Group 1 - The core point of the article is that Anke Bio (300009.SZ) has received approval from the National Medical Products Administration for its product, FSH-CTP injection (brand name: Shengnuo), which is the first long-acting recombinant follicle-stimulating hormone approved in mainland China [1] Group 2 - The product is exclusively distributed by Anke Bio in mainland China and the Hong Kong, Macau, and Taiwan regions [1]

证券代码：300009 证券简称：安科生物 公告编号：2025-048 安徽安科生物工程（集团）股份有限公司 关于独家代理产品重组人卵泡刺激素-CTP 融合蛋白注射液 获批上市的公告 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。 近日，安徽安科生物工程（集团）股份有限公司（以下简称"公司"）在中国 大陆及港澳台地区独家代理苏州晟济药业有限公司的产品重组人卵泡刺激素-CTP 融合蛋白注射液（商品名：晟诺娃®）获得国家药品监督管理局批准上市，该产品 是国内首款获批上市的长效重组人卵泡刺激素（FSH-CTP）。现将相关情况公告如 下： 一、药物基本信息内容 药品批准文号：国药准字 S20250049；国药准字 S20250050 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符 合药品注册的有关要求，批准注册，发给药品注册证书。 二、产品相关情况 FSH-CTP 作为一种关键的辅助生殖药物，联合促性腺激素释放激素(GnRH)拮 抗剂用于控制性卵巢刺激（COS），以诱导多个卵泡发育，达到促生殖的作用。临 床数据显示，FSH-CTP 在获卵数、胚胎质量 ...

Core Viewpoint - Anke Bio (300009) reported that the growth hormone new patient enrollment is expected to maintain year-on-year growth in the first half of 2025, with the revenue share of water injections exceeding 40% of the total growth hormone product revenue [1] Group 1: Company Performance - The revenue from growth hormones is projected to remain stable compared to the same period last year due to less than ideal new patient enrollment in the second half of 2024 [1] - The company aims to achieve a recovery growth target by continuing to promote academic work related to growth hormones, leveraging the year-on-year growth in new patient enrollment in the first half of 2025 [1] Group 2: Market Conditions - The growth hormone market is experiencing intense competition; however, the overall pricing system remains relatively stable [1]

问答环节要点生长激素板块：2025年上半年生长激素新患入组同比增长，水针占比超40%，但因2024年 下半年新患入组不佳，2025年上半年营收与去年同期持平。生长激素市场竞争激烈但价格稳定，与维昇 药业合作的长效生长激素"隆培促生长素"预计2025年下半年获批，定位于高端市场。隆培促生长素优 点：安全性好，通过特定技术使生长激素以特定速率缓慢释放，连接结构和载体分子可排出体外；有效 性高，创新技术保持蛋白活性，免疫原性低，IGF - 1应答高于日制剂；稳定性强，优化冷冻干燥工艺， 储存条件更宽松，降低运输和保存负担；便利性与依从性佳，创新自动注射器，隐形针头，每周仅需注 射一次。博生吉公司CAR - T管线布局：包括自体CAR - T，PA3 - 17注射液纳入突破性治疗品种；通用 现货型CAR - T，UTAA09注射液临床试验进展顺利；In vivo CAR - T平台，完成临床前开发进入IIT阶 段；NKCE平台，进展到动物实验阶段。CD7 - CART规划：后续启动II期单臂注册临床并争取附条件上 市，产品获批后计划在一带一路国家直接申报上市，对欧美国家将视情况独立申报或寻找合作。创新药 研发管线：公 ...

Financial Performance - In the first half of 2025, the company achieved operating revenue of CNY 1,292.19 million, a year-on-year decrease of 0.51% [3] - The net profit was CNY 374.55 million, down 11.61% year-on-year, while the net profit attributable to shareholders was CNY 366.52 million, a decrease of 11.92% [3] - The net cash flow from operating activities increased by 53.75% to CNY 316.42 million [3] - The main business of biological products saw a year-on-year growth of 7.49%, with sales of the injection drug Trastuzumab "Ansatin" increasing by 298% [3] Business Strategy and Market Development - The company is optimizing sales channels and strategies to enhance market development amid intensified competition and fluctuating market demand [3] - Plans for the second half of the year include optimizing business structure, increasing market expansion efforts, and enhancing internal management and resource integration [3] Growth in Specific Product Lines - The growth hormone segment has seen a year-on-year increase in new patient enrollment, with water-based injections accounting for over 40% of the segment's revenue [3][4] - The company is collaborating with Weisheng Pharmaceutical on the long-acting growth hormone "Longpei Growth Factor," expected to be approved in the second half of 2025 [5] Innovative Drug Development - The company is advancing its self-developed innovative drugs, including: - "HuA21 Injection," targeting HER2, currently in Phase III clinical trials [8] - "AK2024 Injection," also targeting HER2, has received clinical approval [8] - "HK010 Injection," a dual-target drug, is progressing well in Phase I trials [8] - "AK2017 Injection," a recombinant human growth hormone, is in Phase II trials [8] - The company is also involved in various collaborative projects, including mRNA drug development and CAR-T therapies [9] Future Financial Outlook - The company anticipates a slight increase in sales and R&D expenses over the next two years due to the rise in clinical trials and new product launches [10] - Overall, the company aims to achieve a recovery growth target for the full year of 2025, supported by product market promotion and sales activities [10][11]

Financial Performance - Anke Bio's net profit for the first half of 2025 decreased by 11.92% year-on-year, amounting to 367 million yuan [1] - Total operating revenue for the same period was 1.292 billion yuan, a slight decline of 0.51% year-on-year [1] - The gross margin was reported at 76.45%, down 2.3% from the previous year, while the net margin fell to 28.99%, a decrease of 11.16% [1] - In Q2 2025, operating revenue was 663 million yuan, reflecting a year-on-year increase of 3.22, but net profit dropped by 20.6% to 158 million yuan [1] Key Financial Metrics - The total of selling, administrative, and financial expenses reached 474 million yuan, accounting for 36.71% of revenue, an increase of 2.1% year-on-year [1] - Earnings per share (EPS) decreased by 12.0% to 0.22 yuan, while operating cash flow per share increased by 54.1% to 0.19 yuan [1] - The company's net assets per share rose by 6.11% to 2.37 yuan [1] Changes in Financial Items - Short-term borrowings increased by 39.92% due to new loans from subsidiary Anke Huajie [3] - Prepayments surged by 219.45%, attributed to increased outsourced R&D payments [3] - Financial expenses saw a significant rise of 352.93%, mainly due to substantial foreign exchange losses [3] Business Evaluation - The company's return on invested capital (ROIC) was 17.1%, indicating strong capital returns, with a historical median ROIC of 14.04% over the past decade [4] - The net profit margin for the previous year was 28.23%, suggesting high added value in products or services [4] - Analysts project a revenue of 794 million yuan and an average EPS of 0.47 yuan for 2025 [4] Research and Development Progress - The company is advancing several clinical projects, including AK1012 for respiratory infections, which has completed Phase I trials [6] - AK2017, a growth hormone injection, is progressing well through clinical trials, with Phase III discussions underway [6] - The company is also developing innovative drugs targeting HER2, with multiple candidates in various stages of clinical trials [6]

Group 1 - The core viewpoint of the report is that Anke Bio (300009.SZ) is rated as a buy due to its continuous development in main business and overall stable performance of the parent company [2] - The company is actively expanding new business areas to create growth points for its performance [2] - Anke Bio is focusing on cutting-edge technologies, with accelerated innovation and research and development efforts [2]

Core Viewpoint - Anke Biological experienced a stock price decline of 2.07% on August 22, with a current price of 11.38 yuan per share and a total market capitalization of 19.033 billion yuan [1] Company Overview - Anhui Anke Biological Engineering (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 composition includes 88.24% from gene engineering drugs, 11.67% from external patches, and 0.09% from other sources [1] Financial Performance - For the first half of 2025, Anke Biological reported operating 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] - Cumulative cash dividends since the A-share listing amount to 2.662 billion yuan, with 1.252 billion yuan distributed in the last three years [3] Shareholder Structure - As of June 30, 2025, the number of shareholders is 65,700, a decrease of 2.17% from the previous period, with an average of 18,598 circulating shares per person, an increase of 2.22% [2] - The top ten circulating shareholders include Hong Kong Central Clearing Limited as the third-largest shareholder, holding 20.7916 million shares, an increase of 7.341 million shares from the previous period [3]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected price increase of over 15% in the next 6-12 months [5][11]. Core Insights - The company reported a revenue of 1.292 billion RMB for the first half of 2025, a slight decrease of 0.51% year-on-year, with a net profit attributable to shareholders of 367 million RMB, down 11.92% year-on-year [2]. - The company's main business, particularly its biological products, has shown resilience with a 5.13% year-on-year increase in revenue for the parent company, despite a decline in net profit [3]. - The company is actively expanding its business through strategic partnerships and new product rights, which are expected to enhance its growth trajectory [3]. - The company is advancing its innovative research and development efforts, with several clinical trials underway for new therapies, including CAR-T cell drugs and mRNA vaccines [4]. Financial Performance - The company expects to achieve net profits of 794 million RMB, 904 million RMB, and 1.011 billion RMB for the years 2025, 2026, and 2027, respectively, reflecting growth rates of 12%, 14%, and 23% [5]. - The earnings per share (EPS) for the years 2025, 2026, and 2027 are projected to be 0.48 RMB, 0.54 RMB, and 0.60 RMB, with corresponding price-to-earnings (P/E) ratios of 24, 22, and 19 [5]. Market Position - The company has successfully reversed the declining trend in its main biological products, with a notable 298% increase in sales of its injection product, "Anshaiting" [3]. - The report highlights the company's strategic collaborations, including exclusive commercialization rights for a new product and a partnership for a growth hormone product, which are expected to strengthen its market position [3].

公募基金方面本期较上一季度持股减少的公募基金共计3个，包括创新药、招商国证生物医药指数A、 天弘国证生物医药ETF发起式联接A，持股减少占比达0.31%。本期较上一季度新披露的公募基金共计7 个，主要包括南方中证1000ETF、富国优化增强债券A/B、富国裕利债券A、富国久利稳健配置混合型 A、国泰君安沪深300指数增强发起A等。本期较上一季未再披露的公募基金共计2个，包括易方达创业 板ETF、南方中证500ETF。 2025年8月22日，安科生物(300009.SZ)发布2025年半年度报告。截至2025年8月21日，共有12个机构投 资者披露持有安科生物A股股份，合计持股量达8164.38万股，占安科生物总股本的4.88%。其中，前十 大机构投资者包括香港中央结算有限公司、中国银行股份有限公司-招商国证生物医药指数分级证券投 资基金、上海银行股份有限公司-银华中证创新药产业交易型开放式指数证券投资基金、招商银行股份 有限公司-南方中证1000交易型开放式指数证券投资基金、国泰海通证券股份有限公司约定购回专用账 户、富国优化增强债券A/B、富国裕利债券A、富国久利稳健配置混合型A、国泰君安沪深300指数增强 ...