Core Viewpoint - Anke Bio announced the smooth progress of its self-developed "AK2017 Injection" clinical trials, having completed the enrollment for Phase II trials and submitted a supplementary application for Phase III trials, which are expected to start in early next year [2] Group 1 - The company has successfully completed the enrollment for Phase II clinical trials of "AK2017 Injection" [2] - A supplementary application for Phase III clinical trials has been submitted [2] - The initiation of Phase III clinical trials is anticipated to begin in early next year [2]

Core Viewpoint - The company, Anke Bio (300009), reported that its self-developed "AK2017 Injection" (recombinant human growth hormone-Fc fusion protein injection) is progressing well in clinical trials, having completed the enrollment for Phase II trials and submitted a supplementary application for Phase III trials, which are expected to commence in early next year [1] Group 1 - The company has successfully completed the enrollment for Phase II clinical trials of AK2017 Injection [1] - A supplementary application for Phase III clinical trials has been submitted [1] - The initiation of Phase III clinical trials is anticipated to start in early next year [1]

Financial Performance - In Q3 2025, the company achieved a revenue of CNY 670 million, a year-on-year increase of 7.70%, and a net profit of CNY 185 million, up by 6.56% [3] - For the first nine months of 2025, the company reported a revenue of CNY 1.963 billion, a year-on-year growth of 2.15%, while net profit decreased by 6.48% to CNY 551 million [3] - The growth in Q3 revenue and net profit was primarily driven by increased sales of growth hormones and antibody drugs [3] Product Development and Clinical Trials - The PA3-17 injection from the company's affiliate, Boshengji, is in Phase II clinical trials and aims for conditional market approval [3] - The "AK2017 injection" (recombinant human growth hormone-Fc fusion protein) has completed Phase II clinical trial enrollment and is expected to start Phase III trials in early 2026 [4] - The "HuA21 injection," targeting HER2, showed an objective response rate (ORR) of 80.8% in the 30 mg/kg group during exploratory studies [5] - The "HK010 injection" (PD-L1*4-1BB) is in Phase I clinical trials, showing good efficacy and safety in various cancers [9] Market Strategy and Future Outlook - The company plans to enhance operational efficiency and solidify the growth of its core business while accelerating the development of other business areas [3] - The collaboration with Weisheng Pharmaceutical on the long-acting growth hormone aims to penetrate the high-end market, enhancing product visibility and sales [4] - The company anticipates a market size exceeding CNY 4 billion for follicle-stimulating hormone in 2025, with plans to capture significant market share [10] - Sales and R&D expenses are expected to increase slightly over the next two years due to the rise in innovative drug trials and new product launches [11] Strategic Initiatives - The company has established an innovation research institution in Shanghai to support the development of self-researched and commercially cooperative products [12] - Plans for expanding production capacity include new production lines in northern and eastern regions, expected to contribute to economic growth [12]

Core Viewpoint - Anke Bio's revenue for the first three quarters of 2025 reached 1.963 billion yuan, reflecting a year-on-year growth of 2.15% while the net profit attributable to shareholders decreased by 6.48% to 551 million yuan [1] Financial Performance - The company's operating revenue for the first three quarters was 1.963 billion yuan, showing a year-on-year increase of 2.15% [1] - The net profit attributable to shareholders was 551 million yuan, which represents a year-on-year decrease of 6.48% [1] - The net profit attributable to shareholders after deducting non-recurring gains and losses was 519 million yuan, down 6.56% year-on-year [1] - Basic earnings per share stood at 0.3297 yuan [1]

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 ...

Core Viewpoint - Anke Biological (300009) is advancing two clinical trials for products targeting respiratory viral infections in children, marking a significant step in addressing urgent healthcare needs in this demographic [1] Group 1: Clinical Trials - Anke Biological held a researcher meeting for the Phase II/III clinical trial of AK1012 inhalation solution and the Phase III clinical trial of human interferon α2b spray [1] - Both products are entering the final stages of clinical verification, focusing on common and urgent diseases affecting children [1] Group 2: Product Details - AK1012 inhalation solution is a modified new formulation of the already marketed product, human interferon α2b injection, intended for treating lower respiratory tract infections caused by respiratory syncytial virus (RSV) in children [1] - The human interferon α2b spray is aimed at treating herpetic pharyngitis in children [1]

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]