Financial Performance - Q3 2025 revenue was CNY 1,625,476,998.14, a decrease of 17.28% year-over-year, and year-to-date revenue was CNY 5,478,085,124.55, down 10.69%[5] - Net profit attributable to shareholders for Q3 2025 was CNY 43,524,470.78, a decline of 14.92% year-over-year, with year-to-date net profit at CNY 172,703,081.21, down 16.96%[5] - Total operating revenue for the current period is ¥5,478,085,124.55, a decrease of 10.7% from ¥6,133,512,515.79 in the previous period[33] - Net profit for the current period is ¥161,044,610.95, a decline of 26.8% compared to ¥220,053,562.43 in the previous period[34] - Earnings per share for the current period is ¥0.1209, down from ¥0.1455 in the previous period[35] Research and Development - R&D expenses for the period amounted to CNY 10,396,000, representing a significant increase of 95% compared to the same period last year[16] - Research and development expenses increased to ¥103,963,842.54, up from ¥53,424,342.80 in the previous period, indicating a focus on innovation[34] - The company received approval for clinical trials of DCTY0801 injection, marking a significant milestone in product development[27] - The company aims to enhance its core competitiveness in the oncology treatment field through accelerated product development[27] Assets and Liabilities - Total assets at the end of the reporting period were CNY 13,648,603,462.73, a decrease of 5.52% from the end of the previous year[5] - Total liabilities amount to ¥8,051,463,190.34, a decrease from ¥8,876,538,951.68 in the previous period[34] - The company’s total assets amount to ¥13,648,603,462.73, down from ¥14,446,181,851.25 in the previous period[34] Cash Flow - Cash flow from operating activities for the year-to-date was CNY 379,202,723.95, a decrease of 11.52%[5] - The net cash inflow from operating activities was CNY 379,202,723.95, a decrease of 11.5% compared to CNY 428,565,749.88 in the previous period[37] - Total cash inflow from financing activities was CNY 9,351,477,799.16, down from CNY 11,004,407,687.50, reflecting a decrease of 15%[38] - The net cash outflow from investment activities was CNY -74,420,303.54, compared to CNY -135,729,071.37 in the previous period, indicating an improvement[37] - Cash received from other operating activities was CNY 173,056,766.13, compared to CNY 223,851,078.74, showing a decline of 22.7%[37] Shareholder Information - Total number of common shareholders at the end of the reporting period is 49,696[26] - Jiangxi Fangda Steel holds 32.08% of shares, totaling 457,861,342 shares[26] - Liaoning Fangda Group holds 23.60% of shares, totaling 329,068,713 shares[26] Inventory and Receivables - Accounts receivable increased to approximately ¥2.25 billion from ¥1.96 billion[30] - Inventory decreased to approximately ¥1.14 billion from ¥1.32 billion[30] - The company's cash and cash equivalents decreased to approximately ¥4.08 billion from ¥4.47 billion[29] Cost Management - Total operating costs for the current period are ¥5,196,594,704.99, down 10.1% from ¥5,783,158,351.88 in the previous period[34] - The company reported a decrease in sales expenses to ¥879,243,019.69 from ¥1,047,384,162.17 in the previous period, reflecting cost control measures[34] - Cash paid for purchasing goods and services was CNY 2,969,341,549.87, down from CNY 3,534,534,806.96, a decrease of 16%[37]

Group 1 - Northeast Pharmaceutical (SZ 000597) announced that as of the date of the announcement, Jiangxi Fangda Steel Group Co., Ltd. has pledged approximately 195 million shares, accounting for 42.6% of its holdings [1] - Liaoning Fangda Group has pledged a total of 48.74 million shares, representing 14.81% of its holdings [1] - As of the report date, Northeast Pharmaceutical's market capitalization is 8.2 billion yuan [1] Group 2 - For the first half of 2025, Northeast Pharmaceutical's revenue composition is as follows: pharmaceutical manufacturing accounts for 52.0%, pharmaceutical commerce accounts for 46.18%, and other industries account for 1.82% [1]

证券代码：000597 证券简称：东北制药 公告编号：2025-064 东北制药集团股份有限公司 关于股东部分股份解除质押的公告 公司股东江西方大钢铁集团有限公司保证向本公司提供的信息内容真实、准确、 完整，没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一致。 注：1.方大钢铁为辽宁方大集团实业有限公司（以下简称"方大集团"）的全资子公司， 为方大集团之一致行动人。 东北制药集团股份有限公司（以下简称"公司"）于近日接到公司第一大股 东江西方大钢铁集团有限公司（以下简称"方大钢铁"）通知，获悉其已将所持 有的公司 90,000,000 股股份办理了解除质押登记手续。具体事项如下： | 股东名称 | 是否为控股 股东或第一 大股东及其 一致行动人 | 本次解除质押 股份数量（股） | 占其所持股 份比例（%） | 占公司总 股本比例 （%） | 起始日 | 解除日期 | 质权人 | | --- | --- | --- | --- | --- | --- | --- | --- | | 江西方大钢铁 集团有限公司 | 是 | 87,000,000 | 19.00 ...

Core Insights - The article highlights the transformation of Northeast Pharmaceutical from a traditional pharmaceutical company to an innovative drug enterprise, marked by the approval of the clinical trial application for DCTY0801 injection, a significant breakthrough in cell therapy [2] R&D Investment - Northeast Pharmaceutical has significantly increased its R&D investment, reaching 83.49 million yuan in the first half of 2025, a year-on-year increase of 84.09%, with a first-quarter increase of 88% [3] - The strategic focus has shifted from generic drugs and raw materials to innovative drug development, particularly in high-end areas such as oncology and autoimmune diseases, driven by the need for long-term growth amid shrinking profit margins in generic drugs [3] Pipeline Development - The company has adopted a three-dimensional R&D strategy of "independent research + joint development + project introduction," achieving multiple breakthroughs in cell therapy and enhancing both the thickness and quality of its pipeline [4] - DCTY0801 injection, a core product for treating EGFRvIII positive recurrent or progressive high-grade glioma, has received orphan drug designation from the FDA, indicating its potential for global market promotion [4] - The DCTY1102 injection is the first domestic and second global TCR-T drug targeting KRAS G12D, addressing previously untreatable cancers, while DCTY3201 is a next-generation TCR-T product targeting multiple sites, with no similar products reported globally [4] Strategic Transformation - Northeast Pharmaceutical's strategy of "introduction-digestion-innovation" has enabled it to rapidly acquire core technologies in specific cell immunotherapy, focusing on clinical treatment pain points for iterative upgrades [5][6] - The combination of high-intensity investment, diversified strategies, and a comprehensive layout positions the company favorably in the global cell therapy competition, with ongoing progress in both innovative drug pipelines and the consistency evaluation of generic drugs [6]

Core Insights - Northeast Pharmaceutical's subsidiary, DCTY0801 injection, has received clinical trial approval, marking a significant advancement in the company's shift from traditional pharmaceuticals to innovative cell therapy [1] - The company aims to accelerate the development of other innovative pipelines, injecting new momentum into its long-term growth [1] R&D Investment - The company has significantly increased its R&D investment, reaching 83.49 million yuan in the first half of 2025, a year-on-year increase of 84.09%, with Q1 showing an even higher increase of 88% [2] - This substantial growth in R&D investment reflects a strategic shift from a focus on generic drugs to innovative drug development, particularly in high-end areas like oncology and autoimmune diseases [2] - The transition is driven by the need to adapt to the ongoing normalization of drug procurement, which has compressed profit margins for generic drugs, necessitating a focus on innovative drugs for long-term growth [2] Pipeline Development - The company has achieved multiple breakthroughs in cell therapy through a three-dimensional R&D strategy of "independent research + joint development + project introduction," resulting in significant improvements in pipeline quality and depth [3] - The DCTY0801 injection is a core product for treating EGFRvIII positive recurrent or progressive high-grade glioma and has received orphan drug designation from the FDA, enhancing its global market potential [3] - The DCTY1102 injection is the first domestic and second global TCR-T drug targeting KRAS G12D to enter Phase I clinical trials, addressing previously untreatable cancers [3] - The company has established a robust pipeline with over 10 tumor-targeted cell therapy products, creating a strong technical barrier in the field of cell immunotherapy [3] Strategic Transformation - The company's strategy of "introducing - digesting - innovating" has effectively shortened the technology catch-up cycle and built a solid technical barrier in the competitive global cell therapy market [4] - The acquisition of DCTY0801 has provided the company with a core technology base for specific cell immunotherapy, allowing for iterative upgrades focused on clinical treatment challenges [4] - The ongoing progress in both cell therapy pipelines and the consistency evaluation of generic drugs validates the effectiveness of the company's R&D strategy and lays a solid foundation for future growth [4] Future Outlook - Northeast Pharmaceutical is leveraging a combination of high-intensity investment, diversified strategies, and a multi-faceted approach to break through the limitations of traditional business models [5] - With the steady advancement of clinical trials and the rollout of more innovative pipelines, the company is poised for greater breakthroughs in the innovative drug sector, marking its transformation from a traditional pharmaceutical company to an innovative drug enterprise [5]

Core Viewpoint - Northeast Pharmaceutical has made significant progress in the innovative drug sector with the approval of the clinical trial application for DCTY0801 injection, a CAR-T cell therapy targeting specific gene mutations, marking a key step in the company's strategic development [1][2] Company Developments - The approval of DCTY0801 injection is a crucial milestone in the company's drug development process, enhancing its core competitiveness in tumor treatment [2] - The company plans to strictly adhere to review requirements and improve the risk management plan for DCTY0801 while accelerating the development of other innovative pipelines [1][2] - Northeast Pharmaceutical acquired a 70% stake in DCTY0801's developer, Dingcheng Peptide Source, in 2024, facilitating its entry into the cell therapy field [1] Market Context - The global cell therapy market is experiencing rapid growth, with the CAR-T cell therapy market in China expanding significantly, indicating substantial development potential [2] - High-grade glioma, a common primary brain tumor in China, presents a significant unmet clinical need due to the short survival period and limited treatment options for patients [2]

Market Overview - The chemical pharmaceutical sector experienced a decline of 0.66% on October 9, with Nanjing New Pharmaceutical leading the drop [1] - The Shanghai Composite Index closed at 3933.97, up 1.32%, while the Shenzhen Component Index closed at 13725.56, up 1.47% [1] Stock Performance - Notable gainers in the chemical pharmaceutical sector included: - Haichen Pharmaceutical (300584) with a closing price of 63.81, up 13.76% and a trading volume of 155,800 shares, totaling 973 million yuan [1] - Changshan Pharmaceutical (300255) closed at 49.29, up 8.21% with a trading volume of 394,400 shares, totaling 1.916 billion yuan [1] - Conversely, Nanjing New Pharmaceutical (688189) saw a significant drop of 19.96%, closing at 9.10 with a trading volume of 32,300 shares, totaling 29.426 million yuan [2] Capital Flow - The chemical pharmaceutical sector experienced a net outflow of 1.108 billion yuan from institutional investors, while retail investors saw a net inflow of 544 million yuan [2] - The capital flow for specific stocks showed: - Changshan Pharmaceutical had a net inflow of 14.6 million yuan from institutional investors, but a net outflow of 14 million yuan from retail investors [3] - Haichen Pharmaceutical recorded a net inflow of 85.3 million yuan from institutional investors, with retail investors showing a net outflow of 68 million yuan [3]

Core Viewpoint - Northeast Pharmaceutical (000597) announced the approval of a clinical trial for its CAR-T cell product DCTY0801 injection, targeting EGFRvIII positive recurrent or progressive high-grade glioma [1] Company Summary - The company’s subsidiary, Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., received the clinical trial approval from the National Medical Products Administration [1] - DCTY0801 injection is specifically designed to target the EGFRvIII mutation antigen [1]

Core Viewpoint - Northeast Pharmaceutical (000597) announced that Beijing Dingcheng Peptide Source Biotechnology Co., Ltd. received the approval from the National Medical Products Administration for the clinical trial of DCTY0801 injection for EGFRvIII positive recurrent or progressive high-grade glioma [1] Summary by Relevant Sections - **Product Development** - DCTY0801 injection is a CAR-T cell product targeting the EGFRvIII mutation antigen, which received orphan drug designation from the FDA in May 2023 [1] - **Clinical Trial Approval** - The approval of the clinical trial is a significant milestone in the product's development, enhancing the company's core competitiveness in the oncology treatment field [1] - **Financial Impact** - There is no significant short-term impact on the company's performance, but drug development is characterized by high investment, high risk, and long cycles, leading to uncertainties in clinical trial progress and results [1]

Core Viewpoint - Northeast Pharmaceutical (000597.SZ) announced that its subsidiary, Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., received approval from the National Medical Products Administration for a clinical trial of DCTY0801 injection, targeting EGFRvIII positive recurrent or progressive high-grade glioma [1][2] Group 1: Company Developments - The DCTY0801 injection is a CAR-T cell product targeting the EGFRvIII mutation, which is present only in tumor cells and not in normal tissues [2] - Approximately 30% of glioblastoma patients have the EGFRvIII mutation, indicating a significant patient population for this treatment [2] - The development of CAR-T therapy targeting EGFRvIII is expected to provide a solution for the treatment of glioblastoma, where current immunotherapy options are limited [2] Group 2: Regulatory and Market Implications - DCTY0801 injection received orphan drug designation from the FDA in May 2023, which allows for expedited review, a seven-year exclusivity period post-approval, and tax incentives in the U.S. [2] - The orphan drug status is highly valuable for the drug's market launch and global promotion [2]