operating revenue for Q3 2022 was ¥119,751,736.11, representing a year-over-year increase of 28.44%[8] - The net profit attributable to shareholders for Q3 2022 was -¥22,922,857.19, with a year-to-date net profit of -¥42,211,182.77[8] - Total operating revenue for the first three quarters of 2022 reached CNY 335,672,990.64, an increase of 21.4% compared to CNY 276,545,965.86 in the same period of 2021[32] - The net loss attributable to shareholders of the parent company for Q3 2022 was CNY -42,211,182.77, compared to a net loss of CNY -24,254,905.09 in Q3 2021[39] - The company reported a total comprehensive loss of CNY -43,778,468.38 for Q3 2022, compared to a loss of CNY -24,254,905.09 in Q3 2021[39] - Basic and diluted earnings per share for Q3 2022 were both CNY -0.1037, compared to CNY -0.0591 in Q3 2021[39] Research and Development - Research and development expenses totaled ¥88,638,551.08 for Q3 2022, an increase of 42.21% compared to the same period last year[11] - R&D expenses accounted for 74.02% of operating revenue in Q3 2022, up by 7.17 percentage points year-over-year[11] - Research and development expenses increased to CNY 128,911,960.16 in Q3 2022, a rise of 40.9% from CNY 91,469,526.90 in Q3 2021[36] - The company continues to focus on independent R&D innovation, necessitating significant investment in R&D to advance ongoing projects[19] Assets and Liabilities - The total assets at the end of Q3 2022 were ¥2,741,364,643.65, reflecting a 44.71% increase from the end of the previous year[11] - Total current assets increased to ¥1,127,300,392.95 from ¥638,821,140.58 year-over-year[28] - Total assets as of September 30, 2022, are ¥2,741,364,643.65, up from ¥1,894,406,023.56 at the end of 2021[31] - The company's fixed assets increased to ¥783,713,505.03 from ¥534,769,585.14 year-over-year[31] - Total liabilities increased to ¥340,987,100.09 from ¥293,839,051.54 year-over-year[31] - Total liabilities amounted to CNY 1,109,267,404.86, significantly higher than CNY 476,792,465.34 from the previous year[32] - Total equity attributable to shareholders of the parent company was CNY 1,568,761,648.34, up from CNY 1,417,613,558.22 in the previous year[32] Cash Flow - The net cash flow from operating activities for the year-to-date period was ¥1,752,038.31, down by 96.89% compared to the previous year[11] - Operating cash inflows totaled approximately ¥368.20 million, slightly up from ¥363.99 million year-over-year[42] - Operating cash outflows increased to ¥366.45 million from ¥307.65 million, resulting in a net cash flow from operating activities of ¥1.75 million, down from ¥56.34 million[42] - Investment cash inflows decreased significantly to ¥259.02 million from ¥706.77 million, while investment cash outflows rose to ¥884.03 million from ¥723.60 million, leading to a net cash flow from investing activities of -¥625.02 million[42] - Financing cash inflows surged to ¥1.11 billion from ¥172.93 million, with net cash flow from financing activities reaching ¥858.59 million, compared to -¥12.32 million previously[44] - Cash and cash equivalents at the end of the period stood at ¥549.93 million, up from ¥298.12 million[44] - The total cash increase for the period was ¥249.77 million, compared to an increase of ¥26.56 million in the prior year[44] Shareholder Information - Total number of common shareholders at the end of the reporting period is 19,781[20] - The largest shareholder, BGI Group, holds 42,919,572 shares, representing 10.45% of total shares[20] - The second largest shareholder, Shenzhen Haiyue Men Biotechnology Development Co., Ltd., holds 22,936,008 shares, representing 5.58%[20] - The company has not engaged in margin trading or securities lending activities among its top shareholders[23] Government Subsidies and Other Income - The company reported a total of ¥3,910,157.23 in government subsidies recognized in Q3 2022[13] - Cash received from sales of goods and services in the first three quarters of 2022 was CNY 351,391,756.24, an increase from CNY 314,128,886.49 in the same period of 2021[40] Financial Expenses - The company’s financial expenses included interest expenses of CNY 10,533,938.08 in Q3 2022, compared to CNY 3,095,043.70 in Q3 2021[36] Employee Compensation and Tax Payments - The company reported a significant increase in employee compensation payments, totaling ¥191.66 million, compared to ¥148.38 million last year[42] - Tax payments decreased slightly to ¥20.70 million from ¥22.04 million[42] Foreign Exchange and Other Gains - The company experienced a foreign exchange gain of ¥14.45 million, contrasting with a loss of ¥0.64 million in the previous period[44]

Financial Performance - The company's operating revenue for the first half of 2022 was ¥215,921,254.53, representing a 17.79% increase compared to ¥183,307,290.44 in the same period last year[24]. - The net profit attributable to shareholders of the listed company was -¥19,288,325.58, compared to -¥7,152,330.88 in the same period last year, indicating a decline in profitability[24]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was -22,583,405.81 RMB, a decrease compared to -14,797,302.70 RMB from the previous year[26]. - The net cash flow from operating activities increased by 29.29% to 22,877,669.34 RMB from 17,695,154.24 RMB in the same period last year[26]. - Total assets increased by 16.96% to 2,215,781,080.44 RMB compared to 1,894,406,023.56 RMB at the end of the previous year[26]. - Basic earnings per share decreased to -0.0474 RMB from -0.0174 RMB in the same period last year[26]. - The cost of goods sold increased by 57.99% to ¥13,675,867.61, primarily due to the growth in sales of the product Xidabonan[96]. - Research and development expenses rose by 31.31% to ¥76,002,719.79, driven by the ongoing progress of various research projects[96]. - The company reported a significant increase in short-term borrowings, which rose by 128.73% to ¥274,822,481.40[99]. Research and Development - The company continues to focus on research and development of innovative drugs targeting new mechanisms and pathways[14]. - Research and development expenses accounted for 60.52% of operating income, an increase of 4.96% compared to 55.56% in the previous year[26]. - The company has developed multiple innovative drug products, including Sidabenan (marketed) and others in various clinical trial phases[33]. - The overall progress of the company's R&D pipeline is advancing, with several products at different stages of clinical trials[33]. - The company is committed to advancing its research and development efforts to bring new therapies to market for unmet medical needs[42]. - The company has a pipeline of new molecular entities for oncology, metabolic diseases, autoimmune diseases, CNS diseases, and antiviral therapies, with candidates like CS32582 and CS271011 in preclinical research[46]. - The company integrates early research, clinical development, and GMP production in its innovative drug development model[49]. - The company has established a robust quality management system, achieving a 100% pass rate for product release during the first half of 2022[90]. - The company has received IND approval for multiple clinical trials, including a Phase II trial for the combination of chidamide and toripalimab for NSCLC, which began patient enrollment in December 2021[67]. Clinical Trials and Product Development - The company has developed a new drug, Chidamide, which is the first oral drug approved for treating peripheral T-cell lymphoma, with a unique mechanism as a selective HDAC inhibitor[42]. - The drug Xiglitazar is the first PPAR pan-agonist approved for treating type 2 diabetes, targeting insulin resistance, and has shown clear efficacy in blood glucose and lipid control[43]. - Xiglitazar is currently undergoing a Phase III clinical trial for combination therapy with metformin for type 2 diabetes patients inadequately controlled by metformin alone[43]. - The company has multiple ongoing clinical trials for Chidamide, including a Phase III trial for treating diffuse large B-cell lymphoma and a Phase II trial for non-small cell lung cancer[43]. - The company is advancing several registration clinical trials for Chidamide in international markets, including melanoma and non-small cell lung cancer[43]. - The company has reported significant progress in its clinical trials, with completed patient enrollment in several Phase III studies[43]. - The Phase III clinical trial for Sidabenan targeting diffuse large B-cell lymphoma (DLBCL) completed participant enrollment in July 2022, marking a global first for this indication[79]. - The Phase III clinical trial for Siglecatin combined with Metformin for type 2 diabetes also completed participant enrollment, with results analysis expected in Q1 2023[79]. - The company is actively pursuing clinical trials for new indications, including a Phase II trial for Xiglitazone in patients with non-alcoholic fatty liver disease[56]. Market Strategy and Sales - The company is focused on expanding its market presence through innovative drug development and strategic partnerships[42]. - The sales strategy includes a structured sales department to enhance market access and product strategy[49]. - The company is expanding its marketing service network by establishing offices in 30 cities, including Beijing, Shanghai, and Shenzhen, to meet the growing market demand[160]. - The company is enhancing internal controls and management levels to ensure normal operations, reduce management risks, and improve operational efficiency and profitability[160]. - The company is focused on expanding its marketing network and sales channels to enhance revenue generation[157]. Corporate Governance and Compliance - The report is unaudited, and the responsible persons have declared the accuracy and completeness of the financial report[7]. - The company has not reported any non-operating fund occupation by controlling shareholders or related parties[9]. - The company has established measures to avoid new industry competition commitments from major shareholders and management[143]. - The company has committed to strict compliance with securities laws regarding the trading of shares and convertible bonds for six months post-issuance[181]. - The company will disclose any failure to fulfill commitments, including specific circumstances and corrective measures, and will compensate investors for any losses incurred due to such failures[13]. Environmental and Social Responsibility - The company’s environmental protection measures include active carbon adsorption for waste gas treatment, complying with emission standards[119]. - The company’s waste gas emissions during the reporting period met environmental protection requirements, with specific VOCs emission limits set at 0.0288 tons per year[119]. - The company conducts monthly monitoring of volatile organic compounds and quarterly monitoring of hydrochloric acid and particulate matter[125]. - The company has established a green low-carbon production principle in its operations[130]. - The company conducts daily safety inspections and monthly safety checks to reduce carbon emissions[132]. Shareholder Commitments and Stock Management - The company has a commitment to not seek control over the company and has fulfilled this commitment[137]. - The company has implemented measures to compensate for the dilution of immediate returns[137]. - The company’s major shareholders have committed to adhere to legal regulations when reducing their holdings, ensuring compliance with the Company Law and Securities Law[144]. - The company will ensure that any share reductions after the lock-up period will be disclosed to maintain stable control over the issuer[144]. - The company has established measures to stabilize stock prices if the closing price falls below the audited net asset value per share for 20 consecutive trading days[150].

2022 年第一季度报告 单位：元 币种：人民币 证券代码：688321 证券简称：微芯生物 深圳微芯生物科技股份有限公司 2022 年第一季度报告 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、准确性和完整性依法承担法律责任。 重要内容提示 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、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 公司负责人、主管会计工作负责人及会计机构负责人（会计主管人员）保证季度报告中财务报表 信息的真实、准确、完整。 第一季度财务报表是否经审计 □是 √否 一、 主要财务数据 (一)主要会计数据和财务指标 | --- | --- | --- | |--------------------------|----------------|-------------------------------------| | 项目 | 本报告期 | 本报告期比上年同 期增减变动幅度 (%) | | 营业收入 | 104,479,337.72 | 38.74 | | 归属于上市公司股东 ...

Financial Performance - The company achieved a revenue growth of 59.74% year-on-year in 2021[15]. - The net profit attributable to shareholders for 2021 was ¥21,958,284.55, while the parent company reported a net profit of ¥72,893,330.19[7]. - The company reported a revenue of 1.2 billion RMB for the fiscal year 2021, representing a year-over-year growth of 15%[21]. - The company's operating revenue for 2021 was ¥430,449,990.57, representing a 59.74% increase compared to ¥269,469,784.74 in 2020[33]. - The net profit attributable to shareholders for 2021 was ¥21,958,284.55, a decrease of 29.27% from ¥31,045,971.89 in 2020[33]. - The net cash flow from operating activities for 2021 was ¥124,783,166.51, an increase of 33.29% compared to ¥93,619,221.86 in 2020[33]. - The company's total assets at the end of 2021 were ¥1,894,406,023.56, a 9.74% increase from ¥1,726,271,014.19 in 2020[33]. - The company reported a basic earnings per share of ¥0.0537 for 2021, down 29.06% from ¥0.0757 in 2020[35]. - The company’s quarterly revenue for Q4 2021 was ¥153,904,024.71, showing a strong performance compared to previous quarters[40]. - The company reported a net profit of 25,864,823.63 RMB for the period, with a significant increase compared to the previous period's profit of 25,475,248.63 RMB, reflecting a growth of approximately 1.53%[42]. Research and Development - The company plans to increase R&D investment in 2022 and will not distribute profits or increase capital reserves for the year 2021[7]. - The company launched its second original innovative drug, Siglecatin Sodium, and initiated key Phase III clinical studies for its third original drug, Sioronib[15]. - The establishment of the R&D product chain and lifecycle management has been further improved and deepened[15]. - Research and development expenses accounted for 54.44% of operating revenue in 2021, up from 50.94% in 2020[35]. - The company plans to increase its R&D budget by 30% in the upcoming fiscal year to support innovation[21]. - The company has invested 200 million RMB in new technology for drug development, focusing on precision medicine[21]. - The company is actively developing a pipeline of over 20 new molecular entities, including CS271011, CS23546, and CS32582[56]. - The company has established an integrated drug discovery and early evaluation platform based on chemical genomics, which helps select compounds with the best comprehensive evaluation indicators for later development, reducing the risk of late-stage drug development[128]. - The company has a strong R&D team with 31 PhD holders and 80 master's degree holders, enhancing its competitive edge in drug development[119]. - The company has a rich pipeline of projects in development, indicating strong potential for future growth and market expansion[128]. Market Expansion and Strategy - The company is expanding its market presence in Southeast Asia, with plans to establish partnerships with local distributors by the end of 2022[21]. - The company aims to leverage national policies supporting technological innovation and capital market support for "hard tech" enterprises in its international development strategy[17]. - The company is committed to sustainable development in the biopharmaceutical sector, integrating early research, clinical development, and market access strategies[46]. - The company is actively engaged in expanding its market presence and enhancing its research and development capabilities to compete with multinational pharmaceutical companies[85]. - The company has established a commercial and market access department to manage distributors and sales contracts effectively[79]. Clinical Trials and Drug Development - The company is advancing four Phase III clinical trials for three major products, which are crucial for ensuring the commercialization of research outcomes and supporting future revenue growth[50]. - The company has received regulatory approval for three new drug applications, expected to boost future revenues significantly[21]. - The clinical trial for CS12192, a selective JAK3 inhibitor, has received FDA approval and is in the initiation phase[56]. - The company has initiated clinical trials for new drugs, including the III phase trial for Xioroni in small cell lung cancer, with FDA approval obtained for related trials[149]. - The company is conducting clinical trials for Xioroni in advanced triple-negative breast cancer patients who have failed anthracycline and taxane treatments, with approval received in July 2021[200]. - The company has submitted multiple clinical trial applications for various indications, including rheumatoid arthritis and non-small cell lung cancer, with approvals received throughout 2021[200]. Challenges and Risks - The company anticipates challenges in balancing long-term development goals with short-term expectations as it continues to grow[17]. - The company faces risks related to significant R&D investments, with potential delays in clinical trials and regulatory approvals impacting future revenue generation[135]. - The company has a high customer concentration risk, with the top five customers accounting for 81.67% of total revenue, which could affect stability if any major customer faces adverse changes[146]. - The company is at risk of insufficient funding for future R&D projects if revenue growth does not meet expectations or if government subsidies decrease[148]. - Regulatory changes in the biopharmaceutical industry could increase operational risks for the company, affecting various aspects of its business[153]. Innovation and Patents - The company has received FDA orphan drug designation for Xioloni for the treatment of small cell lung cancer in September 2021[88]. - The company has accumulated a total of 407 invention patents globally, with 123 granted as of December 31, 2021[98]. - In 2021, the company applied for 126 new invention patents and received 32 authorizations domestically and internationally[100]. - The company has implemented a comprehensive patent layout to prevent competition from generic drugs in the future[98]. - The company has successfully obtained patents for its drug discoveries, including a gold medal from the State Intellectual Property Office of China for Chidamide[67].

2021 年第三季度报告 单位：元 币种：人民币 证券代码：688321 证券简称：微芯生物 深圳微芯生物科技股份有限公司 2021 年第三季度报告 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、准确性和完整性依法承担法律责任。 重要内容提示： 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、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 公司负责人、主管会计工作负责人及会计机构负责人（会计主管人员）保证季度报告中财务 报表信息的真实、准确、完整。 第三季度财务报表是否经审计 □是 √否 一、 主要财务数据 (一)主要会计数据和财务指标 | --- | --- | --- | --- | --- | |------------------------------------------------|----------------|----------------------------------------|----------------|---------------------------- ...

Financial Performance - The company reported a total revenue of 500 million RMB for the first half of 2021, representing a 20% increase compared to the same period last year[2]. - The company's revenue for the first half of 2021 was ¥183,307,290.44, representing a 65.75% increase compared to ¥110,589,665.18 in the same period last year[27]. - The net profit attributable to shareholders was -¥7,152,330.88, a decrease of 124.91% from ¥28,711,659.31 in the previous year[27]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was -¥14,797,302.70, down 195.00% from ¥15,575,672.30 year-on-year[27]. - The net cash flow from operating activities was ¥17,695,154.24, a decline of 69.34% compared to ¥57,717,172.76 in the same period last year[27]. - Cash and cash equivalents at the end of the period amounted to 351,701,960.01, representing 18.95% of total assets, an increase of 10.35% compared to the previous year[99]. - The company reported a net loss of -2,206,811.16, compared to an undistributed profit of 4,945,519.72 in the previous year, reflecting a decline of 144.62%[101]. Research and Development - Research and development expenses increased by 30% year-on-year, totaling 150 million RMB, reflecting the company's commitment to innovation[2]. - The R&D expenditure accounted for 55.56% of the revenue, an increase of 2.12 percentage points compared to 53.44% in the previous year[27]. - R&D investment totaled approximately ¥101.85 million, representing a year-over-year increase of 72.35%[48]. - The company has nearly 20 candidate drug projects, including CS17919, CS27109, and CS23546, currently undergoing preclinical and early exploratory research[36]. - The company has established a reputation and social influence in the innovative drug industry, supported by 20 years of continuous R&D investment[40]. - The company has a strong focus on innovative drug development, with several new molecular entities already approved for clinical use[33]. Product Development and Pipeline - A new product line is set to launch in Q4 2021, anticipated to contribute an additional 100 million RMB in revenue[2]. - The company focuses on original drug research in five major areas: oncology, metabolic diseases, autoimmune diseases, antiviral fields, and central nervous system disorders[33]. - The drug Chidamide has benefited nearly 10,000 lymphoma and breast cancer patients, with cumulative sales reaching nearly 10 million RMB and over 50,000 boxes provided for free[33]. - The company has 11 indications currently in clinical development and nearly 20 projects at different stages of exploratory research[33]. - The company aims to expand the indications for Chidamide as clinical trials progress, potentially leading to long-term sales growth[33]. - The company has established a comprehensive product chain covering innovative drugs from early development to clinical stages[33]. Market Strategy and Expansion - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2022[2]. - The company expects a revenue growth forecast of 25% for the second half of 2021, driven by new product launches and market expansion strategies[2]. - The company has established a modern and standardized management control system, enhancing operational efficiency across production, procurement, and research[71]. - The marketing network covers the entire country, with specialized divisions for oncology and metabolic disease products, supported by a team with extensive medical marketing experience[71]. Financial Integrity and Governance - No significant non-operational fund usage by controlling shareholders was reported, ensuring financial integrity[9]. - The company has committed to stabilizing its stock price and has fulfilled this commitment[132]. - The company has made commitments to not seek control over the company by certain shareholders[132]. - The company has established a plan to address the dilution of immediate returns[132]. - The company has not reported any significant changes in the status of its stock incentive plans since the last announcement[124]. Risks and Challenges - The management highlighted potential risks including regulatory changes and market competition, which could impact future performance[5]. - The company is facing risks related to the failure of new drug development and potential delays in clinical trials due to regulatory challenges[89]. - The increase in management expenses by 92.82% to ¥34,581,387.50 was mainly due to rising personnel costs and share-based payments[90]. Human Resources and Talent Development - The number of R&D personnel increased to 221, up from 131, representing 27.25% of the total workforce compared to 25.69% previously[61]. - Total compensation for R&D personnel reached ¥25,614,045.40, a significant increase from ¥13,131,960.00 in the previous period[61]. - The company has implemented a "100-person plan" to cultivate management talent, successfully training over 90 management reserve talents in two years[84]. Environmental and Social Responsibility - The environmental permit for the company was renewed, effective from June 21, 2021, to June 20, 2026[128]. - The company has implemented measures to establish an environmental protection system and emergency response plans for environmental incidents[129].

2021 年第一季度报告 公司代码：688321 公司简称：微芯生物 深圳微芯生物科技股份有限公司 2021 年第一季度报告 1 / 22 2021 年第一季度报告 重要提示 一、 二、 公司基本情况 三、 重要事项 四、 附录 目录 2 / 22 2021 年第一季度报告 单位：元 币种：人民币 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 XIANPING LU、主管会计工作负责人黎建勋及会计机构负责人（会计主管人员） 左惠萍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 | --- | --- | --- | --- | |-------------------------------------------------|------------------|----------------------|---------------- ...

Financial Performance - The net profit attributable to shareholders for 2020 was CNY 31,045,971.89, while the parent company achieved a net profit of CNY 43,692,898.33[7]. - In 2020, the company's operating revenue increased by 55.05% year-on-year, reaching ¥269,469,784.74, primarily due to the significant sales growth of Xidabengamine[33]. - The net profit attributable to shareholders rose by 59.85% year-on-year to ¥31,045,971.89, driven by the increase in operating revenue[33]. - The net profit attributable to shareholders after deducting non-recurring gains and losses decreased by 59.59% to ¥5,570,723.26, mainly due to increased R&D expenses and the use of government R&D funds[33]. - Basic earnings per share increased by 46.71% to ¥0.0757, reflecting the rise in net profit attributable to shareholders[33]. - The company's total assets at the end of 2020 were ¥1,726,271,014.19, a 2.06% increase from the previous year[30]. - The net assets attributable to shareholders increased by 3.28% to ¥1,493,829,887.04 at the end of 2020[30]. - The net cash flow from operating activities was ¥93,619,221.86, a significant recovery from a negative cash flow of ¥24,553,118.03 in 2019[30]. - The company's operating revenue for the reporting period was ¥269,469,784.74, representing a 55.05% increase compared to ¥173,800,400.62 in the previous year[147]. - The cost of sales increased by 84.85% to ¥13,475,128.14 from ¥7,289,600.22 in the previous year[147]. - The sales revenue from the main product, Sidabone, was ¥245,026,634.74, with a gross margin of 94.50%, down 1.37 percentage points from the previous year[148]. - The company reported a significant increase in R&D expenses, which rose by 79.40% to ¥92,290,557.52, indicating a strong focus on innovation[147]. Research and Development - The company plans to increase R&D investment in 2021, leading to no cash dividends or stock bonuses for the 2020 fiscal year[7]. - R&D investment accounted for 50.94% of operating revenue, an increase of 5.92 percentage points compared to the previous year[30]. - The total R&D investment for the year reached ¥137,264,542.12, a 75.44% increase compared to the previous year[95]. - The company has applied for a total of 281 invention patents, of which 91 have been authorized, showcasing its strong intellectual property portfolio in the innovative drug sector[76]. - The company has a complete innovative drug R&D capability, with all in-development drugs being new molecular entities[76]. - The company has established a comprehensive risk control strategy for clinical development based on scientific principles and mechanisms of action, which is crucial for navigating the complexities of drug development[82]. - The company’s research and development efforts are aimed at addressing critical issues faced by drug development enterprises, thereby increasing the likelihood of successful new drug development[82]. - The company has a strong focus on precision medicine strategies in its early candidate drug screening process[109]. - The company has a strong pipeline of innovative drug candidates with high originality and potential market value, supported by extensive experience in original drug research and development[112]. - The company has received IND approval for multiple Phase III trials, indicating progress towards market approval for several drugs[98]. Clinical Trials and Drug Development - The company has successfully developed innovative drugs, including Chidamide, which has benefited nearly 10,000 lymphoma patients with cumulative sales exceeding 820 million yuan[43]. - The Phase III clinical trial for Chidamide combined with the R-CHOP regimen for treating newly diagnosed MYC/BCL2 double-expressing diffuse large B-cell lymphoma (DLBCL) commenced in May 2020 with the first patient enrolled[86]. - The Phase III clinical trial for Chiglitazar combined with metformin for type 2 diabetes patients, who are inadequately controlled on metformin alone, received clinical trial approval in October 2020 and is currently in the initiation phase[86]. - The company has multiple drug candidates in various stages of clinical development, including CS12192, which received clinical trial approval in June 2020 and has completed the dose escalation for the Phase I trial[86]. - The company is conducting a Phase III clinical trial for Xigletan sodium, with a total expected investment of ¥15,000.00 million and ¥11,816.16 million cumulatively invested[98]. - The company has completed Phase II trials for Xigletan sodium in combination with metformin for Type 2 diabetes, with ongoing Phase III trials[100]. - The company has established a comprehensive drug discovery and early evaluation platform based on chemical genomics, which helps select compounds with the best comprehensive evaluation indicators for later development stages[109]. - The company is actively developing new drugs for non-small cell lung cancer, with multiple targeted kinase inhibitors approved, including Afatinib and Osimertinib, and ongoing research into KRAS inhibitors[80]. - The company has received regulatory acceptance for its investigational new drug applications (IND) for several candidates, indicating progress in its clinical development efforts[86]. - The company has a robust clinical trial pipeline, with several projects at different stages, ensuring a continuous supply of innovative drugs to meet clinical needs[112]. Market and Competitive Landscape - The global pharmaceutical market is projected to reach $1,500 billion by 2021, with the global innovative drug market expected to reach $978.7 billion[53]. - The global pharmaceutical expenditure for cancer treatment reached $75.3 billion in 2016, with a projected compound annual growth rate (CAGR) of 9-12%, expecting to reach $120-130 billion by 2021[56]. - The number of cancer patients globally is expected to grow at a rate of 6-9% from 2016 to 2021, with total cancer treatment costs projected to reach $147 billion by 2021[59]. - In China, the market share of targeted drugs is rapidly increasing, expected to become the largest category in the anti-cancer drug market within 3 to 5 years[60]. - The company has been operational for 20 years and continuously updates its technology based on advancements in life sciences and drug development[43]. - The company has established a strong reputation and social influence in the innovative drug industry, supported by 20 years of continuous R&D investment[76]. - The company aims to achieve global leadership in the treatment of various cancers and diabetes through its innovative drug development[106]. - The company has been recognized for its contributions to the pharmaceutical industry, receiving multiple awards for innovation and growth in recent years[112]. Corporate Governance and Compliance - The audit report issued by KPMG was a standard unqualified opinion, ensuring the accuracy of the financial statements[6]. - The company does not have any non-operating fund occupation by controlling shareholders or related parties[9]. - There are no violations of decision-making procedures regarding external guarantees[11]. - The company has not disclosed any special arrangements for corporate governance[11]. - The company has a dedicated board secretary for information disclosure, ensuring compliance with regulatory requirements[24]. - The company’s financial disclosures are published in major Chinese financial newspapers and on the designated website of the China Securities Regulatory Commission[24]. - The company emphasizes quality management to mitigate risks associated with drug safety and compliance with stringent regulatory requirements[141]. Strategic Initiatives and Future Plans - The company plans to apply for IND for several promising candidates, including CS27109 and CS23546, in 2021, targeting high cholesterol and non-alcoholic fatty liver disease[121]. - The company aims to optimize its innovative drug sales team and model to better meet patient needs, with strategic adjustments to the sales management system based on market demand[125]. - The company has established a quality management system at the group level to ensure speed, quality, and medical risk control capabilities in drug development[124]. - The company is focusing on major diseases and market opportunities, aiming to provide differentiated clinical candidates that meet urgent patient needs[124]. - The company has established a new business unit for metabolic disease products to prepare for the launch of the diabetes product, Siglitazone, in collaboration with Zhejiang Hai Zheng Pharmaceutical Co., Ltd[127].

2020 年第三季度报告 公司代码：688321 公司简称：微芯生物 深圳微芯生物科技股份有限公司 2020 年第三季度报告 1 / 24 2020 年第三季度报告 一、 重要提示 二、 公司基本情况 11[ 重要事项 四、 附录 目录 2 / 24 2020 年第三季度报告 单位：元 币种：人民币 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 XIANPING LU、主管会计工作负责人黎建勋及会计机构负责人（会计主管人员） 左惠萍保证季度报告中财务报表的真实、准确、完整。 1.4 本公司第三季度报告未经审计。 二、 公司基本情况 2.1 主要财务数据 | --- | --- | --- | --- | |-----------------------------------------------|------------------------------|---------------------------- ...