每经AI快讯，东北制药（SZ 000597，收盘价：5.77元）10月22日晚间发布公告称，截至本公告日，江 西方大钢铁集团有限公司累计质押股数约为1.95亿股，占其所持股份比例为42.6%。辽宁方大集团累计 质押股数为4874万股，占其所持股份比例为14.81%。 截至发稿，东北制药市值为82亿元。 每经头条（nbdtoutiao）——展望"十五五"|专访贺铿：必须改变以往将资金过度集中于房屋建设和基础 设施建设的倾向，更加突出民生领域投入 （记者 曾健辉） 2025年1至6月份，东北制药的营业收入构成为：医药制造业占比52.0%，医药商业占比46.18%，其他行 业占比1.82%。 ...

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]

从资金流向上来看，当日化学制药板块主力资金净流出11.08亿元，游资资金净流入5.65亿元，散户资金 净流入5.44亿元。化学制药板块个股资金流向见下表： 证券之星消息，10月9日化学制药板块较上一交易日下跌0.66%，南新制药领跌。当日上证指数报收于 3933.97，上涨1.32%。深证成指报收于13725.56，上涨1.47%。化学制药板块个股涨跌见下表： | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | --- | --- | --- | --- | --- | --- | | 300584 | 海辰药业 | 63.81 | 13.76% | 15.58万 | 9.73亿 | | 300255 | 常山药业 | 49.29 | 8.21% | 39.44万 | 19.16亿 | | 600200 | *ST苏吴 | 1.00 | 5.26% | 48.36万 | 4553.49万 | | 603520 | 司太立 | 11.44 | 5.05% | 1 20.69万 | 2.38亿 | | 300705 | 九典制药 | 17.02 | 3.47% | 15.53万 ...

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]

Core Viewpoint - Northeast Pharmaceutical's subsidiary, Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of DCTY0801 injection, marking a significant milestone in the product's development [1] Company Summary - DCTY0801 injection targets the EGFRvIII mutation antigen and is a CAR-T cell product aimed at treating recurrent or progressive high-grade gliomas [1] - The approval of the clinical trial for DCTY0801 injection is expected to accelerate the development progress of the company's pipeline products and enhance its core competitiveness in the field of cancer treatment [1]