华创证券 医药生物行业 2025 重点研究成果 华创医药生物 郑辰/刘浩团队 2025核心观点 | 创新药 | 中国创新药行业技术水平逐渐赶超欧美、并在部分靶点、部分技术路径已经成为世界第一,出海授权的新药数量/金额持续增加,世界级的 创新带来了世界级的定价和非线性的投资弹性。而国内市场在强劲的需求驱动下,国产新药销售总额持续高增长,一批创新药企实现了扭亏 | | --- | --- | | | 为盈. 迎来稳健成长阶段。 | | | 高值耗材领域, 骨科续标降价或温和,国内持续国产替代,海外业务进展加速推进,神经外科/神经介入等领域集采后增长稳定,新品放量 | | 医疗了 | 有望带来增量。医疗设备领域、县域设备更新中标价格内卷有望缓解、此外今年以来招投标数据持续保持同比高速增长、相关企业去库存 | | 器械 | 进入后期,下半年相关企业业绩同比增速有望好转。低值耗材领域,相关企业产品升级持续推进,海外客户拓展加速,此外丁膈手套行业 | | | 价格有望企稳反弹。体外诊断领域、国内发光虽短期政策承压但进口替代空间巨大、且出海仍有不错表现。 | | 制剂 | 集采优化趋势明确, 制剂公司存量业务风险出清; 同 ...

健友股份 20250915 摘要 高端注射剂出口对健友股份有何影响？ 高端注射剂出口构筑了健友股份的第二增长极。自 2019 年起，公司依诺肝素 制剂在欧美主流市场陆续获批，迅速成为海外收入增长引擎。凭借 FDA 和 EMA 认证优势，公司打通了新兴市场准入通道，并通过战略收购美国梅号建立 本土营销体系，实现品牌影响力和市场份额双提升。截至 2024 年底，公司已 有 82 个美国获批品种，并加速向欧洲及新兴市场渗透。 公司在非肝素领域的发展情况如何？ 健友股份作为肝素原料药及制剂一体化龙头，通过全产业链布局奠定基 础，受益于肝素原料药价格企稳回升，传统业务盈利底部夯实。 高端注射剂出口是健友股份的第二增长极，依诺肝素制剂在欧美市场获 批后迅速增长，凭借 FDA 和 EMA 认证优势，加速向新兴市场渗透，截 至 2024 年底已获批 82 个美国品种。 健友股份在非肝素领域持续扩充产品管线，每年平均新增 10 个左右 ANDA 品种，参考 Hikma 等头部企业，中国高端注射剂出口龙头具有 广阔前景和盈利能力。 中国企业与 Hikma 在美注射剂批文数量仍有差距，但正快速追赶，且中 国企业在综合制造成本方面具 ...

健友股份 20250910 摘要 首先，需要澄清的是，关于乌司奴单抗临床豁免的消息并非 FDA 发布，而是由 一位教授提出的观点。这位教授我们很熟悉，他一直是免临床试验的坚定支持 者。实际上，从 2024 年开始，FDA 在大分子生物类似物领域逐渐转向更为灵 活的小规模临床和临床前风险评估。 对于生物类似物行业而言，目前全球一级 和二级市场基本处于停滞状态，因为研发投入巨大且难以快速见效。当前最大 的挑战在于连续性商业化生产的质量保证以及找到合适的营销合作伙伴。因此， 在未来 5 到 10 年内，能够在财务报表上表现出色的公司将脱颖而出。 尽管专 利到期对原研公司构成巨大冲击，但从整体行业来看，这有利于患者和医保支 付体系。总之，未来 5 到 10 年内，生物类似物行业仍然充满机遇。 健友股份营销团队上半年增长 60%，销售费用增加，团队从区域制转向 全国性和区域性结合，并进行产品线分化，以确保特定方向的产出。 健友股份预计未来三年研发费用控制在 45 亿元以内，小分子药物研发 主要按照欧洲标准，大分子药物研发费用较高，主要投入大分子板块。 生物类似物免临床审批是否降低了中小企业进入市场的门槛？ 生物类似物免 ...

Core Viewpoint - The company reported a decline in revenue and net profit for the first half of 2025, but showed significant improvement in the second quarter, driven by its biopharmaceutical business and export growth in formulations [1][2]. Financial Performance - In 1H25, the company's revenue, net profit attributable to shareholders, and net profit excluding non-recurring items were 1.98 billion, 286 million, and 260 million yuan, respectively, representing year-on-year declines of 7.60%, 29.32%, and 29.46% [1]. - For Q2 2025, the revenue, net profit attributable to shareholders, and net profit excluding non-recurring items were 1.095 billion, 202 million, and 185 million yuan, showing year-on-year declines of 3.84%, 11.53%, and 6.36%, but a quarter-on-quarter improvement of 24%, 138%, and 145% respectively [1][2]. Business Segments - The raw material drug business faced challenges, with revenue declining by 45% year-on-year to 291 million yuan in 1H25, reducing its revenue contribution to 15% from 25% in 1H24 [2]. - The formulation segment showed stable growth, with revenue of 1.659 billion yuan in 1H25, up 7% year-on-year, driven by strong export performance, particularly in the U.S. market, which generated 1.137 billion yuan, a 20% increase year-on-year [3]. - The company has received over 100 overseas approvals and is expanding its pipeline in the European market, aiming to replicate U.S. growth [3]. Biologics Development - The company is building a product matrix in biosimilars, with approvals for adalimumab, liraglutide, and paclitaxel biosimilars, and expects to introduce more potential products [3]. - The collaboration with Tonghua Dongbao on insulin products is anticipated to yield approvals starting in 2026 [3]. Profit Forecast and Valuation - The company forecasts net profits attributable to shareholders of 1.024 billion, 1.327 billion, and 1.650 billion yuan for 2025-2027, representing year-on-year growth of 24%, 30%, and 24% respectively [4]. - The estimated EPS for the same period is 0.63, 0.82, and 1.02 yuan [4]. - A target price of 17.34 yuan is set, based on a 2025 PE of 27.37x, reflecting a 20% discount to the average PE of comparable companies [4].

Group 1 - The company, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd., has approved a stock repurchase plan with a total fund amount between RMB 20 million and RMB 40 million, with a maximum repurchase price of RMB 18.75 per share [2] - The repurchased shares will be used for employee stock ownership plans or equity incentives, and the implementation period is within 12 months from the approval date [2] - As of August 31, 2025, the company has repurchased a total of 880,000 shares, accounting for 0.05% of the total share capital, with a total payment of RMB 10.2207 million [3] Group 2 - The company will comply with relevant regulations and guidelines during the repurchase period and will make repurchase decisions based on market conditions [5] - The company is committed to timely information disclosure regarding the progress of the stock repurchase [5]

债券代码：113579 债券简称：健友转债 | | | 本次回购资金总额不低于人民币 2,000 万元（含）且不超过人民币 4,000 万 元（含），本次回购股份的价格不超过 18.75 元/股（含），本次回购的股份用于 员工持股计划或股权激励，回购股份实施期限为自公司股东大会审议通过本次回 购股份方案之日起 12 个月内。具体内容详见公司于 2025 年 4 月 29 日披露的《健 友股份关于以集中竞价交易方式回购股份的预案》（公告编号：2025-028）。 二、回购股份的进展情况 根据《上市公司股份回购规则》《上海证券交易所上市公司自律监管指引第 7 号——回购股份》等相关规定，公司在回购期间，应于每个月的前 3 个交易日内 披露截至上月末的回购进展情况。现将公司回购股份进展情况公告如下： 截至 2025 年 8 月 31 日，公司通过上海证券交易所交易系统以集中竞价交易 方式已累计回购股份 88 万股，已回购股份占公司总股本的比例为 0.05%，成交最 低价为 11.58 元/股，成交最高价为 11.66 元/股，支付的总金额为人民币 1,022.07 万元（不含交易费用及印花税）。 南京健友生化制药股 ...

Group 1 - The company, Jianyou Co., Ltd. (603707.SH), has announced a share buyback program, having repurchased a total of 880,000 shares as of August 31, 2025 [1] - The repurchased shares account for 0.05% of the company's total share capital [1] - The total amount paid for the repurchased shares is approximately RMB 10.22 million, excluding transaction fees and stamp duty [1] Group 2 - The shares were repurchased through the Shanghai Stock Exchange trading system via centralized bidding [1] - The lowest transaction price for the repurchased shares was RMB 11.58 per share, while the highest was RMB 11.66 per share [1]

Investment Rating - The investment rating for the company is "Recommended" [1][8] Core Views - The company is experiencing rapid growth in its U.S. formulation segment, while its biosimilars are entering a period of significant market release [1][7] - The company reported a revenue of 1.98 billion yuan for the first half of 2025, a year-on-year decrease of 7.6%, and a net profit of 286 million yuan, down 29.32% year-on-year, which was slightly below previous expectations [3][7] - The company is focusing on expanding its biosimilar pipeline and has received multiple approvals from the U.S. FDA and the National Medical Products Administration of China [7][8] Financial Summary - Revenue projections for the company are as follows: 3.93 billion yuan in 2023, 3.92 billion yuan in 2024, 4.29 billion yuan in 2025, 4.95 billion yuan in 2026, and 5.64 billion yuan in 2027, with a year-on-year growth of 9.3% expected in 2025 [6][10] - The net profit is projected to be 826 million yuan in 2024, 753 million yuan in 2025, 866 million yuan in 2026, and 1.08 billion yuan in 2027, with a year-on-year growth of 15% expected in 2026 [6][10] - The gross margin is expected to be 43.2% in 2024, 41.3% in 2025, 43.1% in 2026, and 44.6% in 2027 [6][10] Segment Performance - The company's heparin raw material revenue was 291 million yuan in the first half of 2025, down 45% year-on-year, while the formulation revenue was 1.66 billion yuan, up 7% year-on-year, with the U.S. formulation platform Meitheal generating 1.14 billion yuan, a 20% increase [7][8] - The company has increased its R&D investment to 433 million yuan in the first half of 2025, accounting for 21.85% of revenue, which is a 126.55% increase year-on-year [7][8] Strategic Focus - The company is concentrating on overseas formulation sales and expects biosimilars to provide a new growth curve, maintaining its "Recommended" rating despite slight underperformance in the first half of 2025 [7][8]

Core Viewpoint - The recent financial report of Jianyou Co., Ltd. (603707) indicates a decline in both revenue and net profit for the first half of 2025 compared to the previous year, raising concerns about the company's financial health and operational efficiency [1]. Financial Performance Summary - Total revenue for the first half of 2025 was 1.98 billion yuan, a decrease of 7.6% year-on-year [1]. - Net profit attributable to shareholders was 286 million yuan, down 29.32% from the previous year [1]. - In Q2 2025, total revenue was 1.095 billion yuan, reflecting a year-on-year decline of 3.84% [1]. - Q2 net profit attributable to shareholders was 202 million yuan, a decrease of 11.53% year-on-year [1]. - The gross margin was 37.49%, down 6.83% year-on-year, while the net margin was 14.46%, down 23.51% [1]. - The total of selling, administrative, and financial expenses reached 350 million yuan, accounting for 17.68% of total revenue, an increase of 54.56% year-on-year [1]. Key Financial Ratios - The company's return on invested capital (ROIC) for the previous year was 10.39%, indicating average capital returns [3]. - The historical median ROIC since the company went public is 14.31%, with a significant drop to -1.55% in the worst year, 2023 [3]. - The cash flow situation is concerning, with cash and cash equivalents to current liabilities ratio at 96.18% [3]. - The debt situation is also a concern, with interest-bearing debt ratio reaching 20.97% [3]. - Accounts receivable to profit ratio has reached 154.56%, indicating potential collection issues [3]. Market Sentiment and Fund Holdings - Analysts expect the company's performance in 2025 to reach 1.023 billion yuan, with an average earnings per share of 0.63 yuan [3]. - The company is held by a prominent fund manager, Chen Hao from E Fund, who has recently increased his holdings [3][4]. - The largest fund holding Jianyou shares is the Jiaoyin Growth Mixed Fund, with a scale of 1.719 billion yuan and a recent net value increase of 0.16% [5].

Group 1 - The board of directors of Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. held its 14th meeting of the 5th session on August 28, 2025, with 5 out of 6 directors present [1][2] - The meeting was chaired by Chairman Tang Yongqun and complied with relevant laws and regulations [1] - The board approved the half-year report for 2025 and its summary, which was previously reviewed by the audit committee [1][2] Group 2 - The board also approved a change in accounting policies, which was also reviewed by the audit committee prior to the meeting [2] - The voting results for both resolutions were unanimous, with 6 votes in favor and no votes against or abstaining [2]