Investment Rating - The report maintains a positive investment rating for the pharmaceutical industry, emphasizing the potential for growth in various segments [4]. Core Insights - The report highlights the impact of U.S. tariff policies on the pharmaceutical sector, with a focus on domestic substitution opportunities and the recovery of pharmaceutical consumption [1][2]. - It emphasizes the importance of innovation in pharmaceuticals, particularly in the context of domestic drug development and export potential [2]. - The report suggests that the domestic pharmaceutical market is poised for recovery, driven by strong demand in traditional Chinese medicine and healthcare services [2][3]. Summary by Sections 1. Weekly Insights - The report discusses the potential for domestic substitution in pharmaceuticals, particularly in blood products, medical devices, and consumables [1]. - It notes the recovery of domestic demand in the CXO sector, with expectations for valuation recovery due to improved order fulfillment [2]. 2. Investment Recommendations - The report recommends focusing on companies with strong export potential, such as Jianyou Co., and those benefiting from domestic substitution opportunities [3]. - It also suggests monitoring companies in the traditional Chinese medicine sector and those involved in innovative drug development [3]. 3. Sector-Specific Insights - **Innovative Drugs**: The report highlights the potential for domestic alternatives to imported drugs and the ongoing development of innovative drugs [2]. - **CXO**: The sector is expected to see valuation recovery due to improved domestic and international demand [2]. - **Traditional Chinese Medicine**: The report emphasizes the strong domestic demand and potential for valuation increases in this sector [2]. - **Blood Products**: The report notes the strong pricing power of manufacturers in the context of geopolitical risks and increasing demand for immunoglobulin products [2]. - **Vaccines**: The report indicates a challenging environment for the vaccine sector but highlights potential growth in specific areas [2]. - **Medical Devices**: The report discusses the push for domestic production of key components and the impact of government policies on the sector [2]. - **IVD**: The report emphasizes the potential for domestic companies to gain market share as import substitution accelerates [2]. - **Healthcare Services**: The report suggests that recent policy changes will positively impact consumer healthcare services [2]. - **Pharmacies**: The report indicates a stabilization in the pharmacy sector, with a focus on companies with strong supply chain capabilities [2]. - **Raw Materials**: The report discusses the stabilization of prices in the raw materials sector and the potential for recovery in specific categories [2]. - **Innovative Devices**: The report highlights the potential for domestic companies to replace foreign manufacturers in high-tech medical devices [2]. 4. Key Company Announcements - The report includes updates on significant company announcements, such as new drug approvals and partnerships that may impact market dynamics [63][64][65].

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-012 | | --- | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | | 南京健友生化制药股份有限公司 关于子公司产品腺苷注射液获得美国 FDA 增加生产场地注册批件的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 南京健友生化制药股份有限公司（以下简称"健友股份"或"公司"）子公 司，Meitheal Pharmaceuticals, Inc（以下简称"Meitheal"）于近日收到美国食品 药品监督管理局（以下简称"美国 FDA"）签发的腺苷注射液，3 mg/mL (60 mg/20 mL、90 mg/30 mL),（ANDA 号：077425）增加生产场地的批准信，批准在南京 健友生化制药股份有限公司场地生产。现将相关情况公告如下： 一、药品的基本情况 （一）药品名称：腺苷注射液 （二）适 应 症：对于不能充分运动的患者，腺苷注射液可作为铊-201 心肌 灌注显像的辅助手段。 二、药品其他相关情况 ...

Core Viewpoint - Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. has received FDA approval for its liraglutide injection, which is expected to positively impact the company's operating performance [1][4]. Group 1: Product Information - Product Name: Liraglutide Injection [6] - Dosage Form: Injection [6] - Specification: 18 mg/3 mL (6 mg/mL) [6] - ANDA Number: 218115 [6] - Indication: Assists in blood sugar control for adults and children aged 10 and above with type 2 diabetes [1][2]. Group 2: Market Context - The original drug is held by NOVO NORDISK INC, which was approved by the FDA for marketing in the U.S. on January 25, 2010, under the brand name VICTOZA [3]. - Currently, only one other company, HIKMA PHARMACEUTICALS USA INC, has a similar liraglutide injection approved for sale in the U.S. [3]. Group 3: Financial Implications - The company has invested approximately RMB 57.3731 million in the research and development of liraglutide injection [3]. - The newly approved product is expected to be launched in the U.S. soon, which may have a positive effect on the company's financial performance [4].

证券研究报告 健友股份 (603707 CH) 类似药拾级而上，利拉获批再下一城 | 华泰研究 | | | 公告点评 | | --- | --- | --- | --- | | 2025 年 | 4 月 | 04 日│中国内地 | 化学制药 | 公司于 4 月 3 日公告其利拉鲁肽生物类似药在美获批。此为公司在美第二个 生物类似药批件，我们看好公司生物类似药业务起步，小分子制剂出口维持 较高增速，同时原料药、国内制剂等不确定性趋于出清。新一轮美国加征关 税不涉及药物，我们预计本轮关税对公司业务影响有限。维持"买入"评级。 利拉鲁肽：老牌大单品，类似药竞争格局尚较为健康 利拉鲁肽为一种 GLP-1 类似物，原研为诺和诺德的 Victoza，自 2010 年 以来陆续在美获批降糖/心血管/儿科降糖等多个适应症，在美销售峰值曾达 近 28 亿美元。目前除 Hikma/翰宇药业、健友股份的生物类似药分别于 12M24、4M25 获批外，暂无其他公司获批，竞争格局较为稳定。 制剂：稳增长延续，非肝素制剂出口持续发力 | 投资评级(维持): | 买入 | | --- | --- | | 目标价(人民币): | 22.10 ...

Group 1 - The company announced the approval of its liraglutide biosimilar in the U.S. on April 3, marking its second biosimilar approval in the U.S. The biosimilar business is expected to grow, while small molecule exports maintain a high growth rate, and uncertainties in APIs and domestic formulations are gradually clearing up [1] - The new round of U.S. tariffs does not affect drugs, and the company anticipates limited impact from these tariffs on its business [1] - Liraglutide, a GLP-1 analog originally developed by Novo Nordisk, has seen peak sales in the U.S. reach nearly $2.8 billion since its approval in 2010, with a relatively stable competitive landscape as only a few companies have biosimilars approved [1] Group 2 - The formulation business remains the main growth driver for the company, with strong growth in the U.S. market, where approximately 90 products have been approved, and 7 new products are expected to be approved in 2024. The company estimates a compound annual growth rate (CAGR) of over 20% for overseas formulation revenue from 2025 to 2026 [2] - In the domestic market, the impact of centralized procurement is gradually clearing up, with 8 new products expected to be approved in 2024, including potential blockbuster products already validated overseas [2] - The biosimilar business is expected to further enhance the company's growth trajectory, with the acquisition of the adalimumab biosimilar approval and the anticipated approval of other products like albumin-bound paclitaxel [2] Group 3 - The company forecasts net profit attributable to shareholders for 2024-2026 to be 971 million, 1.136 billion, and 1.443 billion yuan, respectively, with adjustments reflecting geopolitical and potential tariff impacts. The expected year-on-year growth rates for 2025 and 2026 are 17% and 27% [3] - The estimated earnings per share (EPS) for 2024-2026 are 0.60, 0.70, and 0.89 yuan, respectively. The company is assigned a price-to-earnings (PE) ratio of 31.43x for 2025, leading to a reasonable valuation of 35.704 billion yuan and a target price of 22.10 yuan [3]

获得美国 FDA 药品注册批件的公告 | 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-011 | | --- | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | | 南京健友生化制药股份有限公司 关于产品利拉鲁肽注射液 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 南京健友生化制药股份有限公司（以下简称"健友股份"或"公司"）于近日收 到美国食品药品监督管理局（以下简称"美国 FDA"）签发的利拉鲁肽注射液，18 mg/3 mL (6 mg/mL),（ANDA 号：218115）批准信，现将相关情况公告如下： 一、药品的基本情况 （一）药品名称：利拉鲁肽注射液 （二）适 应 症： 作为饮食和运动的辅助手段，改善成人和 10 岁及以上的儿童 2 型糖尿病患 者的血糖控制。 降低伴有心血管疾病的 2 型糖尿病成人患者的主要心血管不良事件的风险。 二、药品其他相关情况 公司于 2025 年 04 月 03 日获得美国 FDA 的通知，公司向美国 FDA 申报的 利拉 ...

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-010 | | --- | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | | 南京健友生化制药股份有限公司 关于"健友转债"转股结果暨股份变动的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 重要内容提示： 转股情况： 未转股可转债情况： 截至 2025 年 3 月 31 日，尚未转股的"健友转债"金额为人民币 502,464,000 元，占"健友转债"发行总量的比例为 99.86%。 一、可转债的发行上市概况 经中国证券监督管理委员会《关于核准南京健友生化制药股份有限公司公开 发行可转换公司债券的批复》（证监许可[2020]603 号）核准，南京健友生化制 药股份有限公司（以下简称"公司"）公开发行了 5,031,900 张可转换公司债券 （以下简称"可转债"或"健友转债"），每张面值人民币 100 元，发行总额人 民币 5.0319 亿元，期限 6 年。经上海证券交易所自律监管决定书[2020]134 ...

根据《证券期货投资者适当性管理办法》及配套指引，本资料仅面向华创证券客户中的金融机构专业投资者，请勿对本资料进行任何形式的转发。若您不是华创证券客户中的金融机构专业投资者，请勿订 阅、接收或使用本资料中的信息。 本资料难以设置访问权限，若给您造成不便，敬请谅解。感谢您的理解与配合。 摘要 高端注射剂平台建成，健友股份 3.0 To 2030 。 健友股份的前身健友生化厂于 1991 年成立，在创立以来三十余年的时间，公司始终保持 着前瞻的战略眼光和高效的执行力。目前健友股份产品管线丰富，业务涵盖无菌注射剂、肝素原料药、 CDMO 及生物药创新，立足中 美，拓展全球。回顾公司的发展历程，我们认为公司的成长模式和核心竞争力均已得到了较为充分的验证，并展现出广阔的成长空间。 原料药制剂一体化：肝素价稳筑基，制剂蓄势待发 。 健友股份作为国内肝素原料药及制剂一体化的龙头企业，凭借其在肝素产业链上的 完整布局，奠定了公司发展的坚实基础。公司不仅在肝素原料药领域占据重要地位，也通过制剂一体化战略，形成了从研发、生产到销 售的完整产业链条。 制剂出口 1 ：依诺肝素开篇，高端注射剂接力。 公司以依诺肝素制剂全球化突破为起点 ...

Core Viewpoint - The article emphasizes the growth potential and strategic positioning of Jianyou Co., highlighting its comprehensive capabilities in high-end injectable drugs and the integration of raw materials and formulations, particularly in the heparin sector, as well as its expansion into biosimilars and innovative drugs. Group 1: High-End Injectable Drug Platform - Jianyou Co. has established a high-end injectable drug platform, showcasing a rich product pipeline that includes sterile injectables, heparin raw materials, CDMO, and biopharmaceutical innovations, with a focus on expanding globally from a strong base in China and the U.S. [2][6] - The company has a solid foundation in the heparin industry, being a leading player in the integrated raw material and formulation sector, which supports its growth trajectory [16][20]. Group 2: Export of Formulations - The company has successfully launched its enoxaparin formulations globally since 2019, becoming a key driver of overseas revenue growth, leveraging FDA/EMA certifications to access emerging markets [29][30]. - As of the end of 2024, Jianyou Co. has obtained 82 approved ANDA products in the U.S., with plans to accelerate penetration into Europe and emerging markets [29][35]. Group 3: Biosimilars and Innovative Drugs - Jianyou Co. is transitioning towards biosimilars and innovative drugs, capitalizing on its manufacturing expertise to explore broader market opportunities, particularly in the U.S. biosimilar market, which is projected to exceed $40 billion by 2027 [4][53]. - The company has made strategic acquisitions, such as the purchase of Coherus' adalimumab biosimilar, to enhance its market position in the U.S. [62]. Group 4: Financial Performance and Projections - For the first three quarters of 2024, the company reported revenues of 3.088 billion yuan, with a net profit of 606 million yuan, reflecting a year-on-year decline of 27.83% [10]. - The projected net profits for 2024-2026 are 816 million, 1.108 billion, and 1.478 billion yuan, respectively, indicating a recovery and growth trajectory [4][10]. Group 5: Market Position and Competitive Landscape - The U.S. injectable generic drug market is characterized by high barriers to entry, with significant growth potential, as evidenced by the market size of $15-20 billion and a projected CAGR in the high single digits [37][49]. - Jianyou Co. is positioned to compete effectively against established players like Hikma, with a focus on leveraging its integrated manufacturing and cost advantages to enhance profitability [49][50].

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-009 | | --- | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | | 南京健友生化制药股份有限公司 关于子公司与 Xentria 签署 根据协议的约定，在完成 XTMAB 多剂量爬坡试验（MAD）或临床 2 期研究入 组时，支付 2,000 万美元。目前 XTMAB 项目临床 2 期受试者已经筛选完毕，经过 联合指导委员会批准，公司子公司于 2025 年 3 月 5 日向 Xentria 支付了 500 万 美元进度款（详见公司在上交所官网披露的公告，公告编号：2025-008），公司 子公司又于 2025 年 3 月 19 日向 Xentria 支付 1,500 万美元进度款。截至本公告 披露日，就 XTMAB 项目公司子公司已累计支付 2,500 万美元。 三、XTMAB 项目进展情况 XTMAB 是一种肿瘤坏死因子 α（TNFα）抑制剂，旨在稳定免疫失调。TNFα 是炎症的关键调节因子，对肉芽肿的形成至关重要，通常导致疾病进展。目前已 经证明 XTMAB-16 对肺结节病患者有治疗作用， ...