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]

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]

一、药物基本信息 药物名称：DCTY0801 注射液 适应症：EGFRvIII 阳性的复发或进展高级别脑胶质瘤 证券代码：000597 证券简称：东北制药 公告编号：2025-063 东北制药集团股份有限公司 关于控股子公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误 导性陈述或重大遗漏。 近日，东北制药集团股份有限公司（以下简称"公司"）控股子公司北京鼎 成肽源生物技术有限公司（以下简称"鼎成肽源"）收到国家药品监督管理局核 准签发的《药物临床试验批准通知书》（受理号：CXSL2500568，通知书编号： 2025LP02565），现就相关情况公告如下： 药品研发具有高投入、高风险、长周期等特点，临床试验进度及结果、未来 产品市场竞争形势均存在不确定性，会受到不可预测因素的影响。公司将积极推 进上述研发进度，并严格按照有关规定及时对项目后续进展情况履行信息披露义 务。敬请广大投资者注意防范投资风险。 特此公告。 二、其他相关信息 DCTY0801 注射液是针对 EGFRvIII 突变抗原的 CAR-T 细胞产品。EGFRvIII 仅存在于肿瘤细 ...

Core Viewpoint - The approval of the clinical trial for DCTY0801 injection marks a significant milestone in the product development process for the company, enhancing its competitiveness in the oncology treatment sector [1] Group 1 - The company's subsidiary, Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., received the clinical trial approval notice from the National Medical Products Administration [1] - The drug DCTY0801 is indicated for EGFRvIII positive recurrent or progressive high-grade glioma [1] - This clinical trial approval is expected to accelerate the progress of the company's research and development products [1]