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]

Core Viewpoint - Anke Bio (300009.SZ) announced the presentation of its self-developed biological innovative drug, recombinant anti-HER2 humanized HuA21 monoclonal antibody injection, at the European Society for Medical Oncology (ESMO) annual meeting in Berlin from October 17 to 21, 2025, showcasing promising clinical research results for treating HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma [1] Group 1 - The clinical research data presented at ESMO further confirms the good anti-tumor activity and tolerable safety of HuA21 in combination with trastuzumab and chemotherapy for HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma [1] - The positive clinical data supports the progression to Phase III clinical trials, accelerating the drug development process [1] - The encouraging results will provide strong support for the market prospects of the product, enhancing the future market competitiveness of the company's offerings [1]

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 ...

Core Viewpoint - Anke Biological's stock price has shown a slight decline but is expected to recover due to performance improvements and market expansion of core products, leading to a positive long-term trend [1] Group 1: Financial Performance - In the first half of 2025, Anke Biological's parent company achieved a revenue of 910 million yuan, representing a year-on-year growth of 5.13%, with the bioproducts segment growing by 7.49%, laying a solid foundation for growth in the second half [2] Group 2: Product Sales Growth - The sales of Trastuzumab (brand name: Ansaiting) are expected to see significant year-on-year growth in 2025, with sales revenue projected to exceed 100 million yuan in 2024. The product has been in a rapid market introduction phase, and its sales volume has consistently increased [3] - Anke Biological received approval for a new specification of Trastuzumab (60mg/vial), which is anticipated to enhance sales growth due to product diversification. The sales revenue for Trastuzumab in the first half of 2025 increased by 298% year-on-year [3] Group 3: Traditional Product Recovery - The sales of Yuliangqing, a traditional Chinese medicine product, are expected to see significant year-on-year growth in the second half of 2025, following a recovery after a production suspension in 2024 [4] Group 4: Hormone Product Outlook - The sales of growth hormone water injections are projected to increase year-on-year in the second half of 2025, supported by a rise in new patient enrollments and a growing proportion of water injection revenue, which now exceeds 40% of the total growth hormone product revenue [5]

Core Viewpoint - Anke Bio's stock has experienced fluctuations, with a recent decline of 2.05% and a year-to-date increase of 19.41%, indicating volatility in investor sentiment and market performance [1][2]. Company Overview - Anhui Anke Bioengineering (Group) Co., Ltd. was established on September 28, 2000, and listed on October 30, 2009. The company specializes in research, development, production, and sales of biotechnological products, including cell engineering, gene engineering, gene testing, and precision medicine [1]. - The main revenue sources for Anke Bio are gene engineering drugs (88.24%), external patches (11.67%), and other supplementary products (0.09%) [1]. Financial Performance - For the first half of 2025, Anke Bio reported a revenue of 1.292 billion yuan, a year-on-year decrease of 0.51%, and a net profit attributable to shareholders of 367 million yuan, down 11.92% year-on-year [2]. - Since its A-share listing, Anke Bio has distributed a total of 2.662 billion yuan in dividends, with 1.252 billion yuan distributed over the past three years [3]. Shareholder Structure - As of June 30, 2025, Anke Bio had 65,700 shareholders, a decrease of 2.17% from the previous period, with an average of 18,598 circulating shares per shareholder, an increase of 2.22% [2]. - The top ten circulating shareholders include Hong Kong Central Clearing Limited, which holds 20.7916 million shares (an increase of 7.341 million shares), and other notable shareholders such as the China National Securities Bio-Medical Index A and the Southern CSI 1000 ETF [3].

10月16日，安科生物跌2.48%，成交额3.15亿元。两融数据显示，当日安科生物获融资买入额4852.75万 元，融资偿还4372.60万元，融资净买入480.16万元。截至10月16日，安科生物融资融券余额合计6.94亿 元。 分红方面，安科生物A股上市后累计派现26.62亿元。近三年，累计派现12.52亿元。 融资方面，安科生物当日融资买入4852.75万元。当前融资余额6.90亿元，占流通市值的4.07%，融资余 额超过近一年80%分位水平，处于高位。 机构持仓方面，截止2025年6月30日，安科生物十大流通股东中，香港中央结算有限公司位居第三大流 通股东，持股2079.16万股，相比上期增加734.10万股。招商国证生物医药指数A（161726）位居第五大 流通股东，持股1869.46万股，相比上期减少149.91万股。创新药（159992）位居第七大流通股东，持股 1102.64万股，相比上期减少366.99万股。南方中证1000ETF（512100）位居第九大流通股东，持股 1079.76万股，为新进股东。易方达创业板ETF（159915）、南方中证500ETF（510500）退出十大流通 股东 ...

Core Insights - The precision medicine sector experienced a 1.97% increase on October 15, with Tsinghua Life leading the gains [1] - The Shanghai Composite Index closed at 3912.21, up 1.22%, while the Shenzhen Component Index closed at 13118.75, up 1.73% [1] Stock Performance - Tsinghua Life (300642) closed at 25.85, up 10.38% with a trading volume of 294,900 shares and a transaction value of 756 million [1] - Beilu Pharmaceutical (300016) closed at 8.77, up 4.78% with a trading volume of 251,800 shares and a transaction value of 26.61 million [1] - Zoli Pharmaceutical (300181) closed at 19.07, up 4.21% with a trading volume of 283,300 shares and a transaction value of 534 million [1] - WuXi AppTec (603259) closed at 99.46, up 3.69% with a trading volume of 421,800 shares and a transaction value of 4.123 billion [1] - Qianhong Pharmaceutical (002550) closed at 9.08, up 3.42% with a trading volume of 301,300 shares and a transaction value of 271 million [1] Capital Flow - The precision medicine sector saw a net inflow of 339 million from institutional investors, while retail investors experienced a net outflow of 18.88 million [2][3] - Major stocks like Zoli Pharmaceutical and Anke Bio (300009) had significant net inflows from institutional investors, with 76.71 million and 54.19 million respectively [3]

Core Viewpoint - Anke Biopharma has received approval from the National Medical Products Administration for a supplemental application for its injection of Trastuzumab (brand name: Ansaiting), adding a new specification of 60mg/bottle [1] Company Summary - Anke Biopharma's Ansaiting is a monoclonal biosimilar drug developed independently according to the "Guidelines for the Research and Evaluation of Biosimilars" [1] - The drug is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer [1]

证券代码：300009 证券简称：安科生物 公告编号：2025-054 安徽安科生物工程（集团）股份有限公司 关于注射用曲妥珠单抗新增规格的补充申请获批的公告 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"）收到国家药 品监督管理局颁发的《药品补充申请批准通知书》，公司注射用曲妥珠单抗（商 品名：安赛汀）（以下简称"安赛汀"）新增 60mg/瓶规格的补充申请获得批准。 具体情况如下： 一、批准通知书基本内容 药品名称：注射用曲妥珠单抗 规 格：60mg/瓶 上市许可持有人：安徽安科生物工程（集团）股份有限公司 二、对公司的影响 安赛汀是公司根据《生物类似药研发与评价技术指导原则》等指导原则自主 研发的单抗生物类似药，用于治疗 HER2 阳性早期乳腺癌、HER2 阳性转移性乳 腺癌、HER2 阳性转移性胃癌。 本次安赛汀新增 60mg/瓶规格获批后，在临床上可以与 150mg/瓶的原规格 产品灵活组合，满足中国女性乳腺癌患者的临床用药需求，实现剂量灵活调整， 提升药物经济性，符合专家共识中"即配即用"的要求，优 ...

Core Insights - Anke Bio's stock price reached a peak of 10.50 yuan, with an increase of 2.1% [1] - The company's targeted therapy drug, Ansatin (Trastuzumab), is primarily used for HER2-positive breast cancer and gastric cancer, marking its first product in the oncology targeted drug sector [1] - Anke Bio anticipates sales revenue from Trastuzumab to exceed 100 million yuan in 2024, with a significant year-on-year growth expected in 2025 [1][3] Financial Performance - Anke Bio reported total revenue of 1.292 billion yuan for the first half of 2025, remaining stable compared to 1.299 billion yuan in 2024 [3] - The company's gross profit was approximately 988 million yuan, resulting in a gross margin of 76.45% [3] - Net profit attributable to the parent company was 367 million yuan, reflecting a year-on-year decline of 11.92%, attributed to investments in multiple new drug research pipelines [3] R&D Progress - Anke Bio has several clinical projects in various stages, including HuA21 injection in phase I, PA3-17 injection in phase I, and others in phase II and III [4][6] - The company is actively developing 13 new clinical drugs, indicating a robust pipeline for future growth [6]