证券代码：688192 证券简称：迪哲医药 （2022 年 6 月） 投资者关系 □特定对象调研 分析师会议 活动类别 □媒体采访 □业绩说明会 □新闻发布会 □路演活动 □现场参观 一对一沟通 其他（电话会议） 融通基金、华泰证券行业分析师、中信证券 2022ASCO 交流会、汇添富基 参与单位 迪哲（江苏）医药股份有限公司 投资者关系活动记录表 | --- | --- | |------------|----------------------------------------------------------------------------------------------------------------------------------------| | 及人员 | 金、鹏华基金、兴业证券分析师、国盛医药投资者交流会 | | 时间 | 2022 年 6 月 7 日， 6 月 8 日， 6 月 10 日， 6 月 14 日， 6 月 15 日 | | 地点 | 音频会议 | | 接待人员 | 迪哲医药董事长、首席执行官张小林博士 迪哲医药董事会秘书、财务总监吕洪斌 迪哲医药证券事务代表董 ...

Financial Performance - The net profit attributable to shareholders for the third quarter was -165,196,869.25 RMB, with a year-to-date total of -510,097,218.65 RMB[2] - The basic earnings per share for the third quarter was -0.41 RMB, and the diluted earnings per share was also -0.41 RMB[4] - The weighted average return on net assets for the third quarter was -8.07%, compared to -23.03% for the same period last year[4] - Net profit for Q3 2022 was a loss of ¥510,097,218.65, compared to a loss of ¥466,389,270.28 in Q3 2021, indicating a worsening of approximately 9.4%[18] - The company reported a basic and diluted earnings per share of -¥1.26 for Q3 2022, slightly improved from -¥1.30 in Q3 2021[19] Revenue and Expenses - The company has not yet commenced commercial production or sales for any of its research products, resulting in no revenue from sales[8] - Total revenue for the first three quarters of 2022 reached ¥6,619,152.00, compared to ¥5,800,609.08 in the same period of 2021[17] - Operating costs for the first three quarters of 2022 were ¥547,752,560.05, an increase from ¥475,720,288.67 in 2021, reflecting a year-over-year growth of approximately 15.1%[17] - Research and development expenses for the third quarter amounted to 151,076,338.85 RMB, representing a 1.02% increase compared to the same period last year[4] - Research and development expenses for the first three quarters of 2022 totaled ¥480,663,642.45, up from ¥407,288,810.30 in 2021, representing an increase of about 17.9%[17] - Management expenses increased by 33.23% year-to-date due to company expansion and increased personnel[8] Cash Flow - The net cash flow from operating activities for the third quarter was -141,087,822.00 RMB, with a year-to-date total of -421,450,780.29 RMB[4] - The company's cash flow from operating activities showed a significant decline, contributing to the overall net loss reported[18] - In the first three quarters of 2022, the cash inflow from operating activities totaled ¥77,623,965.11, a significant increase from ¥26,128,637.69 in the same period of 2021[20] - The cash outflow from operating activities reached ¥499,074,745.40, compared to ¥364,574,934.34 in the previous year, resulting in a net cash flow from operating activities of -¥421,450,780.29[20] Assets and Liabilities - Total assets at the end of the reporting period were 2,267,628,907.88 RMB, a decrease of 17.41% from the previous year[4] - The company's total current assets decreased from RMB 2,112,337,442.79 at the end of 2021 to RMB 1,644,289,196.26 as of September 30, 2022, representing a decline of approximately 22.2%[14] - The company's total liabilities as of Q3 2022 amounted to ¥300,403,755.22, compared to ¥282,911,205.38 in the previous year, marking an increase of approximately 6.4%[16] - The total equity attributable to shareholders decreased to ¥1,967,225,152.66 in Q3 2022 from ¥2,462,845,979.46 in Q3 2021, a decline of about 20.1%[16] Investments and Subsidies - The company reported a significant increase of 2013.03% in investment income year-to-date, primarily from holding IPO fundraising[8] - The company received government subsidies amounting to 1,800,000.00 RMB during the third quarter, with a total of 3,919,137.00 RMB year-to-date[5] - The cash inflow from investment activities was ¥6,755,055,010.28, a substantial rise from ¥397,659,754.50 year-over-year[21] - The cash outflow from investment activities amounted to ¥6,547,990,011.83, compared to ¥308,129,534.36 in the same period last year, leading to a net cash flow from investment activities of ¥207,064,998.45[21] - The company reported a significant increase in cash received from investment income, totaling ¥29,863,735.94, compared to ¥1,659,754.50 in the previous year[21] Shareholder Information - The total number of common shareholders at the end of the reporting period was 18,377, with the largest shareholder holding 26.95% of shares[9] - The company’s largest shareholder, ZYTZ and its concerted action party, Wuxi Dize, collectively hold 15.49% of the shares[11] Product Development - The company's leading product, DZD9008, achieved a confirmed clinical trial objective with a cORR of 59.8% for patients with EGFR Exon 20 insertion mutation advanced non-small cell lung cancer[12] - The company received a drug production license from the Jiangsu Provincial Drug Administration, ensuring qualifications for future product commercialization[12]

Financial Performance - The company's operating income for the first half of 2022 was CNY 3,099,744.00, with a net profit attributable to shareholders of CNY -344,900,349.40, compared to CNY -298,577,103.08 in the same period last year[17]. - The net assets attributable to shareholders decreased by 13.61% to CNY 2,127,769,659.72 from CNY 2,462,845,979.46 at the end of the previous year[17]. - Total assets decreased by 12.56% to CNY 2,400,924,004.11 from CNY 2,745,757,184.84 at the end of the previous year[17]. - The basic earnings per share for the first half of 2022 was -CNY 0.85, compared to -CNY 0.83 in the same period last year[18]. - The weighted average return on net assets was -15.03%, an improvement from -31.65% in the same period last year[18]. - The net loss attributable to shareholders increased by 46,323,200 RMB compared to the same period last year, with a net loss excluding non-recurring items increasing by 70,185,700 RMB[116]. - The total comprehensive loss for the first half of 2022 was -344,895,521.51 CNY, compared to -294,720,849.23 CNY in the same period of 2021, reflecting a decline of about 17%[173]. Research and Development - The company reported R&D expenses of 330 million RMB for the first half of 2022, an increase of 27.88% compared to the same period last year[3]. - The company has increased its R&D investment significantly, leading to higher R&D expenses as it progresses with new product development and clinical trials[18]. - The company’s R&D investment accounted for a significant portion of its operating income, reflecting its commitment to advancing its product pipeline[18]. - The company is focusing on launching new products and advancing them into clinical trials, which requires substantial R&D investment[19]. - The company has established a comprehensive small molecule drug R&D system, leveraging the experience of its R&D team and core technical personnel[65]. - The company has established multiple core technology platforms in the field of small molecule innovative drug development, enhancing the success rate of new drug research and development[66]. - The company has established an integrated R&D capability covering innovative drug discovery to late-stage development, with plans to invest in independent commercial production and R&D facilities in China[37]. Product Pipeline and Clinical Trials - The company is actively developing a pipeline targeting various disease treatments, indicating potential future losses if clinical trials fail or regulatory approvals are not obtained[3]. - The core products are still in the clinical development stage and have not yet commenced commercial production or sales[3]. - The company has five innovative drugs in global clinical stages and multiple candidates in preclinical research, achieving significant milestones[24]. - The drug Shuwotini, a specific EGFR-TKI, is the first and only drug in the lung cancer field recognized as a "breakthrough therapy" by both China and the US[25]. - The company’s drug Golixitinib is the first specific JAK1 inhibitor in global registration clinical stages, recently receiving FDA "fast track designation" for treating r/r PTCL[28]. - The clinical trial for Golixtyne in r/r PTCL demonstrated a duration of response exceeding 14 months, indicating its potential as a new targeted therapy[30]. - The company is currently in the clinical trial phase for its products and has not yet generated sales revenue, but is developing detailed commercialization strategies aligned with product registration timelines[43]. Financial Position and Cash Flow - The net cash flow from operating activities was CNY -280,362,958.29, compared to CNY -240,770,847.23 in the same period last year[17]. - The company’s cash flow from operating activities showed a net outflow of 280,362,958.29 RMB, reflecting increased R&D expenditures[117]. - The company’s cash and cash equivalents decreased due to payments for daily operating activities[119]. - The company reported cash inflows from investment activities totaling 4,182,441,045.35 CNY, a substantial increase from 334,509,203.96 CNY in the previous year[177]. - The cash outflow for investment activities was 4,075,827,702.92 CNY, compared to 244,882,687.73 CNY in the same period last year, indicating a significant increase in investment spending[177]. Risks and Challenges - The company faces risks related to the potential failure of drug candidates in clinical trials and market acceptance[3]. - The company anticipates continued high levels of R&D expenditure as it progresses through clinical trials and prepares for new drug launches[96]. - The company is at risk of losing core technical personnel, which could adversely affect its R&D and commercialization goals[99]. - The company may face increased operational costs due to rising prices of R&D services and materials, impacting its profitability[105]. - The company relies on external financing for operational funding, and any shortfall could delay or cancel R&D projects, adversely affecting its business outlook[107]. Corporate Governance and Compliance - The company has established management practices for waste disposal, ensuring compliance with environmental regulations[127]. - The company strictly adheres to animal welfare standards during animal testing and has received AAALAC International certification[128]. - The company has made commitments regarding share restrictions and intentions to reduce holdings, with a lock-up period extended by 6 months for major shareholders[131]. - The company has implemented measures to avoid competition with peers, with commitments being effective long-term since December 2020[132]. - The financial statements for the first half of 2022 were approved by the board of directors on August 25, 2022[194]. Market Trends and Industry Insights - The global annual new cancer cases increased from 16.8 million in 2015 to 18.5 million in 2019, with a projected CAGR of 2.5% from 2019 to 2024, reaching 21.0 million by 2024[46]. - The global oncology drug market grew from $83.2 billion in 2015 to $143.5 billion in 2019, representing a CAGR of 14.6%, and is projected to reach $244.4 billion by 2024[49]. - The increase in patient numbers and clinical demand, along with favorable policies, are key drivers for the growth of the oncology drug market in China[54][56].

2022 年第一季度报告 单位：元 币种：人民币 证券代码：688192 证券简称：迪哲医药 迪哲（江苏）医药股份有限公司 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 | 0 | 不适用 | | ...

Financial Performance - In 2021, the company's operating revenue was CNY 10,285,449.60, a decrease of 62.95% compared to CNY 27,760,807.05 in 2020[26]. - The net profit attributable to shareholders was a loss of CNY 669,875,908.62, compared to a loss of CNY 586,611,893.63 in the previous year[26]. - The company's total assets increased by 132.29% to CNY 2,745,757,184.84 at the end of 2021, up from CNY 1,182,015,945.62 in 2020[26]. - The net assets attributable to shareholders rose by 128.27% to CNY 2,462,845,979.46, compared to CNY 1,078,910,121.54 in 2020[26]. - The basic earnings per share for 2021 was -CNY 1.86, compared to -CNY 1.63 in 2020[27]. - The net cash flow from operating activities was a negative CNY 492,277,560.57, worsening from a negative CNY 410,012,499.16 in 2020[26]. - The company reported a net loss attributable to ordinary shareholders of 669.88 million yuan for 2021, with a net loss of 681.71 million yuan after excluding non-recurring gains and losses, indicating an increase compared to the previous year due to increased clinical pipeline R&D investment[127]. - The company's revenue for the reporting period decreased by CNY 17.4754 million, a decline of 62.95%, primarily due to reduced technical support services provided to AZAB and its affiliates[146]. Research and Development - The company reported a research and development expenditure of RMB 588 million in 2021, representing a 33.7% increase compared to the previous year[4]. - The research and development expenditure as a percentage of operating revenue was 5712.89%, significantly higher than 1583.15% in 2020, indicating a substantial increase in R&D investment[28]. - The company has established a complete small molecule drug R&D system, leveraging the accumulated expertise of its R&D team to enhance its core competitiveness in innovative drug development[95]. - The company has established multiple core technology platforms in the field of small molecule innovative drug development, enhancing the success rate of new drug research and development[96]. - The company has established a comprehensive drug development risk assessment framework based on five principles, enhancing decision-making efficiency and increasing the success rate of R&D projects[88]. - The company has made significant breakthroughs in drug design, including the development of AZD3759, which penetrates the blood-brain barrier for lung cancer treatment[98]. - The company has established a comprehensive R&D system that spans from molecular design to clinical validation for tumors affecting the central nervous system[98]. - The company aims to select 2 to 3 clinical candidates for further development after rigorous toxicology assessments[105]. - The R&D team has extensive experience, with key members having nearly 20 years in multinational pharmaceutical companies[104]. - The company has established a global synchronized development model for its innovative product pipeline, which includes five innovative drugs in global clinical stages targeting major diseases with significant unmet medical needs[123]. Product Development and Clinical Trials - The main products DZD9008 and DZD4205 are undergoing critical Phase II clinical trials, with uncertain outcomes affecting potential conditional market approval[6]. - DZD9008, an oral small molecule targeted drug for non-small cell lung cancer, entered the critical Phase II clinical trial stage in 2021, having received "Breakthrough Therapy" designation from both China's CDE and the US FDA[38]. - DZD4205, a selective JAK1 inhibitor, is the first of its kind to enter Phase II clinical trials for T-cell lymphoma, with preliminary safety and efficacy results reported[39]. - DZD1516, a targeted drug for HER2-positive breast cancer, has entered global Phase I clinical trials, demonstrating the ability to penetrate the blood-brain barrier[40]. - DZD2269, a selective A2a receptor antagonist, has initiated a Phase I international clinical trial for metastatic castration-resistant prostate cancer, showing significant activity in high adenosine concentrations[57]. - DZD8586 is a globally innovative drug developed for the treatment of tumors and other significant diseases, with clinical trials for relapsed refractory B-cell non-Hodgkin lymphoma (NHL) initiated in China and healthy subject trials ongoing in the U.S.[58]. - DZD9008 and DZD4205 are currently in international multi-center Phase II pivotal clinical trials, while DZD1516, DZD2269, and DZD8586 have initiated international multi-center Phase I clinical trials[118]. - The company has received regulatory approval for multiple clinical trial applications, including DZD4205 and DZD9008, from the National Medical Products Administration[174]. Commercialization and Market Strategy - The company lacks experience in commercializing products, which may hinder the transition from clinical advantages to market recognition[7]. - The company is establishing a commercial sales team and production layout, with plans to build a competitive global product pipeline and seek partnerships for commercialization in key markets[43]. - The company plans to adopt a contract manufacturing organization (CMO) model for early-stage commercialization and is initiating the construction of its own production base to enhance quality control[44]. - The company plans to adopt a combination of self-built teams and external partnerships for global commercialization, with intentions to build its own sales team in key markets like the U.S.[65]. - The company is focused on maintaining its competitive edge in the oncology field through continuous exploration of new drug targets and compounds[189]. - The company is actively pursuing market expansion strategies and evaluating potential mergers and acquisitions to enhance its product pipeline[175]. Governance and Management - The company has established specialized committees under the board, including a strategy committee, audit committee, compensation and assessment committee, and nomination committee, enhancing governance practices[196]. - The management team consists of 9 senior executives, including a chairman who also serves as the general manager, ensuring effective daily operations and governance[196]. - The board of directors consists of 11 members, including 4 independent directors, and held 4 meetings during the reporting period, all conducted in accordance with regulations[196]. - The supervisory board is composed of 3 members, including 1 employee supervisor, and held 4 meetings during the reporting period, ensuring compliance with legal requirements[196]. - There are no significant discrepancies between the company's governance practices and the regulations set forth by relevant laws and the China Securities Regulatory Commission[195]. - The company has established clear responsibilities and effective checks and balances within its governance structure[195]. Risks and Challenges - The company faces risks related to the commercialization of its drugs, including potential delays in market entry and regulatory approvals[6]. - The company faces risks related to technological upgrades and product iterations, as competitors may develop superior innovative drugs that could impact the market value of its pipeline products[128]. - The company relies heavily on core technical personnel for R&D, facing risks of talent loss and potential financial impact due to increased compensation needs[129]. - The ongoing COVID-19 pandemic may delay clinical trials and impact patient recruitment, affecting R&D timelines[145]. - Regulatory changes in the pharmaceutical industry may pose risks to company operations and market adaptability[141]. - Potential price reductions for drugs due to national healthcare policies could negatively affect future product revenues[142]. - The dynamic adjustment mechanism for the medical insurance catalog may influence product pricing and market access post-launch[143].