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 Dizal (Jiangsu) Pharmaceutical Co., Ltd. （无锡市新吴区和风路 26 号汇融商务广场 C 栋 404、405、416 室） 关于本次募集资金投向属于 科技创新领域的说明 （修订稿） 二〇二四年十一月 迪哲（江苏）医药股份有限公司 关于本次募集资金投向属于科技创新领域的说明（修订稿） 迪哲（江苏）医药股份有限公司 关于本次募集资金投向属于科技创新领域的说明 迪哲（江苏）医药股份有限公司（以下简称"迪哲医药"或"公司"）根据 《上市公司证券发行注册管理办法》（以下简称"《注册管理办法》"）等有关规定， 结合公司2023年度向特定对象发行A股股票（以下简称"本次发行"）方案及实际 情况，对本次发行募集资金投向是否属于科技创新领域进行了研究，制定了《迪 哲（江苏）医药股份有限公司关于本次募集资金投向属于科技创新领域的说明》 （以下简称"本说明"），具体内容如下： 一、公司的主营业务 公司是一家具备全球竞争力的创新驱动型生物医药公司。公司坚持源头创新 的研发理念，致力于新靶点的挖掘与作用机理验证，借助公司自 ...

Investment Rating - The report maintains a "Buy" rating for the company, with an expectation of continued growth in its innovative drug pipeline and global market expansion [4][13] Core Views - The company's revenue for Q1-3 2024 reached 338 million yuan, a 744% year-on-year increase, with a net loss of 558 million yuan, showing improvement compared to the same period in 2023 [5][7] - Two key products, Sunvozertinib and Golvatinib, are performing well post-launch, with Sunvozertinib submitting a new drug application to the US FDA for NSCLC treatment [5][7][9] - The company's pipeline includes promising FIC/BIC drugs such as DZD8586 and DZD6008, with DZD8586 expected to present updated data at the 2024 ASH conference [12] - The company's expense ratios are declining, indicating improved scale efficiency, with a gross margin of 97.73% in Q1-3 2024 [13] Financial Performance - The company's revenue is projected to grow significantly, with 2024E revenue expected at 914 million yuan, a 341.7% year-on-year increase, and further growth to 1.914 billion yuan by 2026E [2][13] - Gross margin remains high, projected at 97.5% in 2024E, slightly decreasing to 96.5% by 2026E [2][13] - The company is expected to turn profitable by 2026E, with EPS projected at 0.10 yuan, compared to losses in previous years [4][13] Product Pipeline and Market Potential - Sunvozertinib has shown strong clinical data in international trials, with a 53.3% ORR and 57% DoR rate at 9 months, positioning it as a potential best-in-class treatment for EGFR20ins NSCLC [9] - Golvatinib, approved in China for PTCL, has demonstrated impressive global clinical data, with a 44.3% ORR and 23.9% CR rate, and is expected to submit an application to the US FDA [10][11] - DZD8586, a FIC drug targeting BTK/Lyn, has shown promising results in DLBCL patients and is advancing in clinical trials, with updated data expected at the 2024 ASH conference [12] Operational Efficiency - The company's sales and management expense ratios have decreased significantly, with sales expense ratio dropping to 88.32% in Q3 2024, reflecting improved operational efficiency [13] - R&D expenses have also decreased slightly, with a 1.94% year-on-year reduction in Q1-3 2024, indicating better cost control as the company scales [13]

Investment Rating - The report initiates coverage on Dizal Pharmaceutical-U (688192 SH) with an "Overweight" rating and a target price of 61 82 RMB [1][2][3] Core Views - Dizal Pharmaceutical focuses on source innovation and has a globally competitive pipeline with core products Suvotinib and Golvatinib entering the harvest phase [2] - The company is expected to achieve revenues of 467 973 and 1 582 billion RMB in 2024 2025 and 2026 respectively driven by the commercialization of Suvotinib and Golvatinib [2] - Suvotinib has shown global best-in-class potential in treating EGFR ex20ins NSCLC and has received breakthrough therapy designations in both China and the US [2] - Golvatinib a next-generation JAK1 inhibitor has demonstrated clinical breakthroughs in treating r/r PTCL and is expected to provide new treatment options [2] - The early-stage pipeline is robust with several first-in-class molecules such as DZD8586 showing promising early data [2] Product Pipeline Suvotinib - Suvotinib is a targeted therapy for EGFR ex20ins NSCLC a difficult-to-treat mutation with limited treatment options [2] - It has shown superior efficacy with ORRs of 60 8% and 53 3% in domestic and international trials respectively outperforming existing therapies [2] - The drug has been approved in China and is under review in the US with potential for significant market penetration [2] - Suvotinib is also being developed for first-line treatment with early data showing mPFS of 10 2 and 12 4 months for different dose groups [2] Golvatinib - Golvatinib is a highly selective JAK1 inhibitor with a long half-life of 40-50 hours allowing for once-daily dosing [2] - It has shown breakthrough efficacy in r/r PTCL with an ORR of 44 3% and a CR rate of 23 9% significantly higher than existing treatments [2] - The drug has been approved in China and is expected to enter the commercialization phase in overseas markets [2] Early-Stage Pipeline - DZD8586 a first-in-class LYN/BTK inhibitor has shown promising early data and potential to overcome BTK inhibitor resistance [2] - Other early-stage candidates such as DZD6008 DZD2269 and DZD1516 are progressing through clinical trials with potential to validate their first-in-class or best-in-class potential [2] Financial Projections - The company is expected to achieve significant revenue growth from 467 million RMB in 2024 to 1 582 billion RMB in 2026 driven by the commercialization of Suvotinib and Golvatinib [2] - Despite being in a strategic loss-making phase the company's net loss is expected to narrow as revenues grow [2] Valuation - The target price of 61 82 RMB is derived using both absolute and relative valuation methods with a focus on the discounted cash flow (DCF) model [2][19] - The relative valuation method using PS multiples suggests a target price of 74 93 RMB but the more conservative DCF-based target is chosen [19]

Investment Rating - The investment rating for the company is "Buy" with a 6-month outlook [2][8]. Core Views - The company has submitted a new drug application for Shuwotini to the FDA, marking significant progress in internationalization [2]. - Shuwotini has received breakthrough therapy designation (BTD) in both China and the U.S. for the treatment of EGFR exon 20 insertion mutation non-small cell lung cancer (NSCLC) [3]. - The sales of Shuwotini have rapidly increased since its launch in August 2023, with projected sales of approximately 0.91 billion yuan in 2023 and 2.04 billion yuan in the first half of 2024 [5][6]. - The company is also negotiating for the inclusion of Shuwotini and Golixitinib in the national medical insurance directory, which is expected to further boost sales [6]. Financial Summary - The company's revenue forecast for 2024-2025 has been adjusted down to 5.00 billion yuan and 10.51 billion yuan, respectively, with an expected revenue of 18.96 billion yuan in 2026 [8]. - The net profit attributable to the parent company is projected to be -7.95 million yuan and -3.23 million yuan for 2024 and 2025, respectively, with an expected net profit of -0.30 million yuan in 2026 [8]. - The company reported a significant increase in operating revenue from 0 million yuan in 2022 to 91.29 million yuan in 2023, with further growth expected [9]. Clinical Progress - The company is advancing multiple innovative drugs in clinical trials, including DZD8586, a dual-target small molecule inhibitor, and DZD6008, a small molecule targeted inhibitor for NSCLC [7].

Investment Rating - The investment rating for the company is "Buy" (maintained) [2][6][9] Core Views - The company has achieved significant revenue growth, with a 743.97% year-on-year increase in revenue for the first three quarters of 2024, totaling 338 million yuan [2][3] - The net loss attributable to shareholders has narrowed from 829 million yuan in the same period of 2023 to 558 million yuan in 2024, indicating improved operational efficiency [3][6] - The company is focusing on R&D investment, with R&D expenses amounting to 568 million yuan, representing 167.74% of sales [3][6] - Two innovative drugs have been approved for commercialization, which is expected to further enhance the company's performance [3][4] Summary by Sections Financial Performance - For the first three quarters of 2024, the company reported a revenue of 338 million yuan, with a quarterly revenue of 135 million yuan in Q3, reflecting a year-on-year increase of 236.39% [2][3] - The net profit for Q3 was a loss of 214 million yuan, a reduction of 32.09% compared to the previous year [2][3] R&D and Product Development - The company has maintained its commitment to R&D, with a slight decrease in R&D expenses by 1.94% year-on-year [3] - The approval of the innovative drug "Golixtin" for treating peripheral T-cell lymphoma and "Shuwotai" for non-small cell lung cancer is expected to drive future revenue growth [3][4] Market Position and Future Outlook - The company is projected to achieve revenues of 471 million yuan, 1.049 billion yuan, and 1.646 billion yuan for 2024, 2025, and 2026 respectively, with net losses expected to decrease over the same period [6][7] - The company is positioned to benefit from expanding its product pipeline and increasing market share in the innovative drug sector [6][7]

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]

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 ...

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 ...