智通财经APP讯，安科生物(300009.SZ)发布2025年三季度报告，该公司前三季度营业收入为19.63亿 元，同比增长2.15%。归属于上市公司股东的净利润为5.51亿元，同比减少6.48%。归属于上市公司股东 的扣除非经常性损益的净利润为5.19亿元，同比减少6.56%。基本每股收益为0.3297元。 ...

证券日报网讯安科生物（300009）2025年10月27日在互动平台回答投资者提问时表示，截至2025年10月 20日，公司的股东总数为73497户。 ...

安徽安科生物工程(集团)股份有限公司 2025 年第三季度报告 证券代码：300009 证券简称：安科生物 公告编号：2025-056 安徽安科生物工程(集团)股份有限公司 2025 年第三季度报告 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。 重要内容提示： 1.董事会、监事会及董事、监事、高级管理人员保证季度报告的真实、准确、完整，不存在 虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 2.公司负责人、主管会计工作负责人及会计机构负责人(会计主管人员)声明：保证季度报告 中财务信息的真实、准确、完整。 3.第三季度财务会计报告是否经过审计 □是 否 1 安徽安科生物工程(集团)股份有限公司 2025 年第三季度报告 一、主要财务数据 （一） 主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 □是 否 | | 本报告期 | 本报告期比上年同 | 年初至报告期末 | 年初至报告期末比上 | | --- | --- | --- | --- | --- | | | | 期增减 | | 年同期增减 | | 营业收入（元） | 670,4 ...

此次启动Ⅲ期临床的两款产品，均针对儿童常见且需求迫切的疾病领域。其中，AK1012吸入用溶液是 公司已上市产品"人干扰素α2b注射液"的改良型新制剂，拟用于治疗由呼吸道合胞病毒(RSV)引起的儿 童下呼吸道感染。人干扰素α2b喷雾剂拟用于治疗儿童疱疹性咽峡炎。 人民财讯10月27日电，安科生物（300009）在厦门召开"AK1012吸入用溶液Ⅱ/Ⅲ期临床试验研究者 会"及"人干扰素α2b喷雾剂Ⅲ期临床试验研究者会"，两款聚焦儿童呼吸道病毒感染产品同步进入临床验 证冲刺阶段。 ...

Core Viewpoint - Anke Bio (300009.SZ) presented the latest research results of its self-developed biological innovative drug HuA21 at the ESMO annual meeting in Berlin, demonstrating promising efficacy and safety in treating HER2-positive advanced gastric/GEJ adenocarcinoma [1][2]. Summary by Sections Research Overview - The study titled "HuA21 combined with trastuzumab and chemotherapy in HER2-positive advanced gastric/GEJ adenocarcinoma: Phase Ib/II dose-escalation and expansion study" was led by researchers from Fudan University and Anhui Medical University [2]. - HuA21 is a monoclonal antibody targeting HER2 with a unique amino acid sequence, distinct from trastuzumab and pertuzumab, and possesses independent intellectual property rights [2]. Mechanism of Action - HuA21 induces internalization and downregulation of the HER2 receptor, disrupting cancer cell signaling pathways, inhibiting growth and proliferation, promoting apoptosis, and reducing tumor angiogenesis [2]. Clinical Trial Details - Early clinical trials indicated good safety (no dose-limiting toxicities observed at doses ≤15 mg/kg) and significant anti-tumor activity (objective response rate of 63.6% when combined with trastuzumab and chemotherapy) [3]. - The study enrolled 60 patients with HER2-positive advanced gastric/GEJ adenocarcinoma, utilizing a "3+3" design for dose escalation and expansion [3]. Efficacy Results - The objective response rates (ORR) were 80.8% for the HuA21 (30 mg/kg) group and 76.7% for the HuA21 (20 mg/kg) group, indicating strong anti-tumor activity [4]. - Disease control rates (DCR) were 96.2% for the 30 mg/kg group and 100% for the 20 mg/kg group, with mPFS and mOS data still maturing [4]. Safety Profile - Overall safety was good, with treatment-emergent adverse events (TEAE) occurring in 100% of the 30 mg/kg group and 96.7% of the 20 mg/kg group, primarily grade 1-2 [4]. - Serious adverse events (SAE) occurred in 6.7% of the 30 mg/kg group and 23.3% of the 20 mg/kg group, with manageable common TEAEs including thrombocytopenia, anemia, and elevated liver enzymes [4]. Conclusion - The HuA21 (30 mg/kg) group showed a higher ORR of 80.8% compared to the 20 mg/kg group, with a lower incidence of SAEs, supporting the recommendation of 30 mg/kg as the phase III dose for HER2-positive advanced gastric cancer or GEJ cancer [5].

Core Viewpoint - Anke Bio announced the presentation of its self-developed biological innovative drug HuA21 at the ESMO annual meeting, showcasing its efficacy in treating HER2-positive advanced gastric/GEJ adenocarcinoma in combination with trastuzumab and chemotherapy [1] Group 1: Study Overview - The study titled "HuA21 combined with trastuzumab and chemotherapy in HER2-positive advanced gastric/GEJ adenocarcinoma: Phase Ib/II dose-escalation and expansion study" was led by researchers from Fudan University and Anhui Medical University [2] - HuA21 is a monoclonal antibody targeting HER2 with a unique amino acid sequence, possessing independent intellectual property rights [2] Group 2: Efficacy and Safety - Early clinical trials indicated that HuA21 demonstrated good safety with no dose-limiting toxicities observed at doses ≤15 mg/kg and significant anti-tumor activity, achieving an objective response rate (ORR) of 63.6% when combined with trastuzumab and chemotherapy [3] - The study enrolled 60 patients with HER2-positive advanced gastric/GEJ adenocarcinoma, using a "3+3" design for dose escalation and expansion [3] - The ORR for the HuA21 (30 mg/kg) group was 80.8%, while the ORR for the HuA21 (20 mg/kg) group was 76.7%, indicating strong anti-tumor activity [4] Group 3: Safety Profile - The overall safety profile was good, with treatment-emergent adverse events (TEAEs) occurring in 100% of the HuA21 (30 mg/kg) group and 96.7% of the HuA21 (20 mg/kg) group, primarily grade 1-2 [4] - Serious adverse events (SAEs) occurred at rates of 6.7% for the HuA21 (30 mg/kg) group and 23.3% for the HuA21 (20 mg/kg) group [4] - Common TEAEs included thrombocytopenia, anemia, neutropenia, leukopenia, and elevated aspartate aminotransferase, all of which were manageable [4] Group 4: Conclusion - The HuA21 (30 mg/kg) group showed a higher ORR of 80.8% compared to the 20 mg/kg group, with a lower incidence of SAEs, supporting the recommendation of 30 mg/kg as the phase III dose for HER2-positive advanced gastric cancer or GEJ cancer [5]

Core Viewpoint - Anke Biopharma announced the presentation of clinical research data for its innovative drug HuA21 at the ESMO annual meeting, highlighting its efficacy and safety in treating HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma [1] Group 1: Company Developments - Anke Biopharma will present the latest research findings on HuA21, a recombinant anti-HER2 humanized monoclonal antibody injection, at the ESMO annual meeting in Berlin from October 17 to 21, 2025 [1] - The clinical study data for HuA21 in combination with trastuzumab and chemotherapy further confirms its good anti-tumor activity and tolerable safety profile [1] Group 2: Industry Implications - The results from the clinical research provide support for the Phase III clinical trial, potentially accelerating the drug development process [1]

Core Viewpoint - The company announced promising results from its clinical trial of the innovative biological drug HuA21 in combination with trastuzumab and chemotherapy for treating HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma [1] Group 1: Clinical Trial Results - The latest research findings were presented at the 2025 European Society for Medical Oncology (ESMO) annual meeting [1] - A total of 60 HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma patients were enrolled in the study as of February 20, 2025 [1] - The objective response rate (ORR) for the HuA21 (30 mg/kg) group was 80.8%, while the ORR for the HuA21 (20 mg/kg) group was 76.7%, indicating strong anti-tumor activity [1] - There were no statistically significant differences in demographic and baseline characteristics between the two patient groups [1]

智通财经APP讯， 安科生物(300009.SZ)发布公告，公司于2025年 10 月17日至21日在德国柏林召开的欧 洲肿瘤内科学会(ESMO)年会上，以壁报形式公布自主研发的生物创新药重组抗HER2人源化HuA21单克 隆抗体注射液(以下简称"HuA21")联合曲妥珠单抗和化疗治疗HER2阳性晚期胃/胃食管交界处腺癌Ib/II 期剂量递增和扩展研究的最新研究成果。 本次在ESMO年会上披露的HuA21联合曲妥珠单抗联合化疗治疗HER2阳性晚期胃/胃食管交界处腺癌的 临床研究数据进一步证实了其良好的抗肿瘤活性和可耐受的安全性，为III期临床试验提供了支持，加速 药物研发进程。此外，积极的临床数据将为产品市场前景提供有力支持，有助于增强公司产品的未来市 场竞争力。 ...

本公司及董事会全体成员保证公告内容真实、准确和完整，没有虚假记载、 误导性陈述或者重大遗漏。 安徽安科生物工程（集团）股份有限公司（以下简称"公司"）于 2025 年 10 月 17 日至 21 日在德国柏林召开的欧洲肿瘤内科学会（ESMO）年会上，以壁 报形式公布自主研发的生物创新药重组抗 HER2 人源化 HuA21 单克隆抗体注射 液（以下简称"HuA21"）联合曲妥珠单抗和化疗治疗 HER2 阳性晚期胃/胃食管 交界处腺癌 Ib/II 期剂量递增和扩展研究的最新研究成果，相关情况如下： 证券代码：300009 证券简称：安科生物 公告编号：2025-055 安徽安科生物工程（集团）股份有限公司 关于自愿披露创新药 HuA21 注射液在 2025 年欧洲肿瘤内科学会 （ESMO）年会公布临床研究数据的公告 孙倍成，安徽医科大学第一附属医院 HuA21 是公司自主开发的一种靶向 HER2 亚结构域 I/II 的单克隆抗体，含有 与曲妥珠单抗和帕妥珠单抗完全不同的氨基酸序列，具有完全自主知识产权。 HuA21 通过诱导 HER2 受体的内吞和下调，打断癌细胞信号通路，从而抑制癌 细胞生长和增殖，产生促进癌细 ...