股票代码：688192 股票简称：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） 2023 年度向特定对象发行 A 股股票预案 （修订稿） 二〇二四年十一月 迪哲（江苏）医药股份有限公司 2023 年度向特定对象发行 A 股股票预案（修订稿） 公司声明 1、公司及董事会全体成员保证本预案内容真实、准确、完整，并确认不存在虚 假记载、误导性陈述或重大遗漏。 2、本预案按照《上市公司证券发行注册管理办法》等法规及规范性文件的要求 编制。 3、本次向特定对象发行股票完成后，公司经营与收益的变化由公司自行负责； 因本次向特定对象发行股票引致的投资风险，由投资者自行负责。 4、本预案是公司董事会对本次向特定对象发行股票的说明，任何与之相反的声 明均属不实陈述。 5、投资者如有任何疑问，应咨询自己的股票经纪人、律师、专业会计师或其他 专业顾问。 6、本预案所述事项并不代表审批机关对于本次向特定对象发行股票相关事项的 实质性判断、确认、批准或核准，本预案所述本次向特定对 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2024-44 迪哲（江苏）医药股份有限公司 表决结果：同意 3 票，反对 0 票，弃权 0 票。 具体内容详见公司刊登于上海证券交易所网站（www.sse.com.cn）的 《迪哲医药：2023 年度向特定对象发行 A 股股票预案（修订稿）》。 3. 审议通过《关于公司向特定对象发行 A 股股票发行方案论证分析报告 （修订稿）的议案》 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： 第二届监事会第九次会议决议公告 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。 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 11 月 24 日召开公司第二届监事会第九次会议（以下简称"会议"）。本次会议通知于 2024 年 11 月 22 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 ...

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 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2024-45 迪哲（江苏）医药股份有限公司 关于向特定对象发行 A 股股票预案（修订稿）披露的 提示性公告 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。 《迪哲（江苏）医药股份有限公司 2023 年度向特定对象发行 A 股股票预 案（修订稿）》（以下简称"预案"）及相关公告已于同日在上海证券交易所网站 （www.sse.com.cn）及《上海证券报》《证券时报》《中国证券报》《证券日 报》披露，敬请广大投资者注意查阅。 该预案及相关文件所述事项并不代表审核、注册部门对于公司本次向特定 对象发行 A 股股票相关事项的实质性判断、确认、批准或核准，预案所述公司 本次向特定对象发行 A 股股票相关事项尚需上海证券交易所审核通过及中国证 券监督管理委员会同意注册后方可实施，本次向特定对象发行 A 股股票能否成 功实施存在不确定性，敬请广大投资者注意投资风险。 特此公告。 迪哲（江苏）医药股份有限公司董事会 2024 年 11 月 25 日 1 迪哲（江苏）医药股份有限公司（以 ...

迪哲（江苏）医药股份有限公司 2023 年度向特定对象发行 A 股股票发行方案论证分析报告（修订稿） 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） 2023 年度向特定对象发行 A 股股票 发行方案的论证分析报告 （修订稿） 二〇二四年十一月 迪哲（江苏）医药股份有限公司 2023 年度向特定对象发行 A 股股票发行方案论证分析报告（修订稿） 迪哲（江苏）医药股份有限公司（以下简称"迪哲医药"或"公司"）是上 海证券交易所科创板上市的公司。为满足公司业务发展的资金需求，增强公司的 资本实力和盈利能力，根据《中华人民共和国公司法》《中华人民共和国证券法》 和《上市公司证券发行注册管理办法》（以下简称"《注册管理办法》"）等有关法 律、行政法规、部门规章或规范性文件和《公司章程》的规定，公司编制了2023 年度向特定对象发行A股股票发行方案论证分析报告。 本论证分析报告中如无特别说明，相关用语具有与《迪哲（江苏）医药股份 有 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2024-43 迪哲（江苏）医药股份有限公司 第二届董事会第十次会议决议公告 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。 一、董事会会议召开情况 迪哲（江苏）医药股份有限公司（以下简称"公司"）于 2024 年 11 月 24 日召开公 司第二届董事会第十次会议（以下简称"会议"）。本次会议通知于 2024 年 11 月 22 日 以邮件方式送达董事。本次会议应到董事 7 人，实到董事 7 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、董事会会议审议情况 全体董事对本次董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《关于调整公司向特定对象发行 A 股股票方案的议案》 董事发言要点与主要意见：无异议。 表决结果：同意 7 票，反对 0 票，弃权 0 票。 2. 审议通过《关于公司 2023 年度向特定对象发行 A 股股票预案（修订稿）的议案》 董事发言要点与主要意见： ...

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]