证券代码：688513 证券简称：苑东生物 公告编号：2025-079 目前，上海优洛已就该药品的相关技术提交了 1 项国际专利申请。针对 TF 靶点开发的 ADC 药物，国外已有 Tivdak®上市，用于治疗宫颈癌；国内则有乐 普生物、信诺维等公司正在开展不同阶段的临床研究，适应症主要集中于宫颈癌、 卵巢癌及胰腺癌。 1 成都苑东生物制药股份有限公司 关于自愿披露注射用 YLSH003 启动 I/II 期临床试验 并完成首例受试者入组的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 成都苑东生物制药股份有限公司（以下简称"公司"）全资子公司优洛生物（上 海）有限公司（以下简称"上海优洛"）自主研发的 1 类生物药注射用 YLSH003 正在开展用于晚期实体瘤的 I/II 期临床试验，首例受试者已于近日成功入组给药。 现将相关情况公告如下： 一、注射用 YLSH003 的基本情况 注射用 YLSH003 是一种靶向组织因子（Tissue Factor，TF）的新型抗体偶 联药物（antibody-drug conju ...

Core Viewpoint - Yuan Dong Biotech (688513.SH) announced that its wholly-owned subsidiary, Shanghai Youluo, has initiated Phase I/II clinical trials for its self-developed antibody-drug conjugate, YLSH003, targeting advanced solid tumors, with the first patient successfully enrolled for treatment [1] Group 1: Product Development - YLSH003 is a novel antibody-drug conjugate designed to target Tissue Factor (TF), which plays a crucial role in the coagulation process and is highly expressed in advanced solid tumors [1] - The development of YLSH003 aims to address the recurrence and metastasis issues associated with high TF expression in late-stage solid tumors [1]

Core Viewpoint - Yuan Dong Biotech (688513.SH) announced that its wholly-owned subsidiary, You Luo Biotech (Shanghai) Co., Ltd., has initiated I/II clinical trials for its self-developed antibody-drug conjugate, YLSH003, targeting advanced solid tumors, with the first patient successfully enrolled for treatment [1] Group 1: Product Development - YLSH003 is a novel antibody-drug conjugate designed to target Tissue Factor (TF), which plays a crucial role in the coagulation process and is highly expressed in advanced solid tumors [1] - The development of YLSH003 aims to address the recurrence and metastasis issues associated with high TF expression in late-stage solid tumors [1] Group 2: Clinical Trials - The I/II phase clinical trials for YLSH003 are currently underway, marking a significant step in the company's research and development efforts in oncology [1] - The successful enrollment of the first patient indicates progress in the clinical trial process and potential future advancements in treatment options for patients with advanced solid tumors [1]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Shanghai Youlu, has initiated clinical trials for a new biopharmaceutical, YLSH003, targeting advanced solid tumors, with the first patient successfully enrolled for treatment [1] Group 1: Product Development - YLSH003 is a novel antibody-drug conjugate targeting tissue factor, and the company has submitted an international patent application for the related technology [1] - The clinical trials consist of Phase I and Phase II studies, with Phase I focusing on safety and tolerability, while Phase II will assess efficacy [1] - The drug is expected to be accepted and approved by 2025, with the first patient already enrolled in Phase I and recruitment for additional subjects ongoing [1] Group 2: Market Context - The pharmaceutical development process is characterized by high risks, and the timeline for project approval and outcomes remains uncertain [1]

Group 1 - On November 7, a total of 3,739 A-shares received financing buy-ins, with 434 stocks having buy-in amounts exceeding 100 million yuan [1] - The top three stocks by financing buy-in amount were Tianfu Communication, TBEA, and Sungrow Power Supply, with buy-in amounts of 3.043 billion yuan, 2.5 billion yuan, and 2.44 billion yuan respectively [1] - Six stocks had financing buy-in amounts accounting for over 30% of the total transaction amount on that day, with Botao Biology, Hengxing New Materials, and Yuandong Biology leading at 37.56%, 37.18%, and 35.51% respectively [1] Group 2 - There were 35 stocks with net financing buy-ins exceeding 100 million yuan, with Tianfu Communication, Tongwei Co., and Longi Green Energy ranking the highest with net buy-in amounts of 1.491 billion yuan, 433 million yuan, and 419 million yuan respectively [1]

Core Insights - Rui Jian Pharmaceutical has achieved significant milestones in the development of its Parkinson's disease cell therapy product NouvNeu001, becoming the first globally to receive Fast Track designation from the FDA and entering Phase II clinical trials in China [1][4] - Chengdu High-tech Zone is emerging as a key player in the biopharmaceutical industry, with a focus on innovative drug development and a robust ecosystem supporting various companies [3][12] Company Developments - Rui Jian Pharmaceutical's NouvNeu001 is the first iPSC-derived universal cell therapy for Parkinson's disease to gain Fast Track status from the FDA, while also progressing in clinical trials in China [1] - The company is also advancing other products, such as NouvNeu004 for multiple system atrophy, which has received approval for full-cycle clinical trials in China [4] - Recent funding of over 300 million yuan for Rui Jian Pharmaceutical will accelerate the development of its Parkinson's and ophthalmic treatment products [14] Industry Trends - Chengdu High-tech Zone has been recognized as a leading biopharmaceutical hub, ranking alongside other major innovation districts in China [3] - The region is witnessing a surge in innovative products, with multiple companies achieving significant breakthroughs in various therapeutic areas, including diabetes and cancer [7][5] - The biopharmaceutical industry in Chengdu is projected to exceed 128 billion yuan in scale by 2024, with over 3,000 companies contributing to this growth [7] Ecosystem and Collaboration - The development of Rui Jian Pharmaceutical is closely tied to the supportive ecosystem in Chengdu High-tech Zone, which includes a network of suppliers and clinical resources [8][10] - The establishment of the "Global New Drug Discovery Center" aims to integrate resources from over 3,000 biopharmaceutical companies in the region, enhancing collaboration and innovation [11] - The collaboration between enterprises and institutions, such as Sichuan University West China Hospital, is fostering a comprehensive innovation chain from research to commercialization [12][18] Policy and Financial Support - Chengdu High-tech Zone has implemented supportive policies and established a substantial investment fund to facilitate the growth of the biopharmaceutical sector [16][17] - The "Wutong Plan" provides a comprehensive service framework for biopharmaceutical companies, covering all stages from drug development to market entry [17] - The region's proactive approach in policy-making and capital investment is crucial in overcoming challenges in the biopharmaceutical innovation landscape [16][14]

二、交易进展情况 成都苑东生物制药股份有限公司 关于向参股公司增资暨关联交易完成的进展公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 一、已披露的增资暨关联交易概述 为加快公司创新转型战略的实施步伐，公司分别于 2025 年 9 月 23 日召开第 四届董事会第八次会议、于 2025 年 10 月 9 日召开 2025 年第二次临时股东大会， 审议通过了《关于向参股公司增资暨关联交易的议案》，由公司全资子公司苑东 生物投资管理（上海）有限公司（以下简称"上海投资公司"）作为投资主体以货 币资金的形式对上海超阳药业有限公司（以下简称"上海超阳"）实施增资，增资 价格为 2.27 元/注册资本，增资总金额 8,571.00 万元（对应上海超阳注册资本 3,771.00 万元），资金来源均为自有资金。本次增资完成后，上海超阳的注册资 本将由原 8,800.00 万元增加至 12,571.00 万元，公司间接持有上海超阳的股权比 例将由 30.68%增加至 51.48%，上海超阳将变更为公司控股子公司，纳入公司合 并报表范围 ...

Core Viewpoint - The company has increased its investment in Shanghai Chaoyang Pharmaceutical Co., Ltd., resulting in a controlling stake and consolidation into its financial statements [1] Group 1: Investment Details - The company’s wholly-owned subsidiary, Yuandong Bio Investment Management (Shanghai) Co., Ltd., has invested 85.71 million yuan in Shanghai Chaoyang Pharmaceutical [1] - The investment price is set at 2.27 yuan per registered capital, corresponding to a registered capital of 37.71 million yuan for Shanghai Chaoyang [1] - Following this investment, the registered capital of Shanghai Chaoyang will increase from 88 million yuan to 126 million yuan [1] Group 2: Ownership Changes - The company's indirect ownership stake in Shanghai Chaoyang will rise from 30.68% to 51.48% [1] - As a result of this increase, Shanghai Chaoyang will become a controlled subsidiary of the company [1] - The financial results of Shanghai Chaoyang will now be included in the company’s consolidated financial statements [1]

Group 1 - The innovative drug concept sector experienced a significant decline in early trading on November 4, with Changshan Pharmaceutical dropping over 15% [1] - Other companies in the sector, including Yuandong Biological, Rejing Biological, Baiyang Pharmaceutical, Yipinhong, and Sanofi Guojian, saw declines exceeding 4% [1]

Core Viewpoint - Yuan Dong Bio, established in 2009 and listed in 2020, specializes in the research, production, and sales of chemical raw materials and formulations, particularly in anesthetic and analgesic drugs, showcasing a technical advantage in the domestic chemical pharmaceutical sector [1] Financial Performance - In Q3 2025, Yuan Dong Bio achieved a revenue of 1.019 billion yuan, ranking 49th among 110 companies in the industry, with the industry leader, Huadong Medicine, reporting 32.664 billion yuan [2] - The net profit for the same period was 220 million yuan, placing the company 31st in the industry, while the top performer, Heng Rui Medicine, reported a net profit of 5.76 billion yuan [2] Financial Ratios - As of Q3 2025, the company's debt-to-asset ratio was 19.47%, down from 21.68% year-on-year and below the industry average of 35.26%, indicating strong solvency [3] - The gross profit margin was 75.69%, slightly lower than the previous year's 77.55%, but still above the industry average of 57.17% [3] Executive Compensation - The chairman, Wang Ying, received a salary of 1.4022 million yuan in 2024, an increase of 302,700 yuan from the previous year [4] - The general manager, Yuan Mingxu, saw his compensation rise to 1.5363 million yuan, up by 370,400 yuan from 2023 [4] Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 18.67% to 6,482, while the average number of shares held per shareholder decreased by 15.74% to 27,200 shares [5] - Notable new shareholders include Boshi Research Preferred Mixed A and Great Wall Pharmaceutical Industry Selected Mixed Initiated A [5] Business Highlights - The company reported a revenue decline of 2.00% year-on-year for the first three quarters of 2025, while net profit increased by 1.45% [5] - R&D investment averaged over 20% of revenue in the past three years, with at least 10 new formulation products approved annually since 2023 [5] - The company increased its stake in Shanghai Chaoyang in September 2025, which is expected to enhance its core pipeline clinical research [5] - The core pipeline HP-001 is currently undergoing Phase I clinical trials, showing promising safety characteristics [5] Future Projections - Revenue projections for 2025 to 2027 are 1.359 billion, 1.564 billion, and 1.855 billion yuan, respectively, with net profits expected to be 245 million, 280 million, and 333 million yuan [5] - Another analysis estimates revenues of 1.528 billion, 1.766 billion, and 2.086 billion yuan for the same period, with net profits of 271 million, 319 million, and 382 million yuan [6]