西南证券、兴业证券自营、迎水投资、禹田资本、银杏资本、源 乘投资、中信资管、仁布投资、中泰证券、高能资本、青骊投 资、远策投资、平安基金、新华基金、华泰资管、思晔投资、易 方达基金、永赢基金、华夏久盈资管、天虫资本、九泰基金、国 信资管、方正富邦、熙德博远、健顺投资、天弘基金、中航信 托、中融基金、理成资本、润邦投资、大成基金、平安证券、诺 鼎资产、百域资产，光大证券、中信建投证券、湘财基金、富盛 参与单位 德资产、华能贵诚信托、观富资产、光大资产、前海开源基金、 国任财保、国盛证券、云门投资、平安资管、华泰柏瑞基金、华 安证券、兴银基金、山楂树资产、涌竹投资、光大自营、太朴生 科、幂方资本、广州安创、鼎丰泰投资、特步投资、平安养老、 国新基金、和君资本、APL、余道投资、农银汇理、东吴证券、天 风证券、安信证券、华西资本、睿亿投资、优益增投资、拾贝投 资、理成资产、华尔资本、海南三力、国家开发投资集团、海南 宽行、上海人寿 活动主要内 问 1：公司管线较多，涉及领域也较为广泛，请问公司的重点发展 证券代码：688062 证券简称：迈威生物 迈威（上海）生物科技股份有限公司 投资者关系活动记录表 编号：202 ...

Financial Performance - The company's revenue for Q3 2022 was ¥9,369,817.81, representing a year-over-year increase of 138.65%[5] - The net profit attributable to shareholders for Q3 2022 was -¥269,140,668.32, with a cumulative net profit of -¥692,421,947.18 for the year-to-date[5] - The company reported a net loss of ¥692,443,802.24 for the third quarter of 2022, compared to a net loss of ¥516,785,354.81 in the same quarter of 2021[36] - The net profit attributable to the parent company was -692,421,947.18 CNY, compared to -514,677,543.83 CNY in the previous period, indicating a decline of approximately 34.5%[38] - The total comprehensive income attributable to the parent company was -686,548,898.54 CNY, compared to -514,892,058.85 CNY in the previous period, reflecting a decrease of about 33.3%[38] - The basic and diluted earnings per share for Q3 2022 were both -¥0.67[9] - The basic and diluted earnings per share were both -1.73 CNY, slightly worse than -1.72 CNY in the previous period[38] Research and Development - Research and development (R&D) expenses for Q3 2022 totaled ¥219,632,291.20, an increase of 54.71% compared to the same period last year[9] - R&D expenses accounted for 2,344.04% of revenue in Q3 2022, a decrease of 1,271.75 percentage points year-over-year[9] - The company plans to continue investing heavily in R&D and market expansion efforts[15] Assets and Liabilities - Total assets at the end of Q3 2022 were ¥4,674,158,465.61, reflecting a 193.00% increase from the end of the previous year[9] - Total assets increased to ¥4,674,158,465.61 from ¥1,595,272,932.19, marking a rise of 193.5%[32] - Non-current assets totaled ¥1,738,655,425.89, up from ¥1,350,536,548.64, reflecting a growth of 28.7%[32] - Current liabilities rose to ¥376,505,738.52, compared to ¥270,413,111.77, an increase of 39.1%[32] - Non-current liabilities increased to ¥549,994,973.00 from ¥316,239,201.27, representing a growth of 73.8%[32] - Total liabilities reached ¥926,500,711.52, up from ¥586,652,313.04, indicating a rise of 57.9%[32] Cash Flow - The company reported a net cash flow from operating activities of -¥507,698,762.84 for the year-to-date[5] - The net cash flow from operating activities was -507,698,762.84 CNY, worsening from -273,217,072.76 CNY year-over-year[42] - Cash inflow from operating activities totaled 210,660,495.27 CNY, up from 148,466,934.72 CNY in the previous year, representing an increase of approximately 41.9%[42] - Cash outflow from operating activities increased to 718,359,258.11 CNY, compared to 421,684,007.48 CNY in the previous year, marking a rise of about 70.5%[42] - The net cash flow from investing activities was -463,962,377.75 CNY, a decline from 67,436,973.20 CNY in the previous year[45] - Cash inflow from financing activities was 3,620,363,660.33 CNY, significantly higher than 219,891,719.89 CNY in the previous year, indicating an increase of approximately 1,646.5%[45] - The net cash flow from financing activities was 3,589,758,174.71 CNY, compared to 152,716,637.57 CNY in the previous year, showing a substantial increase of about 2,252.5%[45] - The ending cash and cash equivalents balance was 2,715,179,589.74 CNY, up from 251,874,170.63 CNY in the previous year, reflecting a growth of approximately 976.5%[45] Market and Sales Performance - The company attributed the increase in revenue to higher technical service income from Shengsen Pharmaceutical Co., Ltd.[15] - The company achieved a product sales volume of over 13,000 units in the first month after the launch of the adalimumab injection, with a total of 6,925 units sold in Q3 2022 due to temporary production supply issues[24] - The company has initiated sales control measures in Q3 2022 due to short-term production supply issues, impacting overall sales performance[24] - As of September 30, 2022, the company had a total of 447 hospitals and 653 pharmacies covered, with 45 hospitals achieving procurement access[24] - The company's strategic partnerships and collaborations, such as with Junshi Biosciences for the development of adalimumab, are expected to drive future growth and market expansion[24] Equity and Shareholder Information - Shareholders' equity attributable to the company was ¥3,749,863,521.15 at the end of Q3 2022, up 270.98% from the previous year[9] - The company's equity attributable to shareholders amounted to ¥3,749,863,521.15, compared to ¥1,010,804,531.15, an increase of 270.5%[32]

Research and Development - The company invested significant funds in R&D, with expenses of CNY 363.04 million in 2019, CNY 581.33 million in 2020, CNY 622.51 million in 2021, and CNY 315.56 million in the first half of 2022[5]. - The company has 13 products in its pipeline, which require ongoing substantial R&D investment for preclinical research, clinical trials, and new drug market preparation[5]. - The R&D of innovative drugs is characterized by long cycles and high investment, with a typical timeline of around ten years from development to market approval[8]. - The company reported no profit distribution plan or capital reserve transfer plan for the reporting period[13]. - The company has 13 ongoing research projects, indicating a strong focus on innovation and product development[5]. - The company emphasizes the importance of clinical value in drug development, aligning with national guidelines for oncology drug research[8]. - The company continues to invest heavily in preclinical research and clinical trials for its pipeline products, impacting its financial performance[37]. - The company has a robust research and development model that emphasizes independent research, supplemented by collaborative and commissioned research[106]. - The company has established five key technology platforms for drug development, including high-throughput antibody discovery and dual-specificity antibody development[9]. - The company has filed for 126 new intellectual property applications during the reporting period, with 31 granted, bringing the total to 518 applications and 218 granted[150]. - The company has established a comprehensive technology system for drug development, including high-expression cell line construction, molecular discovery, process development, and quality management[129]. - The company has built five major technology platforms in antibody drug discovery, enhancing its core competitiveness in innovative drug development[130]. Financial Performance - The company reported a significant increase in revenue, achieving a total of 1.5 billion RMB for the first half of 2022, representing a 25% year-over-year growth[24]. - The company's operating revenue for the first half of 2022 was ¥11,054,308.26, representing a year-on-year increase of 62.99%[36]. - The net loss attributable to shareholders for the same period was ¥423,281,278.86, an increase of ¥83,891,200 compared to the previous year[37]. - The net cash flow from operating activities showed a net outflow of ¥263,101,627.81, which increased by ¥127,535,600 compared to the previous year[40]. - The total assets at the end of the reporting period were ¥4,748,680,839.03, a significant increase of 197.67% compared to the end of the previous year[36]. - The net assets attributable to shareholders increased to ¥3,983,165,088.00, reflecting a growth of 294.06% year-on-year[36]. - The basic earnings per share for the first half of 2022 was -¥1.06, compared to -¥1.13 in the same period last year[36]. - The company reported a significant increase in technical service revenue from Shengsen Bio, amounting to ¥10,934,600, which contributed to the revenue growth[37]. - The company achieved revenue of RMB 11.05 million, primarily from technology service income, representing a year-on-year growth of 62.99%[169]. - The company reported a net cash flow from operating activities of -263,101,627.81 CNY, worsening from the previous year[199]. Market and Product Development - The company provided a positive outlook for the next quarter, projecting a revenue growth of 20% driven by new product launches and market expansion efforts[24]. - New product development includes the launch of 9MW1911, a recombinant humanized anti-ST2 monoclonal antibody injection, expected to enter clinical trials by Q3 2022[24]. - The company is expanding its market presence in Europe, targeting a 30% increase in market share by the end of 2023[24]. - A strategic acquisition of a biotech firm was completed, enhancing the company's R&D capabilities and expected to contribute an additional 200 million RMB in revenue annually[24]. - The company is focusing on regulatory approvals for its key products, with an aim to secure at least three new drug approvals by the end of 2022[24]. - The company has initiated a partnership with a leading research organization to accelerate the development of its pipeline products[24]. - The company has signed 6 formal agreements and 2 framework agreements for the commercialization of products in overseas markets, with a total agreement amount of 1.598 billion RMB for technology licensing cooperation[69]. - The company has signed three external technology licensing agreements for clinical development products, with a total agreement amount of RMB 1.598 billion, which includes revenue sharing post-product launch[127]. - The company is focused on building a global commercialization system to enhance the market presence of its products[174]. - The marketing strategy emphasizes a dual approach of specialized academic promotion in core cities and refined recruitment of partners in non-core cities[176]. Risks and Challenges - The company faces risks related to centralized procurement of biological products, which could lower sales prices and gross margins, impacting profitability[7]. - The report includes a risk statement regarding forward-looking statements, cautioning investors about potential investment risks[14]. - The company faces risks from rapid technological advancements in the life sciences sector, which could impact the competitiveness and commercial value of its products[183]. - The company's future sales revenue will depend on market promotion efforts and acceptance of its products by doctors and patients, which may not meet growth expectations[182]. - The company has submitted drug registration applications for its self-developed products 9MW0311 and 9MW0321, with expected approval in 2023; failure to obtain approval could adversely affect sales revenue[185]. Workforce and Operational Capacity - The company plans to increase its workforce by 15% to support its growth strategy and enhance operational capabilities[24]. - As of June 30, 2022, the company employed 917 people, with 488 in R&D, representing 53.22% of the workforce, and 24.65% holding master's degrees or higher[10]. - The average salary of R&D personnel is 29.45 million, up from 28.92 million in the previous year[158]. - The company has a proactive approach to industrial preparation, with facilities compliant with international standards and a complete drug production quality management system[163]. - The company has established a marketing system with a dedicated sales team for rheumatology, oncology, and chronic diseases, and has completed the team for the rheumatology product line[68]. Production and Quality Management - The production facility in Taizhou has been built to meet GMP standards from China, FDA cGMP, and EU EMA GMP, with a capacity of 4,000L for antibody drugs, expandable to 8,000L, and 4,000L for recombinant protein drugs[64]. - The Shanghai Jinshan production base has initiated a project for an annual production capacity of 1,000kg of antibodies, covering an area of 69,700 square meters, and is expected to start trial production in the first half of 2023[65]. - The company has established a comprehensive drug production quality management system, achieving compliance with China GMP, FDA cGMP, and EU EMA GMP standards, with a production capacity of 4,000L for antibody drugs, expandable to 8,000L[113]. - The company has implemented a procurement management system that includes online approval processes for procurement requests, negotiations, contracts, and payments, enhancing efficiency and compliance[109]. - The company has optimized its supplier management system, focusing on quality management measures to improve supplier product and service quality while reducing costs and risks[110]. - The company has established a quality management system compliant with post-marketing commercial production requirements, marking its capability for commercial production of listed drugs[142].

2022 年第一季度报告 单位：元 币种：人民币 证券代码：688062 证券简称：迈威生物 迈威（上海）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 | 4,067,989.0 ...

Financial Performance - The company reported a significant increase in revenue, achieving a total of $500 million for the fiscal year, representing a 25% year-over-year growth[23]. - The company's operating revenue for 2021 was CNY 1,622.62 million, representing a 206.03% increase compared to CNY 530.22 million in 2020[37]. - The net profit attributable to shareholders for 2021 was a loss of CNY 76,958.67 million, compared to a loss of CNY 64,254.54 million in 2020[37]. - The net cash flow from operating activities for 2021 was a negative CNY 42,240.30 million, an improvement from a negative CNY 51,498.74 million in 2020[37]. - The total assets as of the end of 2021 were CNY 159,527.29 million, a decrease of 2.66% from CNY 163,889.71 million at the end of 2020[37]. - The net assets attributable to shareholders decreased by 31.27% to CNY 101,080.45 million at the end of 2021 from CNY 147,066.07 million at the end of 2020[37]. - The basic earnings per share for 2021 was -2.57 RMB, compared to -2.26 RMB in 2020[40]. - The weighted average return on equity was -63.62% in 2021, down from -44.82% in 2020[40]. Research and Development - The company reported a research and development expenditure of 622.51 million yuan in 2021, an increase of 7.08% compared to 2020[5]. - The company has invested significantly in clinical research and trials, with R&D expenses of 363.04 million yuan in 2019, 581.33 million yuan in 2020, and 622.51 million yuan in 2021[6]. - The company has multiple projects in clinical stages, including 9MW0113, which has reached the market stage with a total investment of ¥12,993.23 million[195]. - The project 9MW0321 has a total investment of ¥33,004.18 million and is currently at the NDA stage, targeting new drug market entry[195]. - The company continues to prioritize R&D investment to advance its clinical research and trials, reflecting a commitment to innovation and market expansion[192]. - The company has established a comprehensive technology system for drug development, including high-expression cell line construction and quality control systems[155]. - The company has achieved significant research progress with multiple products advancing to clinical research stages during the reporting period[51]. - The company has established a robust internal control system for R&D projects, ensuring effective monitoring and evaluation of progress and feasibility[118]. Product Development and Pipeline - As of the report date, the company has 1 commercialized product and 14 products under development, including 11 innovative drugs and 4 biosimilars[5]. - The company has a total of 14 products in its pipeline, which require substantial ongoing R&D investment[6]. - Clinical trials for two key products are on track, with expected completion dates in Q4 2022[26]. - The company has completed the clinical sample preparation for 8 in-development products, with a total of 38 batches of raw liquid produced[67]. - The company has signed 4 formal agreements and 6 framework agreements for overseas market promotion of three products, with a total agreement amount of CNY 1.598 billion, which includes revenue sharing from post-market sales[61]. - The company has received clinical trial approvals for multiple drug candidates, including 6MW3211 and 9MW2821, with 6MW3211 obtaining approvals from both China's NMPA and the US FDA in July and August 2021 respectively[181]. Market Strategy and Expansion - The company is expanding its market presence in Europe, targeting a 15% market share by 2025[26]. - The company has a clear strategy for overseas market expansion, leveraging local partnerships for resource and capital access[114]. - The company is focusing on a dual-line business layout for marketing, combining a specialized academic promotion team in core cities with a refined recruitment team for non-core cities[131]. - The company is leveraging commercial health insurance to support the high return lifecycle of innovative drugs, with the "Hui Min Bao" program providing higher-level medical expense reimbursement[136]. Financial Risks and Challenges - The company has not achieved profitability since its establishment and continues to have cumulative losses, which may expand in the future due to ongoing high R&D investments[5]. - The company is at risk of cash flow tightness if operational expenses exceed available external financing[5]. - The company faces risks related to the approval of its self-developed drugs 9MW0311 and 9MW0321, which are expected to receive approval in 2023[6]. - The company emphasizes the risk of reduced product pricing and gross margins due to potential participation in centralized procurement for biological products[9]. Technological Advancements - The automated high-throughput hybridoma antibody discovery platform significantly enhances the success rate of antibody discovery, achieving a binding affinity of less than 10^-10 M[156]. - The efficient B lymphocyte screening platform can identify over 100,000 antigen-specific B lymphocytes from a pool of 1 billion, with a positive rate exceeding 90%[161]. - The company has developed a unique primary culture technology for stable antibody sequence screening, allowing for the cloning and selection of antigen-specific B lymphocytes, enhancing the reliability and efficiency of antibody development[162]. - The ADC drug development platform utilizes two advanced conjugation technologies, enabling the development of ADC drugs with improved uniformity and simplified quality control, enhancing therapeutic windows[170]. Regulatory and Compliance - The company has established a quality management system covering the entire product lifecycle based on Chinese GMP, FDA cGMP, and EU GMP standards[124]. - The production of clinical samples is primarily handled by the subsidiary Taikang Bio, which has obtained production licenses and adheres to EU GMP, FDA cGMP, and China GMP standards[121]. - The company has developed analysis techniques compliant with Chinese, American, and European pharmacopoeias, facilitating international drug registration[179].