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 2020 年员工股份期权计划 第二个行权期第二次行权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"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 2020 年员工股 份期权计划第二个行权期第二次行权限售股上市流通事项进行了核查，核查的具 体情况如下： 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。 本次上市流通的限售股为公司首次公开 ...

Core Viewpoint - Dige Medical announced the release of restricted shares from the second exercise period of its 2020 employee stock option plan, with 991,000 shares set to be listed for trading on February 24, 2026 [1] Group 1 - The number of shares being released for trading is 991,000 [1] - These shares are part of the second exercise period of the employee stock option plan initiated in 2020 [1] - The listing date for these shares is specified as February 24, 2026 [1]

Core Viewpoint - Dize Pharmaceutical has submitted an application for a Hong Kong stock listing, aiming to leverage the international financing platform and higher valuation standards of the Hong Kong market to enhance its global market presence and attract international investors [1][2]. Group 1: Company Developments - Dize Pharmaceutical has achieved a revenue of 586 million yuan in the first three quarters, representing a 73% year-on-year increase, and is expected to reach approximately 800 million yuan for the full year, with a projected growth of 122.28% [2]. - The company has achieved commercial profitability, with product revenues covering all operating expenses beyond R&D costs, marking a significant milestone [2]. - The launch of its core product, Shuwozhe®, which received FDA accelerated approval, has established Dize's capability to transition from laboratory to international market, opening new overseas growth opportunities [2]. Group 2: Market Strategy - The decision to list in Hong Kong aligns with Dize's strategy to utilize the advantages of dual listings to attract international investors and facilitate collaboration with multinational pharmaceutical companies [1]. - Dize's product pipeline is developed with a global synchronization strategy, aiming to create a differentiated matrix of globally innovative and best-in-class potential products [1]. - The company plans to maintain a high level of R&D investment, with ongoing progress in product development and expansion of indications for already launched products [2].

Core Viewpoint - DIZHE Pharmaceutical (688192.SH) is pursuing an "A+H" listing by submitting an application to the Hong Kong Stock Exchange, aiming to raise funds for clinical development, sales, and operational expenses, while currently being in the commercialization phase with two approved products [2][3]. Financial Performance - The company raised approximately 2.1 billion yuan in its 2021 IPO and 1.8 billion yuan through a private placement in April 2025 [2]. - DIZHE expects to achieve revenue of around 800 million yuan in 2025, representing a year-on-year growth of approximately 122.28%, with a projected net loss of about 770 million yuan [2][5]. - The company reported a net profit of approximately -1.1 billion yuan in 2023 and -846 million yuan in 2024, with an expected reduction in net loss by about 75.96 million yuan in 2025 [7]. Product Pipeline and Market Strategy - DIZHE has two approved products, Shuwotini (舒沃哲) and Gelixitini (高瑞哲), which are expected to significantly enhance patient accessibility after being included in the national medical insurance catalog [4][5]. - The company is focusing on expanding the indications for its existing products and advancing its pipeline, which includes seven products currently in clinical stages [8]. R&D Investment and Challenges - DIZHE is in the early stages of commercialization and continues to incur significant R&D expenses, with an expected R&D expenditure of around 860 million yuan in 2025, reflecting a year-on-year increase of approximately 18.84% [7]. - The company is facing challenges in achieving positive operating cash flow, as it continues to invest heavily in R&D while striving for commercial profitability [6][8]. Market Position and Future Outlook - DIZHE aims to leverage its products' inclusion in the medical insurance directory to enhance market penetration and drive revenue growth, with a sales expense ratio significantly reduced to 72% in the first three quarters of 2025 [6]. - The company is committed to ensuring the advancement of its core global pipeline and key market development while maintaining a focus on sustainable high-quality profitability [8][9].

Group 1: Core Insights - The article discusses the recent trend of Chinese pharmaceutical companies, including Dizhe Pharmaceutical, applying for listings on the Hong Kong Stock Exchange (HKEX), marking a new wave of "A+H" listings since 2025 [1][2] - Policy support from the China Securities Regulatory Commission (CSRC) and HKEX has facilitated this trend, with measures such as fast-track approvals for A-share companies and dedicated services for tech and biotech firms [1][2] - The drive for A+H listings is also fueled by companies' need for diversified capital channels to mitigate A-share market volatility and to support significant R&D investments and international commercialization efforts [2] Group 2: Company-Specific Developments - Dizhe Pharmaceutical aims to enhance its global strategy and brand image through its HKEX listing, which is expected to attract international investors and foster collaborations with multinational pharmaceutical companies [2][4] - Despite projected revenue growth from 1 billion yuan in 2023 to 800 million yuan in 2025, Dizhe Pharmaceutical anticipates a net loss of 770 million yuan in 2025, highlighting the ongoing challenge of high R&D and sales expenses [3][5] - The company is actively advancing its core products, with ongoing clinical trials and plans to expand indications, while also focusing on improving operational efficiency and reducing sales expense ratios [4][5] Group 3: Market Trends and Challenges - The A+H listing trend is expected to continue into 2026, but there may be a significant differentiation between leading companies and mid-tier firms, with the latter facing greater pressure [3][10] - There are rumors of tightening listing requirements for HKEX, potentially raising the market capitalization threshold to 30 billion yuan, which could impact the number of companies able to list [6][7][8] - The HKEX has seen a substantial increase in IPO activity, with 117 companies listed in 2025, raising a total of 285.69 billion HKD, indicating a robust market despite potential pressures from increased supply [9][10]

Core Viewpoint - The company, Dize Pharmaceutical, is pursuing a listing on the Hong Kong Stock Exchange to enhance its global strategy, improve its international brand image, and strengthen its core competitiveness, rather than solely for fundraising purposes [1]. Group 1 - The company has successfully completed a targeted private placement and is now planning to issue H-shares [1]. - The primary goal of the Hong Kong listing is to deepen the company's global strategic layout and attract international investors [1]. - The company aims to leverage the advantages of dual listings to facilitate cooperation and communication with multinational pharmaceutical companies [1].

证券代码：688192 证券简称：迪哲医药 公告编号：2026-007 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的第二类激励对 象第二个归属期部分归属、预留授予的激励对象第一个 归属期部分归属结果暨股票上市公告 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股权激励股份；股票认购方式为网下，上 市股数为614,375股。 本次股票上市流通总数为614,375股。 本次股票上市流通日期为2026 年 2 月 2 日。 根据中国证监会、上海证券交易所、中国证券登记结算有限责任公司上海分 公司有关业务规则的规定，迪哲（江苏）医药股份有限公司（以下简称"公司"）于 近日收到中国证券登记结算有限责任公司上海分公司出具的《证券变更登记证明》， 公司完成了 2022 年限制性股票激励计划（以下简称"限制性股票激励计划"）首次 授予的第二类激励对象第二个归属期部分归属、预留授予的激励对象第一个归属 期部分归属的股份登记工作，现将有关情况公告如下： 一、本次限制性股票归属的决策 ...

Core Insights - The innovative drug Shuwotini tablets, which targets a rare mutation in non-small cell lung cancer, has won the first prize in Jiangsu Province's Science and Technology Progress Award, highlighting its significant breakthrough in original innovation and clinical application [1] - Shuwotini tablets are the first and only drug approved for the EGFR 20 insertion mutation, receiving market approval in China in August 2023 and subsequently being included in the national medical insurance directory, significantly reducing patient costs [1] - The award recognizes the project's contributions to technological innovation and its impact on economic and social development, emphasizing the comprehensive strength of the research and development company in key technology breakthroughs and results transformation [1] Company and Industry Developments - The company, Dizhe Pharmaceutical, aims to continue addressing unmet clinical needs through technological innovation, accelerating the delivery of globally competitive original innovations to benefit patients worldwide [2] - The drug is expected to gain international recognition, as it was approved by the U.S. FDA in 2025, marking it as the first independently developed innovative drug from China to be approved in the U.S. and included in the National Comprehensive Cancer Network guidelines for non-small cell lung cancer [1]

Company Overview - Dize Pharmaceutical has submitted its listing application to the Hong Kong Stock Exchange, with Goldman Sachs and Huatai International as joint sponsors [1] - The company is a commercial-stage biopharmaceutical firm focusing on oncology and hematological diseases [1] Core Products - The core drug, Shuwozhe, is the only approved small molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor for treating EGFR 20 insertion mutation lung cancer globally [1] - Shuwozhe is the first lung cancer drug developed in China to receive breakthrough therapy designation from both the FDA and the National Medical Products Administration of China [1] - It is the only targeted drug recommended by the NCCN guidelines for non-small cell lung cancer (NSCLC) and included in China's national medical insurance catalog for this indication as of January 18, 2026 [1] - The second core drug, Gaoruizhe, is the first and only approved JAK1 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma [1] - Gaoruizhe has received fast track and orphan drug designations from the FDA and is also included in China's national medical insurance catalog [1] Pipeline and Market Potential - In addition to the two approved drugs, the pipeline includes one asset in the registration clinical stage, three in the post-concept validation stage, and one in the early clinical stage [1] - The global and Chinese oncology drug markets are experiencing significant growth, particularly in the treatment of lung cancer and NSCLC, which have substantial unmet medical needs [1] - The global market for EGFR 20 insertion mutation NSCLC is projected to grow from $1 billion in 2024 to $8 billion by 2035 [1]

Investment Rating - The report maintains a positive investment rating for the pharmaceutical sector [5] Core Views - The report emphasizes three main investment themes for 2026: innovation, overseas expansion, and turnaround impulses, with a focus on BD2.0, small nucleic acids, and supply chain (CXO and upstream) [2][3] - The report suggests that the pharmaceutical sector is currently experiencing a rotation in investment focus, particularly in areas such as brain-computer interfaces, AI integration, small nucleic acids, and medical robotics [3] Summary by Sections Public Fund Holdings Update for Q4 2025 - Overall, the market value of public funds holding pharmaceutical stocks has decreased, with a total market value of 217.6 billion yuan, down by 51 billion yuan from the previous quarter [14] - The pharmaceutical sector's allocation in public funds is 7.96%, a decrease of 1.74 percentage points [19] - Chemical preparations remain the most heavily weighted sub-industry, while allocations to medical devices have increased [14][25] Market Review and Analysis - The pharmaceutical and biotechnology index decreased by 0.39% week-on-week, outperforming the CSI 300 index but underperforming the ChiNext index [1] - The total trading volume in the pharmaceutical sector was 554.24 billion yuan, accounting for 4.00% of the total trading volume in the Shanghai and Shenzhen markets [1] Investment Opportunities - The report identifies specific companies for potential investment, including: - CXO and innovative drug companies such as Tigermed, Zhaoyan New Drug, and Hai Si Ke, which have seen significant increases in fund holdings [16][38] - AI innovative drug companies like Jingtai Holdings and small nucleic acid firms such as Frontier Biotech and Yuyuan Pharmaceutical [3][38] - The report also highlights the importance of exploring CROs, essential drugs, and companies showing signs of bottoming out [3]