证券代码：688192 证券简称：迪哲医药 公告编号：2024-23 （一）会议召开时间：2024 年 5 月 20 日下午 15:00-17:00 迪哲（江苏）医药股份有限公司关于参加 2023 年度 科创板制药专场业绩说明会的公告 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： 迪哲（江苏）医药股份有限公司（以下简称"公司"）已于 2024 年 4 月 30 日发布公司 2023 年年度报告，为便于广大投资者更全面深入地了解公司 2023 年年度经营成果、财务状况，公司计划于 2024 年 5 月 20 日下午 15:00-17:00 举 行 2023 年年度业绩说明会，就投资者关心的问题进行交流。 一、说明会类型 本次投资者说明会以网络互动形式召开，公司将针对 2023 年年度的经营成 果及财务指标的具体情况与投资者进行互动交流和沟通，在信息披露允许的范 围内就投资者普遍关注的问题进行回答。 会议召开时间：2024 年 5 月 20 日（星期一）下午 15:00-17:00 会 议 召 开 地 点 ...

华泰联合证券有限责任公司 关于迪哲（江苏）医药股份有限公司 2023年年度持续督导跟踪报告 | 保荐机构名称：华泰联合证券有限责任公司 | 被保荐公司简称：迪哲医药 | | --- | --- | | 保荐代表人姓名：许超 | 联系电话：010-56839300 | | 保荐代表人姓名：丁明明 | 联系电话：010-56839300 | 根据《证券法》、《证券发行上市保荐业务管理办法》和《上海证券交易所科 创板股票上市规则》等有关法律、法规的规定，华泰联合证券有限责任公司（以 下简称"华泰联合证券"或"保荐机构"）作为迪哲（江苏）医药股份有限公司 （以下简称"迪哲医药"或"公司"）2023 年度向特定对象发行 A 股股票的保 荐机构，承接公司首次公开发行的原保荐机构中信证券股份有限公司未完成的持 续督导工作，对迪哲医药进行持续督导，并出具本年度持续督导跟踪报告。 一、保荐机构和保荐代表人发现的问题及整改情况 无。 二、重大风险事项 （一）尚未盈利的风险 创新药研发时限长、资金投入大、盈利周期长。公司作为一家全球创新型生 物医药企业，正处于重要研发投入期，针对不同靶点研制多款产品。报告期（指 2023 年度，下 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2024-22 本公司董事会及全体董事保证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： 迪哲（江苏）医药股份有限公司 关于公司董事、高级管理人员增持股份计划 实施完毕暨增持结果的公告 P A G E 增持计划的基本情况：迪哲（江苏）医药股份有限公司（以下简称"公 司"）董事长兼首席执行官张小林博士，董事会秘书、首席财务官吕洪斌 先生以及副总经理、首席商务官吴清漪女士基于为践行以"以投资者为本" 的上市公司发展理念，维护公司全体股东利益，基于对公司未来发展前景 的信心、对公司价值的认可和切实履行社会责任，计划使用自有资金或自 筹资金，自 2024 年 1 月 31 日起 6 个月内，通过上海证券交易所交易系统 允许的方式（包括但不限于集中竞价、连续竞价和大宗交易等）增持公司 A 股股份，合计增持金额不低于人民币 650 万元且不超过人民币 1,300 万 元，以维护公司股价稳定，树立良好的市场形象。本次增持计划的具体内 容详见公司 2024 年 1 月 31 日于上海证券交易所网站 ...

Investment Rating - The report maintains a "Buy" rating for the company, indicating a positive outlook based on expected performance relative to market indices [10][15]. Core Insights - The company is focused on translational medicine, specializing in the development of innovative drugs and breakthrough therapies, with a robust product pipeline that enhances its competitive edge in the industry [10][25]. - The sales of Shuwotini have exceeded expectations, with significant revenue growth anticipated from ongoing global clinical developments and the introduction of new products [22][31]. - The financial forecasts for the company indicate expected EPS of -2.25 yuan, -1.40 yuan, and -0.12 yuan for the years 2024 to 2026, respectively [10][25]. Financial Summary - For the fiscal year 2023, the company reported total revenue of 0.91 billion yuan and a net loss attributable to shareholders of -11.08 billion yuan, compared to a loss of -7.36 billion yuan in the previous year [20][33]. - In Q1 2024, the company achieved revenue of 0.81 billion yuan, reflecting a quarter-on-quarter increase of 58.87%, with a net loss of -2.24 billion yuan [27][31]. - The gross margin for Q4 2023 was 97.06%, with a decrease in various expense ratios indicating a potential for improved operational efficiency as revenue grows [29][31]. Product Development and Pipeline - Shuwotini has received regulatory approval for the treatment of non-small cell lung cancer (NSCLC) and has shown promising clinical data, positioning it as a leading option in its category [22][35]. - The company is advancing its pipeline with DZD8586, which has demonstrated potential in treating resistant forms of blood cancers, and DZD6008, which has entered clinical trials for lung cancer [35][36].

Financial Performance - The company's operating revenue for Q1 2024 was RMB 81,318,560.00[21] - The net profit attributable to shareholders of the listed company was a loss of RMB 224,234,890.87[21] - The net profit attributable to shareholders after deducting non-recurring gains and losses was a loss of RMB 254,748,635.69[21] - The basic and diluted earnings per share were both negative RMB 0.54[21] - Net profit for Q1 2024 was a loss of CNY 224,234,890.87, compared to a loss of CNY 239,523,659.32 in Q1 2023, showing a slight improvement[49] - Basic and diluted earnings per share for Q1 2024 were both CNY -0.54, compared to CNY -0.59 in Q1 2023[50] Cash Flow - The net cash flow from operating activities was a negative RMB 126,071,888.78[21] - Net cash inflow from operating activities in Q1 2024 was CNY 125,113,639.21, compared to CNY 11,119,984.71 in Q1 2023[37] - Cash outflow from operating activities totaled $251,185,527.99, an increase from $214,333,920.75 in the previous period[53] - Net cash flow from operating activities was -$126,071,888.78, improving from -$203,213,936.04 year-over-year[53] - The total cash inflow from other operating activities in Q1 2024 was CNY 28,651,415.21, compared to CNY 5,548,147.78 in Q1 2023[37] Assets and Liabilities - Total assets amounted to RMB 1,552,238,258.99, an increase from RMB 1,496,378,567.44 in the previous period[16] - Total liabilities increased to RMB 855,645,592.62 from RMB 647,751,151.64[17] - Current assets totaled RMB 978,932,665.10, compared to RMB 910,361,387.23 in the previous period[16] - Non-current assets decreased to RMB 573,305,593.89 from RMB 586,017,180.21[16] - Equity attributable to shareholders decreased by 17.92% to ¥696,592,666.37 from ¥848,627,415.80 at the end of the previous year[22] Research and Development - Total R&D investment reached ¥204,770,425.91, representing a year-on-year increase of 30.75%[22] - Research and development expenses for Q1 2024 were CNY 204,770,425.91, up from CNY 156,614,796.50 in Q1 2023, indicating a 30.7% increase[47] Government Support - Government subsidies recognized in the current period amounted to ¥26,680,000.00, primarily from government support income[23] Shareholder Information - The total number of shareholders with voting rights was reported, with the top ten shareholders holding significant stakes[25] Cash and Cash Equivalents - The company’s cash and cash equivalents increased to ¥95,312,852.54 from ¥74,201,573.96 at the end of the previous year[30] - The ending balance of cash and cash equivalents increased to $95,037,852.54 from $85,008,536.02[54] - Total cash and cash equivalents increased by $21,111,278.58, contrasting with a decrease of $36,390,963.65 in the previous period[54] Operating Costs - Total operating costs for Q1 2024 were CNY 338,128,124.10, an increase from CNY 251,337,057.44 in Q1 2023, representing a 34.4% increase[47] - Sales expenses for Q1 2024 were CNY 91,500,983.93, compared to CNY 35,756,837.80 in Q1 2023, reflecting a 156.5% increase[47] Financial Investments - The company’s financial investments generated a fair value change gain of ¥3,833,744.82[22] Accumulated Deficit - The company reported an accumulated deficit of ¥2,737,799,757.84, compared to ¥2,513,564,866.97 in the previous year[33]

Financial Performance - The company has not yet achieved profitability and has accumulated losses as of December 31, 2023[3]. - The company's revenue for 2023 reached ¥91,288,640, a significant increase from ¥10,285,449.60 in 2021[21]. - The net profit attributable to shareholders for 2023 was -¥1,107,713,253.26, compared to -¥669,875,908.62 in 2021, indicating a worsening financial position[21]. - The net cash flow from operating activities for 2023 was -¥967,882,951.13, reflecting increased cash outflows compared to previous years[21]. - As of the end of 2023, the total assets decreased by 28.12% to ¥1,496,378,567.44 from ¥2,081,908,055.24 in 2022[21]. - The net assets attributable to shareholders fell by 51.74% to ¥848,627,415.80 at the end of 2023, down from ¥1,758,481,039.11 in 2022[21]. - The company reported a net profit excluding non-recurring gains and losses of -¥1,160,727,128.66 for 2023, worsening from -¥681,711,003.34 in 2021[21]. - The company reported a basic earnings per share of -2.72 CNY, compared to -1.82 CNY in the previous year, indicating a decline[23]. - The company reported a net loss attributable to shareholders of 239.52 million CNY in Q1, increasing to 314.70 million CNY in Q3[25]. - The company’s cash flow from operating activities was negative at CNY -967.88 million, primarily due to increased R&D and operational expenditures[113]. Research and Development - The company increased its R&D expenses significantly to advance registration clinical trials and expand its sales team for product promotion[3]. - The company invested CNY 806 million in R&D during the reporting period, a year-on-year increase of 21.23%[39]. - Research and development expenses accounted for 882.47% of operating revenue, reflecting a substantial investment in innovation[23]. - The company has established a comprehensive R&D platform, enhancing efficiency and reducing development time for new drugs[87]. - The company has established several core technology platforms for drug development, including a CNS metastasis research platform and a drug metabolism evaluation platform, enhancing the success rate of new drug development[74]. - The company has a robust pipeline with six globally competitive products, focusing on innovative therapies for malignant tumors and immune diseases[41]. - The company is focused on transitioning from research and development to commercialization, marking a significant milestone in its growth strategy[34]. - The company is currently not profitable, with ongoing high R&D expenditures and uncertainty regarding future sales revenue from its core products[90]. - The company incurred a research and development expense of 805.5985 million yuan during the reporting period, indicating a significant investment in product pipeline clinical and preclinical studies[105]. Product Development and Commercialization - The first commercial product, Shuwotai (舒沃替尼片), achieved sales revenue of RMB 91.29 million during the reporting period[3]. - The new drug application (NDA) for Golixitin (戈利昔替尼) was accepted by the NMPA in September 2023 and is under priority review[3]. - The company plans to expand its sales team and increase promotional efforts for Shuwozhe® following its market launch[34]. - Shuwozhe® achieved an objective response rate (ORR) of 60.8% in a clinical study involving 97 patients with EGFR Exon20ins mutation advanced NSCLC, demonstrating its efficacy and safety comparable to traditional EGFR TKIs[35]. - The NDA for Golixitinib, a selective JAK1 inhibitor for relapsed/refractory peripheral T-cell lymphoma (r/r PTCL), has been accepted by NMPA and is under priority review[37]. - The company launched the first-in-class targeted drug Shuwozhe® for advanced NSCLC with EGFR Exon20ins mutation, receiving NMPA approval in August 2023, marking it as the first innovative drug for this indication in China and the only one globally recognized as a breakthrough therapy by the FDA[68]. - The company is actively exploring the potential of Shuwozhe® in first-line treatment and in patients resistant to EGFR TKIs through multiple clinical studies[39]. - The company has established a competitive commercialization team for Shuwozhe® and increased its workforce to 581 employees, a growth of 77.13% year-on-year[40]. - The company is focused on developing new products and technologies to enhance its market position[21]. Market and Competitive Landscape - The global oncology drug market size grew from $128.1 billion in 2018 to $205.1 billion in 2022, with a projected growth to $458.6 billion by 2030, representing a CAGR of 12.5% from 2018 to 2022[58][59]. - The Chinese oncology drug market size increased from ¥157.5 billion in 2018 to ¥233.6 billion in 2022, with an expected growth to ¥586.6 billion by 2030, reflecting a CAGR of 10.3% from 2018 to 2022[63][64]. - The oncology drug market is driven by an increasing patient population, rising R&D investments, and supportive government policies[64][65]. - The innovative drug market is expanding rapidly, with increased investment in R&D and favorable domestic policies facilitating faster market entry for new drugs[72]. - Domestic innovative pharmaceutical companies are shifting focus from Me-too drugs to First-in-class and Best-in-class products, aligning with international drug development guidelines[72]. Governance and Management - The company emphasizes a "shareholder-centric" development philosophy, focusing on enhancing governance and operational efficiency[158]. - The board of directors has been reduced from 11 to 7 members, increasing the proportion of independent directors to enhance governance[161]. - The company has established various specialized committees under the board to improve governance and operational effectiveness[163]. - The company has a remuneration and assessment committee that oversees the compensation of directors and senior management[179]. - The company has established a sound governance system, enhancing its strategic development and internal auditing processes[164]. - The company has not reported any changes in the implementation of differential voting rights during the reporting period[167]. - The company faced disciplinary action from the Shanghai Stock Exchange due to long-term fund occupation by its controlling shareholder, resulting in a public reprimand[182]. Strategic Initiatives - The company is exploring potential acquisitions to further enhance its product offerings and market presence[170]. - The company is actively pursuing external investments and collaborations to enhance growth opportunities[185]. - The company plans to issue shares to specific investors, with a focus on technology innovation funding[184]. - A three-year shareholder return plan (2023-2025) was proposed, emphasizing sustainable returns[184]. - The company intends to improve its industrialization and commercialization capabilities by constructing a new production base and expanding its commercialization team[158].

证券代码：688192 证券简称：迪哲医药 公告编号：2024-13 迪哲（江苏）医药股份有限公司 自愿披露关于舒沃哲®一线治疗 EGFR 20 号外显子插入突 变型晚期非小细胞肺癌获美国 FDA 突破性疗法认定的公告 本公司董事会及全体董事保证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。 近日，迪哲（江苏）医药股份有限公司（以下简称"公司"）产品舒沃哲® （通用名：舒沃替尼）获美国食品药品监督管理局（以下简称"FDA"）"突破 性疗法认定（Breakthrough Therapy Designation）"，用于一线治疗携带表皮生长 因子受体（EGFR）20 号外显子插入（Exon20ins）突变的晚期非小细胞肺癌 （NSCLC）患者，这是继针对经治 EGFR Exon20ins 突变型晚期 NSCLC，舒沃 哲®成为肺癌领域首个获中、美双"突破性疗法认定"国创新药后的又一重要里 程碑。目前，舒沃哲®是唯一全线获 FDA 突破性疗法认定治疗 EGFR Exon20ins 突变型 NSCLC 的药物。 一、药品相关情况 EGFR Exon20ins ...

迪哲（江苏）医药股份有限公司 章 程 2024年3月 | | | | 第一章 | 总 | 则 2 | | --- | --- | --- | | 第二章 | | 经营宗旨和范围 3 | | 第三章 | 股 | 份 3 | | 第一节 | | 股份发行 3 | | 第二节 | | 股份增减和回购 5 | | 第三节 | | 股份转让 6 | | 第四章 | | 股东和股东大会 7 | | 第一节 | | 股东 7 | | 第二节 | | 股东大会的一般规定 9 | | 第三节 | | 股东大会的召集 14 | | 第四节 | | 股东大会的提案与通知 15 | | 第五节 | | 股东大会的召开 17 | | 第六节 | | 股东大会的表决和决议 20 | | 第七节 | | 累积投票制 24 | | 第五章 | | 董事会 25 | | 第一节 | | 董事 25 | | 第二节 | | 董事会 29 | | 第六章 | | 总经理及其他高级管理人员 33 | | 第七章 | | 监事会 35 | | 第一节 | | 监事 35 | | 第二节 | | 监事会 35 | | 第八章 | | 财务会计制度、利润 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2024-11 迪哲（江苏）医药股份有限公司 2024 年第一次临时股东大会决议公告 本公司董事会及全体董事保证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： 本次会议是否有被否决议案：无 | 1、出席会议的股东和代理人人数 | 43 | | --- | --- | | 普通股股东人数 | 43 | | 2、出席会议的股东所持有的表决权数量 | 329,673,064 | | 普通股股东所持有表决权数量 | 329,673,064 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的 | 79.3144 | | 比例（%） | | | 普通股股东所持有表决权数量占公司表决权数量的比例 | 79.3144 | | （%） | | （四） 表决方式是否符合《公司法》及公司章程的规定，大会主持情况等。 1 本次会议由公司董事会召集，采用现场投票和网络投票相结合的方式召开。会议 由董事长张小林博士主持。 （五） 公司董事、监事和董事会秘书的出席情况 1、 公司在任董事 7 人，出席 ...

北京市中伦律师事务所 关于迪哲（江苏）医药股份有限公司 2024 年第一次临时股东大会的 北京市中伦律师事务所 关于迪哲（江苏）医药股份有限公司 2024 年第一次临时股东大会的 法律意见书 致：迪哲（江苏）医药股份有限公司 法律意见书 二〇二四年三月 北京市朝阳区金和东路 20 号院正大中心 3 号南塔 22-31 层 邮编：100020 22-31/F, South Tower of CP Center, 20 Jin He East Avenue, Chaoyang District, Beijing l00020, P.R. China 电话/Tel : +86 10 5957 2288 传真/Fax : +86 10 6568 1022/1838 www.zhonglun.com 根据迪哲（江苏）医药股份有限公司（以下简称"公司"）与北京市中伦律 师事务所（以下简称"本所"）签订的《常年法律服务协议》的约定及受本所指 派，本所律师对公司 2024 年第一次临时股东大会（以下简称"本次股东大会"） 的合法性进行见证并出具法律意见。 本法律意见书根据《中华人民共和国公司法》（以下简称"《公司法》"）、 ...