Core Viewpoint - The commercialization success of Shuwotini has propelled DiZhe Pharmaceutical into a challenging position, heavily reliant on this single product for revenue growth, while facing concerns over product line imbalance and future sustainability [2][3][4]. Financial Performance - In the first half of 2025, DiZhe Pharmaceutical reported a revenue increase of 74.4% year-on-year, reaching 355 million yuan, primarily driven by Shuwotini and Golixitinib [2][6]. - The company’s revenue trajectory shows a significant dependency on Shuwotini, with 2024 revenue surging 294.35% to 360 million yuan, despite a net loss of 846 million yuan [6][7]. - The company’s net loss expanded to 1.11 billion yuan in 2023, despite revenue growth following Shuwotini's approval [6][12]. Product Dependency and Market Dynamics - Shuwotini is the only approved targeted therapy for EGFR exon20ins non-small cell lung cancer, with a projected sales figure of nearly 400 million yuan in 2024 [4][8]. - The limited patient population for EGFR exon20ins mutations poses a growth ceiling, with peak sales expected to reach 2 billion yuan [9]. - The inclusion of Shuwotini in the national medical insurance directory in November 2024 significantly enhanced its market accessibility [7][9]. R&D and Pipeline Challenges - DiZhe Pharmaceutical has faced criticism regarding its R&D efficiency, with cumulative R&D expenditures reaching 2.204 billion yuan over three years, yet progress on new products has been slower than expected [12][13]. - The company is investing heavily in its production base to support Shuwotini's global supply, which raises concerns about the risks associated with reliance on a single product [11][12]. - The company has initiated global clinical trials for Shuwotini, but the effectiveness of these efforts in overcoming market limitations remains uncertain [11][12]. Executive Actions and Market Sentiment - Concerns about the company's future have been exacerbated by significant share sell-offs by executives, including the chairman, which the company attributes to personal financial needs [3][13]. - The market sentiment reflects skepticism about the sustainability of DiZhe Pharmaceutical's growth model, heavily reliant on Shuwotini, amidst a shift in the industry towards value-driven strategies [13].

Core Insights - The company reported its latest research findings on two innovative lung cancer drugs, Shuwozhe® and GaoRuizhe®, at the 2025 World Lung Cancer Conference (WCLC) [1][2] - Shuwozhe® has been approved in the U.S. as the only oral targeted therapy for EGFR Exon20ins NSCLC, demonstrating significant and durable anti-tumor efficacy with manageable safety [1] - GaoRuizhe® is undergoing ongoing research in combination with anti-PD-1 monoclonal antibodies for advanced NSCLC, showing no dose-limiting toxicities in the dose escalation phase [2] Group 1 - The company presented 11 new studies on Shuwozhe® and GaoRuizhe® in the NSCLC field at WCLC [1][2] - The international multicenter registration clinical study "Wu-Kong1B" for Shuwozhe® showed a favorable benefit/risk ratio for treating EGFR Exon20ins NSCLC [1] - Shuwozhe® received priority review approval in the U.S. in July 2025 based on the "Wu-Kong1B" study [1] Group 2 - GaoRuizhe® is currently in a study that combines it with anti-PD-1 therapy for late-stage NSCLC, with ongoing patient enrollment and data collection [2] - The research on GaoRuizhe® has not observed dose-limiting toxicities during the initial phases [2]

证券代码：688192 证券简称：迪哲医药 公告编号：2025-53 迪哲（江苏）医药股份有限公司 自愿披露关于公司肺癌领域多项最新研究成果在 2025 年世界肺癌大会（WCLC）上公布的公告 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"）于 2025 年 9 月 6 日 至 9 日在 2025 年世界肺癌大会（WCLC）上，报告了其自主研发的新型肺癌靶 向药舒沃哲®（通用名：舒沃替尼片）和高选择性 JAK1 抑制剂高瑞哲®（通用名： 戈利昔替尼胶囊）在非小细胞肺癌（NSCLC）领域的 11 项最新研究。其中，舒 沃哲®国际多中心注册临床研究"悟空 1B"（WU-KONG1B）的最新研究结果在 大会进行口头报告。 一、关于舒沃哲®相关研究 舒沃哲®首个国际多中心注册临床研究"悟空 1B"（WU-KONG1B）最新研 究结果显示，舒沃哲®二/后线治疗表皮生长因子受体（EGFR）20 号外显子插入 突变（Exon20ins）NSCLC 具有良好的获益/风险比：抗肿瘤疗效显著且持久 ...

Core Insights - The company reported on its new targeted lung cancer drug, Shuwozhe (generic name: Shuwotini tablets), and the highly selective JAK1 inhibitor, Gaoruizhe (generic name: Goliqixitini capsules), at the 2025 World Lung Cancer Conference (WCLC) [1][2] - The latest results from the international multicenter registration clinical study "WUKONG1B" for Shuwozhe showed a favorable benefit/risk ratio for treating EGFR Exon20ins NSCLC, with significant and durable anti-tumor efficacy and manageable safety [1] - Shuwozhe received priority review approval in the U.S. in July 2025, making it the only approved oral small molecule targeted therapy for EGFR Exon20ins NSCLC globally [1] Group 1 - The company presented 11 new studies related to non-small cell lung cancer (NSCLC) at WCLC [1] - The "WUKONG1B" study results were reported orally at the conference [1] - The ongoing research for Gaoruizhe in NSCLC treatment shows no dose-limiting toxicities (DLT) observed during the dose escalation phase [2] Group 2 - The research for Gaoruizhe is still ongoing with patient enrollment and data collection, which will provide important evidence for its clinical application in NSCLC [2]

Core Insights - The company reported its latest research findings on two new targeted therapies for lung cancer at the 2025 World Lung Cancer Conference (WCLC) [1] Group 1: Company Developments - The company presented 11 recent studies on its self-developed lung cancer targeted drug, Shuwotai (generic name: Shuwotai tablets), and the highly selective JAK1 inhibitor, Gaoruizhe (generic name: Golixitinib capsules) in the non-small cell lung cancer (NSCLC) field [1] - The international multicenter registration clinical study "Wukong 1B" (WU-KONG1B) of Shuwotai had its latest research results reported orally at the conference [1]

Core Viewpoint - DIZHE Pharmaceutical (688192.SH) reported promising results for its self-developed lung cancer targeted drug, Shuwozhe®, and high-selectivity JAK1 inhibitor, Gaoruizhe®, at the 2025 World Lung Cancer Conference (WCLC) [1] Group 1: Clinical Research Findings - The latest results from the international multicenter registration clinical study "WUKONG1B" for Shuwozhe® were presented at the conference [1] - Shuwozhe® demonstrated a favorable benefit/risk ratio in the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations [1] - The overall response rate (ORR) for Shuwozhe® combined with Anlotinib in first-line treatment of EGFR-sensitive mutations with co-mutations in NSCLC was reported at 77.8%, with a disease control rate (DCR) of 100% [1]

证券日报网讯 9月5日晚间，迪哲医药发布公告称，公司计划于2025年9月16日（星期二）15：00-17： 00参加2025年半年度科创板创新药行业集体业绩说明会。 （文章来源：证券日报） ...

Core Viewpoint - The company, Dizalpharma, is set to hold a collective performance briefing for the first half of 2025 on September 16, 2025, to discuss its operational results and financial status with investors [1][2]. Group 1: Meeting Details - The meeting will take place on September 16, 2025, from 15:00 to 17:00 [1][2]. - It will be held at the Shanghai Stock Exchange Roadshow Center, accessible via the website [1][2]. - The format of the meeting will be an interactive online session [2]. Group 2: Participation Information - Investors can submit questions from September 9, 2025, to September 15, 2025, via the Roadshow Center website or through the company's email [3]. - The company will address commonly asked questions during the briefing [3]. Group 3: Participants - Key participants include the Chairman and General Manager, Dr. Zhang Xiaolin, and the Secretary of the Board and CFO, Mr. Lv Hongbin, along with independent directors [2]. Group 4: Contact Information - For inquiries, investors can contact the Board Office via phone or email [3].

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 2025 年半年度持续督导跟踪报告 | 保荐机构名称：华泰联合证券有限责任 | 被保荐公司简称：迪哲（江苏）医药股份有限公 | | --- | --- | | 公司 | 司 | | 保荐代表人姓名：许超 | 联系电话：010- 56839300 | | 保荐代表人姓名：丁明明 | 联系电话：010- 56839300 | 华泰联合证券有限责任公司（以下简称"华泰联合证券"、"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《证券法》《证券发行上市保荐 业务管理办法》和《上海证券交易所科创板股票上市规则》等有关法律、法规的 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，对迪哲医药 进行持续督导，并出具本持续督导跟踪报告： 一、保荐机构和保荐代表人发现的问题及整改情况 无。 二、重大风险事项 （一）尚未盈利的风险 创新药研发周期长、资金投入大、盈利周期长。作为一家致力于创新的全球 性生物医药企业，公司目前有七款创新药物处于全球临床研发阶段。其中 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2025-52 迪哲（江苏）医药股份有限公司 关于参加 2025 年半年度科创板创新药行业 集体业绩说明会的公告 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、准确性和完整性承担法律责任。 重要内容提示： https://roadshow.sseinfo.com/） ● 会议召开方式：上证路演中心网络互动 ● 投资者可于 2025 年 9 月 9 日（星期二）至 9 月 15 日（星期一） 16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过 公司邮箱 IR@dizalpharma.com 进行提问。公司将在说明会上对投资 者普遍关注的问题进行回答。 迪哲（江苏）医药股份有限公司（以下简称"公司"）已于 2025 年 8 月 23 日发布公司 2025 年半年度报告，为便于广大投资者更全面 深入地了解公司 2025 年半年度经营成果、财务状况，公司计划于 2025 年 9 月 16 日（星期二）15:00-17:00 参加 2025 年半年度科创板创新药 行业集体业绩说明会，就投资者关心 ...