四、风险提示 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"）签发的盐酸尼卡地平注射液，25 mg/10mL (2.5 mg/mL)（ANDA号：216819） 批准信，现将相关情况公告如下： 公司于2025年08月20日获得美国FDA的通知，公司向美国FDA申报的盐酸尼卡地平注射液，25 mg/10mL (2.5 mg/mL) 的ANDA申请获得批准。 盐酸尼卡地平注射液，25 mg/10mL (2.5 mg/mL) 的参比制剂，由HIKMA INTL PHARMS持有，在2008 年7月24日经FDA批准在美国上市。NDA申请号为N022276。 经查询，美国境内，目前有包括HIKMA INTL PHARMS，AM REGENT，RK PHARMA等7家产品上 市。目前国内没有盐酸尼卡地平注射液25 mg/10mL (2.5 mg/mL)上市。 截至目前，公司在盐酸尼卡地平注射液研发项目上已投入研发费用约人民币1,835.43万元。 三、对公司的影响 新批准产品近期将安排在美国上市销售，有望对公司经营业绩产生积极影响。 本公司董事会 ...

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-064 | | --- | --- | --- | | 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 关于获得美国FDA盐酸尼卡地平注射液 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 到美国食品药品监督管理局（以下简称"美国 FDA"）签发的盐酸尼卡地平注射 液，25 mg/10mL (2.5 mg/mL)（ANDA 号：216819）批准信，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 08 月 20 日获得美国 FDA 的通知，公司向美国 FDA 申报的 盐酸尼卡地平注射液，25 mg/10mL (2.5 mg/mL) 的 ANDA 申请获得批准。 经查询，美国境内，目前有包括 HIKMA INTL PHARMS，AM REGENT， RK PHARMA等 7家产品 ...

每经AI快讯，8月21日，健友股份(603707.SH)公告称，公司于近日收到美国FDA签发的盐酸尼卡地平注 射液，25mg/10mL(2.5mg/mL)（ANDA号：216819）批准信。该药品适应症为治疗当口服治疗不可行时 的高血压短期治疗。公司在研发项目上已投入约人民币1,835.43万元。新批准产品近期将安排在美国上 市销售，有望对公司经营业绩产生积极影响。但需注意销售不达预期等风险。 ...

Group 1 - The core viewpoint of the article highlights the stock performance of Jianyou Co., which reported a slight decline in share price on August 4, 2025, closing at 11.66 yuan, down 0.02 yuan or 0.17% from the previous trading day [1] - Jianyou Co. operates in the chemical pharmaceutical sector, with its main business in pharmaceutical manufacturing, which accounted for 99.85% of its operations in 2024 [1] - The company specializes in the research, production, and sales of heparin products, including both active pharmaceutical ingredients and formulations [1] Group 2 - In the first quarter of 2025, Jianyou Co. achieved a revenue of 885 million yuan and a net profit attributable to shareholders of 84.71 million yuan [1] - As of July 31, 2025, the company had repurchased a total of 880,000 shares, representing 0.05% of its total share capital, with a total repurchase amount of 10.22 million yuan at prices ranging from 11.58 yuan to 11.66 yuan [1] - On August 4, 2025, the net outflow of main funds was 22.63 million yuan, accounting for 0.12% of the circulating market value, with a cumulative net outflow of 10.12 million yuan over the past five days, representing 0.05% of the circulating market value [1]

| | | 债券代码：113579 债券简称：健友转债 根据《上市公司股份回购规则》《上海证券交易所上市公司自律监管指引第 7 号——回购股份》等相关规定，公司在回购期间，应于每个月的前 3 个交易日内 披露截至上月末的回购进展情况。现将公司回购股份进展情况公告如下： | 回购方案首次披露日 | 2025/4/29，由董事长唐咏群先生提议 | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 回购方案实施期限 | 2025 年 5 月 5 | 20 | 日~2026 | 年 | 月 | 19 日 | | 预计回购金额 | 2,000万元~4,000万元 | | | | | | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 | | | | | | | | □用于转换公司可转债 □为维护公司价值及股东权益 | | | | | | | 累计已回购股数 | 88万股 | | | | | | | 累计已回购股数占总股本比例 | 0.05% | | | | | | | 累计已回购金额 | 1,022.07万元 | | | | | | | 实际 ...

Group 1 - The company, Jianyou Co., Ltd. (SH 603707), announced on August 4 that it has repurchased a total of 880,000 shares through the Shanghai Stock Exchange, accounting for 0.05% of its total share capital [2] - The repurchase was conducted at a minimum price of 11.58 CNY per share and a maximum price of 11.66 CNY per share, with a total expenditure of 10.22 million CNY [2] - For the year 2024, the company's revenue composition indicates that 99.85% comes from the pharmaceutical manufacturing industry, while other businesses contribute 0.15% [2]

Core Insights - The article highlights the rapid development and success of the Nanjing Biopharmaceutical Valley, showcasing the approval of new drugs and the establishment of biotech companies in the region [1][2][4]. Group 1: New Drug Approvals - Nanjing Zhengxiang Pharmaceutical's new flu drug, Jike Shou (Marcelosavir), received approval from the National Medical Products Administration on July 18 [1]. - The antibody drug, Suweishitamon (Enzeshu), developed by Xiansheng Pharmaceutical, was approved just half a month earlier [1]. - The Nanjing Biopharmaceutical Valley has over 200 new drugs in development, with a total of 405 approved drugs, including six new drugs [3]. Group 2: Innovative Drug Development - Jike Shou was developed in just six years, breaking the conventional "three tens" rule of a 10-year development cycle, $1 billion investment, and a success rate below 10% [2]. - The drug demonstrated rapid efficacy, with significant symptom relief achieved in just 23.6 hours during clinical trials [2]. - The success of Zhengxiang Pharmaceutical is attributed to a team of experts returning from the San Francisco Bay Area, focusing on unmet clinical needs in oncology and infectious diseases [2]. Group 3: Company Growth and Listings - Nanjing Weilizhibo Biotechnology successfully listed on the Hong Kong Stock Exchange on July 25, following the earlier listing of Yaojie Ankang [1][5]. - Weilizhibo has developed 14 innovative drug candidates, with six in clinical stages, including the globally leading PD-L1×4-1BB dual antibody [4][5]. - The company’s rapid growth is supported by its pilot production base established in the Biopharmaceutical Valley [5]. Group 4: Ecosystem and Collaboration - The Nanjing Biopharmaceutical Valley fosters a collaborative ecosystem, integrating research, production, and application to support company growth [6][9]. - The establishment of the Nanjing Biopharmaceutical Center has facilitated technology transfer and innovation, with over 1,300 biopharmaceutical companies in the area [6][9]. - The center has partnered with over 100 research institutions and companies, significantly reducing research and development costs [7]. Group 5: Future Development and Urban Integration - The Nanjing Biopharmaceutical Valley aims to become a leading technology city, enhancing living spaces and ecological networks [11]. - Plans include the construction of scenic areas and improved infrastructure to support both innovation and quality of life for residents and professionals [11].

| | | 南京健友生化制药股份有限公司 关于子公司获得美国 FDA 依托泊苷注射液 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。 （四）规 格：100 mg/5 mL, 500 mg/ 25 mL 和 1 g/50 mL （五）ANDA 号：074529 （六）申 请 人：Meitheal Pharmaceuticals, Inc. 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 Meitheal 向美国 FDA 申报的 依托泊苷注射液，100 mg/5 mL, 500 mg/ 25 mL 和 1 g/50 mL（ANDA 号：074529） 生产场地转移至健进制药有限公司的申请已获得批准。 依托泊苷注射液参比制剂为 CORDEN PHARMA LATINA SPA 持有，于 1983 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 ...

Group 1 - The company, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd., has announced a share buyback plan approved by its board and shareholders, with a total buyback amount between RMB 20 million and RMB 40 million, and a maximum price of RMB 18.75 per share [2] - The buyback is intended for employee stock ownership plans or equity incentives, with a buyback period of 12 months from the approval date [2] - As of June 30, 2025, the company has repurchased 880,000 shares, accounting for 0.05% of the total share capital, with a total expenditure of RMB 10.2207 million, excluding transaction fees and stamp duty [3] Group 2 - The company will adhere to relevant regulations and guidelines during the buyback period and will make decisions based on market conditions while fulfilling information disclosure obligations [5]

Group 1 - The company announced a share repurchase plan with a total expected amount between RMB 20 million and RMB 40 million [1][2] - The repurchase period is set from May 20, 2025, to May 19, 2026 [1] - The repurchased shares will be used for employee stock ownership plans or equity incentives [1][2] Group 2 - As of June 30, 2025, the company has repurchased a total of 880,000 shares, accounting for 0.05% of the total share capital [2] - The total amount spent on the repurchase is RMB 10.2207 million, with a price range of RMB 11.58 to RMB 11.66 per share [2][3] - The company will continue to make repurchase decisions based on market conditions and will fulfill information disclosure obligations [3]