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].

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5]. Core Insights - The company, established in 2017, is a globally competitive innovative biopharmaceutical firm focusing on the research, development, and commercialization of therapies for malignant tumors and immune diseases [8][18]. - The company has a robust pipeline of innovative small molecule products, with all products enjoying complete global rights and developed in a synchronized global manner [18]. - The company is expected to achieve revenue of 458 million, 1.049 billion, and 1.646 billion yuan for the years 2024, 2025, and 2026 respectively, with a projected net profit of -74.9 million, -42.7 million, and 1.7 million yuan [5]. Company Overview - The company has successfully commercialized its product, Shuwotini, which has been approved for use in China [11]. - The company’s chief scientist, Dr. Zeng Qingbei, has over 20 years of experience in new drug design and development, previously holding significant positions at AstraZeneca and other major pharmaceutical companies [10][23]. - The management team is experienced, with key members having extensive backgrounds in drug development and management from leading pharmaceutical companies [23]. Financial Performance - In 2023, the company reported a net loss attributable to shareholders of 1.108 billion yuan, a significant increase compared to the previous three years, primarily due to high R&D expenditures [25]. - The R&D expenses for 2023 were 805 million yuan, reflecting a year-on-year increase of approximately 21% as the company accelerates its R&D progress [26]. Product Pipeline - The company has six small molecule products in various stages of global clinical development, with two leading products, Shuwotini and Golixitini, in critical clinical trial phases [14][18]. - Shuwotini has been approved in China for the treatment of EGFR Ex20ins mutation-positive advanced non-small cell lung cancer (NSCLC) [16][29]. - The company’s pipeline includes multiple indications for its products, with a focus on significant diseases such as malignant tumors and hematological malignancies [18]. Market Potential - The report highlights a significant unmet medical need for effective treatments for patients with EGFR Ex20ins mutations, which account for approximately 9-10% of NSCLC cases [17][29]. - The company’s products are positioned to capture market share in a growing patient population, with projections indicating increasing numbers of new NSCLC cases in the coming years [42].

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。 迪哲（江苏）医药股份有限公司（以下简称"公司"）自主研发的 I 类新药高 瑞哲®（通用名：戈利昔替尼胶囊）正式获得国家药品监督管理局（NMPA）批准， 单药适用于既往至少接受过一线系统性治疗的复发或难治的外周 T 细胞淋巴瘤 （r/r PTCL）成人患者。高瑞哲®是全球首个且唯一作用于 JAK/STAT 通路的治疗 外周 T 细胞淋巴瘤的新药物。单药治疗呈现出病症深度缓解、所有亚型全面获 益、显度延长生存的突破性优势。 一、药品相关情况 证券代码：688192 证券简称：迪哲医药 公告编号：2024-27 迪哲（江苏）医药股份有限公司 自愿披露关于高瑞哲®（戈利昔替尼胶囊） 获得国家药监局批准上市的公告 研究结果显示，高瑞哲®单药治疗复发难治外周 T 细胞淋巴瘤： ● 深度缓解：经 IRC 确认的 ORR 达 44.3%，完全缓解（CR）率达 23.9%， 均是既往靶向治疗方案的近 2 倍。 ● 全面获益：在不同亚型 PTCL 中均观察到肿瘤缓解，满足了既往药物无 法覆盖的 P ...

Summary of Conference Call Transcript Company Overview - The company discussed is DiZhe, which is focused on innovation at the source [1] Core Insights and Arguments - DiZhe's commitment to innovation is emphasized, with a focus on developing drugs that effectively meet market needs [1] - Following the release of the report, the company's stock performance has been notably positive [1] Additional Important Content - The overall outlook for DiZhe is optimistic, indicating confidence in the company's future prospects [1]

证券代码：688192 证券简称：迪哲医药 公告编号：2024-26 一、ASCO 大会口头报告 舒沃哲®是一款针对多种 EGFR 突变亚型的高选择性 EGFR 靶向药物，是肺 癌领域首个获中美双"突破性疗法认定"的国创新药。基于中国注册临床研究"悟 空 6"（WU-KONG6）的积极结果，舒沃哲®于 2023 年 8 月在国内获批上市，是 目前全球唯一获批且可及的靶向 EGFR Exon20ins NSCLC 的小分子酪氨酸激酶 抑制剂（TKI）。 "悟空 1B"（WU-KONG1B）是一项在欧美、澳洲、亚洲等全球 10 个国家 及地区开展的 II 期、开放标签、国际多中心注册临床研究，旨在评估舒沃哲®治 疗含铂化疗失败或不耐受的 EGFR Exon20ins NSCLC 的疗效和安全性，主要研 究终点为独立影像评估委员会（IRC）评估的客观缓解率（ORR），关键次要研 究终点为中位缓解持续时间（mDoR）。 截至 2024 年 3 月 22 日，II 期推荐剂量（RP2D）300 mg 剂量组共纳入 111 1 例经治 EGFR Exon20ins NSCLC 患者，其中 107 例纳入疗效分析集，亚裔/ ...

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4月-5月） 投资者关系 □特定对象调研 分析师会议 □媒体采访 业绩说明会 活动类别 □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 浙商证券，中金公司，天风证券，中信证券，兴业证券，申万宏 及人员 源，东吴证券，长江证券，海通证券，信达证券，华西证券，广 发证券，保宁资产等 ...