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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
Core Viewpoint - Chengdu Yuandong Biopharmaceutical Co., Ltd. has announced the initiation of I/II phase clinical trials for its novel antibody-drug conjugate YLSH003, aimed at treating advanced solid tumors, with the first subject successfully enrolled [1][3]. Group 1: Drug Overview - YLSH003 is a new type of antibody-drug conjugate targeting Tissue Factor (TF), which is implicated in the recurrence and metastasis of many solid tumors [1][2]. - The drug is developed using a high-affinity humanized IgG1 antibody and a small molecule topoisomerase I inhibitor, utilizing the Uni-linker ADC technology platform [2]. - Preclinical studies indicate that YLSH003 has high anti-tumor activity and potential superior safety, offering better treatment options for patients with advanced solid tumors [2]. Group 2: Clinical Trial Details - YLSH003 received acceptance from the National Medical Products Administration (NMPA) in July 2025 and was granted a clinical trial approval notice in September 2025 [3]. - The I/II phase clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YLSH003 in patients with advanced solid tumors, with the I phase focusing on dose escalation and the II phase on efficacy at the recommended dose [3]. - The first subject in the I phase has been successfully enrolled, and recruitment for additional subjects is progressing rapidly [3].
11月10日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-10 12:00
Group 1 - Digital Zhengtong's subsidiary Baoding Jindi won a bid for a smart water project in Jinan, with a total contract value of 109 million yuan, of which Baoding Jindi's share is approximately 77 million yuan [1] - Lingzhi Software plans to acquire 100% equity of Kaimiride through a combination of cash and stock issuance, with the final transaction price yet to be determined [1] - Tianjin Port's subsidiary plans to transfer 60% equity of China Railway Storage and Transportation, with an estimated value of 37.54 million yuan for the entire equity [2] Group 2 - New Wufeng reported a 56.97% year-on-year increase in pig sales in October, selling 610,000 pigs [3] - New Peng Co. announced a joint investment of approximately 15 million USD with Jabil to build a battery storage box project in Thailand [4] - Maiwei Bio received approval for a clinical trial of its 9MW3811 injection for pathological scars [6] Group 3 - Jiangsu Sopo completed maintenance and resumed production of its methanol and acetic acid facilities [8] - Luoniushan reported a 24.65% year-on-year increase in pig sales revenue in October, totaling 116 million yuan [9][10] - Zhongbei Communication signed a 1 billion yuan comprehensive computing service framework agreement with Xiamen Hongxin Electronics [11] Group 4 - Huayang New Materials announced the resignation of its general manager, Wu Yuehua [12] - Zhongxin Co. used 50 million yuan of idle funds to purchase structured deposits with expected annual returns between 0.55% and 2.05% [14] - Huajian Group's subsidiary signed a construction engineering design contract worth 96.54 million yuan [16] Group 5 - Jianyou Co. received FDA approval for a new production site for its injectable drug [17] - Beilu Pharmaceutical obtained a drug registration certificate for its iodine mepivacaine injection, which is included in the national medical insurance catalog [19] - *ST Yuancheng's stock will be suspended due to falling below the market cap threshold for delisting [20] Group 6 - Xiantan Co. reported a 9.3% year-on-year increase in chicken product sales revenue in October, totaling 503 million yuan [21] - Huanxu Electronics reported an 8.93% year-on-year decrease in consolidated revenue for October, amounting to 5.598 billion yuan [23] - Yisheng Co. reported a 22.97% year-on-year decrease in white feather chicken seed sales revenue in October [25] Group 7 - Yuandong Bio initiated a Phase I/II clinical trial for its ADC drug YLSH003 targeting advanced solid tumors [25] - Xiaoming Co. reported a 34.89% year-on-year decrease in chicken product sales revenue in October [26] - Nanjiao Food reported a 5.27% year-on-year decrease in consolidated revenue for October, totaling 235 million yuan [28] Group 8 - Chuangye Huikang announced a potential change in control, leading to a temporary stock suspension [30] - Tangrenshen reported a 17.91% year-on-year decrease in pig sales revenue in October, totaling 828 million yuan [32][33] - Wancheng Group plans to distribute a cash dividend of 1.5 yuan per 10 shares to shareholders [34] Group 9 - Kangguan Technology plans to distribute a cash dividend of 3.6 yuan per 10 shares to shareholders [36] - Shoudu Online's executive plans to reduce holdings of up to 19,400 shares [38] - Maolai Optical received approval for the issuance of convertible bonds [40] Group 10 - Jinkai New Energy plans to distribute a cash dividend of 0.1 yuan per share to shareholders [41] - Tianchen Medical raised the upper limit for share repurchase to 70 yuan per share [42] - Tianmu Lake used 38 million yuan of idle funds to purchase structured deposits [43]
苑东生物:注射用YLSH003启动Ⅰ/Ⅱ期临床试验并完成首例受试者入组
Core Viewpoint - Yuan Dong Biotech (688513) announced that its wholly-owned subsidiary, Shanghai Youluo, has initiated Phase I/II clinical trials for its self-developed Class I biological drug, YLSH003, targeting advanced solid tumors, with the first subject successfully enrolled for treatment recently [1] Group 1 - The company is advancing its clinical research with YLSH003, which is a significant step in its drug development pipeline [1] - The initiation of clinical trials indicates the company's commitment to addressing unmet medical needs in oncology [1] - The successful enrollment of the first subject marks a critical milestone in the development process of YLSH003 [1]
苑东生物(688513) - 苑东生物: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
2025-11-10 08:00
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 ...
苑东生物(688513.SH):注射用YLSH003启动I/II期临床试验并完成首例受试者入组
Ge Long Hui A P P· 2025-11-10 07:58
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]
苑东生物:注射用YLSH003启动I/II期临床试验并完成首例受试者入组
Zhi Tong Cai Jing· 2025-11-10 07:44
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]
苑东生物:注射用YLSH003启动I/II期临床试验并完成首例入组
Xin Lang Cai Jing· 2025-11-10 07:41
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]
苑东生物(688513) - 苑东生物:关于向参股公司增资暨关联交易完成的进展公告
2025-11-04 09:45
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 ...
苑东生物:向参股公司增资暨关联交易完成
Di Yi Cai Jing· 2025-11-04 09:23
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]
苑东生物的前世今生:2025年三季度营收10.19亿排行业49,净利润2.2亿排31
Xin Lang Cai Jing· 2025-10-31 23:32
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]