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创新药板块反复活跃,润都股份、江苏吴中涨停
news flash· 2025-04-23 01:42
这几只票暗盘资金正在偷偷流入,立即查看>> 创新药板块反复活跃,润都股份(002923)、江苏吴中(600200)涨停,健友股份(603707)涨超 6%,康辰药业(603590)、贝达药业(300558)上扬。 ...
健友股份(603707) - 健友股份关于董事长提议回购公司部分股份的提示性公告
2025-04-21 08:49
| 股票代码:603707 | 股票简称:健友股份 | 公告编号:2025-014 | | --- | --- | --- | | 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 关于董事长提议回购公司部分股份的提示性公告 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、准确性和完整性依法承担法律责任。 南京健友生化制药股份有限公司(以下简称"公司")于2025年4月21日 收到公司董事长唐咏群先生《关于提议南京健友生化制药股份有限公司以 集中竞价交易方式回购公司部分股份的函》。提议内容主要如下: 一、提议回购股份的原因和目的 基于对公司未来持续稳定发展的信心和对公司价值的认可,综合考虑 公司目前经营情况、财务状况、未来盈利能力等因素,提议公司以自有资 金或自筹资金回购公司股份,推进公司股价与内在价值相匹配。结合公司 经营情况及财务状况等因素,根据相关法律法规,唐咏群先生提议公司以集 中竞价交易方式回购部分社会公众股份。 二、提议内容 1.回购股份的种类及方式:通过上海证券交易所股票交易系统以集中竞 价交易方式回购公司 ...
健友股份(603707) - 南京健友生化制药股份有限公司可转换公司债券2025年付息公告
2025-04-15 10:52
| 股票代码:603707 | 股票简称:健友股份 公告编号:2025-013 | | --- | --- | | 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 可转换公司债券 2025 年付息公告 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: 南京健友生化制药股份有限公司(以下简称"发行人"或者"本公司")于 2020 年 4 月 23 日发行的 2020 年南京健友生化制药股份有限公司可转换公司债 券(以下简称"本期债券"或"本次可转债"),将于 2025 年 4 月 23 日开始支付 本期债券自 2024 年 4 月 23 日至 2025 年 4 月 22 日期间的利息。根据《健友股份 公开发行可转换公司债券募集说明书》(以下简称"《募集说明书》")的规定,现 将有关事宜公告如下: 一、本期债券的基本情况 1、债券名称:2020 年南京健友生化制药股份有限公司可转换公司债券。 可转债付息债权登记日:2025 年 4 月 22 日 可转债除息日:2025 年 4 ...
医药行业周报:聚焦医药国产替代及医药消费复苏-2025-04-07
Minsheng Securities· 2025-04-07 10:50
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].
健友股份(603707) - 健友股份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
2025-04-07 10:30
| 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 ...
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获得美国FDA药品注册批件的公告
Shang Hai Zheng Quan Bao· 2025-04-06 18:16
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].
健友股份(603707):类似药拾级而上,利拉获批再下一城
HTSC· 2025-04-06 03:30
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 ...
健友股份(603707):类似药拾级而上 利拉获批再下一城
Xin Lang Cai Jing· 2025-04-06 01:23
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]
伪造器械注册资料,江苏立峰生物被罚没3773万元:同仁堂2024年净利润减少8.5%丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-04-03 23:29
Group 1 - Fudan University Zhongshan Hospital has developed a bile duct cancer precision testing kit that has received approval from the Shanghai Municipal Drug Administration, achieving an 86% increase in overall detection rate and reducing average testing time from 17.6 days to 5 days [1] - Jianyou Co., Ltd. announced that its liraglutide injection has received FDA approval, which may enhance its competitiveness and brand influence in the international market [2] - Jiangsu Lifeng Biotechnology was fined a total of 37.73 million yuan for falsifying registration documents for medical devices, highlighting the regulatory body's zero-tolerance policy towards fraud [3] Group 2 - Tongrentang reported a 4.12% increase in total operating revenue for 2024, reaching 18.597 billion yuan, but its net profit decreased by 8.54% to 1.526 billion yuan, attributed to rising raw material costs and imbalances in marketing and R&D investments [4]
健友股份(603707) - 健友股份关于产品利拉鲁肽注射液获得美国FDA药品注册批件的公告
2025-04-03 08:15
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 ...