您可使用手机"扫一扫" 此码用于证明该审计报告是否由具有执业许可的会计师事务 您可使用手机"扫一扫"或进入"注册会计师行业统一监管平台（http://acc.mof.eov.cn） 内部控制审计报告 迪哲(江苏)医药股份有限公司 内部控制审计报告 二〇二五年度 | 迪哲(江苏)医药股份有限公司全体股东: 按照《企业内部控制审计指引》及中国注册会计师执业准则的相 关要求,我们审计了迪哲(江苏)医药股份有限公司(以下简称"迪 哲医药")2025年12月31日的财务报告内部控制的有效性。 一、 企业对内部控制的责任 按照《企业内部控制基本规范》、《企业内部控制应用指引》、《企 业内部控制评价指引》的规定,建立健全和有效实施内部控制,并评 价其有效性是迪哲医药董事会的责任。 二、 注册会计师的责任 我们的责任是在实施审计工作的基础上,对财务报告内部控制的 有效性发表审计意见,并对注意到的非财务报告内部控制的重大缺陷 进行披露。 三、内部控制的固有局限性 内部控制具有固有局限性,存在不能防止和发现错报的可能性。 此外,由于情况的变化可能导致内部控制变得不恰当,或对控制政策 和程序遵循的程度降低,根据内部控制审计结果推测 ...

迪哲(江苏)医药股份有限公司 非经营性资金占用及其他关联资金往来 情况的专项报告_ 2025年度 您可使用手机"扫一扫"或进入"注册会计师行业统一监管平台（http://acc.mof.gov.cn） 所出! 报告编码:沪26G 关于迪哲(江苏)医药股份有限公司 非经营性资金占用及其他关联资金往来情况 的专项报告 信会师报字[2026]第 ZA10730 号 迪哲(江苏)医药股份有限公司全体股东: 我们审计了迪哲(江苏)医药股份有限公司(以下简称"迪哲医 药")2025年度的财务报表,包括 2025年12月 31 目的合并及母公司 资产负债表、2025 年度合并及母公司利润表、合并及母公司现金流 量表、合并及母公司所有者权益变动表和相关财务报表附注,并于 2026 年 3 月 30 日出具了报告号为信会师报字[2026]第 ZA10727 号的 无保留意见审计报告。 立信会计师事务所(特殊普通合伙) hina shu lun pan certified Public Accountants LLP 本报告仅供迪哲医药为披露 2025 年年度报告的目的使用,不得 用作任何其他目的。 迪哲医药管理层根据中国证券监 ...

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 使用部分暂时闲置募集资金临时补充流动资金的核查意见 华泰联合证券有限责任公司（以下简称"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》《上海证券交易 所科创板股票上市规则》以及《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，对迪哲医药使用部分暂时闲 置募集资金临时补充流动资金事项进行了核查，核查的具体情况如下： 一、募集资金基本情况 | 发行名称 | 2023 | 年度向特定对象发行 A 股股票 | | --- | --- | --- | | 募集资金总额 | 1,795,886,744.00 | 元 | | 募集资金净额 | 1,773,446,130.53 | 元 | | 募集资金到账时间 | 2025 年 4 月 | 10 日 | | | 年 月 2026 3 6 | 日归还 万 10,336.33 | | 前次用于暂时补充流动资金的募集资金归还日期 | | 元，前次临时补充流动 ...

北京市中伦律师事务所 关于迪哲（江苏）医药股份有限公司 2022 年限制性股票激励计划 首次授予部分限制性股票归属事项的法律意见书 二〇二六年三月 法律意见书 北京市中伦律师事务所 关于迪哲（江苏）医药股份有限公司 2022 年限制性股票激励计划首次授予部分 限制性股票归属事项的法律意见书 致：迪哲（江苏）医药股份有限公司 北京市中伦律师事务所（以下简称"本所"）接受迪哲（江苏）医药股份有 限公司（以下简称"迪哲医药"或"公司"）委托，就公司 2022 年限制性股票 激励计划（以下简称"激励计划"或"本激励计划"）相关事宜担任专项法律顾 问，并就本激励计划首次授予部分限制性股票归属（以下简称"本次归属"）相 关事项出具本法律意见书。 为出具本法律意见书，本所律师审阅了《迪哲（江苏）医药股份有限公司 2022 年限制性股票激励计划（草案）》（以下简称"《激励计划（草案）》"）、《迪 哲（江苏）医药股份有限公司 2022 年限制性股票激励计划实施考核管理办法》 （以下简称"《考核办法》"）、公司相关董事会会议文件以及本所律师认为需要审 查的其他文件，并对相关的事实和资料进行了核查和验证。 为出具本法律意见书，本所 ...

迪哲(江苏)医药股份有限公司 审计报告及财务报表 二〇二五年度 Treat 您可使用手机"扫一扫"或进入 迪哲(江苏)医药股份有限公司 审计报告及财务报表 (2025年01月 01日至 2025年 12月 31 日止) | 目录 | 页次 | | --- | --- | | 审计报告 | 1-5 | | 财务报表 | | | 合并资产负债表和母公司资产负债表 | 1-4 | | 合并利润表和母公司利润表 | 5-6 | | 合并现金流量表和母公司现金流量表 | 7-8 | | 合并所有者权益变动表和母公司所有者权益变动表 | 9-12 | | 财务报表附注 | 1-81 | 审计报告 信会师报字[2026]第 ZA10727 号 迪哲(江苏)医药股份有限公司全体股东: 一、审计意见 我们审计了迪哲(江苏)医药股份有限公司(以下简称"迪哲医 药")财务报表,包括2025年12月31日的合并及母公司资产负债表, 2025 年度的合并及母公司利润表、合并及母公司现金流量表、合并 及母公司所有者权益变动表以及相关财务报表附注。 我们认为,后附的财务报表在所有重大方面按照企业会计准则的 规定编制,公允反映了迪哲医药 2 ...

Summary of Key Points from Conference Call Records Industry Overview - **Industry Focus**: Innovative pharmaceuticals, particularly in the context of China's biopharmaceutical sector and its international expansion - **Market Growth**: The total value of BD (Business Development) transactions for innovative drugs is projected to reach $137.7 billion by 2025, a 1.6 times increase year-on-year, significantly surpassing the electric vehicle sector's $74 billion in the same timeframe [1][2][3] Core Insights and Arguments - **International Expansion**: The innovative drug sector is experiencing explosive growth in international markets, with Q1 2026 BD transactions already reaching $60 billion, accounting for 46% of the total for 2025 [1][2] - **Policy Support**: Biopharmaceuticals have been designated as a new pillar industry by the Chinese government, shifting focus from public welfare to GDP contribution, indicating a supportive policy environment for growth [2][3] - **Performance Expectations**: Companies like Heng Rui Medicine are expected to see over 30% growth in innovative drug revenue by 2026, with significant contributions from key products [1][3] - **Clinical Developments**: Major clinical data releases are anticipated from key conferences such as AACR and ASCO, which could catalyze market movements [1][5] Notable Companies and Their Prospects - **Heng Rui Medicine**: Expected to achieve over 30% growth in innovative drug revenue, with a strong pipeline of 53 products anticipated for approval between 2022 and 2028 [15] - **Kangfang Biopharma**: Key product AK112 is set to release critical clinical data in 2026, which could significantly impact its market position [11][13] - **Baiyi Shenzhou**: Projected profits of $700-800 million in 2026, indicating a rapid profit climb [1][8] - **Xinda Biopharma**: Anticipated to benefit from new product approvals and commercial launches, with a focus on expanding its product pipeline [6][8] Investment Opportunities - **Recommended Stocks**: Key investment targets include Kangfang Biopharma, Xinda Biopharma, Baiyi Shenzhou, and Kelong Biotechnology in the H-share market, and Xintai, Haishike, and Heng Rui Medicine in the A-share market [4][8] - **Undervalued Stocks**: Companies like Hot Scene Biopharma and Yifang Biopharma, which have seen significant price declines, are suggested for bottom-fishing opportunities [4][8] Emerging Trends - **Small RNA Technology**: The small RNA sector is entering a critical phase with breakthroughs in liver-targeted delivery technologies, and several companies are expected to announce significant clinical data in 2026 [18][22] - **Clinical Data Impact**: Recent clinical data from companies like Serapta and Wave Life Sciences highlight the potential and challenges within the small RNA space, influencing market sentiment and investment strategies [20][21] Conclusion - The innovative pharmaceutical sector in China is poised for significant growth driven by international expansion, supportive policies, and strong company performances. Key clinical events and emerging technologies present substantial investment opportunities, particularly in small RNA and innovative drug development.

证券代码：688192 证券简称：迪哲医药 公告编号：2026-013 迪哲（江苏）医药股份有限公司 自愿披露关于舒沃哲®一线治疗 EGFR PACC 或 其他罕见突变非小细胞肺癌的最新数据于 2026 年欧洲肺癌大会（ELCC）发布的公告 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。 迪哲（江苏）医药股份有限公司（以下简称"公司"）宣布，公司于当地时 间 3 月 25 日-28 日在丹麦哥本哈根举行的 2026 年欧洲肺癌大会（ELCC）上， 公布舒沃哲®（通用名：舒沃替尼片）一线治疗携带表皮生长因子受体（EGFR） P 环和αC 螺旋压缩（PACC）或其他罕见突变的晚期非小细胞肺癌（NSCLC） 的最新研究数据（壁报编号：44P）。研究结果显示，舒沃哲®一线治疗 EGFR PACC 或其他罕见突变 NSCLC 患者的客观缓解率（ORR）达 81.3%，展现出良好的抗 肿瘤疗效和可控的安全性。 一、大会数据 在 EGFR 突变型 NSCLC 中，PACC 突变约占 12.5%，常以高比例复合突变 出现，异质性强，治疗难度 ...

Core Viewpoint - The innovative drug sector is experiencing significant growth, with multiple companies seeing substantial stock price increases, indicating a bullish trend in the market [1]. Group 1: Stock Performance - Shuyatain's stock price increased by 14.66%, reaching 26.52 [2] - Other notable performers include Dizhe Pharmaceutical with a 10.70% increase, Baili Tianheng at 10.63%, and Huana Pharmaceutical at 10.33% [2] - In the Hong Kong market, Keystone Pharmaceuticals surged over 18%, while CSPC Pharmaceutical and Xiansheng Pharmaceutical rose by over 12% and 8%, respectively [3] Group 2: Market Trends - The overall trend in the innovative drug sector shows a strong upward movement, with several companies hitting their daily price limits [1] - The performance of stocks in both mainland and Hong Kong markets reflects a growing investor confidence in the pharmaceutical industry [3]

Investment Rating - The report does not explicitly state an investment rating for the industry, but it suggests focusing on domestic biotech companies with differentiated competitive advantages [2]. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.77% from March 16 to March 20, underperforming the CSI 300 index, which fell by 2.19%. Medical consumables, raw materials, and vaccines were the leading sub-sectors, while medical devices and outsourced medical research saw the largest declines [2][7]. - A significant milestone was achieved on March 21 when Dizhe Pharmaceutical announced positive top-line results from its Phase III clinical trial for its core product, Shuwotai (suwonitinib), for the treatment of EGFR exon20ins mutation advanced non-small cell lung cancer. This marks the first oral monotherapy to achieve positive results in this indication globally, indicating a breakthrough for domestic small molecule TKI drugs [2][10]. Market Weekly Review - The pharmaceutical and biotechnology sector declined by 2.77%, underperforming the CSI 300 index, which fell by 2.19%. The leading sub-sectors included medical consumables (4.1%), raw materials (1.32%), and vaccines (1.29%), while medical devices (-2.04%), outsourced medical research (-1.63%), and chemical preparations (-0.82%) lagged behind. Notable stock performances included *ST Jingfeng (27.7%), Sanofi (23.1%), and Jidan Bio (15.6%) for gains, while *ST Changyao (-52.2%), Xiangyu Medical (-21.4%), and Sanbo Brain Science (-20.7%) faced significant losses [2][7][10]. Industry News and Key Company Announcements - On March 21, Dizhe Pharmaceutical announced that its new targeted lung cancer drug, Shuwotai, achieved positive results in a Phase III clinical trial for treating advanced non-small cell lung cancer with EGFR exon20ins mutation, marking a significant advancement in the field [10]. - On March 20, Novartis announced an agreement to acquire Pikavation Therapeutics for a total potential cash consideration of up to $3 billion, including a $2 billion upfront payment and $1 billion in milestone payments [13]. - Eli Lilly reported positive results from its Phase III trial for a new treatment for type 2 diabetes, showing significant reductions in HbA1c levels and weight loss among patients [13]. - Aiming for growth, various companies reported their annual earnings, with notable performances from Dong'e Ejiao, which saw a revenue increase of 8.83%, and Tianjin Tasly, which reported a revenue decrease of 3.08% [13][14].

Investment Rating - The report does not explicitly state an investment rating for the industry, but it suggests focusing on domestic biotech companies with differentiated competitive advantages. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.77% from March 16 to March 20, underperforming the CSI 300 index, which fell by 2.19%. Notably, medical consumables, raw materials, and vaccines showed positive growth, while medical devices and chemical preparations faced declines. Individual stock performances varied significantly, with *ST Jingfeng rising by 27.7% and *ST Changyao dropping by 52.2% [2][7][10]. - A significant milestone was achieved by Dize Pharmaceutical on March 21, with its core product, Shuwotai (舒沃替尼), demonstrating positive results in a Phase III clinical trial for treating advanced non-small cell lung cancer with EGFR exon20ins mutations. This marks a breakthrough in the availability of oral monotherapy options in this field and highlights the potential of Chinese biotech companies to innovate and compete globally [2][10]. Market Weekly Review - The pharmaceutical and biotechnology sector declined by 2.77%, underperforming the CSI 300 index, which fell by 2.19%. Medical consumables (4.1%), raw materials (1.32%), and vaccines (1.29%) led the gains, while medical devices (-2.04%), medical research outsourcing (-1.63%), and chemical preparations (-0.82%) faced losses. Notable stock performances included *ST Jingfeng (27.7%), Sanofi (23.1%), and Jidan Biology (15.6%) for gains, while *ST Changyao (-52.2%), Xiangyu Medical (-21.4%), and Sanbo Brain Science (-20.7%) faced significant declines [2][7][10]. Industry News and Key Company Announcements - On March 21, Dize Pharmaceutical announced that its new targeted lung cancer drug, Shuwotai (舒沃替尼), achieved positive results in a Phase III clinical trial for treating advanced non-small cell lung cancer with EGFR exon20ins mutations, becoming the first oral targeted drug to achieve such results in an international multi-center study [10]. - On March 20, Novartis announced an agreement to acquire Pikavation Therapeutics for a total potential cash consideration of up to $3 billion, including an upfront payment of $2 billion and milestone payments of $1 billion [13]. - Eli Lilly reported positive results from its Phase III trial for a new treatment for type 2 diabetes, showing significant reductions in HbA1c levels and weight loss among patients [13]. - Other companies, such as Aimeike and Dong'e Ejiao, reported their annual earnings, with Aimeike experiencing a revenue decline and Dong'e Ejiao showing revenue growth [13][15].