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。 三、对公司的影响 新批准产品进一步丰富了公司国际化的产品管线，强化公司国际市场布局。若后续推进美国市场上市销 售，有望对公司经营业绩产生积极影响。 四、风险提示 公司高度重视药品研发，严格控制药品研发、生产、销售环节的质量和安全。但产品的生产和销售容易 受国家政策、市场环境等不确定因素的影响，有可能存在销售不达预期等情况。敬请广大投资者谨慎决 策，注意防范投资风险。 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"）子公司香港健友实业有限公司（以下 简称"香港健友"）于近日收到美国食品药品监督管理局（以下简称"美国FDA"）签发的来法莫林注射 液，150 mg/15 mL，单剂量（NDA号：211673）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 公司于近日收到美国FDA的通知，公司子公司香港健友向美国FDA申报的来法莫林注射液，150 mg/15 mL（NDA号：211673 ...

证券日报网讯 2月26日，健友股份发布公告称，公司子公司香港健友实业有限公司于近日收到美国食品 药品监督管理局（简称"美国FDA"）签发的来法莫林注射液，150mg/15mL，单剂量（NDA号： 211673）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。 （编辑 任世碧） ...

| 证券代码：603707 | 证券简称：健友股份 公告编号：2026-007 | | --- | --- | | 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 关于子公司获得美国 FDA 来法莫林注射液 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 司香港健友实业有限公司（以下简称"香港健友"）于近日收到美国食品药品监 督管理局（以下简称"美国 FDA"）签发的来法莫林注射液，150 mg/15 mL， 单剂量（NDA 号：211673）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 新批准产品进一步丰富了公司国际化的产品管线，强化公司国际市场布局。 若后续推进美国市场上市销售，有望对公司经营业绩产生积极影响。 四、风险提示 公司高度重视药品研发，严格控制药品研发、生产、销售环节的质量和安全。 但产品的 ...

健友股份公告，子公司香港健友向美国FDA申报的来法莫林注射液，150mg/15mL（NDA号：211673） 生产场地转移至健进制药有限公司的申请已获得批准。来法莫林注射液作为创新药，于2019年8月19日 获得美国FDA批准上市，商品名为XENLETA。经查询，美国目前暂无仿制药获批上市。 ...

Investment Rating - The report maintains a "Market Perform" rating for the pharmaceutical and biotechnology industry, indicating that the industry index is expected to perform within ±10% of the market index over the next six months [28][37]. Core Insights - The SW pharmaceutical and biotechnology industry underperformed the CSI 300 index, declining by 1.91% from January 23 to February 5, 2026, which is approximately 0.74 percentage points lower than the index [12]. - Most sub-sectors within the industry recorded negative returns during the same period, with offline pharmacies and vaccine sectors showing the best performance, increasing by 3.01% and 0.12% respectively, while other sectors like biological products and chemical preparations saw declines of 3.28% and 3.27% [13]. - Approximately 34% of stocks in the industry recorded positive returns, while 66% experienced negative returns during the reporting period [14]. - The overall price-to-earnings (PE) ratio for the SW pharmaceutical and biotechnology industry was approximately 51.00 times as of February 5, 2026, indicating a decrease in industry valuation [18]. Summary by Sections 1. Market Review - The SW pharmaceutical and biotechnology industry underperformed the CSI 300 index, with a decline of 1.91% from January 23 to February 5, 2026 [12]. - Most sub-sectors recorded negative returns, with offline pharmacies and vaccines performing relatively well [13]. - About 34% of stocks in the industry had positive returns, with significant variations in individual stock performance [14]. - The industry valuation has decreased, with a PE ratio of approximately 51.00 times [18]. 2. Industry News - The 11th batch of national procurement results is set to be implemented in February, with notifications already released by 17 provinces [26]. - The National Medical Insurance Administration has issued a notice to accelerate the cultivation and opening of application scenarios in the medical insurance field [25]. 3. Company Announcements - Jianyou Co., Ltd. announced that its subsidiary received FDA approval for its product, sodium selenite injection [27]. 4. Industry Outlook - The report suggests a focus on investment opportunities in the brain-computer interface sector as part of the 14th Five-Year Plan, with ongoing policy support [28]. - Recommended sectors for investment include medical devices, pharmaceutical commerce, aesthetic medicine, scientific services, hospital and diagnostic services, traditional Chinese medicine, innovative drugs, biological products, and CXO services [29].

Core Viewpoint - The Ministry of Industry and Information Technology (MIIT) has released a public list of green factories and green industrial parks for the year 2025, highlighting the importance of sustainable development in the manufacturing sector [2]. Group 1: Green Factories and Industrial Parks - The list includes newly cultivated green factories and industrial parks, as well as those undergoing dynamic management adjustments, which were recommended by provincial industrial and information departments and reviewed by experts [4]. - Notable companies included in the list are Beijing Haibo Sichuang Technology Co., Ltd., Envision Energy Technology (Jiangsu) Co., Ltd., and Honeycomb Energy Technology Co., Ltd. [3][4]. Group 2: Contact Information and Public Notice - The public notice period for the list is from February 5, 2026, to February 19, 2026, during which any objections can be submitted to the MIIT [5]. - The contact unit for inquiries is the Energy Conservation and Comprehensive Utilization Department of the MIIT, with a provided contact number for further communication [5].

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：2026-006 | | --- | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | | 二、药品其他相关情况 关于子公司产品亚硒酸注射液获得美国 FDA 批准的公告 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"）签发的亚硒酸注射液（600 mcg/10 mL）的 ANDA 批准通知（ANDA 号：219472）。现将相关情况公告如下： 一、药品的基本情况 （一）药品名称：亚硒酸注射液 （二）适 应 症：适用于需要肠外营养的成人与儿科患者，作为肠外营养液 中硒的来源，用于当口服或肠内营养无法实施、不足或存在禁忌时。 （三）剂 型：注射剂 （四）规 格：600 mcg/10 mL （五）ANDA 号：219472 （六）申 请 ...

Core Viewpoint - The company, Jianyou Co., Ltd. (603707.SH), announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., has received ANDA approval from the U.S. FDA for its selenium injection (600mcg/10mL) [1] Group 1 - The approved product is indicated for adult and pediatric patients requiring parenteral nutrition, serving as a source of selenium in parenteral nutrition solutions [1] - The approval is significant for patients who cannot implement, have insufficient, or have contraindications for oral or enteral nutrition [1]

Core Viewpoint - The company Jianyou Co., Ltd. has received ANDA approval from the U.S. FDA for its injectable sodium selenite solution, indicating a significant milestone for the company in expanding its product offerings in the parenteral nutrition market [1] Group 1 - Jianyou's subsidiary, Jianjin Pharmaceutical Co., Ltd., has been granted ANDA approval for sodium selenite injection (600mcg/10mL) [1] - The approved indication is for use in adult and pediatric patients requiring parenteral nutrition, serving as a source of selenium when oral or enteral nutrition is not feasible, insufficient, or contraindicated [1]

健友股份公告，子公司健进制药有限公司于近日收到美国食品药品监督管理局签发的亚硒酸注射液 （600 mcg/10 mL）的ANDA批准通知（ANDA号：219472）。该药品适用于需要肠外营养的成人与儿 科患者，作为肠外营养液中硒的来源，用于当口服或肠内营养无法实施、不足或存在禁忌时。目前，美 国境内共有5家亚硒酸注射液仿制药获批上市。公司在该项目上已投入研发费用约人民币656.05万元。 新批准产品有望对公司经营业绩产生积极影响。 ...