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 投资者关系活动记录表 | --- | --- | --- | |------------|-------------------------------|------------------------------------------------------------| | | | （ 2024 年 8 月 -9 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） | | | 出席单位 | | 中信证券，兴业证券，浙商证券，华西证券，东吴证券，国海证 | | 及人员 | | 券，申万宏源证券，广发证券，国联证券，东北证券，平安基金， | | | | 易方达，汇添富，富国基金，鹏华基金，中欧基金，朱雀基金，摩 | | | 根基金等 | | | 时间 | 2024 年 8 月 6 日-9 | 月 18 日 | | 地点 | 线上会议及公司会议室 | | | 接 ...

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 投资者关系活动记录表 | --- | --- | --- | |------------|------------------------------|-------------------------------------------------------------------------| | | | | | | （ | 2024 年 9 月 18 日） | | 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） | | | 出席单位 | 2024 | 年半年度科创板制药及生物制品专场集体业绩说明会 | | 及人员 | | | | 时间 | 2024 年 9 月 18 日 | 14：00-16 ： 00 | | 地点 | roadshow.sseinfo.com/ | 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： http:// ） | | ...

自愿披露关于舒沃哲®全球注册临床研究亚组数据获选 2024 年欧洲肿瘤内科学会（ESMO）大会报告的公告 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"）在 2024 欧洲 肿瘤内科学会（ESMO）大会公布了舒沃哲®（通用名：舒沃替尼片）国际多中心 注册临床研究"悟空 1 B"（WU-KONG1B）最新全球亚组数据，其中非亚裔患 者占比超过 40%。研究结果显示，舒沃哲®针对经治 EGFR 20 号外显子插入突变 证券代码：688192 证券简称：迪哲医药 公告编号：2024-35 （Exon20ins）非小细胞肺癌（NSCLC），无论患者的突变亚型、人种、地区、 基线脑转移、既往接受埃万妥单抗或免疫治疗的情况如何，均显示出强效持久的 抗肿瘤疗效和良好的安全性，研究结果在全球范围内具有代表性。 迪哲（江苏）医药股份有限公司 截至 2024 年 3 月 22 日，疗效分析集共纳入 107 例患者，涵盖至少 33 种 EGFR Exon20ins 亚型。研究结果显示： ● 根 ...

公司代码：688192 公司简称：迪哲医药 迪哲（江苏）医药股份有限公司 2024 年第二次临时股东大会会议资料 | 2024 | 年第二次临时股东大会会议须知 | 1 | | --- | --- | --- | | 2024 | 年第二次临时股东大会会议议程 | 3 | | 一、 | 关于变更 2024 | 年度会计师事务所的议案 5 | 迪哲（江苏）医药股份有限公司 2024 年第二次临时股东大会会议须知 为维护全体股东的合法权利，确保股东大会的正常秩序和议事效率，保证 大会的顺利进行，根据《中华人民共和国公司法》《中华人民共和国证券法》 《上市公司股东大会规则（2022 年修订）》以及《迪哲（江苏）医药股份有限 公司章程》《迪哲（江苏）医药股份有限公司股东大会议事规则》等相关规定， 迪哲（江苏）医药股份有限公司（以下简称"公司"）特制定 2024 年第二次临时 股东大会会议须知： 一、为确认出席大会的股东或其代理人或其他出席者的出席资格，会议工 作人员将对出席会议者的身份进行必要的核对工作，请被核对者予以配合。 二、为保证本次大会的严肃性和正常秩序，切实维护股东的合法权益，请 出席大会的股东或其代理人或 ...

无。 二、重大风险事项 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 2024 年半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 | 被保荐公司简称：迪哲（江苏）医药股份有限公 | | --- | --- | | 公司 | 司 | | 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"）向特定对象发行股票的保荐机构，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 （一）尚未盈利的风险 报告期内，公司尚未盈利，主要原因系公司尚处于商业化早期且多数产品仍 处于药物研发阶段，持续投入大量研发费用。公司进展最快的产品管线舒沃哲® 1 ...

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： 证券代码：688192 证券简称：迪哲医药 公告编号：2024-34 公司已于 2024 年 8 月 30 日发布公司 2024 年半年度报告，为便于广大投资 者更全面深入地了解公司 2024年半年度经营成果、财务状况，公司将于 2024年 9 月 18 日下午 14:00-16:00 参加由上海证券交易所主办的 2024 年半年度科创板 制药及生物制品专场集体业绩说明会，此次活动将采用网络文字互动的方式举 行，投资者可登录上海证券交易所上证路演中心（http://roadshow.sseinfo.com/） 参与线上互动交流。 迪哲（江苏）医药股份有限公司关于参加 2024 年半年度科创板制药及生物制品专场集体 业绩说明会的公告 会议召开时间：2024 年 9 月 18 日（星期三）14:00-16:00 会议召开地点：上海证券交易所上证路演中心 （网址：http://roadshow.sseinfo.com/） 会议召开方式：网络文字互动 投资者可于 ...

Investment Rating - The report gives a "Buy" rating for the company, indicating a positive outlook for its future performance [2][30]. Core Insights - The company has entered a phase of rapid development in both research and commercialization, with two leading products, Shuwotini and Golixitinib, having received approval for sale in China [2][30]. - The sales of Shuwotini have shown strong growth, achieving sales revenue of 0.91 billion CNY within four months of its launch and exceeding 2 billion CNY in the first half of 2024, with a growth rate of over 50% for two consecutive quarters [1][12]. - The company is expanding its research team and increasing R&D investment, with R&D expenses reaching 3.83 billion CNY in the first half of 2024, a year-on-year increase of 11.7% [1][12]. - Shuwotini has been included in the CSCO guidelines and is progressing well in global development, with ongoing clinical trials in multiple regions [1][12]. - Golixitinib has also been approved for sale, addressing treatment gaps in PTCL, with a reported ORR of 44% in clinical trials [19][20]. Summary by Sections Financial Performance - In the first half of 2024, the company reported revenue of 2.04 billion CNY, with a net loss of 3.45 billion CNY, narrowing by 32.96% year-on-year [1][12]. - The company expects revenues of 4.51 billion CNY, 9.48 billion CNY, and 16.47 billion CNY for 2024, 2025, and 2026 respectively, with net losses projected at -7.96 billion CNY, -5.16 billion CNY, and -2.94 billion CNY [2][30]. Product Development - Shuwotini is the first approved targeted therapy for EGFR Exon20ins NSCLC, with clinical data showing an ORR of 61% for second-line treatment [15][16]. - Golixitinib is the first high-selectivity JAK1 inhibitor for PTCL, with a CR rate of 24% and a mDoR of 20.7 months in clinical trials [19][20]. Valuation Analysis - The DCF valuation model estimates the company's reasonable market value at 217.48 billion CNY, with a sensitivity range of 188.70 to 255.77 billion CNY [30].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has reported a significant increase in revenue, achieving 204 million yuan in the first half of 2024, compared to no revenue in the same period of 2023. The net profit attributable to shareholders was -345 million yuan, showing a reduction in losses year-on-year [2] - The company is expected to see accelerated revenue growth as its product pipeline continues to expand and adapt to new indications, with projected revenues for 2024, 2025, and 2026 being 471 million yuan, 1.049 billion yuan, and 1.646 billion yuan respectively [6][7] - The company’s drug, Shuwotini, has been included in the CSCO guidelines and is expected to continue its growth in sales due to its unique position as the only approved targeted therapy for EGFR Exon20ins NSCLC [4] Summary by Sections Financial Performance - In the first half of 2024, the company achieved revenue of 204 million yuan, with a net profit of -345 million yuan, indicating a year-on-year reduction in losses [2] - The projected revenues for the next three years are 471 million yuan in 2024, 1.049 billion yuan in 2025, and 1.646 billion yuan in 2026, reflecting a growth rate of 416% in 2024 [6][7] Product Pipeline - The company’s drug, Shuwotini, received approval in August 2023 and has been recommended as a first-line treatment in the CSCO guidelines, which is expected to drive sales growth [4] - The company is advancing its other drug candidates, including DZD8586 and DZD6008, which are in various stages of clinical trials and have shown promising results [3][4] Market Performance - The company has outperformed the CSI 300 index with a 12-month performance of 14.0%, while the index itself has declined by 12.3% [3] - As of August 30, 2024, the company's stock price is 37.65 yuan, with a market capitalization of approximately 15.65 billion yuan [3]

Financial Performance - The company's operating revenue for the first half of 2024 was CNY 203,550,120, showing a significant decrease compared to the previous year[14]. - The net profit attributable to shareholders for the same period was a loss of CNY 344,750,887.77, an improvement from a loss of CNY 514,252,601.51 in the previous year[14]. - The net cash flow from operating activities was a negative CNY 300,946,766.51, compared to a negative CNY 440,326,121.29 in the same period last year[14]. - The total assets increased by 9.93% to CNY 1,644,969,645.45 compared to the end of the previous year[14]. - The net assets attributable to shareholders decreased by 28.23% to CNY 609,058,359.39 compared to the end of the previous year[14]. - The basic earnings per share for the first half of 2024 was -CNY 0.83, an improvement from -CNY 1.26 in the same period last year[15]. - The company reported a net loss of CNY 2,210,149,621.38 for the first half of 2024, an improvement from a loss of CNY 2,491,375,362.62 in the previous period[110]. - The total comprehensive loss for the first half of 2024 was CNY 432,298,176.68, compared to a loss of CNY 514,252,601.51 in the same period of 2023[113]. Research and Development - The R&D investment accounted for 188.05% of the operating revenue, indicating a strong focus on research and development[15]. - The company achieved a sales revenue of CNY 203.55 million in the first half of 2024, with the product GaoRuizhe® receiving its registration certificate and issuing the first prescriptions within two days[26]. - The company has established a strong clinical development pipeline, addressing unmet clinical needs in oncology[20]. - The company is committed to source innovation and has a team with over 20 years of experience in drug development and clinical research[25]. - The company has six innovative drugs in global clinical research, with two already approved for market[43]. - The total R&D investment reached approximately ¥382.77 million, an increase of 11.45% compared to the previous year[38]. - The company is transitioning from Me-too drugs to First-in-class and Best-in-class innovations, aligning with new national guidelines for drug development[34]. Corporate Governance - The board of directors confirmed the authenticity, accuracy, and completeness of the semi-annual report[2]. - There are no special arrangements for corporate governance[4]. - The company has not violated decision-making procedures for external guarantees[4]. - The company has not reported any non-recurring gains or losses for the current period[16]. - The company has no major litigation or arbitration matters pending during the reporting period[80]. - The company has no significant related transactions involving asset acquisitions or share purchases that have not been disclosed[82]. Market and Competition - The global oncology drug market is projected to reach USD 419.8 billion by 2030, with China's market expected to reach CNY 548.4 billion[30]. - The company faces competition from major pharmaceutical and biotech firms, which may develop superior drugs, posing a risk to the market value of its existing and pipeline products[48]. - The company is actively pursuing inclusion of its products in the national medical insurance directory to improve patient accessibility[26]. Financial Management - The company relies on external financing for operational funding, and any shortfall in securing sufficient funds could pressure its financial situation[50]. - The company’s long-term borrowings increased by 206.31% to CNY 424 million, primarily due to mid-term working capital loans and project financing[58]. - The average price reduction for drugs successfully negotiated in 2023 was 61.7%, which may impact future product revenues[52]. - The company’s cash and cash equivalents increased by 38.60% to CNY 103 million, reflecting improved operational cash flow[58]. Environmental and Social Responsibility - The company invested 19.84 million yuan in environmental protection during the reporting period[70]. - The company has committed to carbon neutrality by reducing greenhouse gas emissions through various energy-saving technologies and clean energy procurement[70]. - The company promotes water conservation and has implemented water reuse systems, reducing the demand for fresh water resources[72]. Shareholder Information - The company has extended the lock-up period for major shareholders by 6 months following its initial public offering[74]. - The company has a commitment that shareholders cannot reduce their holdings of pre-IPO shares for three full accounting years unless the company becomes profitable[100]. - The company has a total of 288,616,387 shares under equity incentives, with various exercise periods scheduled until 2027[94]. Risk Factors - Risks include potential further losses due to increased investments in clinical trials, drug registration, and market promotion, which may adversely affect financial conditions[47]. - There is a risk of losing core technical personnel, which could negatively impact R&D capabilities and financial performance due to the need for higher compensation to retain talent[48]. - Clinical trial progress may be hindered by various factors, potentially delaying regulatory approvals and adversely affecting business operations[49]. Accounting Policies - The financial statements are prepared in accordance with the Chinese Accounting Standards and reflect the company's financial position accurately[136]. - The company’s accounting policies are tailored to its operational characteristics, including the measurement of expected credit losses and depreciation of fixed assets[135]. - The group recognizes expected credit losses based on historical experience and current conditions, with a focus on the probability-weighted present value of cash flows[146].

迪哲医药-U(688192.SH)深度报告： 周小刚(证券分析师) 万鹏辉(证券分析师) S0350521090002 S0350524050003 zhouxg@ghzq.com.cn wanph@ghzq.com.cn | --- | --- | |--------------------|-------------| | 市场数据 | 2024/06/19 | | 当前价格（元） | 41.01 | | 52周价格区间（元） | 24.82-54.58 | | 总市值（百万） | 17,045.93 | | 流通市值（百万） | 5,047.72 | | 总股本（万股） | 41,565.31 | | 流通股本（万股） | 12,308.50 | | 日均成交额（百万） | 65.01 | | 近一月换手（%） | 22.86 | 表现 请务必阅读报告附注中的风险提示和免责声明 2 u 盈利预测：考虑到公司产品创新性高，随着在研管线陆续获批上市，我们预计公司2024-2026年收入分别为4.58、10.49、16.46亿元， 对应归母净利润-7.49、-4.27、0.17亿元，公司是创新型生物医药企业， ...