证券代码：688192 证券简称：迪哲医药 公告编号：2024-42 迪哲（江苏）医药股份有限公司 自愿披露关于向美国 FDA 递交舒沃替尼新药上市申请的公告 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"）已向美国食品 药品管理局（FDA）递交舒沃替尼片的新药上市申请（New Drug Application， NDA），用于既往经含铂化疗治疗时或治疗后出现疾病进展，并且经 FDA 批准 的试剂盒检测确认，存在表皮生长因子受体（EGFR）20 号外显子插入突变 （Exon20ins）的局部晚期或转移性非小细胞肺癌（NSCLC）的成人患者。舒沃 替尼成为首款向美国 FDA 递交新药上市申请的中国源创肺癌靶向药。 一、药品相关情况 舒沃替尼是公司自主研发的新型肺癌靶向药，于 2023 年 8 月通过优先审评 在中国获批上市，已成为 EGFR Exon20ins NSCLC 二/后线唯一标准治疗方案。 凭借优异的疗效和安全性数据，舒沃替尼此前已获 FDA 授予全线治疗 EGF ...

Group 1: Financial Performance - The company achieved a sales revenue of 338 million yuan in the first three quarters of 2024, representing a year-on-year increase of 744% [3] - The sales growth is attributed to the performance of Shuwozhe® and Gaoruizhe® [2] Group 2: Product Information - Shuwozhe® is the only approved targeted therapy for NSCLC with EGFR Exon 20 insertion mutations, launched in August 2023 [3] - Gaoruizhe® was approved in June 2024 for the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL), with an objective response rate (ORR) of 44.3% and a complete response (CR) rate of 23.9% [3] Group 3: Market Strategy and Regulatory Engagement - The company is actively participating in national medical insurance negotiations for its products, which is expected to support the development of innovative drugs in the industry [4] - Ongoing global registration clinical studies for Shuwozhe® are progressing, with significant data expected to support overseas market applications [4][5]

Financial Performance - In the first three quarters of 2024, the company achieved a sales revenue of 338 million CNY, representing a year-on-year growth of 744% [2] - The net loss attributable to shareholders for the same period was 558 million CNY, narrowing by 33% year-on-year [2] Product Development and Clinical Trials - The global registration clinical trial "WUKONG1B" for Shuwozhe® (generic name: Shuwotini tablets) has reached its primary research endpoint, with over 40% of non-Asian patients included [2] - The clinical trial results for the "JACKPOT8B" study of Gaoruizhe® have also reached the primary research endpoint, with results presented at the 2023 ASH conference and published in the international journal Lancet Oncology [3] - The company is actively preparing for overseas new drug listing applications based on these clinical trial results [3] Pipeline and Future Prospects - The company is exploring the application of its marketed products in lung cancer, with ongoing global registration clinical trials for Shuwozhe® in first-line treatment of EGFR Exon20ins mutation NSCLC [3] - Two new products, DZD6008 and DZD8586, are under development, targeting unmet clinical needs in lung cancer and hematological malignancies [4] - DZD6008 is a novel small molecule targeted inhibitor for NSCLC, currently in Phase I clinical trials in China [4] - DZD8586 is a dual-target small molecule inhibitor that can penetrate the blood-brain barrier, with ongoing Phase II clinical studies for CLL/SLL and DLBCL [5] Clinical Efficacy - DZD8586 has shown promising anti-tumor activity and safety in patients with multiple B-NHL, with an overall response rate (ORR) of 64.7% in patients who had previously received three lines of treatment [5] - In patients with DLBCL, the ORR reached 83.3%, and in those who had previously received BTK inhibitors, the ORR was 50% [5]

Financial Performance - The company's revenue for Q3 2024 was ¥134,900,880, representing a 236.39% increase compared to the same period last year[2]. - The net profit attributable to shareholders for Q3 2024 was -¥213,709,642.17, with a year-to-date net profit of -¥558,460,529.94[2]. - The weighted average return on equity for Q3 2024 was -41.20%, down from -85.92% year-to-date[3]. - The company reported a net cash flow from operating activities of -¥162,361,573.91 for Q3 2024, with a year-to-date figure of -¥463,308,340.42[2]. - The net profit for Q3 2024 was -649,647,448.06 RMB, an improvement from -828,949,591.21 RMB in Q3 2023, indicating a reduction in losses by approximately 21.6%[20]. - The total operating profit for Q3 2024 was -651,046,906.08 RMB, compared to -828,916,026.19 RMB in the same period last year, reflecting a year-over-year improvement of about 21.4%[20]. - The company reported a total comprehensive income of -649,647,448.06 RMB for Q3 2024, compared to -828,949,591.21 RMB in Q3 2023, showing a year-over-year improvement[21]. Research and Development - Research and development expenses totaled ¥184,958,456.88 in Q3 2024, accounting for 137.11% of revenue, a decrease of 450.2 percentage points year-on-year[3]. - Research and development expenses for the first three quarters of 2024 were CNY 567,728,545.76, slightly lower than CNY 578,964,914.76 in the previous year[19]. - The company accelerated its product development investments, leading to significant losses but also increased sales from newly approved innovative drugs[6]. - The company’s new drug, Goliqizhen (generic name: Goliqizhen Capsules), received approval from NMPA for treating r/r PTCL, showing an objective response rate (ORR) of 44.3%[12]. - The company’s new lung cancer drug, Shuwozhe (generic name: Shuwotini Tablets), received Breakthrough Therapy Designation for treating EGFR Exon20ins NSCLC[13]. - The median overall survival (OS) for patients treated with Goliqizhen reached 24.3 months[13]. Assets and Liabilities - Total assets at the end of Q3 2024 were ¥1,642,509,057.58, an increase of 9.77% from the end of the previous year[3]. - The company's total assets increased to CNY 1,642,509,057.58 in Q3 2024, up from CNY 1,496,378,567.44 in Q3 2023[18]. - The total liabilities of the company reached CNY 1,205,262,190.98 in Q3 2024, compared to CNY 647,751,151.64 in the same quarter of 2023[17]. - The company's equity attributable to shareholders decreased by 49.51% year-on-year, primarily due to ongoing losses[8]. - The company's equity attributable to shareholders decreased to CNY 428,433,784.72 in Q3 2024 from CNY 848,627,415.80 in Q3 2023[18]. Shareholder Information - The total number of common shareholders at the end of the reporting period is 8,642[9]. - The largest shareholder, Advanced Manufacturing Industry Investment Fund, holds 108,923,023 shares, representing 26.21% of total shares[9]. - The company has a total of 57,451,788 shares held by Jiangsu Wuxi Dizhe Enterprise Management Partnership, accounting for 13.82% of total shares[9]. - The company has not reported any changes in the lending of shares for margin trading among the top shareholders[11]. Cash Flow and Financing - The company reported cash and cash equivalents of RMB 130,831,963.06, an increase from RMB 74,201,573.96 in the previous period[15]. - Cash flow from operating activities for the first three quarters of 2024 was -463,308,340.42 RMB, an improvement from -669,132,575.97 RMB in the same period of 2023[23]. - The company reported cash inflow from operating activities totaling 387,967,942.27 RMB in Q3 2024, significantly higher than 26,305,772.19 RMB in Q3 2023[23]. - The net cash flow from financing activities for Q3 2024 was 606,803,240.41 RMB, compared to 175,902,153.78 RMB in Q3 2023, indicating a significant increase in financing[24]. - The company recorded investment cash inflow of 2,709,870,267.04 RMB in the first three quarters of 2024, compared to 3,468,191,094.88 RMB in the same period of 2023[23]. Operating Costs - Total operating revenue for the first three quarters of 2024 reached CNY 338,451,000, a significant increase from CNY 40,102,400 in the same period of 2023[19]. - Total operating costs for the first three quarters of 2024 amounted to CNY 1,031,763,876.35, compared to CNY 896,482,852.81 in 2023, indicating a rise in costs[19]. - Short-term borrowings increased to CNY 235,184,441.10 in Q3 2024, up from CNY 200,114,966.97 in the previous year[17]. - The company’s long-term borrowings surged to CNY 584,395,297.38 in Q3 2024, compared to CNY 138,313,291.49 in Q3 2023, indicating a significant increase in leverage[17].

证券代码：688192 证券简称：迪哲医药 公告编号：2024-41 迪哲（江苏）医药股份有限公司 关于使用暂时闲置募集资金进行现金管理的公告 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。 （一） 投资目的 迪哲（江苏）医药股份有限公司（以下简称 "公司"）于 2024 年 10 月 30 日 分别召开第二届董事会第九次会议、第二届监事会第八次会议，审议通过了 《关于使用暂时闲置募集资金进行现金管理的议案》，同意公司在不影响募集 资金投资计划正常进行的前提下，公司拟使用最高不超过人民币 50,000.00 万元 （含本数）的暂时闲置募集资金进行现金管理，使用期限自 2024 年 12 月 19 日 起 12 个月之内有效。公司会选择信誉好、规模大、有能力保障资金安全的发行 主体所发行的投资安全性高、流动性好的银行理财产品或存款类产品或保本型 券商收益凭证（包括但不限于保本型理财产品、协定性存款、结构性存款、定 期存款、大额转让存单、保本型券商收益凭证等）。在上述额度及期限范围内， 公司可以循环滚动使用资金。同时，公司董事 ...

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 使用暂时闲置募集资金进行现金管理的核查意见 根据《证券发行上市保荐业务管理办法》《上市公司监管指引第 2 号——上 市公司募集资金管理和使用的监管要求》《上海证券交易所科创板股票上市规则 （2024 年 4 月修订）》《上海证券交易所科创板上市公司自律监管指引第 1 号—— 规范运作》等有关法律、行政法规、部门规章及业务规则的要求，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，对迪哲医药使用暂时闲置募集资金进行现金管理相关情况进行了 审慎核查，核查情况如下： 二、本次使用暂时闲置募集资金进行现金管理的基本情况 （一） 投资目的 为进一步规范公司募集资金的使用与管理，在不影响募集资金投资计划正常 进行的前提下，合理利用部分暂时闲置募集资金进行现金管理，可以提高募集资 金使用效益，为公司及股东获取更多回报。 （二） 额度及期限 在保证不影响募集资金投资项目实施 ...

一、监事会会议召开情况 迪哲（江苏）医药股份有限公司（以下简称"公司"）于 2024 年 10 月 30 日召开 公司第二届监事会第八次会议（以下简称"会议"）。本次会议通知于 2024 年 10 月 21 日以邮件方式送达监事。会议应出席监事 3 人，实际出席监事 3 人。会议的召集、 召开程序以及召开方式符合相关法律法规以及《迪哲（江苏）医药股份有限公司公司章 程》的规定，会议决议合法、有效。 二、监事会会议审议情况 全体监事对本次监事会会议议案进行了审议，经表决形成如下决议： 1. 审议通过《关于公司 2024 年第三季度报告的议案》 证券代码：688192 证券简称：迪哲医药 公告编号：2024-40 迪哲（江苏）医药股份有限公司 第二届监事会第八次会议决议公告 本公司监事会及全体监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。 特此公告。 迪哲（江苏）医药股份有限公司监事会 2024 年 10 月 31 日 2 经审议，监事会认为：第三季度报告的编制、审议程序符合相关法律法规及规 范性文件的规定和要求，报告的内容真实、准确、完整地反映 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2024-39 迪哲（江苏）医药股份有限公司 关于召开 2024 年第三季度业绩说明会的公告 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法律责任。 会议召开时间：2024 年 11 月 05 日(星期二)下午 13:00-14:00 会议召开地点：上海证券交易所上证路演中心（网址： https://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 本次投资者说明会以网络互动形式召开，公司将针对 2024 年第 三季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。 二、说明会召开的时间、地点 （一）会议召开时间：2024 年 11 月 05 日下午 13:00-14:00 （二）会议召开地点：上证路演中心 （三）会议召开方式：上证路演中心网络互动 三、参加人员 董事长兼总经理首席执行官：张小林博士 重要内容提示： 投资者可于 2024 年 10 月 29 日(星期二)至 11 月 0 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2024-38 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 变的晚期非小细胞肺癌获得 CDE 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，国家药品监督管理局药品审评中心（以下简称"CDE"）授予迪哲（江 苏）医药股份有限公司（以下简称"公司"）首款自主研发的新型肺癌靶向药舒 沃哲®（通用名：舒沃替尼片）突破性疗法认定（Breakthrough Therapy Designation， BTD），用于未接受过系统性治疗、携带表皮生长因子受体（EGFR）20 号外显 子插入突变（Exon20ins）的局部进展或转移性非小细胞肺癌（NSCLC）。 舒沃哲®是肺癌领域首个获中、美两国双 BTD 资格的国产创新药，用于二/ 后线治疗 EGFR Exon20ins NSCLC。今年 4 月，舒沃哲®一线治疗该适应症获美 国食品药品管理局（FDA）授予 BTD，此次一线治疗再获 CDE 认定，舒沃哲®成 为 ...

2024 年第二次临时股东大会决议公告 证券代码：688192 证券简称：迪哲医药 公告编号：2024-37 迪哲（江苏）医药股份有限公司 （一） 股东大会召开的时间：2024 年 9 月 19 日 （二） 股东大会召开的地点：无锡市新吴区和风路 26 号汇融商务广场 C 栋 4 楼会议室 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。 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 92 | | --- | --- | | 普通股股东人数 | 92 | | 2、出席会议的股东所持有的表决权数量 | 299,717,504 | | 普通股股东所持有表决权数量 | 299,717,504 | | 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比 | 72.1076 | | 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（%） | 72.1076 | （四） 表决方式是否符合《公司法》及公司章程的规定，大会主持 ...