| 证券代码：603707 | 证券简称：健友股份 公告编号：2024-062 | | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | （一）药品名称：盐酸罗哌卡因注射液 （二）适 应 症：盐酸罗哌卡因注射液适用于外科手术麻醉和急性疼痛控制 （三）剂 型：注射剂 南京健友生化制药股份有限公司 关于子公司产品盐酸罗哌卡因注射液 获得美国 FDA 批准的公告 本公司董事会、全体董事及相关股东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"）子公司健 进制药有限公司（以下简称"健进制药"）于近日收到美国食品药品监督管理局（以 下简称"美国 FDA"）签发的盐酸罗哌卡因注射液，USP，20 mg/10 mL (2 mg/mL), 40 mg/20 mL (2 mg/mL), 100 mg/20 mL (5 mg/mL), 150 mg/30 mL (5 mg/mL), 100 mg/10 mL (10 mg/mL), 200 mg/20 mL (10 mg/ ...

Summary of Conference Call Transcript Company and Industry Involved - The company mentioned is involved in the pharmaceutical industry, specifically in the context of product approval and market entry in the United States. Core Points and Arguments - The company successfully filed for approval in the United States in 2013, indicating a significant milestone in its product development timeline [1] - The company claims to be the fastest in the market among its peers, having achieved product launch in the U.S. within a 19-year timeframe [1] - The company highlights that its investment and efforts towards product development began as early as 2010, showcasing a long-term commitment to innovation and market readiness [1] Other Important but Possibly Overlooked Content - The reference to being the "slowest" in the context of the timeline suggests a competitive landscape where speed to market is critical, emphasizing the importance of regulatory processes and strategic planning [1]

Financial Data and Key Metrics Changes - The company has seen a significant increase in R&D expenses, reaching 360 million yuan, with two-thirds of this amount allocated to biopharmaceuticals, indicating a strong focus on this area [2][4] - The company anticipates a net profit margin of approximately 15% to 20% for 2024 compared to 2023, reflecting a positive outlook on profitability despite market challenges [28] Business Line Data and Key Metrics Changes - The company aims to expand its product offerings from over 50 to 120 by 2027, focusing on small molecule drugs, which have been a significant contributor to gross profit [1][4] - The company is actively developing three insulin products, with expectations for clinical trials to progress as planned, indicating a robust pipeline in the diabetes treatment segment [11] Market Data and Key Metrics Changes - The company predicts a gradual recovery in raw material prices, with expectations of a 10% increase by early next year, following a period of price stabilization [14][22] - The biopharmaceutical market is expected to see significant growth, with the company projecting that biosimilars could capture 70% to 80% of the market by 2030 [33] Company Strategy and Development Direction - The company is positioning itself as a key player in the U.S. biopharmaceutical market, emphasizing rapid product development and high-quality standards [1][4] - The strategy includes a focus on collaboration in R&D, particularly in the biopharmaceutical sector, to enhance innovation and market competitiveness [2][4] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the approval timelines for key products, including a biosimilar expected to be approved in Q4 of this year, which could generate significant revenue [8][9] - The management highlighted the importance of maintaining price stability in a competitive market, indicating a preference for sustainable profit margins over aggressive pricing strategies [49][54] Other Important Information - The company has successfully resolved patent challenges for key products, which is expected to facilitate smoother market entry and sales [7][8] - The management noted that the global market for biopharmaceuticals is becoming increasingly competitive, with a focus on quality and compliance as critical success factors [4][5] Q&A Session Summary Question: What is the market outlook for the biosimilar Adalimumab? - The company anticipates that biosimilars will significantly increase their market share, potentially reaching 70% to 80% by 2030, driven by the expiration of patents and increased competition [33][35] Question: How does the company plan to manage its inventory levels? - Management clarified that while inventory levels are currently high, they are not overly concerning, as they are in line with industry standards and will be managed strategically to avoid price wars [42][44] Question: What is the company's strategy regarding pricing in a competitive environment? - The company aims to maintain price stability and avoid aggressive price competition, focusing instead on quality and sustainable profit margins [49][54]

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 司健进制药有限公司（以下简称"健进制药"）于近日收到国家药品监督管理局 （以下简称"国家药监局"）关于核准签发注射用阿扎胞苷（规格：100mg）药 品注册证书的通知（药品批准文号：国药准字 H20244451），现将相关情况公告 如下： | 证券代码：603707 | 证券简称：健友股份 公告编号：2024-061 | | --- | --- | | 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 关于子公司产品注射用阿扎胞苷 获得国家药品监督管理局药品注册证书的公告 本公司董事会、全体董事及相关股东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、药品的基本情况 1、 药品名称：注射用阿扎胞苷 规格：100mg（按 C8H12N4O5 计） 剂型：注射剂（冻干粉针剂） 申请事项：仿制药申请 注册分类：化学药品 4 类 申报阶段：生产 上市许可持有人：健进制药有限公司 受理号：CYHS2201599 药品批准文号：国药准字 H202444 ...

Summary of the Conference Call for Jianyou Co., Ltd. Company Overview - **Company**: Jianyou Co., Ltd. - **Industry**: Pharmaceutical and Biopharmaceuticals Key Points and Arguments 1. **Market Conditions**: The current pharmaceutical market is experiencing a downturn, but Jianyou Co., Ltd. believes the worst is over and is focusing on strategic execution capabilities [2][3] 2. **Transition to Formulations**: The company has successfully transitioned from raw materials to formulation exports, with 75% of its business now related to formulations, primarily for export to the U.S. [8][9] 3. **Market Share**: Jianyou holds approximately 20% market share in the U.S. for its products, with a significant portion of its revenue coming from non-Gansu products [9][10] 4. **Biologics Development**: The company has invested 5 to 6 years in biologics research and has recently gained market access for its adalimumab product in the U.S. [10][11] 5. **Future Growth Plans**: From 2024 to 2030, Jianyou aims to increase its commercialized products from over 50 to 120, focusing on biosimilars [11][12] 6. **Quality Control and Regulatory Compliance**: The company emphasizes the importance of maintaining high-quality standards and compliance with FDA regulations, especially in light of recent scrutiny of other companies [18][19] 7. **Market Dynamics**: The company anticipates an increase in regulatory scrutiny and inspections as more Chinese companies enter the U.S. market, which may lead to more frequent audits [20][21] 8. **Raw Material Pricing**: The raw material market has seen a decline, impacting profit margins, but Jianyou expects to stabilize and improve its financial performance in the coming years [44][45] 9. **Profit Margins**: The company projects that its gross margins will remain stable, with expectations of slight improvements as market conditions recover [50][53] 10. **Product Pipeline**: Jianyou is focused on launching several biologics, including insulin and growth hormone products, with expected commercialization timelines within the next 1 to 2 years [58][59] Additional Important Information - **Strategic Focus**: The company is committed to enhancing its competitive edge through continuous improvement in operational capabilities and resource allocation [13][14] - **Market Trends**: There is a growing demand for high-quality biologics and sterile injectables, which Jianyou aims to capitalize on [32][33] - **Global Expansion**: Jianyou is exploring opportunities in non-regulated markets while maintaining a primary focus on regulated markets [35][36] - **Investor Engagement**: The company encourages investor questions and discussions to foster transparency and engagement [14][15] This summary encapsulates the key insights and strategic directions discussed during the conference call for Jianyou Co., Ltd., highlighting its market position, growth strategies, and operational focus.

Summary of Conference Call Company/Industry Involved - The conference call involves Guoyi Shengshi 300 Cloud Knowledge and Construction Co., Ltd. [1] Core Points and Arguments - The call begins with a welcome message and a disclaimer regarding the meeting [1] Other Important but Possibly Overlooked Content - All participants are currently muted, indicating a structured format for the call [1]

Investment Rating - The report initiates coverage with an "Accumulate" rating for the company [6]. Core Views - The company is transforming from a heparin leader to an international high-end formulation leader, focusing on a comprehensive product chain that includes standard heparin, low molecular weight heparin, small molecule anti-tumor injectables, and other high-end formulations [3][11]. - The international and domestic markets are driving growth in the formulation segment, with significant capacity expansion and product approvals expected to enhance performance [4][30]. - The risks associated with the heparin raw material segment have been mitigated to some extent, with prices and export volumes at historical lows, indicating potential recovery as inventory levels normalize [5]. Summary by Sections 1. Transformation and Strategy - The company has over 30 years of experience in the biopharmaceutical industry and is implementing a dual-driven strategy focusing on both raw materials and formulations, with a global market perspective [11][12]. - The company has successfully integrated its heparin business and is expanding into high-end biopharmaceuticals, aiming to become a world-class comprehensive pharmaceutical enterprise [3][11]. 2. Growth Drivers - The international market is primarily driven by the approval of new products and the commercialization of complex formulations like albumin-bound paclitaxel, with significant capacity expansion in the U.S. [4][30]. - The domestic market is expected to recover steadily due to the implementation of centralized procurement, with core products maintaining a strong market position despite short-term disruptions [4][40]. 3. Financial Forecast - The company projects earnings per share (EPS) of 0.54, 0.69, and 0.92 yuan for 2024, 2025, and 2026, respectively, with corresponding price-to-earnings (PE) ratios of 21.41, 16.50, and 12.51 [6]. - Revenue is expected to grow from 39.31 billion yuan in 2023 to 64.20 billion yuan in 2026, reflecting a compound annual growth rate (CAGR) of approximately 22.7% [6]. 4. Product and Market Position - The company has a robust pipeline with over 59 projects under development, including high-demand areas such as anti-infectives, anti-tumor drugs, and diabetes treatments [26][31]. - The company has established a strong presence in the U.S. market, with significant growth in its subsidiary Meitheal, which achieved revenue of 1.63 billion yuan in 2023, a 37.71% increase year-on-year [22][30]. 5. Competitive Landscape - The company ranks third among domestic firms in terms of ANDA approvals, indicating a strong competitive position in the international market [22]. - The global generic drug market is projected to grow steadily, with the U.S. market for shortage drugs reaching a ten-year high, presenting significant opportunities for the company [25][24].

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2024-060 | | --- | --- | --- | | 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： （二）因"健友转债"触发《南京健友生化制药股份有限公司公开发行可转 换公司债券募集说明书》中约定的回售条款，公司于 2024 年 6 月 17 日至 2024 年 6 月 21 日进行了回售，回售数量为 70 张，回售资金已于 2024 年 6 月 26 日发 放。 二、可转债本次转股情况 自 2024 年 4 月 1 日至 2024 年 6 月 30 日期间，有人民币 18,000 元"健友转 债"转为公司普通股。自 2024 年 4 月 1 日至 2024 年 6 月 30 日期间"健友转债" 转股数为 733 股。 截至 2024 年 6 月 30 日，累计已有人民币 708,000 元"健友转债 ...

每股分配比例 证券代码：603707 证券简称：健友股份 公告编号：2024-058 南京健友生化制药股份有限公司 2023 年年度权益分派实施公告 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法律责任。 重要内容提示： A 股每股现金红利 0.1 元 相关日期 | 股份类别 | 股权登记日 | 最后交易日 | 除权（息）日 | 现金红利发放日 | | --- | --- | --- | --- | --- | | Ａ股 | 2024/7/5 | － | 2024/7/8 | 2024/7/8 | 差异化分红送转： 否 一、 通过分配方案的股东大会届次和日期 本次利润分配方案经公司 2024 年 5 月 17 日的 2023 年年度股东大会审议通过。 二、 分配方案 截至股权登记日下午上海证券交易所收市后，在中国证券登记结算有限责任公司上海分 公司（以下简称"中国结算上海分公司"）登记在册的本公司全体股东。 3. 分配方案： 本次利润分配以方案实施前的公司总股本 1,615,634,520.00 股为基数，每股派发现金红利 0.1 元 ...

南京健友生化制药股份有限公司 关于"健友转债"转股价格调整公告 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法律责任。 重要内容提示： 经中国证券监督管理委员会证监许可[2020]134 号文核准，南京健友生化制药 股份有限公司（以下简称"公司"）于 2020 年 4 月 23 日公开发行了 5,031,900 张 可转换公司债券，每张面值 100 元，发行总额 50,319 万元，并于 2020 年 5 月 22 日起在上海证券交易所挂牌交易，债券简称"健友转债"，债券代码 113579。健友 转债存续期 6 年，自 2020 年 4 月 23 日至 2026 年 4 月 22 日，转股起止日期自 2020 年 10 月 29 日至 2026 年 4 月 22 日，初始转股价格为 54.97 元/股。由于公司实施 2020 年限制性股票激励计划及公司 2019 年度权益分派，转股价格调整为 42.05 元 /股；由于公司实施 2021 年限制性股票激励计划，"健友转债"自 2021 年 6 月 25 日转股价格调整为 42.01 元 ...