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健友股份(603707) - 健友股份关于子公司获得美国FDA盐酸伊达比星注射液药品转移生产场地注册批件的公告
2025-05-19 10:00
| 证券代码:603707 | 证券简称:健友股份 公告编号:2025-036 | | --- | --- | | 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 盐酸伊达比星注射液 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")签发的盐酸伊达比星注射液,5 mg/5 mL, 10 mg/10 mL 和 20 mg/20 mL,单剂量(ANDA 号:065036)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 (一)药品名称:盐酸伊达比星注射液 (二)适 应 症:与其他抗白血病药物联合使用,适用于成人急性髓细胞性 白血病(AML)的治疗。 (三)剂 ...
医药行业周报:本周医药上涨1.3%,恒瑞正式启动港股招股,健友、双成合作白紫品种美国ANDA获批-20250518
Shenwan Hongyuan Securities· 2025-05-18 09:41
Investment Rating - The report rates the pharmaceutical industry as "Overweight" indicating a positive outlook for the sector compared to the overall market performance [4][3]. Core Insights - The pharmaceutical sector saw a weekly increase of 1.3%, outperforming the Shanghai Composite Index which rose by 0.8% [5][4]. - The overall valuation of the pharmaceutical sector is at 27.7 times PE (2025E), ranking 6th among 31 primary industries [7][12]. - Key events include the official launch of Hong Kong IPO by Heng Rui Pharmaceutical, aiming to issue approximately 225 million H shares with a maximum fundraising of 13.08 billion HKD [13][4]. - A collaboration between Jianyou and Shuangcheng for the injection of paclitaxel (albumin-bound) received FDA approval, highlighting significant market opportunities [14][4]. Market Performance - The pharmaceutical bio index ranked 11th among 31 primary sub-industries, with various sub-sectors showing mixed performance: raw materials (+3.8%), chemical preparations (+1.0%), and traditional Chinese medicine (+1.7%) [4][5]. - The report notes that the pharmaceutical sector's performance is driven by innovations and regulatory approvals, which are crucial for future growth [4][14]. Key Company Developments - Heng Rui Pharmaceutical's IPO is set to take place from May 15 to May 20, with the final price expected to be determined by May 22 [13][4]. - The collaboration between Jianyou and Shuangcheng is expected to generate significant revenue through profit-sharing agreements following FDA approval [14][4]. Valuation Metrics - The report provides a detailed valuation table for key companies in the pharmaceutical sector, indicating projected EPS and PE ratios for 2025 to 2027 [17][4].
健友股份(603707) - 健友股份关于“健友转债”预计满足转股价格修正条款的提示性公告
2025-05-16 08:17
南京健友生化制药股份有限公司 | 证券代码:603707 | 证券简称:健友股份 | 公告编号:2025-035 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 关于"健友转债"预计满足 转股价格修正条款的提示性公告 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、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,本次可转债存续期限为发行之日起六年,即自 2020 年 4 月 23 日至 2026 年 4 月 22 日。 经上海证券交易所自律监管决定书[2020]134 号文同意,公司 5.0319 亿元 可转债于 2020 年 5 月 22 日起在上海证券 ...
健友股份(603707):点评:生物药进入兑现期,看好向上拐点
ZHESHANG SECURITIES· 2025-05-15 14:25
Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The company is entering a realization phase for its biopharmaceuticals, with expectations of an upward turning point [1] - The company achieved a revenue of 3.924 billion yuan in 2024, a slight decrease of 0.20% year-over-year, while the net profit attributable to shareholders increased significantly by 536.09% to 826 million yuan [1][9] - The first quarter of 2025 saw a revenue of 885 million yuan, down 11.85% year-over-year, and a net profit of 85 million yuan, down 52.19% year-over-year [1] Revenue and Profitability - The company's revenue from non-heparin formulations is expected to drive growth in overseas formulations, with a projected revenue of 3.050 billion yuan from formulations in 2024, representing a year-over-year increase of 10.05% [1][2] - The revenue from non-heparin formulations reached 1.467 billion yuan in 2024, showing a year-over-year growth of 24.25% [1][2] - The company’s heparin raw material revenue is declining, with a projected revenue of 787 million yuan in 2024, accounting for 20.06% of total revenue [2] Future Growth Drivers - The company is expected to see significant growth from its high-margin biopharmaceutical product line, which is entering a realization phase [2][3] - The company has received FDA approvals for several products, including Liraglutide in April 2025, which is anticipated to enhance its international market presence [1][2] Financial Forecasts - The projected earnings per share (EPS) for 2025, 2026, and 2027 are 0.65 yuan, 0.90 yuan, and 1.22 yuan respectively [3][9] - The company’s revenue is expected to grow to 4.785 billion yuan in 2025, representing a year-over-year increase of 21.95% [9] Market Position - The company is successfully transitioning from a traditional raw material supplier to an international sterile injection enterprise, with a focus on quality and cost leadership [2]
健友股份(603707) - 健友股份关于回购股份事项前十大股东和前十大无限售条件股东持股情况的公告
2025-05-15 09:15
南京健友生化制药股份有限公司 关于回购股份事项前十大股东和前十大无限售条件 股东持股情况的公告 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 2025 年 4 月 28 日召开了第五届董事会第十二次会议,审议通过了《关于拟通过集中 竞价方式回购股票的议案》,该议案尚需提交公司 2024 年度股东大会审议通过。 具体内容详见 2025 年 4 月 29 日披露于上海证券交易所网站(www.sse.com.cn)的 《健友股份关于以集中竞价方式回购股份的预案》(公告编号:2025-028)。 | 证券代码:603707 | 证券简称:健友股份 | 公告编号:2025-034 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 量、比例情况公告如下: | | 合 | | | | --- | --- | --- | --- | | 9 | 基本养老保险基金一二零五组合 | 9,899,590 | 0.61 | ...
健友股份20250513
2025-05-13 15:19
Summary of Key Points from the Conference Call of Jianyou Co., Ltd. Company Overview - Jianyou Co., Ltd. started with heparin raw materials and has gradually developed into enoxaparin sodium injections, small molecule injections, and large molecule biosimilars, establishing three growth curves with significant synergy in the industrial chain, production technology, registration, commercialization, and marketing [2][4] Core Business and Market Position - The company has a strong presence in the U.S. market, with formulation revenue accounting for over 70% and overseas formulation revenue approximately 54% [2][9] - The heparin preparation market has a natural growth rate of about 5%, with a projected global market size of $6.05 billion in 2024, expected to reach around $10 billion by 2034 [5][25] - The biosimilar market is expected to grow significantly, with projections of a market size between $30 billion and $35.5 billion in 2024, potentially reaching over $120 billion by 2032 [11][12] Future Growth Drivers - The U.S. Inflation Reduction Act (IRA) is expected to enhance the profitability of biosimilars by restructuring insurance payment systems, encouraging doctors to prescribe lower-cost biosimilars [2][13] - Jianyou's biosimilar products, such as adalimumab, are anticipated to generate $30 million in sales by 2025, with significant orders for liraglutide and plans for rapid approval of high-concentration adalimumab [2][14][16] Production and Capacity - The company has 12 FDA-approved injection production lines, with capacity utilization expected to reach 80%-90% by the end of 2026 to 2027 [2][21] - The U.S. sterile injection market is in a long-term shortage, providing Jianyou with a competitive advantage due to its strong commercialization capabilities and production capacity [2][21] Financial Performance and Projections - Expected revenues for 2025 and 2026 are projected to be $5.5 billion and $7 billion, respectively, with net profits ranging from $1.15 billion to $1.5 billion [5][29] - The overall revenue growth rate is expected to reach 30%-34.8%, driven by high-margin products and a stable domestic market [29] Strategic Advantages - Jianyou has significant advantages in the industrial chain, including vertical integration from raw materials to finished products, ensuring product quality and pricing power [6] - The company has developed strong sales networks through acquisitions and partnerships, enhancing its market position and reducing sales costs [8][24] Challenges and Risks - The heparin raw material business faces challenges from price fluctuations due to the pig farming cycle and epidemic risks, but a price stabilization is expected by 2025 [28] - The company has taken measures to mitigate risks, including significant inventory write-downs, allowing for flexible price adjustments [28] Conclusion - Jianyou Co., Ltd. is well-positioned for future growth with a strong product pipeline, significant market opportunities in biosimilars, and a robust production capacity. The company is expected to benefit from favorable regulatory changes and market dynamics, making it an attractive investment opportunity [10][29]
健友股份(603707) - 健友股份2024年度股东大会会议资料
2025-05-13 08:30
南京健友生化制药股份有限公司 2024 年度股东大会会议资料 公司代码:603707 公司简称:健友股份 南京健友生化制药股份有限公司 2024 年度股东大会会议资料 2025 年 5 月 20 日 | | | | 2024 年度股东大会会议须知 | 1 | | --- | --- | | 2024 年度股东大会会议议程 | 3 | | 关于 年董事会工作报告的议案 2024 | 4 | | 关于 2024 年监事会工作报告的议案 | 8 | | 关于公司 2024 年财务决算报告的议案 12 | | | 公司 2024 年度报告及摘要的议案 16 | | | 关于申请 2025 年度综合授信额度及相关担保事项的议案 17 | | | 关于使用闲置自有资金进行现金管理及委托理财的议案 20 | | | 关于公司拟开展外汇套期保值业务的议案 23 | | | 关于公司续聘 2025 年审计机构的议案 26 | | | 关于制定 2025 年董事、监事及高级管理人员薪酬方案的议案 29 | | | 关于公司拟购买董监高责任险的议案 31 | | | 年利润分配预案的议案 2024 32 | | | 关于拟通过集中 ...
健友股份: 健友股份关于召开2024年度暨2025年第一季度业绩暨2024年度现金分红说明会的公告
Zheng Quan Zhi Xing· 2025-05-09 08:28
证券代码:603707 证券简称:健友股份 公告编号:2025-033 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 关于召开 2024 年度暨 2025 年第一季度业绩 ? 会议召开方式:上证路演中心网络互动 ? 投资者可于 2025 年 05 月 12 日(星期一)16:00 前登录上证路演中心网站首 页点击"提问预征集"栏目或通过公司邮箱 nkf-pharma@nkf-pharma.com.cn 进 行提问。公司将在说明会上对投资者普遍关注的问题进行回答。 南京健友生化制药股份有限公司(以下简称"公司")已于 2025 年 4 月 29 日发布公司 2024 年度报告和 2025 年一季度报告,为便于广大投资者更全面深入 地了解公司 2024 年度和 2025 年一季度的经营成果、财务状况,公司计划于 2025 年 05 月 13 日(星期二)09:00-10:00 举行 2024 年度暨 2025 年第一季度业绩暨 一、说明会类型 本次投资者说明会以网络互动形式召开,公司将针对 2024 年度和 2025 年一 季度的经营成果及财务指标的具体情况与投资者进行互动交流和沟通, ...
健友股份(603707) - 健友股份关于召开2024年度暨2025年第一季度业绩暨2024年度现金分红说明会的公告
2025-05-09 07:45
南京健友生化制药股份有限公司 关于召开 2024 年度暨 2025 年第一季度业绩 暨 2024 年度现金分红说明会的公告 证券代码:603707 证券简称:健友股份 公告编号:2025-033 债券代码:113579 债券简称:健友转债 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: https://roadshow.sseinfo.com/) 会议召开方式:上证路演中心网络互动 投资者可于 2025 年 05 月 12 日(星期一)16:00 前登录上证路演中心网站首 页点击"提问预征集"栏目或通过公司邮箱 nkf-pharma@nkf-pharma.com.cn 进 行提问。公司将在说明会上对投资者普遍关注的问题进行回答。 南京健友生化制药股份有限公司(以下简称"公司")已于 2025 年 4 月 29 日发布公司 2024 年度报告和 2025 年一季度报告,为便于广大投资者更全面深入 地了解公司 2024 年度和 2025 年一季度的经营成果、财务状况,公司计划于 2025 年 05 月 13 日(星 ...
健友股份:原料药阶段承压,类似药驱动向好-20250509
HTSC· 2025-05-09 02:40
Investment Rating - The investment rating for the company is "Buy" with a target price of 17.41 RMB [8][9] Core Views - The company's revenue for 2024 is projected to be 39.24 billion RMB, with a slight decrease of 0.20% year-over-year, while the net profit is expected to turn positive at 8.26 billion RMB [1] - The biopharmaceutical business, particularly the biosimilar drugs, is expected to drive performance improvement throughout the year [1] - The company has seen strong growth in its formulation segment, with a revenue increase of 10% year-over-year in 2024, particularly in non-heparin formulations which grew by 24% [2] - The biosimilar drugs are anticipated to become the next growth engine, with significant revenue contributions from products like Adalimumab and Liraglutide [3] Revenue and Profit Forecast - The company forecasts net profits of 10.25 billion RMB, 13.46 billion RMB, and 16.62 billion RMB for the years 2025, 2026, and 2027 respectively, reflecting year-over-year growth rates of 24%, 31%, and 23% [5] - The earnings per share (EPS) are projected to be 0.63 RMB, 0.83 RMB, and 1.03 RMB for the same years [5] Financial Metrics - The company's revenue for 2024 is expected to be 39.24 billion RMB, with a slight decline from the previous year, while the net profit is projected to be 8.26 billion RMB [1][7] - The gross margin is expected to decline to 43.21% in 2024, primarily due to pressures in the heparin raw material segment [4] - The company has a market capitalization of approximately 16.95 billion RMB as of May 8 [9]