Core Viewpoint - Anke Biological (300009) reported on October 29 that the company's growth hormone new patient enrollment has continued to increase, with the water injection form of growth hormone accounting for a growing proportion of the overall growth hormone product line, enhancing the company's product competitiveness and contributing to profit growth [1] Group 1 - The company has seen a continuous increase in new patient enrollment for its growth hormone products [1] - The water injection form of growth hormone is becoming a larger part of the company's overall growth hormone product portfolio [1] - The increase in product competitiveness is expected to lead to profit growth for the company [1]

Core Viewpoint - Anke Bio's trastuzumab product "Ansaiting" is expected to be approved for market launch by the end of 2023, with projected revenue of 100 million yuan in 2024, and significant year-on-year growth in revenue for the first nine months of 2025, although current profits from this product are relatively low [1] Group 1 - The company anticipates that the upcoming centralized procurement of biosimilars will be beneficial for manufacturers entering the market later, as the current procurement policies are relatively mild [1] - After several rounds of price reductions, the price impact on the market is expected to be minimal, allowing the company to quickly transform this product from a revenue-generating product to a profit-generating product by rapidly reducing sales expenses [1]

Core Viewpoint - Anke Biotechnology (300009) announced on October 29 that its InvivoCAR-T platform, based on a lentiviral vector system, has completed preclinical development and is about to enter the investigator-initiated trial (IIT) phase [1] Group 1 - The company is actively engaging in technical exchanges with domestic and international CAR-T companies to prepare for overseas expansion and business collaborations [1]

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]