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 ...

据介绍，舒沃替尼片是全球首个且唯一用于表皮生长因子受体（EGFR）20号外显子插入突变的非小细 胞肺癌新药，于2023年8月在我国获批上市。其所靶向的靶点罕见难治，缺乏临床共识的标准治疗方 案，传统治疗方案疗效十分有限。尽管如此，创新药研发企业迪哲医药仍积极申报医保，并于去年1月 实现医保落地，大幅降低了患者的用药成本。 科技进步奖旨在表彰在技术发明、技术开发、社会公益、重大工程中取得关键技术或系统创新成果，并 为经济社会发展做出重要贡献的项目，以"原创突破、战略价值、转化实效"为评选核心。舒沃替尼片此 次获奖表明其在源头创新与临床转化领域取得的重大突破获权威认可，也充分体现了研发企业在源头创 新、关键技术攻关与成果转化方面的综合实力。 科技日报记者 张佳星 近日，纳入国家医保目录的国产"全球新"创新药舒沃替尼片的研发及应用转化项目获得江苏省科技进步 奖一等奖。 2025年，凭借独特的创新分子结构设计以及疗效和安全性验证成果，舒沃替尼片获美国食品药品监督管 理局批准上市，成为中国首个独立研发在美获批的全球首创新药，并同步纳入美国国立综合癌症网络非 小细胞肺癌指南。这也标志着中国源头创新获得国际认可。 迪哲方面 ...

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]

Core Viewpoint - Dize Pharmaceutical is seeking to list on the Hong Kong Stock Exchange to alleviate its ongoing financial pressures despite recent revenue growth and reduced losses from its core products [1][4]. Financial Performance - In 2024, Dize Pharmaceutical's revenue is projected to be 360 million RMB, with losses narrowing to 940 million RMB; in the first three quarters of 2025, revenue is expected to rise to 586 million RMB, a year-on-year increase of over 73%, while losses are expected to decrease to 583 million RMB [1][4]. - The company has accumulated losses exceeding 4.567 billion RMB since its establishment in 2017, with R&D expenses totaling 3.853 billion RMB from 2018 to 2024 [6]. Product Development - Revenue growth is primarily driven by two core products: Shuwozhe® (Shuwotini tablets) and Gaoruizhe® (Golisitin capsules), which were launched in August 2023 and June 2024, respectively, and are expected to be included in the national medical insurance directory by the end of 2024 [4][6]. - The flagship product, Shuwozhe®, is projected to contribute revenues of 311 million RMB in 2024 and 422 million RMB in the first three quarters of 2025 [4]. Funding and Capital Strategy - Dize Pharmaceutical has relied heavily on capital markets for funding, raising approximately 2.103 billion RMB through its IPO on the STAR Market in 2021 and planning to raise about 1.796 billion RMB through a private placement in 2025 [6]. - The company aims to use the proceeds from its Hong Kong listing to enhance its R&D efforts and support the clinical development of its products [7]. Market Positioning - The decision to list in Hong Kong is part of Dize Pharmaceutical's strategy to deepen its global presence and enhance its international brand image, while also addressing the structural challenges of "increasing revenue without increasing cash" [4][7].

Core Viewpoint - Dize Pharmaceutical Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, focusing on its innovative cancer treatment products, particularly Shuwozhe and GaoRuizhe, which are pivotal for the company's revenue generation [1][2]. Group 1: Company Overview - Dize Pharmaceutical is a commercial-stage biopharmaceutical company specializing in oncology and hematological diseases [1]. - The company’s main product, Shuwozhe, is the only approved small molecule EGFR tyrosine kinase inhibitor for treating EGFR 20 insertion mutation lung cancer globally [1]. - GaoRuizhe is the first and only JAK1 inhibitor approved for treating relapsed or refractory peripheral T-cell lymphoma [2]. Group 2: Financial Performance - Revenue for Dize Pharmaceutical during the reporting period (2023, 2024, and the first three quarters of 2025) was RMB 91.29 million, RMB 360 million, and RMB 586 million respectively [2][3]. - Shuwozhe's revenue contribution was 100%, 86.4%, and 72% over the same periods, indicating a decline in its revenue share but still being the primary income source [2]. - The company reported net losses of RMB 1.11 billion, RMB 940 million, and RMB 649 million for the respective years [2][3]. Group 3: Cost Structure and Profitability - The company has incurred significant R&D expenses, amounting to RMB 806 million, RMB 724 million, and RMB 644 million, which are substantially higher than its revenue [4]. - Gross profit margins were relatively high at 96.5%, 97.4%, and 95.7%, attributed to strong R&D capabilities and pricing power from innovative products [4]. - The company has faced continuous net losses since its establishment, accumulating over RMB 4 billion in losses from 2018 to 2024 [3][4]. Group 4: Market Position and Client Concentration - Dize Pharmaceutical's revenue is highly concentrated, with the top five customers accounting for 90.8%, 89.6%, and 81.7% of total revenue during the reporting periods, and the largest customer contributing around 40% [5]. - The company also relies on a limited number of suppliers, with the top five suppliers representing 60.6%, 57.0%, and 57.8% of total procurement [5]. - Dize Pharmaceutical was founded in October 2017 and was listed on the Shanghai Stock Exchange in December 2021, with a current market capitalization of RMB 27.84 billion [5].

Company Overview - Dize Pharmaceutical Co., Ltd. is a commercial-stage biopharmaceutical company focused on oncology and hematology diseases, with its core product, Shuwozhe®, being the only approved small molecule EGFR tyrosine kinase inhibitor for treating EGFR 20 insertion mutation lung cancer globally [3] - The company was established in 2017, originating from AstraZeneca's global oncology translational science center, and possesses significant competitive advantages, including a strong research heritage and a mature scientific team with experience in drug discovery and development [3] - Dize has a robust product pipeline, including two approved drugs (Shuwozhe® and Gaoruizhe®), one candidate drug in the registration clinical stage, three assets in the concept validation stage, and one asset in the early clinical stage [3] Product Details - Shuwozhe® has been approved in China and the U.S., recognized as 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 [4] - Gaoruizhe® is the first and only approved JAK1 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma, having received fast track and orphan drug designations from the FDA [4] Financial Performance - The company reported revenues of approximately 91.29 million RMB for the fiscal year 2023, projected to increase to 360 million RMB in 2024 and 586 million RMB in 2025 [5][7] - Research and development expenses were approximately 806 million RMB in 2023, decreasing to 724 million RMB in 2024 and 644 million RMB in 2025 [6][7] - The gross profit margin for the company was approximately 96.5% in 2023, 97.4% in 2024, and 95.7% in 2025 [8] Industry Overview - The global oncology drug market is expected to grow from $167 billion in 2020 to $262 billion by 2024, with a compound annual growth rate (CAGR) of 11.9%, and projected to reach $724.9 billion by 2035 [9] - In China, the oncology drug market is anticipated to expand from $25.8 billion in 2020 to $37.2 billion by 2024, with a CAGR of 13.1%, reaching $143.7 billion by 2035 [9] - Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases, with the global incidence expected to rise from about 1.9 million cases in 2020 to 2.9 million by 2035 [12] - The global NSCLC drug market is projected to grow from $22.5 billion in 2020 to $49.2 billion by 2024, with a CAGR of 21.6%, and expected to reach $97.5 billion by 2035 [12]