● 本报记者 宋维东 东北制药相关负责人日前在接受中国证券报记者采访时表示，近年来，公司聚焦创新驱动与主业深耕， 在研发突破与主业提质方面取得重要成果，构建起了"研发创新破局、主业盈利稳盘、资产运营增效"的 协同发展格局。特别是在医药行业创新转型加速的背景下，公司以"传统主业筑牢基本盘、创新药业务 开辟增长极"的差异化战略，既守住了盈利底线，又打开了成长空间。日前，东北制药控股子公司鼎成 肽源自主研发的DCTY0801注射液获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》。未 来，随着创新药管线研发逐步推进、传统业务结构持续升级，公司将进一步释放高质量发展动能，在激 烈的市场竞争中不断突围。 近年来，东北制药核心业务保持稳健发展态势。今年第三季度，公司扣非归母净利润较上年同期增长 27.54%。"这得益于公司在传统优势领域持续深耕细作与产品竞争力不断提升。"该负责人说。 作为国内重要的药品生产与出口基地，东北制药在多个细分领域占据全球重要地位。其中，东北制药是 全球维生素C原料药主要供应商、左卡系列产品核心供应商、全球最大的磷霉素系列产品生产商及全球 氯霉素主要供应商，同时拥有国际最大的黄连素全合成生 ...

Core Insights - Northeast Pharmaceutical has demonstrated significant progress in R&D and core business performance despite a complex market environment characterized by raw material price fluctuations and differentiated end-user demand [1] R&D Investment - The company has significantly increased its R&D investment, with expenses reaching 104 million yuan, a substantial increase of 95% year-on-year [2] - The approval of DCTY0801 injection for clinical trials marks a key breakthrough in the development of innovative cancer drugs, specifically targeting EGFRvIII positive recurrent or progressive high-grade gliomas [2] - This approval not only fills a gap in the company's oncology treatment portfolio but also positions it advantageously in the glioma segment, indicating a critical transition from sustained investment to tangible outcomes in innovative drug development [2] Core Business Growth - Despite external market pressures, the company's core business has shown resilience, with a net profit attributable to shareholders of 42.79 million yuan, reflecting a year-on-year increase of 27.54% [3] - The company maintains a leading position in several niche markets, including being a major global supplier of vitamin C raw materials and the largest producer of phosphomycin [3] - The dual-market strategy of expanding both domestic and international markets has enhanced the company's risk resilience [3] Operational Structure Optimization - The company has focused on optimizing its asset and financial management, leading to improved operational quality and financial flexibility [4] - The balance of prepaid accounts decreased by 49% compared to the beginning of the year, indicating enhanced cash flow management [4] - The company has established a synergistic development framework that combines R&D innovation, stable core business profitability, and efficient asset operations, positioning it well for future growth in a rapidly evolving pharmaceutical industry [4]

Core Insights - Northeast Pharmaceutical's Q3 2025 report indicates adjustments in revenue and net profit due to a complex market environment, but the company demonstrates strong operational resilience through innovation, core business profitability, and asset management [1][2] Innovation and R&D - The company has increased its R&D investment significantly, with expenses reaching 104 million yuan, a 95% increase year-on-year, focusing on advancing its core product pipeline [1] - A major milestone was achieved with the approval of clinical trials for DCTY0801 injection, targeting EGFRvIII positive recurrent or progressive high-grade glioma, filling a gap in the company's oncology treatment portfolio and enhancing its competitive edge in innovative drugs [1] Core Business Performance - Despite market pressures, the company's core business profitability remains resilient, with a non-GAAP net profit attributable to shareholders of 42.79 million yuan, reflecting a 27.54% year-on-year increase, indicating strong product competitiveness and market risk resilience [2] - The company has improved operational efficiency, with a 49% reduction in the balance of prepaid accounts compared to the beginning of the year, and a 39% increase in cash received from borrowings, ensuring necessary funding for future R&D and operations [2] Financial Management and Future Outlook - The company continues to optimize its asset-liability structure, providing a solid financial foundation for future growth [2] - With the progress of DCTY0801 clinical trials and the gradual transformation of innovative R&D results, the company is expected to establish a differentiated competitive advantage in the oncology treatment sector [2]

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]

Group 1 - Weisheng Information won 5 projects in September with a total amount of 287 million yuan, accounting for 10.45% of the audited revenue for 2024 [1] - Foton Motor's total vehicle sales in September reached 55,300 units, a year-on-year increase of 6.08%, with new energy vehicle sales growing by 47.09% [1] Group 2 - *ST Jianyi plans to terminate the investment cooperation agreement for the monocrystalline silicon project and deregister its subsidiary [2] - Bofei Electric intends to transfer 100% equity of its subsidiary for 38.52 million yuan [3] Group 3 - BYD's new energy vehicle sales in September reached 396,300 units, with a cumulative sales of 3.2601 million units from January to September, a year-on-year increase of 18.64% [4] - Nocera Pharma's subsidiary signed a licensing agreement worth over 2 billion USD for the product Obutin and two preclinical assets [6] Group 4 - Seres reported total sales of 48,286 units in September, an increase of 8.33%, while cumulative sales for the year decreased by 7.79% [8] - BAIC Blue Valley's subsidiary sold 20,539 vehicles in September, a year-on-year increase of 30.15% [9] Group 5 - Huaxin Cement decided to terminate the plan for the overseas subsidiary's spin-off listing due to time constraints and regulatory compliance risks [10] - Huaxin Cement also plans to repurchase shares worth between 32.25 million and 64.5 million yuan [11] Group 6 - Yonghe Co. expects a net profit increase of 211.59% to 225.25% for the first three quarters of 2025 [13] - Runjian Co. won a wind power EPC project worth 1.753 billion yuan [13] Group 7 - Hainan Development plans to apply for bankruptcy liquidation for its subsidiary due to continuous losses and insolvency [14] - Xinjiang Jiaojian won a highway construction project worth 483 million yuan [15] Group 8 - Baili Tianheng's innovative drug BL-ARC001 received approval for clinical trials [16] - Longquan Co. was selected as a candidate for a project worth 50.76 million yuan [18] Group 9 - *ST Gaohong received a notice of termination of listing due to stock price falling below 1 yuan for twenty consecutive trading days [19] - Hainan Huatie's general manager terminated a share reduction plan and plans to increase holdings between 30 million and 50 million yuan [19] Group 10 - OFILM's application for issuing shares to purchase assets has been accepted by the Shenzhen Stock Exchange [20] - Northeast Pharmaceutical's subsidiary received approval for clinical trials of a CAR-T new drug [21] Group 11 - Huangting International's Shenzhen Huangting Plaza was judicially auctioned to offset debts, contributing 56.03% of the company's total revenue [21]

Policy Developments - The National Healthcare Security Administration (NHSA) has initiated a crackdown on "returning drugs" through a "100-day action" plan, emphasizing comprehensive regulation across all stages of the drug supply chain [2] - The NHSA aims to enhance intelligent regulatory systems to preemptively manage healthcare fund oversight [2] Drug and Device Approvals - The FDA has approved Boehringer Ingelheim's small molecule tablet Jascayd (nerandomilast) for the treatment of idiopathic pulmonary fibrosis (IPF), marking the first new therapy for IPF in over a decade [5] - Roche and Jazz Pharmaceuticals received FDA approval for the PD-L1 inhibitor Tecentriq (atezolizumab) in combination with Zepzelca (lurbinectedin) as a first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) [6] - Northeast Pharmaceutical announced that its DCTY0801 injection has received clinical trial approval for treating EGFRvIII positive recurrent or progressive high-grade glioma [7] - BaiLi Tianheng has received clinical trial approval for its innovative drug BL-ARC001 for advanced solid tumors, which is a first-in-class antibody-drug conjugate [9] Capital Markets - Chengyi Biotechnology has submitted a listing application to the Hong Kong Stock Exchange, with Jefferies, BofA Securities, and CICC as joint sponsors [11] - Changfeng Pharmaceutical's IPO on the Hong Kong Stock Exchange saw a significant opening increase of over 218%, trading at HKD 47 per share [12] Industry Developments - Innovent Biologics has entered into a licensing agreement with Zenas BioPharma for three autoimmune pipeline products, including a USD 100 million upfront payment and potential milestone payments exceeding USD 2 billion [14] - AstraZeneca has signed a USD 555 million collaboration agreement with Algen Biotechnologies to leverage AI for discovering new therapeutic targets in immunology [16][17]

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]