Core Viewpoint - Dige Medical (688192.SH) reported significant revenue growth in the first three quarters of 2025, but also faced substantial net losses [1] Financial Performance - The company achieved a revenue of 586 million yuan in the first three quarters, representing a year-on-year growth of 73.23% [1] - The net loss attributable to shareholders was 580 million yuan [1] - The non-recurring net profit loss was 631 million yuan [1] - The basic earnings per share were -1.32 yuan [1]

Core Insights - The company reported a significant increase in revenue for the first three quarters of 2025, reaching 586 million yuan, which represents a year-on-year growth of 73.23% [1] - Despite the revenue growth, the company recorded a net profit attributable to shareholders of -580 million yuan [1] - The revenue increase is primarily attributed to the inclusion of two core products, Shuwozhe and Gaoruizhe, in the national medical insurance drug list, leading to sustained sales growth [1]

Core Insights - The company, Dizhe Pharmaceutical, reported a strong revenue growth of 73.23% year-on-year, reaching 586 million yuan in the first three quarters of 2025, with a quarterly revenue of 231 million yuan in Q3 2025 [1] - Despite being in a research and development phase with net profits not yet positive, the strong revenue growth and improving cash flow indicate that the company has entered a new stage of product volume expansion and value realization [1] Revenue Growth Drivers - The significant revenue increase is primarily driven by two core products: Shuwozhe (Shuwotini) and Gaoruizhe (Golisib), which have been included in the national medical insurance drug list in 2024, leading to rapid sales growth [2] - Shuwozhe is the first and only domestic innovative drug approved for EGFR Exon20ins mutation non-small cell lung cancer (NSCLC) in both China and the US, marking a key milestone in the company's internationalization [2] - Gaoruizhe is the first high-selective JAK1 inhibitor approved for relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) in China, filling a clinical gap in the market for nearly a decade [2] - The company has demonstrated a stable self-sustaining capability with all revenue growth coming from commercialized products, validating its business model [2] Research and Development Progress - The company maintains high R&D investment despite rapid revenue growth, with multiple competitive product pipelines in oncology, including two products already launched and two in late clinical stages [3] - Recent R&D advancements include the FDA's accelerated approval of Shuwozhe and the recognition of the dual-target inhibitor birelentinib for chronic lymphocytic leukemia/small lymphocytic lymphoma [3] - The company has over 1.9 billion yuan in cash reserves, providing solid support for ongoing R&D, clinical development, and commercialization efforts [3] Investment Outlook - Analysts believe that Dizhe Pharmaceutical has established a virtuous development pattern characterized by rapid cash flow from commercialized products, high growth expectations from innovative pipelines, and successful global market expansion of key products [4] - The investment logic is based not only on short-term growth from the domestic medical insurance market but also on the long-term global value supported by its innovative capabilities [4]

Core Insights - The company reported a significant revenue increase of 73.23% year-on-year, reaching 586 million yuan in the first three quarters of 2025, driven by the commercialization of its core products, Shuwozhe® and Gaoruizhe® [1][2] - The company achieved commercial profitability for the first time in the first half of 2025, marking a milestone in its financial sustainability [2][3] - The company is advancing its innovative pipeline, with the dual-target inhibitor Birelentinib entering Phase III clinical trials and receiving Fast Track designation from the FDA [1][6] Commercialization and Financial Performance - Revenue growth showed a quarterly upward trend, with Q1, Q2, and Q3 sales of 160 million yuan, 195 million yuan, and 231 million yuan respectively, indicating a compound growth rate of 20% [2][3] - The sales expense ratio decreased to 72% in the first three quarters, down from 124% in the previous year, reflecting improved cost control and operational efficiency [3] Research and Development Progress - The company is actively expanding the indications for its two marketed products and has a robust pipeline with seven globally competitive products, each with first-in-class or best-in-class potential [5][6] - Recent research presented at the World Lung Cancer Conference highlighted positive results for Shuwozhe® in treating various NSCLC mutations, showcasing its efficacy and safety [4][5] Strategic Focus and Market Position - The company is committed to addressing unmet clinical needs globally, enhancing its core competitiveness, and creating value for shareholders [2] - The strategic focus on source innovation and global development has led to significant milestones, including the FDA's accelerated approval of Shuwozhe® [6]

Core Insights - The company reported a significant revenue increase of 73% year-on-year, reaching 586 million yuan in the first three quarters of 2025 [1] - The core products have shown substantial market penetration and sales growth, with ongoing clinical research for two already launched products [1] - The company’s innovative drug birelentinib has entered Phase III clinical trials and received Fast Track designation from the FDA [1] - Another key product, DZD6008, is advancing in dosage expansion studies targeting EGFR mutation non-small cell lung cancer [1] - The CEO highlighted that the revenue growth is attributed to the commercialization of core products and the establishment of a global innovation strategy [1] Financial Performance - Revenue for the first three quarters reached 586 million yuan, marking a 73% increase compared to the previous year [1] - The company achieved a historical high in revenue during this period [1] Product Development - Birelentinib, a dual-target inhibitor, is in Phase III clinical trials [1] - DZD6008, an EGFR TKI, is progressing in clinical studies for EGFR mutation non-small cell lung cancer [1] Strategic Vision - The company is focusing on unmet clinical needs globally and aims to expand treatment boundaries [1] - Milestones in the company’s global innovation blueprint have been reached [1]

Core Insights - Dige Pharmaceutical reported a significant increase in revenue for Q3 2025, achieving 231 million yuan, which represents a year-on-year growth of 71.46% [1] - Despite the revenue growth, the company recorded a net loss attributable to shareholders of 203 million yuan for Q3 2025 [1] - For the first three quarters of 2025, the total revenue reached 586 million yuan, marking a year-on-year increase of 73.23%, while the net loss attributable to shareholders amounted to 580 million yuan [1]

Core Insights - Dige Pharmaceutical (688192.SH) reported a total revenue of 586 million yuan for the first three quarters of 2025, representing a year-on-year increase of 73.23% [1] - The net profit attributable to shareholders of the parent company was -580 million yuan, which is a deterioration of 21.4873 million yuan compared to the same period last year [1] - The basic earnings per share stood at -1.32 yuan [1]

证券代码：688192 证券简称：迪哲医药 公告编号：2025-56 迪哲（江苏）医药股份有限公司 关于首次公开发行之暂时闲置募集资金进行现金管 理的公告 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"）于 2025 年 10 月 30 日 分别召开第二届董事会第十六次会议，审议通过了《关于首次公开发行之暂时 闲置募集资金进行现金管理的议案》，同意公司在不影响募集资金投资计划正 常进行的前提下，公司拟使用最高不超过人民币 42,000.00 万元（含本数）的暂 时闲置募集资金进行现金管理，使用期限自 2025 年 12 月 19 日起 12 个月之内 有效。公司会选择信誉好、规模大、有能力保障资金安全的发行主体所发行的 投资安全性高、流动性好的银行理财产品或存款类产品或保本型券商收益凭证 （包括但不限于保本型理财产品、协定性存款、结构性存款、定期存款、大额 转让存单、保本型券商收益凭证等）。在上述额度及期限范围内，公司可以循 环滚动使用资金。同时，公司董事会授权董事长或董事长授 ...

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首次公开发行之 暂时闲置募集资金进行现金管理的核查意见 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》 《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》等相关规定履行公司 2023 年度向特定对象 发行 A 股股票的持续督导职责并承接公司首次公开发行的原保荐机构中信证券 股份有限公司未完成的首次公开发行相关的持续督导工作，对迪哲医药使用首次 公开发行之暂时闲置募集资金进行现金管理事项进行了核查，核查的具体情况如 下： 一、募集资金基本情况 根据中国证券监督管理委员会于 2021 年 11 月 5 日印发的《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）的决定，公司获准向社会公开发行人民币普通股 A 股 40,000,100 股， 发行价格为人民币 52.58 元 ...

Financial Performance - The company's revenue for the third quarter reached ¥231,299,714.08, representing a year-on-year increase of 71.46%[3] - The total profit for the period was a loss of ¥203,910,752.21, with a cumulative loss of ¥582,901,080.21 for the year to date[3] - The basic earnings per share for the current period was -¥0.44, compared to -¥1.32 for the year to date[3] - The net profit for the first three quarters of 2025 was -582,953,152.35 RMB, compared to -649,647,448.06 RMB in the same period of 2024, showing an improvement[25] - Basic and diluted earnings per share for the first three quarters of 2025 were both -1.32 RMB, slightly better than -1.35 RMB in 2024[25] - The total comprehensive income attributable to the parent company's owners was -579,947,780.97 RMB in 2025, compared to -558,460,529.94 RMB in 2024[25] Research and Development - Research and development expenses totaled ¥235,968,603.38, accounting for 102.02% of revenue in the current period, a decrease of 35.09 percentage points[4] - The company plans to maintain stable funding for ongoing clinical research and development of its products[9] - The company is actively expanding its research and development efforts, particularly in the field of T-cell lymphoma treatment, as evidenced by multiple studies on its product, 高瑞哲®[16] - Research and development expenses increased to 644,235,609.66 RMB in 2025 from 567,728,545.76 RMB in 2024, reflecting a growth of approximately 13.5%[24] Assets and Liabilities - Total assets at the end of the reporting period were ¥2,955,346,622.51, an increase of 71.95% compared to the end of the previous year[4] - The equity attributable to shareholders of the listed company increased to ¥1,440,437,716.45, reflecting a significant rise of 643.43% year-on-year[4] - As of September 30, 2025, the company's total assets amounted to RMB 2,955,346,622.51, a significant increase from RMB 1,718,737,884.05 at the end of 2024[19][21] - The company’s total liabilities as of September 30, 2025, were RMB 1,511,613,180.21, slightly down from RMB 1,518,680,986.42 at the end of 2024[21] Cash Flow - The net cash flow from operating activities was -¥159,387,479.24 for the current period, with a cumulative cash flow of -¥424,056,847.98 for the year[3] - Operating cash flow for the first three quarters of 2025 was -424,056,847.98 RMB, slightly better than -463,308,340.42 RMB in 2024[28] - The company reported a significant increase in cash inflow from investment activities, totaling 7,282,910,041.68 RMB in 2025 compared to 2,709,870,267.04 RMB in 2024[28] - The net cash flow from financing activities was 1,640,908,417.60 RMB in 2025, compared to 606,803,240.41 RMB in 2024, indicating a substantial increase[29] Shareholder Information - The total number of common shareholders at the end of the reporting period is 8,806[11] - The largest shareholder, Advanced Manufacturing Industry Investment Fund, holds 108,923,023 shares, representing 23.71% of total shares[11] - AstraZeneca AB also holds 108,923,023 shares, accounting for 23.71%[11] - The company’s stockholders include Jiangsu Wuxi Dize Enterprise Management Partnership, holding 57,451,788 shares, or 12.51%[11] - The company’s stockholders also include Industrial Bank Co., Ltd. - Yongying Pharmaceutical Innovation Mixed Fund, holding 5,910,918 shares, or 1.29%[11] Product Development and Approvals - The company received FDA accelerated approval for ZEGFROVY® on July 2025, making it the first and only EGFR Exon20ins NSCLC innovative drug approved in the U.S.[13] - The company presented 11 new research results in the NSCLC field at the 2025 WCLC, demonstrating good efficacy and safety for ZEGFROVY® across various treatment stages[14] - Birelentinib (DZD8586) received FDA Fast Track Designation in August 2025 for treatment of relapsed/refractory CLL/SLL patients[15] - The company has initiated an international multi-center Phase III clinical study for birelentinib targeting relapsed/refractory CLL/SLL[15] - The company’s research on high瑞哲® (Golitinib) in combination with anti-PD-1 monoclonal antibodies is ongoing, providing important evidence for its clinical application in NSCLC[14] Operating Costs - Total operating revenue of RMB 586,301,134.90 for the first three quarters of 2025, a significant increase from RMB 338,451,000.00 in the same period of 2024, representing a growth of approximately 73.4%[23] - Total operating costs for the first three quarters of 2025 were RMB 1,234,483,936.24, compared to RMB 1,031,763,876.35 in the first three quarters of 2024, indicating an increase of about 19.6%[23] - The company incurred financial expenses of 22,699,804.01 RMB in 2025, up from 15,863,566.73 RMB in 2024, representing a rise of about 43.3%[24] - Sales revenue from goods and services received cash of 559,618,110.76 RMB in 2025, compared to 351,202,757.00 RMB in 2024, marking a growth of approximately 59.4%[28]