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 ...

股票代码：688192 股票简称：迪哲医药 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） 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 募集资金使用的可行性分析报告 （修订稿） 二〇二四年十一月 一、本次募集资金使用计划 迪哲（江苏）医药股份有限公司（以下简称"迪哲医药"或"公司") 为进 一步增强公司综合竞争力，根据公司发展需要，拟向特定对象发行A股股票募集 资金总额不超过184,842.00万元（含本数），扣除发行费用后，实际募集资金将 用于投资以下项目： 单位：万元 | 序 | 项目名称 | 项目投资金额 | 拟使用募集资金金额 | | --- | --- | --- | --- | | 号 | | | | | 1 | 新药研发项目 | 104,170.00 | 104,170.00 | | 2 | 国际标准创新药产业化项目 | 100,000.00 | 60,672.00 | | 3 | 补充流动资金 | 20,000.00 | 20,000.00 | | | ...

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 ...

独立董事发言要点与主要意见:公司对本次向特定对象发行 A 股股票的 方案调整,符合《中华人名共和国公司法》(以下简称"《公司法》") 《中华人民共和国证券法》（以下简称"《证券法》"）《上市公司证 券发行注册管理办法》(以下简称"《注册管理办法》")等法律、法 规和规范性文件的相关规定,符合公司的长远发展战略,不存在损害公 司、股东尤其是中小股东利益的情形。 独立董事一致同意该议案,并同意将本议案提交公司董事会审议。 表决结果:同意 4 票,反对 0 票,弃权 0 票。 迪哲(江苏)医药股份有限公司 第二届董事会独立董事专门会议第二次会议决议 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 以通讯表决的方式召开第二届董事会独立董事第二次专门会议(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。会议应到独 立董事 4 人,实际出席独立董事 4 人。会议的召集、召开程序以及召开方式符 合相关法律法规、《公司独立董事专门会议工作制度》及《公司独立董事工作 制度》的规定,会议决议合法、有效。 全体独立董事对本次会议议案进行了审议,经表决形成如下决议 ...

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 ...