证券代码：688192 证券简称：迪哲医药 公告编号： 2023-54 迪哲（江苏）医药股份有限公司 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"）于 2023 年 8 月 21 日召开 2023 年第一次临时股东大会，选举产生公司第二届董事会非独立董事和独立董事、 第二届监事会非职工代表监事，非职工代表监事与公司第三次职工代表大会选举产 生的职工代表监事共同组成第二届监事会。2023 年 8 月 29 日，公司召开第二届董 事会第一次会议、第二届监事会第一次会议，选举产生董事长、董事会下属各专门 委员会委员、监事会主席，并聘任高级管理人员、证券事务代表。现将相关情况公 告如下： 一、 董事会换届选举情况 （一） 董事选举情况 2023 年 8 月 21 日，公司召开 2023 年第一次临时股东大会，采取累积投票制 的方式，选举 XIAOLIN ZHANG（张小林）先生、SIMON DAZHONG LU（吕大 忠）先生、RODOLPHE PETER ANDRE GREPIN ...

证券代码：688192 证券简称：迪哲医药 公告编号：2023-50 迪哲（江苏）医药股份有限公司 关于持股 5%以上股东权益变动超过 1%的提示性公告 公司于 2023 年 8 月 25 日收到公司持股 5%以上股东 Imagination V 出具的告知 函，在 2023 年 7 月 24 日至 2023 年 8 月 24 日期间，Imagination V 通过大宗交易方 式减持公司股份 4,126,308 股，占公司总股本的 1.0110%；通过转融通出借公司股 份 820,000 股，占公司总股本的 0.2009%。本次权益变动后，Imagination V 持有公 司股份 22,890,901 股，占公司总股本的比例为 5.6084%。现将其权益变动情况如下： 一、本次权益变动情况 1. 信息披露义务人基本情况 | 企业名称 | Imagination V (HK) Limited | | --- | --- | | 企业类型 | 境外有限公司 | 1 本次权益变动属于减持，不触及要约收购。 本次权益变动后，迪哲（江苏）医药股份有限公司（以下简称"公 司"）股东 Imagination V (HK ...

证券代码：688192 证券简称：迪哲医药 公告编号：2023-47 迪哲（江苏）医药股份有限公司 关于选举第二届监事会职工代表监事的公告 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。 迪哲（江苏）医药股份有限公司（以下简称"公司"）第一届监事会任期即将届 满，根据《中华人民共和国公司法》《上海证券交易所科创板股票上市规则》《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》等法律、法规、 规范性文件以及《迪哲（江苏）医药股份有限公司公司章程》等有关规定，公司于 2023 年 8 月 21 日召开第三次职工代表大会，经出席会议的全体代表投票表决，一 致审议通过了《关于选举迪哲（江苏）医药股份有限公司第二届监事会职工代表监 事的议案》，同意选举董韡雯女士、康晓静女士（简历详见附件）为公司第二届监 事会职工代表监事。 公司第二届监事会由三名监事组成，本次职工代表大会选举产生的职工代表 监事将与公司 2023 年第一次临时股东大会选举产生的一名非职工代表监事共同组 成第二届监事会。第二届监事会监事自公司 2023 ...

北京市中伦律师事务所 关于迪哲（江苏）医药股份有限公司 2023 年第一次临时股东大会的 法律意见书 二〇二三年八月 北京市朝阳区金和东路 20 号院正大中心 3 号南塔 22-31 层 邮编：100020 22-31/F, South Tower of CP Center, 20 Jin He East Avenue, Chaoyang District, Beijing l00020, P.R. China 电话/Tel : +86 10 5957 2288 传真/Fax : +86 10 6568 1022/1838 www.zhonglun.com 北京市中伦律师事务所 关于迪哲（江苏）医药股份有限公司 2023 年第一次临时股东大会的 法律意见书 致：迪哲（江苏）医药股份有限公司 根据迪哲（江苏）医药股份有限公司（以下简称"公司"）与北京市中伦律 师事务所（以下简称"本所"）签订的《常年法律服务协议》的约定及受本所指 派，本所律师对公司 2023 年第一次临时股东大会（以下简称"本次股东大会"） 的合法性进行见证并出具法律意见。 本法律意见书根据《中华人民共和国公司法》（以下简称"《公司法》"）、 ...

2023 年第一次临时股东大会决议公告 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。 重要内容提示： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2023 年 8 月 21 日 证券代码：688192 证券简称：迪哲医药 公告编号：2023-48 迪哲（江苏）医药股份有限公司 本次会议由公司董事会召集，采用现场投票和网络投票相结合的方式召开。 会议由董事长张小林博士主持。 （五） 公司董事、监事和董事会秘书的出席情况 1、 公司在任董事 10 人，出席 7 人，Rodolphe Peter André Grépinet 先生、傅晓女 士和林亮先生因时差和工作原因未能出席本次会议； 2、 公司在任监事 3 人，出席 3 人； 3、 董事会秘书吕洪斌出席了本次会议；其他部分高管列席了本次会议； 4、 因工作安排原因，部分人员通过通讯方式出席或列席此次会议。 （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 （三） 出席会议的普通股股东、特别表决权 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2023-46 一、2023 WCLC 大会报告项目 舒沃替尼（商品名：舒沃哲®）是公司自主研发的一款针对多种 EGFR 突变 亚型的高选择性 EGFR 酪氨酸激酶抑制剂（TKI），是首款针对 EGFR Exon20ins 突变型晚期非小细胞肺癌（NSCLC）的国创新药，也是肺癌领域首个且目前唯一 获中、美双"突破性疗法认定"的国创 1 类新药。舒沃替尼在中国的注册临床试 验（悟空 6，WU-KONG6，针对既往接受含铂化疗失败的 EGFR exon20ins 晚期 NSCLC）结果显示其"高效低毒、潜在同类最佳"，主要终点经独立影像评估委 员会（IRC）确认的客观缓解率（cORR）达 60.8%，新药上市申请于 2023 年 1 月获国家药监局受理并纳入优先审评。 使用肿瘤组织和血浆 ctDNA 进行突变检测是确认 EGFR Exon20ins 突变型 晚期 NSCLC 的重要手段。公司将在本届 WCLC 大会报告的研究采用二代测序 技术，对悟空 6（WU-KONG6）疗效分析集受试者的肿瘤组织和血浆 ctDNA 中 1 迪哲（江苏）医药股份有限公司 自 ...

公司代码：688192 公司简称：迪哲医药 迪哲（江苏）医药股份有限公司 2023 年第一次临时股东大会会议资料 2023 年 8 月 | 2023 | 年第一次临时股东大会会议须知 1 | | --- | --- | | 2023 | 年第一次临时股东大会会议议程 3 | | 一、 | 关于修订《迪哲（江苏）医药股份有限公司章程》并授权董事会办理 | | | 工商变更登记的议案 5 | | 二、 | 关于选举公司第二届监事会非职工代表监事的议案 6 | | 三、 | 关于选举公司第二届董事会非独立董事的议案 7 | 迪哲（江苏）医药股份有限公司 2023 年第一次临时股东大会会议须知 为维护全体股东的合法权利，确保股东大会的正常秩序和议事效率，保证大 会的顺利进行，根据《中华人民共和国公司法》《中华人民共和国证券法》《上 市公司股东大会规则（2022 年修订）》以及《迪哲（江苏）医药股份有限公司章 程》《迪哲（江苏）医药股份有限公司股东大会议事规则》等相关规定，迪哲（江 苏）医药股份有限公司（以下简称"公司"）特制定 2023 年第一次临时股东大会 会议须知： 一、为确认出席大会的股东或其代理人或其他出席者 ...

2023 年第一季度报告 1 / 13 迪哲（江苏）医药股份有限公司 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、准确性和完整性依法承担法律责任。 公司董事会、监事会及董事、监事、高级管理人员保证季度报告内容的真实、准确、完整，不存 在虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 第一季度财务报表是否经审计 一、 主要财务数据 | --- | --- | --- | |-----------------------------------------------|-----------------|---------------------------------------| | 项目 | 本报告期 | 本报告期比上年同期 \n增减变动幅度 (%) | | 营业收入 | - | 不适用 | | 归属于上市公司股东的净利润 | -239,523,659.32 | 不适用 | | 归属于上市公司股东的扣除非经 常性损益的净利润 | -250,734,331.87 | 不适用 | | 经营活动产生的现金流量净额 | -203,213,936 ...

重要内容提示： 证券代码：688192 证券简称：迪哲医药 公告编号：2023-26 迪哲（江苏）医药股份有限公司 关于参加 2022 年度制药专场集体业绩说明会的公告 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。 董事长兼总经理：张小林博士 独立董事：张昕女士 二、 说明会召开的时间、方式 1 会议线上交流时间：2023 年 4 月 24 日（星期一）上午 9: 00-10: 00 会议召开方式：视频和线上文字互动 视频和线上文字互动平台：上海证券交易所上证路演中心 (http://roadshow.sseinfo.com/) 投资者可于 4 月 21 日（星期五）16: 00 前通过邮件、电话等形式将需要了解 和关注的问题提前提供给公司。公司将在文字互动环节对投资者普遍关注的 问题进行回答。 三、 参加人员 迪哲（江苏）医药股份有限公司（以下简称"公司"）已于 2023 年 3 月 24 日 发布公司 2022 年度报告，为便于广大投资者更全面深入地了解公司 2022 年度 经营成果、财务状况、发展理念，公司参与了由上 ...

Product Pipeline and Clinical Development - The company's product pipeline includes 5 products in global clinical development, with 2 products in global registration clinical trials, and 1 product in the process of market application[17] - Shuvotinib, a self-developed EGFR-TKI targeting EGFR Exon20 insertion mutations, achieved a confirmed tumor response rate (cORR) of 59.8%, with a cORR of 48.4% for patients with stable, asymptomatic brain metastases[22] - Golvatinib, a next-generation JAK1-specific inhibitor, has been granted "Fast Track Designation" by the US FDA and is undergoing registration clinical trials in China, the US, South Korea, and Australia[16] - DZD2269, a self-developed A2aR antagonist, showed dose-dependent efficacy in blocking adenosine/A2aR-mediated pathway activation in a Phase I trial, with no drug-related side effects observed at a 160mg dose[28] - DZD1516, a self-developed HER2 inhibitor, is designed to penetrate the blood-brain barrier and target HER2-positive breast cancer with CNS metastasis[13] - Golvatinib demonstrated significant efficacy in treating r/r PTCL, with 42.9% of patients achieving tumor response, including 22.4% complete response (CR) and 20.4% partial response (PR)[34] - DZD1516 showed a Kpuu,CSF ratio of 2.1, indicating complete penetration of the blood-brain barrier, and was well-tolerated at doses below 300 mg twice daily[43] - DZD8586 demonstrated promising preclinical results, effectively inhibiting the growth of B-cell non-Hodgkin lymphoma cells[42] - Sunvotinib received FDA Breakthrough Therapy Designation in January 2022[44] - Golvatinib received FDA Fast Track Designation for r/r PTCL in February 2022[53] - Sunvotinib's efficacy in EGFR Exon20ins NSCLC patients was presented at the 2022 ASCO and WCLC conferences[53] - DZD1516's Phase I clinical data for HER2-positive metastatic breast cancer was presented at the 2022 ESMO and SABCS conferences[53] - The leading product, Sunvozertinib, has reached the primary endpoint in its China registration clinical trial, and the new drug application has been accepted by the China National Medical Products Administration[116] - The company's main products, Suvotinib and Golixitinib, face uncertainty in obtaining conditional approval for market entry, with Suvotinib's application under priority review by the NMPA and Golixitinib under accelerated review by the FDA[169] Market and Commercialization Strategy - The company has established a globally competitive product pipeline and is building a commercial team in China to prepare for product launches[17] - The company is building a commercialization team in China and planning to establish independent production and R&D facilities[50] - The company plans to actively promote the inclusion of approved products in the national medical insurance catalog and explore innovative payment strategies to enhance product accessibility[58] - The company aims to expand market coverage and build a professional promotion team through continuous personnel training[58] - The company is focusing on market sales system construction and commercial production layout in 2022[72] - The company plans to adopt a combination of self-built teams and external cooperation for overseas market sales[86] - The company is actively seeking partners globally to promote the commercialization of core products[86] - The company is considering building its own sales team in key markets like the US to establish long-term global commercialization competitiveness[86] - The company's sales expenses were RMB 22,976,644.36, as the company prepared for product commercialization by building a sales team and market promotion[166] - The company's revenue and cost of sales were not applicable for the current period, as the company's products are still in the R&D phase and have not yet generated sales[166] R&D Strategy and Investment - The company focuses on clinical demand-driven drug development, conducting extensive research on clinical issues, future trends, and competitive product development[56] - The company tests and screens thousands to millions of compounds to identify lead compounds, optimizing them to select 2-3 candidate compounds with different characteristics[56] - The company prioritizes indications with potential for accelerated or conditional approval based on single-arm trial results to achieve rapid product commercialization[61] - The company's R&D strategy involves a comprehensive approach from protein to cell to animal and ultimately human trials to validate scientific hypotheses[56] - The company's clinical research is divided into Phase I, II, and III trials, with Phase III results being crucial for drug approval[61] - The company's R&D expenditure as a percentage of revenue was 5,712.89% in 2021, indicating a heavy focus on research and development[110] - The company's R&D expenses increased by 13.09% year-on-year to RMB 665 million, with rapid progress in research projects[116] - The company's R&D expenses for the reporting period amounted to 664.52 million yuan, reflecting significant investment in clinical and preclinical research[139] - The company's R&D expenses increased by 13.09% to RMB 664,521,836.83 due to ongoing investments in clinical trials and new product development[182] - The company's future performance may be impacted by ongoing large-scale R&D investments required for its product pipeline, including clinical trials and pre-market preparations[139] Financial Performance and Risks - Non-recurring gains and losses for 2022 include government subsidies of 6,385,137.00, primarily from government subsidy income[70] - The company's financial assets fair value change gains for 2022 amounted to 42,158,220.60, mainly from the fair value change gains of company's financial management[70] - The company's basic earnings per share for 2022 were -1.82 RMB, showing a slight improvement from -1.86 RMB in 2021[110] - The weighted average return on equity (ROE) for 2022 was -34.90%, a significant improvement from -86.44% in 2021[110] - Net profit attributable to shareholders in Q4 2022 was -225,905,869.78 RMB, the lowest among all quarters[112] - Net cash flow from operating activities in Q4 2022 was -181,921,939.10 RMB, showing a consistent negative trend throughout the year[112] - The company reported a net loss attributable to shareholders of 66.13 million yuan, an increase of 66.13 million yuan compared to the same period last year, primarily due to increased R&D expenses[147] - The company's foreign exchange gains amounted to 10.10 million yuan, driven by exchange rate fluctuations[140] - The company's financial expenses decreased by 212.39% to RMB -8,249,168.49, primarily due to foreign exchange gains from holding USD[182] - The company's management expenses increased by 19.91% to RMB 105,463,826.75, mainly due to increased administrative costs[182] - The company's net cash flow from operating activities was RMB -603,372,719.39, reflecting increased R&D expenditures[182] - The company's net cash flow from investing activities was RMB 384,556,016.08, driven by the maturity of large financial products[182] - The company's net cash flow from financing activities was RMB -33,264,923.37, mainly due to IPO issuance costs and rental payments[182] - The company's unprofitability is expected to continue, with cumulative losses likely to expand due to ongoing large-scale R&D investments[161] - The company's products are still in the clinical development stage and have not yet entered commercialization[189] Regulatory and Compliance - Shuvotinib's new drug application was accepted by the NMPA and included in the priority review and approval process in January 2023[22] - The company has obtained a "Drug Manufacturing License" (Bh) from the Jiangsu Provincial Drug Administration, ensuring the qualification for commercial production of its products[17] - The company has no major litigation or arbitration matters in the reporting period[102] - The company and its major shareholders have good integrity status[102] - The company's registered address was changed during the reporting period, moving to a new location in Wuxi[105] - The company maintains offices in both Wuxi and Shanghai, with postal codes 214135 and 201203 respectively[105] - The company's annual report is disclosed through major financial media outlets and the Shanghai Stock Exchange website[106] - The company's financial statements are audited by PricewaterhouseCoopers Zhong Tian LLP, with signing accountants Hu Wei and Guo Yike[109] - The company's sponsor for continuous supervision is CITIC Securities, with designated representatives Ding Yuan and Peng Liuyong[109] - The company renewed its appointment of PricewaterhouseCoopers Zhong Tian LLP (Special General Partnership) as its 2022 audit firm[190] - The company's 2022 annual report indicates no profit forecast or performance commitment was applicable[187] - The company's 2022 annual report was confirmed to be true, accurate, and complete by more than half of the directors[196] - The company's internal control audit was conducted by PricewaterhouseCoopers Zhong Tian LLP (Special General Partnership) with a fee of 450,000 RMB[190] - The company's domestic accounting firm remuneration for 2022 was 1.45 million RMB[190] Market and Industry Trends - HER2-positive breast cancer accounts for approximately 25% of all breast cancer cases, with CNS metastasis rates as high as 50% in HER2-positive patients[29] - PTCL accounts for 7%–10% of NHL globally, with a higher incidence rate of 25% in China compared to Western countries[25] - The global and Chinese NHL patient populations are projected to reach 670,000 and 117,000 by 2030, respectively[42] - Global new cancer cases increased from 17.64 million in 2017 to 19.74 million in 2021, with a compound annual growth rate of 2.8%[84] Risks and Challenges - The company faces significant market competition risks, particularly from large multinational corporations and domestic companies with stronger commercialization experience and resources[133] - The company faces risks from potential price increases in R&D technical services and materials, which could significantly impact operating costs[134] - The company's reliance on external financing for operational expenses poses a risk if funding is insufficient, potentially delaying or canceling R&D projects[137] - The company's equity incentive plans may lead to substantial share-based payment expenses, impacting future financial performance[138] - The company is exposed to risks from changes in drug pricing policies, including potential price reductions due to national medical insurance negotiations[142] - The company's international expansion may be affected by geopolitical and regulatory changes, impacting R&D and commercialization activities[155] - The company's leasing arrangements include a significant property lease in Shanghai with an annual rent and fixed property fee of 16.66 million yuan[151] - The company's trading financial assets decreased by RMB 416.18 million, from RMB 1.71 billion to RMB 1.29 billion, impacting the current profit by RMB 42.16 million[114] - The company's 2020 employee stock option plan requires incentive recipients to not sell shares for 36 months from the exercise date[184] Translational Science and Publications - DZD2269's translational science and pharmacodynamic biomarker research were published in the Journal of Experimental & Clinical Cancer Research (Impact Factor: 12.658)[46] Production and Supply Chain - The company has established standardized procurement processes, including end-to-end procurement procedures and supplier qualification management, to ensure efficient procurement of R&D services and materials[61] - The company's products are currently in the clinical trial stage and are produced through contract manufacturing organizations (CMO)[85]