Core Points - Diger Pharma announced that its new drug application for ZEGFROVY® (generic name: suvoritinib tablets) has been officially approved by the U.S. Food and Drug Administration (FDA) [1] - The drug is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression after platinum-based chemotherapy and have confirmed epidermal growth factor receptor (EGFR) exon 20 insertion mutations [1] Company Summary - Diger Pharma's ZEGFROVY® is now FDA-approved, marking a significant milestone for the company in the oncology market [1] - The approval targets a specific patient population, enhancing the company's portfolio in precision medicine [1] Industry Summary - The approval of ZEGFROVY® reflects ongoing advancements in targeted therapies for NSCLC, particularly for patients with specific genetic mutations [1] - This development may influence competitive dynamics within the oncology sector, as companies focus on personalized treatment options [1]

迪哲（江苏）医药股份有限公司（以下简称"公司"）自主研发的舒沃哲® （英文商品名：ZEGFROVY®，通用名：舒沃替尼片）的新药上市申请（New Drug Application，NDA），正式获得美国食品药品监督管理局（FDA）批准，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。 舒沃哲®通过通过优先审评（Priority Review）程序获得批准上市，成为目前 全球首个且唯一在美获批的 EGFR Exon20ins NSCLC 国创新药。其在分子设计的 源头进行了重大创新，突破难治靶点，是中国首个独立研发在美获批的全球首创 新药。 一、药品相关情况 舒沃哲®是一款口服、不可逆且针对多种 EGFR 突变亚型的高选择性 EGFR 酪氨酸激酶抑制剂（TKI），于 2023 年 8 月在中国获批上市，是目前 EGFR Exon20ins NSCLC 二/后线唯一标准治疗方案，填补了该领域近 20 年临床空白。 基于优异的疗效和安全性，舒沃 ...

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。 证券代码：688192 证券简称：迪哲医药 公告编号：2025-42 迪哲（江苏）医药股份有限公司 关于股东部分股份解除质押的公告 重要内容提示: 迪哲（江苏）医药股份有限公司（以下简称"公司"）股东、董事长兼首 席执行官张小林博士直接持有公司股份 5,483,972 股，占公司总股本的 1.19%。 张小林博士本次解除质押股份 2,771,620 股，占其直接持股数量的 50.54%，占公司总股本的 0.60%。 一、本次股份解除质押情况 1 二、股东累计质押股份情况 （注：上述持股数量不包括张小林博士通过江苏无锡迪喆企业管理合伙企业（有限合伙） 及 ZYTZ Partners Limited 间接持有的股份，间接持股部分不存在质押、冻结情况。） 公司将持续关注上述股东的质押情况及质押风险情况，并严格遵守相关规 公司近日接到股东张小林博士通知，获悉其所持有本公司的部分股份已经 办理解除质押手续，具体事项如下： | 原出质 | | | | 本次解质数 | 本次解质数 | 本次 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2025-41 迪哲（江苏）医药股份有限公司 关于高级管理人员减持股份计划公告 本公司董事会、全体董事及相关股东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。 重要内容提示： 1 持前所持有公司股份数量均不超过 25%。减持期间自 2025 年 7 月 18 日至 2025 年 10 月 17 日，减持价格将按照减持实施期间的市场价格确定。 | 股东名称 | 陈素勤 | | | | --- | --- | --- | --- | | 股东身份 | 控股股东、实控人及一致行动人 | □是 | √否 | | | 直接持股 5%以上股东 | □是 | √否 | | | 董事、监事和高级管理人员 | √是 | □否 | | | 其他：无 | | | | 持股数量 | 519,500股 | | | | 持股比例 | 0.1131% | | | | 当前持股股份来源 | 股权激励取得：519,500股 | | | | 股东名称 | Qingbei Zeng | | | --- | --- | --- ...

Core Viewpoint - The announcement details the upcoming listing and circulation of restricted shares for Dize Pharmaceutical Co., Ltd., with a total of 223,013,329 shares set to be released on July 1, 2025, representing 48.54% of the company's total share capital [1][3][13]. Summary by Sections Listing of Restricted Shares - The type of shares being listed is restricted shares from the company's initial public offering (IPO) [2]. - The total number of shares to be listed is 223,013,329, which will be available for trading starting July 1, 2025 [1][6]. Shareholder Commitments - Major shareholders, including Advanced Manufacturing Industry Investment Fund and AstraZeneca AB, are required to adhere to specific commitments regarding share lock-up and reduction [2][3]. - The first major shareholder, Advanced Manufacturing, and AstraZeneca AB are prohibited from reducing their holdings through trading until certain conditions are met, particularly if the company has not paid cash dividends due to losses [2][3]. Changes in Share Capital - The company's total share capital has increased from 400,000,100 shares to 459,412,894 shares due to various stock option plans and incentive programs [4][5]. - The increase includes 12,103,020 shares from the 2020 employee stock option plan and additional shares from the 2022 restricted stock incentive plan [4][5]. Commitments from Major Shareholders - Advanced Manufacturing and AstraZeneca AB have committed not to transfer or manage their shares for 36 months following the company's IPO [8][10]. - If the company does not achieve profitability, these shareholders cannot reduce their holdings for three full accounting years after the IPO [8][10]. Verification by Intermediaries - The underwriting institution, Huatai United Securities, has confirmed that all commitments related to the restricted shares have been strictly adhered to by the shareholders [11]. - The verification indicates that the listing of restricted shares complies with relevant laws and regulations [11]. Details of Restricted Shares - The total number of restricted shares being listed is 223,013,329, which will be available for trading on July 1, 2025 [6][13]. - The shareholders holding these restricted shares include Advanced Manufacturing, AstraZeneca AB, and ZYTZ Partners Limited [3][13].

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 首次公开发行部分限售股上市流通的核查意见 华泰联合证券有限责任公司（以下简称"华泰联合"、"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"）2023 年度向特定对 象发行 A 股股票的保荐机构，根据《证券发行上市保荐业务管理办法》 《科创板 上市公司持续监管办法（试行）》《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》等相关规定履行 持续督导职责，对迪哲医药首次公开发行部分限售股上市流通的相关情况进行了 审慎核查，核查情况如下： 一、本次上市流通的限售股类型 根据中国证券监督管理委员会于 2021 年 11 月 3 日出具的《关于同意迪哲 （江 | | 股份变动事项 | | 公告索引 | | | --- | --- | --- | --- | --- | | 号 间 | 权新增的股份完成登记 | 量（股） | | （公告编号：2021-006） | | | | | 动的公告》 | | | | 一次行权新增的股份完 | | | 股份变动的公告》（公告编 | | 号： ...

Meeting Overview - The shareholders' meeting of Dize Pharmaceutical (Jiangsu) Co., Ltd. was held on June 23, 2025, in Wuxi City, Xinwu District [1] - A total of 99 ordinary shareholders attended the meeting, holding 295,711,183 voting rights, which accounts for 64.3671% of the company's total voting rights [1] Voting Results - All proposed resolutions were approved during the meeting [2][3] - The voting results showed that for the first resolution, 295,693,167 votes (99.9939%) were in favor, with only 4,600 votes against [2] - Subsequent resolutions also received overwhelming support, with approval rates consistently above 99.98% [2][3] Legal Compliance - The meeting was conducted in accordance with the Company Law and the company's articles of association, with the presence of qualified attendees and proper voting procedures [3][4] - Legal opinions were provided by lawyers Wang Yuan and Chen Tong, confirming the legality of the meeting and its resolutions [3]

Core Points - The legal opinion letter confirms the legality of the 2024 annual general meeting of Dize (Jiangsu) Pharmaceutical Co., Ltd. [1][16] - The opinion is based on the review of relevant laws, regulations, and the company's articles of association [1][2] Group 1: Meeting Procedures - The notice for the 2024 annual general meeting was properly communicated to all shareholders, including details on time, location, and agenda [3][4] - The meeting was convened in accordance with the relevant legal and regulatory requirements [4][15] Group 2: Attendance and Qualifications - A total of 9 shareholders and their proxies attended the meeting, representing 178,558,990 shares, which is 38.87% of the total voting shares [4][6] - The qualifications of the attendees were verified, confirming their legitimacy to participate in the meeting [4][6] Group 3: Voting Procedures and Results - Voting was conducted through both on-site and online methods, with results being monitored and counted by designated personnel [6][15] - The voting results showed that 295,693,967 shares were in favor of the proposals, representing a significant majority of the votes cast [7][14]

证券代码：688192 证券简称：迪哲医药 公告编号：2025-39 迪哲（江苏）医药股份有限公司 首次公开发行部分限售股上市流通公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 本次股票上市类型为首发限售股份；股票认购方式为网下，上市股数为 223,013,329股。 本次股票上市流通总数为223,013,329股。 本次股票上市流通日期为2025 年 7 月 1 日。 相关股东除遵守作出的关于所持迪哲（江苏）医药股份有限公司（以下简称 "公司"或"迪哲医药"）股份锁定、减持相关承诺外，还需遵守《上市公司股 东减持股份管理暂行办法》《上海证券交易所上市公司自律监管指引第 15 号—— 股东及董事、高级管理人员减持股份》等法规及规范性文件中关于股份减持的相 关规定。根据前述规定，截至本公告出具日，在公司最近三个已披露经审计的年 度报告的会计年度因亏损而未进行现金分红的情况下，第一大股东先进制造产业 投资基金（有限合伙）（以下简称"先进制造"）和 AstraZeneca AB （以下简称 "AZAB"）不 ...

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 首次公开发行部分限售股上市流通的核查意见 华泰联合证券有限责任公司（以下简称"华泰联合"、"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"）2023 年度向特定对 象发行 A 股股票的保荐机构，根据《证券发行上市保荐业务管理办法》《科创板 上市公司持续监管办法（试行）》《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》等相关规定履行 持续督导职责，对迪哲医药首次公开发行部分限售股上市流通的相关情况进行了 审慎核查，核查情况如下： 一、本次上市流通的限售股类型 根据中国证券监督管理委员会于 2021 年 11 月 3 日出具的《关于同意迪哲（江 苏）医药股份有限公司首次公开发行股票注册的批复》（证监许可〔2021〕3494 号），公司首次向社会公开发行人民币普通股（A 股）40,000,100 股，并于 2021 年 12 月 10 日在上海证券交易所科创板上市。发行完成后公司总股本为 400,000,100 股，其中有限售条件流通股 363,050,516 股，无限 ...