Summary of the Conference Call for Dize Pharmaceutical Company Overview - **Company**: Dize Pharmaceutical - **Key Products**: Shuorze (舒尔哲), 8,586, 6,008, and Grixotin (格力西替尼) Industry Insights - **FDA Approvals**: Shuorze received accelerated approval from the FDA, becoming the first oral EGFR TKI for small cell lung cancer with an insertion of easy-to-interact factor 20, gaining significant market advantage [2][3] - **Market Position**: 8,586 is the first dual-pathway BTK inhibitor globally, showcasing promising results in CLL and SLL treatments at the ASCO conference [2][3] Financial Performance - **Revenue Growth**: In the first half of 2025, Dize Pharmaceutical's revenue increased by 74% year-on-year to 355 million RMB, with a sales expense ratio reduction of approximately 24% [2][5] - **Cash Reserves**: The company successfully raised nearly 1.8 billion RMB through refinancing, increasing cash reserves to 2.251 billion RMB, alleviating investor concerns about cash flow [2][6] Key Milestones - **Shuorze Developments**: - Approved by the FDA in July 2025 and included in the NCCN guidelines shortly after [3][7] - Ongoing Phase III registration studies to meet FDA requirements [8] - **8,586 Developments**: - Demonstrated significant efficacy in DLBCL patients, with an objective response rate (ORR) of 84.2% in frontline treatment failure patients [16] - Fast track designation from the FDA based on clinical results [18] - **6,008 Developments**: - Showed significant effects on resistant EGFR mutations, with over 50 times selectivity against wild-type EGFR [19] - Currently progressing towards registration clinical trials with over 100 patients enrolled [30] Research and Development - **Pipeline Projects**: - GW5,282 is in the dose escalation phase, showing potential in both hematological and solid tumors [23][25] - Grixotin is undergoing multiple Phase II clinical trials to determine first-line treatment strategies [24][32] - **Clinical Trials**: - Multiple Phase III trials are set to begin or are already underway, with expectations for positive results to enhance investor returns [33] Strategic Focus - **Market Strategy**: The company emphasizes maximizing product value through strategic partnerships rather than merely pursuing business development [22] - **Future Directions**: Dize Pharmaceutical aims to explore new targets and non-oncological indications while ensuring existing product lines are fully developed [26] Conclusion - Dize Pharmaceutical is positioned for significant growth with its innovative drug pipeline, strong financial performance, and strategic market positioning, indicating a promising outlook for investors and stakeholders in the pharmaceutical industry.

Core Viewpoint - Dize Pharmaceutical achieved commercial profitability for the first time in the first half of 2025, with a revenue of 355 million yuan, a year-on-year increase of 74.4%, but still reported a net loss of 377 million yuan [1][3][6] Financial Performance - The company reported a revenue of 355 million yuan in the first half of 2025, up 74.4% from the same period last year [2][3] - The net profit attributable to shareholders was a loss of 377 million yuan, compared to a loss of 345 million yuan in the same period last year [3][6] - R&D expenses reached 408 million yuan, accounting for 115% of revenue, although this was a decrease from 188.05% in the previous year [7][8] Product Development and Market Position - Dize Pharmaceutical's core products, Shuwozhe and Gaoruizhe, were included in the national medical insurance catalog, significantly enhancing their market accessibility [3][4] - Shuwozhe generated sales of approximately 91.29 million yuan after its launch in August 2023, while both core products together achieved sales of 360 million yuan in 2024 [4][6] Funding and Future Outlook - The company has accumulated losses of 4.567 billion yuan from 2018 to 2024, necessitating ongoing capital market financing to support R&D and operational costs [6][8] - Dize Pharmaceutical plans to raise up to 1.848 billion yuan through a private placement to fund new drug development and operational liquidity [8]

财务报表中对有大幅变动的财务项目的原因说明如下： 货币资金变动幅度为397.5%,原因:向特定对象发行股票，募集资金到位。 在建工程变动幅度为66.92%,原因:公司研发及生产基地一期建设项目投入增长。 交易性金融资产变动幅度为70.58%,原因:公司利用闲置募集资金购买结构性存款。 据证券之星公开数据整理，近期迪哲医药（688192）发布2025年中报。根据财报显示，迪哲医药增收不 增利。截至本报告期末，公司营业总收入3.55亿元，同比上升74.4%，归母净利润-3.77亿元，同比下降 9.46%。按单季度数据看，第二季度营业总收入1.95亿元，同比上升59.83%，第二季度归母净利润-1.85 亿元，同比下降53.38%。 本次财报公布的各项数据指标表现一般。其中，毛利率95.6%，同比减2.11%，净利率-106.77%，同比 增49.73%，销售费用、管理费用、财务费用总计3.55亿元，三费占营收比99.87%，同比减28.75%，每股 净资产3.54元，同比增141.27%，每股经营性现金流-0.58元，同比增20.43%，每股收益-0.87元，同比减 4.82% | 项目 | 2024年中报 | ...

Core Viewpoint - Dize Pharmaceutical reported a significant increase in revenue driven by the sales of its innovative drugs, despite continuing net losses. The company is actively exploring international market opportunities and assessing diverse collaboration strategies for global commercialization [1][3][5]. Financial Performance - The company achieved a revenue of 355 million yuan in the first half of 2025, representing a year-on-year growth of 74.40% [2]. - The net profit attributable to shareholders was -377 million yuan, compared to -345 million yuan in the same period last year [2]. - The total assets increased by 87.26% to approximately 3.22 billion yuan, while net assets surged by 738.25% to about 1.62 billion yuan [2]. Product Development and Market Potential - The sales growth is primarily attributed to two innovative drugs: Shuwotini and Golixitini, targeting unmet medical needs in specific cancer types [4][5]. - Shuwotini is the first and only FDA-approved drug for EGFR exon20ins non-small cell lung cancer, with an expected peak sales potential of 500 million USD in the U.S. market [3][7]. - Golixitini is the first selective oral JAK1 inhibitor for peripheral T-cell lymphoma, with a projected compound annual growth rate of 2.2% from 2024 to 2030 [4]. Strategic Initiatives - The company plans to invest approximately 1 billion yuan from its fundraising into new drug research and development [6]. - Dize Pharmaceutical is actively evaluating various collaboration methods for overseas market expansion, focusing on pipeline synergy and global commercialization capabilities [3][7]. - The company aims to maximize project value and maintain a strong focus on independent industrial development while exploring international opportunities [7].

Core Viewpoint - The company has achieved commercial profitability as its revenue can now cover costs beyond research and development expenses, despite still reporting a net loss [1][4]. Group 1: Financial Performance - In the first half of the year, the company reported a revenue of 355 million yuan, representing a year-on-year growth of 74.4% [1]. - The net loss attributable to shareholders was 377 million yuan [1]. - The company’s research and development expenses amounted to 408 million yuan, reflecting a year-on-year increase of 6.66% [4]. Group 2: Product Development and Market Approval - The company has two products that have received market approval: the lung cancer drug Shuwotai (generic name: Shuwotai tablets) approved in both China and the U.S., and the lymphoma drug Gaoruizhe (generic name: Golisitinib capsules) approved in China [3]. - The increase in revenue is attributed to these products being included in the Chinese medical insurance reimbursement list, leading to a significant increase in sales [3]. Group 3: Pricing Strategy and Market Expansion - The company plans to set the U.S. price for Shuwotai based on the pricing of similar drugs and its clinical advantages, indicating that domestic insurance pricing will not directly constrain U.S. pricing [3]. - The company is actively evaluating diverse collaboration methods for overseas market expansion, focusing on pipeline synergy, global commercialization capabilities, and development potential [3]. Group 4: Future Outlook - The company aims to achieve a positive cycle between research and commercialization efficiency, which is expected to accelerate its path to breakeven [5].

Core Insights - Dize Pharmaceutical achieved a revenue of 355 million yuan in the first half of 2025, representing a year-on-year growth of 74.4% [1] - The company reported a net profit attributable to shareholders of -378 million yuan, marking a 12% reduction in losses compared to the previous year [1] - Dize Pharmaceutical has reached commercial profitability, indicating that its drug sales now cover production and promotion costs, excluding R&D expenses [1] Commercialization and Product Development - The company’s core products, Shuwozhe® and Gaoruizhe®, have seen significant sales growth, driven by support from medical insurance [1] - Shuwozhe® received FDA approval in July, becoming the first and only domestically developed innovative drug for EGFR exon 20 insertion mutation non-small cell lung cancer (NSCLC) approved in the U.S. [1] - Dize Pharmaceutical is accelerating its R&D efforts, with a global Phase III clinical trial for Shuwozhe® in first-line treatment of EGFR exon 20 insertion NSCLC completed patient enrollment in the first half of this year [2] Clinical Research and Future Prospects - At the ASCO conference, Dize Pharmaceutical presented clinical results for DZD6008, showing an 83.3% tumor reduction rate in patients previously treated with third-generation EGFR TKIs [2] - The company’s product Birelentinib received FDA "Fast Track" designation in August, which may expedite its Phase III clinical progress for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - The founder and CEO emphasized the recognition of the company’s innovative achievements in the global market and the importance of steady revenue growth and cash flow for efficient R&D [3]

Group 1 - The core point of the article is that Dize Pharmaceutical announced the approval of multiple proposals during the 15th meeting of its second board of directors [2]

新浪科技讯 8月22日晚间消息，迪哲医药发布2025半年报，宣布期内实现营业收入3.55亿元，较上年度 同比增长74%。随着增收减亏的持续推进，迪哲医药首度实现商业化盈利，营收已覆盖研发费用之外的 成本（销售、管理费用），财务可持续性闭环已经初具雏形。 2025年上半年，迪哲医药在医保赋能的推动下，旗下舒沃哲®（通用名：舒沃替尼片）和高瑞哲®（通 用名：戈利昔替尼胶囊），销售持续放量，保持高速增长。自我造血能力不断增强的同时，公司净亏损 持续缩窄，同比下降12%，公司账上现金及现金等价物达 22.51 亿元。 今年上半年，公司在扩大商业化团队的同时，继续开展"提质增效重回报"行动，持续推动商业化效率的 提高。数据显示：销售费用率为76%，同比下降24%，显著低于2024年全年的124%的销售费用率水平。 作为创新型药企成长中的重要指标，实现商业化盈利是指创新药企业的药品销售的收入，已经能够完全 覆盖自身生产和推广的成本。这意味着，迪哲医药已经具备全面的自我造血能力，自身创造的现金流将 通过持续循环支撑业务发展。 责任编辑：何俊熹 迪哲医药创始人、董事长兼首席执行官张小林表示："回首这半年，迪哲在研发和商业化均 ...

智通财经APP讯，迪哲医药(688192.SH)发布2025年半年度报告，报告期内，公司实现营业收入3.55亿 元，同比增长74.40%。归属于上市公司股东净亏损3.77亿元，归属于上市公司股东的扣除非经常性损益 净亏损4.19亿元，基本每股亏损0.87元。 ...

Core Viewpoint - Dige Pharmaceutical reported a significant increase in revenue for the first half of 2025, but continued to face net losses [1] Financial Performance - The company achieved an operating revenue of 355 million yuan, representing a year-on-year growth of 74.4% [1] - The net loss attributable to shareholders was 377 million yuan, compared to a loss of 345 million yuan in the same period last year [1] - The net loss attributable to shareholders after deducting non-recurring gains and losses was 419 million yuan, compared to a loss of 381 million yuan in the previous year [1]