| 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， ...

健友股份 20250320 由于 2023 年肝素原料药行业不景气，无论是销售额还是价格均有所下滑。健友 股份因此计提了 12.4 亿元存货跌价准备，导致 2023 年归母净利润为负。到 2024 年肝素钠行业温和复苏，公司原材料采购价明显降低，因此转回存货跌价 准备 1.6 至 2.4 亿元，提高了归母净利润。2024 年公司发布业绩预告显示归母 净利润约为 8.0 至 10.5 亿元，实现扭亏为盈。 摘要 Q&A 健友股份近年来的转型和业务发展情况如何？ 健友股份近年来成功从肝素原料药企业转型为高端制剂企业。公司制剂业务的 营收占比已超过七成，成为主营业务，并且覆盖国内外市场，尤其在海外市场 拥有成熟的自营团队和丰富的 ANDA 批件数。在包括美国等海外市场，公司有超 过 50 个产品正在运行，同时在超过二十多个国家推进注册和销售拓展工作。公 司还与国内优秀企业合作拓展海外市场，如与双城药业合作白蛋白紫杉醇、与 通化东宝合作多个胰岛素类似物，这些产品在美国及其他海外市场上市工作正 在推进中。 健友股份在国内外市场的发展情况如何？ 在国内，健友股份近几年受到集采影响，其主要制剂进入国采范围后，通过集 采实现 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5]. Core Views - The company is transitioning from heparin raw materials to high-end injectable formulations, with a significant increase in the proportion of its formulation business, which accounted for over 70% of revenue in 2023 [1][17]. - The company has established a strong presence in the U.S. market, with over 50 products running and a sales revenue of 1.63 billion yuan in 2023, marking it as one of the largest Chinese pharmaceutical companies in the U.S. high-end formulation market [2][19]. - The heparin raw material business is stabilizing after a period of decline, with a projected mild recovery in 2024, which is expected to positively impact net profit [3][19]. Company Overview - The company is one of the largest global suppliers of heparin raw materials and formulations, with over 80 formulation varieties operating in more than 60 countries [1][10]. - The company has a mature R&D, quality, registration, and sales team in the U.S., leading the domestic industry in ANDA approvals [1][10]. Formulation Business - The formulation business is the main source of revenue and profit for the company, with sales increasing from 762 million yuan in 2019 to 2.77 billion yuan in 2023, representing 70.50% of total revenue [22]. - The company has been actively expanding its domestic market presence through successful bids in national procurement, although sales have faced pressure due to price reductions [24][40]. - The company is also expanding its global footprint, with overseas revenue exceeding 70% of total revenue in 2023, driven by a robust product pipeline and strategic market entry [19][41]. Heparin Raw Material Business - The heparin raw material business has shown a stable production trend, with a slight recovery expected in 2024, which will help mitigate previous losses from inventory write-downs [3][19]. - The company recorded a write-down of 1.24 billion yuan in 2023 due to declining heparin prices, impacting net profit [3][19]. Financial Forecast and Investment Recommendations - The company is expected to achieve revenues of 4.24 billion yuan, 5.57 billion yuan, and 7.19 billion yuan for 2024, 2025, and 2026, respectively, with corresponding net profits of 946 million yuan, 1.16 billion yuan, and 1.62 billion yuan [4][19]. - The report anticipates continued growth in the formulation business, which will drive overall performance improvements [4][19].

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5]. Core Views - The company is transitioning towards high-end formulations, with a significant increase in the proportion of its formulation business, which accounted for over 70% of total revenue in 2023. This shift reflects a successful transformation from a traditional raw material supplier to an international sterile injection enterprise [1][17]. - The company has established a strong presence in the U.S. market, with over 50 products operational and a leading position in ANDA approvals among domestic peers. The U.S. subsidiary generated sales of 1.63 billion yuan in 2023, marking it as one of the largest Chinese pharmaceutical companies engaged in high-end formulation sales in the U.S. [2][19]. - The report forecasts revenue growth for the company, projecting revenues of 4.24 billion yuan, 5.57 billion yuan, and 7.19 billion yuan for 2024, 2025, and 2026, respectively, with corresponding net profits of 946 million yuan, 1.16 billion yuan, and 1.62 billion yuan [4][19]. Summary by Sections Company Overview - The company is one of the largest global suppliers of heparin raw materials and formulations, with over 80 formulation varieties marketed in more than 60 countries. It has been increasing R&D investments to support its transition to high-end formulations [1][10]. Formulation Business - The formulation business is the main source of revenue and profit for the company, with sales increasing from 762 million yuan in 2019 to 2.77 billion yuan in 2023, representing 70.50% of total revenue. The gross profit from this segment also rose significantly during the same period [22][23]. - The company has been actively expanding its domestic market presence through successful bids in national procurement, although sales have faced pressure due to price reductions [24][40]. Heparin Raw Materials - The heparin raw material business has shown a mild recovery, with stable production levels. However, the company faced a significant inventory impairment in 2023, leading to a net profit decrease of 1.05 billion yuan. A recovery in the global heparin market is expected in 2024, with potential reversals of inventory impairments [3][19]. Financial Forecast and Investment Recommendations - The report anticipates substantial growth in the company's overseas formulation business, which is expected to drive overall performance. The projected earnings per share (EPS) for 2024, 2025, and 2026 are 0.59 yuan, 0.72 yuan, and 1.00 yuan, respectively [4][19].

Investment Rating - The report gives a "Buy" rating for the company [5]. Core Views - The company is transitioning towards high-end formulations, with a significant increase in the proportion of formulation business, which accounted for over 70% of total revenue in 2023. This shift reflects a successful transformation from a traditional raw material supplier to an international sterile injection enterprise [1][17]. - The company has established a strong presence in the U.S. market, with over 50 products operational and a leading position in ANDA approvals among domestic peers. The U.S. subsidiary generated sales of 1.63 billion yuan in 2023, marking it as one of the largest Chinese pharmaceutical companies engaged in high-end formulation sales in the U.S. [2][19]. - The report forecasts revenue growth driven by overseas formulation business, with projected revenues of 4.24 billion yuan, 5.57 billion yuan, and 7.19 billion yuan for 2024, 2025, and 2026, respectively [4][19]. Summary by Sections Company Overview - The company is one of the largest global suppliers of heparin raw materials and formulations, with over 80 formulation varieties in more than 60 countries. It has been increasing R&D investments to support its transition to high-end formulations [1][10]. Formulation Business - The formulation business is the main source of revenue and profit for the company, with sales increasing from 762 million yuan in 2019 to 2.77 billion yuan in 2023, representing 70.50% of total revenue. The gross profit from this segment also rose significantly during the same period [22][23]. - The company has been actively participating in national procurement, which has helped maintain growth in domestic formulation sales despite some price pressures [24][40]. Heparin Raw Materials - The heparin raw material business has seen a mild recovery, with stable production levels. However, the company faced a significant inventory impairment charge of 1.24 billion yuan in 2023 due to declining prices, which impacted net profit [3][19]. - The report anticipates a recovery in the global heparin market in 2024, with a potential reversal of inventory impairment provisions, which could positively affect net profit [3][19]. Financial Forecast and Investment Recommendations - The company is expected to achieve a turnaround in profitability, with projected net profits of 946 million yuan, 1.16 billion yuan, and 1.62 billion yuan for 2024, 2025, and 2026, respectively. The earnings per share (EPS) are forecasted to be 0.59 yuan, 0.72 yuan, and 1.00 yuan for the same years [4][19]. - The report emphasizes the company's commitment to high-margin formulation business and its ongoing expansion into international markets, which are expected to drive future growth [17][19].

公 华福证券 生物类似药出海天地广阔，自研+BD 模式进一步打开成长天花板 随着全球多个重磅生物药专利陆续到期，全球生物类似药市场规 模有望快速增长。自研方面，截至 23 年公司多肽类制剂有 4 个产品 美国审批中、1 个产品注册批生产完成、6 个产品前期研发中。BD 方 面，公司 2024 年购买阿达木单抗类似药取得美国生物类似药市场入场 券， 近年来公司积极寻求外部合作，先后与海南双成、通化东宝达成 战略合作，取得白蛋白紫杉醇、甘精、门冬、赖脯三种胰岛素在美国 市场的独家商业化权益，未来随着生物类似药在美国市场获批，有望 助力海外制剂业务快速放量。 华福证券 投资要点： 肝素原料药市场边际改善，公司 API 业务有望稳健增长 公 司 首 次 覆 盖 2023 受到下游企业去库存影响，肝素原料药需求端减弱，价格进 入下跌周期，公司于 23 年对 API 存货计提 12.4 亿元跌价准备，当前 随着供给端格局稳定+需求端去库存周期或接近尾声，肝素价格有望恢 复。公司作为肝素原料药龙头，相关业务收入体量及毛利率未来有望 回升。2024 年公司拟转回存货跌价准备 1.6-2.4 亿元，我们认为若未来 肝素行业景气 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5][7]. Core Views - The heparin raw material market is showing marginal improvement, and the company's API business is expected to grow steadily [3][29]. - The company is focusing on sterile injection formulations, with rapid growth in overseas formulation business [4][41]. - The global biosimilar drug market is anticipated to grow significantly, with the company leveraging both self-research and business development (BD) models to expand its growth potential [5][67]. Summary by Sections 1. Company Overview - The company is a leading supplier of heparin raw materials and has been transitioning towards high-end injection formulations and biosimilars, aiming to reduce its reliance on traditional raw material labels [13][16]. 2. Heparin Raw Material Market - The heparin raw material market is expected to recover as supply-side stability and the end of inventory destocking on the demand side are anticipated [3][31]. - The company has established stable supply relationships with major global heparin formulation manufacturers, providing a solid cash flow for its injection business [36][37]. 3. Focus on Sterile Injection Formulations - The company's injection business has shown robust growth, with a revenue increase of 12.8% in 2023 and a compound annual growth rate (CAGR) of 47.4% from 2018 to 2023 [41][46]. - The company has a diverse product matrix in sterile injections, including low molecular weight heparin and anti-tumor agents, with a significant portion of revenue coming from overseas markets [47][55]. 4. Biosimilar Drug Development - The global biosimilar market is projected to grow rapidly, with the company actively pursuing opportunities in this space, including acquiring rights to a biosimilar of adalimumab [5][72]. - The company has multiple biosimilar products in various stages of development, enhancing its growth prospects in international markets [67][72]. 5. Financial Projections - The company is expected to achieve net profits of 0.9 billion, 1.2 billion, and 1.5 billion yuan for the years 2024, 2025, and 2026, respectively, with significant growth rates projected [5][6].

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-008 | | --- | --- | --- | | 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 许可协议暨关联交易的进展公告 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。 一、本次交易概述 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 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 1,000 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 ...

南京健友生化制药股份有限公司 关于获得国家药品监督管理局 罗库溴铵注射液药品注册批件的公告 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"）于近 日收到国家药品监督管理局（以下简称"NMPA"）签发的罗库溴铵注射液 5ml： 50mg 及 10ml：100mg 的药品注册证书（药品批准文号分别为：国药准字 H20253446、国药准字 H20253447），现将相关情况公告如下： 一、药品的基本情况 （一）药品名称：罗库溴铵注射液 （二）适 应 症： | 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-007 | | --- | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | | 公司于 2025 年 02 月 28 日获得 NMPA 通知，公司注册申报的罗库溴铵注射 液（5ml：50mg、10ml：100mg）的化学药品 4 类上市许可申请获得批准。 国内上市原研药参比制剂罗库溴铵注射液（中文商品名为爱 ...

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"）签发的重酒石酸去甲肾上腺素注射液， 4mg/4mL（ANDA 号：040455）生产场地转移批准信，批准在公司子公司健进制 药有限公司场地生产。现将相关情况公告如下： 一、药品的基本情况 二、药品其他相关情况 公司于 2025 年 2 月 27 日收到美国 FDA 的通知，公司子公司 Meitheal 向美 国 FDA 申报的重酒石酸去甲肾上腺素注射液，4 mg/4 mL（ANDA 号：040455） 生产场地转移至健进制药的申请已获得批准。 | 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-006 | | --- | --- | --- | | 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 子公司关于获得美国 FDA 重酒石酸去甲肾 上腺素注射液药品生产场地转移注册批件的公告 本公司董事会及全体董事保证本公告内容不存在任何 ...