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健康元(600380) - 健康元药业集团股份有限公司关于获得药物临床试验批准通知书的公告
2025-06-24 08:00
证券代码:600380 证券简称:健康元 公告编号:临 2025-051 健康元药业集团股份有限公司 关于获得药物临床试验批准通知书的公告 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法律责任。 近日,健康元药业集团股份有限公司(以下简称:本公司)控股子公司丽珠医 药集团股份有限公司(以下简称:丽珠集团)收到国家药品监督管理局核准签发的 《药物临床试验批准通知书》(通知书编号:2025LP01629),批准 YJH-012 注射 液开展临床试验。现将有关详情公告如下: 健康元药业集团 关于获得药物临床试验批准通知书的公告 申请人:丽珠医药集团股份有限公司 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,2025 年 4 月 14 日受理的 YJH-012 注射液临床试验申请符合药品注册的有关要求,同意 本品开展痛风适应症临床试验。 二、药品研发及相关情况 YJH-012 注射液是丽珠集团与佑嘉(杭州)生物医药科技有限公司联合开发的 新型 siRNA 药物。区别于传统药物抑制酶活性以阻断尿酸合成,YJH-012 注射液 采 ...
健康元:YJH-012注射液获药物临床试验批准
news flash· 2025-06-24 07:35
Core Viewpoint - The company announced that its subsidiary, Lizhu Group, received approval from the National Medical Products Administration for clinical trials of YJH-12 injection, a new siRNA drug for gout [1] Group 1: Company Developments - Lizhu Group, a subsidiary of the company, is collaborating with Youjia (Hangzhou) Biopharmaceutical Technology Co., Ltd. to develop the YJH-12 injection [1] - The total research and development expenses incurred for YJH-12 injection amount to approximately RMB 25.7386 million [1] - There are currently no similar small nucleic acid products approved for the same indication in the domestic market [1]
健康元: 健康元药业集团股份有限公司关于获得临床试验批准通知书的公告
Zheng Quan Zhi Xing· 2025-06-19 09:53
Group 1 - The company has received approval from the National Medical Products Administration for clinical trials of the drug JKN2301, which is a dry suspension intended for children aged 2 to 12 years with uncomplicated influenza [1][2] - JKN2301 is developed from the patented compound Marapacisavir and aims to meet the clinical needs in the treatment of influenza in children, allowing for flexible dosage adjustments based on weight [1][2] - The total research and development expenses incurred by the company for JKN2301 amount to approximately RMB 6.9453 million [2] Group 2 - Influenza poses a global public health issue, with seasonal outbreaks leading to significant health impacts; the estimated domestic terminal sales of antiviral drugs for influenza in 2024 is around RMB 4.7 billion [2]
健康元(600380) - 健康元药业集团股份有限公司关于获得临床试验批准通知书的公告
2025-06-19 09:30
健康元药业集团 关于获得临床试验批准通知书的公告 证券代码:600380 证券简称:健康元 公告编号:临 2025-050 健康元药业集团股份有限公司 关于获得临床试验批准通知书的公告 申请人:健康元药业集团股份有限公司 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。 近日,健康元药业集团股份有限公司(以下简称:本公司)收到国家药品监督管理局 (以下简称:国家药监局)核准签发的《药物临床试验批准通知书》,批准公司的 JKN2301 干混悬剂开展临床试验。现将有关详情公告如下: 一、批准通知书的主要内容 药物名称:JKN2301 干混悬剂 剂型:干混悬剂 申请事项:临床试验申请 注册分类:化学药品 1 类 审批结论:经审查,2025 年 3 月 26 日受理的 JKN2301 干混悬剂临床试验申请符合药 品注册的有关要求,同意本品开展临床试验。申请的适应症:本品适用于 2 至 12 周岁以 下单纯性甲型和乙型流感儿童患者。 二、药品研发及相关情况 本次获批临床试验的 JKN2301 干混悬剂,是以专利化合物玛帕西沙韦开发的创新药 ...
健康元:JKN2301干混悬剂获临床试验批准
news flash· 2025-06-19 09:07
健康元(600380)公告,公司收到国家药监局核准签发的《药物临床试验批准通知书》,批准JKN2301 干混悬剂开展临床试验。该药品适用于2至12岁以下单纯性甲型和乙型流感儿童患者,是以专利化合物 玛帕西沙韦开发的创新药,可根据儿童体重灵活调整剂量,提高儿童用药依从性。 ...
行业深度报告:管线布局迈入收获期,2025开启国产流感新药元年
KAIYUAN SECURITIES· 2025-06-15 05:13
Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The flu virus is a highly pathogenic pathogen, and the development of new mechanism drugs is imperative [4] - The flu is a common respiratory infectious disease with a high transmission rate, affecting approximately 1 billion people globally each year, with 300,000 to 500,000 severe cases and 290,000 to 650,000 deaths due to flu-related respiratory diseases [4][15] - The domestic flu drug market has exceeded 10 billion yuan, with Oseltamivir holding over 80% market share, while Baloxavir has seen rapid growth from 0.07 billion yuan in 2022 to 0.63 billion yuan in 2023 [6][36] Summary by Sections 1. Flu Virus and Drug Development - The flu virus is categorized into four types: A, B, C, and D, with A and B being the primary types responsible for widespread outbreaks [17][20] - The main drug targets during flu infection include the surface proteins Hemagglutinin (HA) and Neuraminidase (NA), with RNA polymerase inhibitors emerging as the mainstream research target in antiviral drug development [5][26] 2. Market Dynamics - The flu drug market in China is projected to grow significantly, with new domestic drugs expected to launch in 2025, enhancing sales potential and company performance [7][36] - The sales of flu drugs in the domestic market reached 11.405 billion yuan in 2023, with Oseltamivir accounting for 86.48% of the market share [36] 3. Investment Recommendations - Recommended stocks include Jichuan Pharmaceutical and Health元, with beneficiaries including Zhongsheng Pharmaceutical and Xiansheng Pharmaceutical [7]
健康元药业集团2024年年度股东大会通过多项议案 现金分红方案获高票支持
Zhong Jin Zai Xian· 2025-06-07 12:11
Core Points - The company held its 2024 annual shareholders' meeting on June 6, 2025, with a shareholder attendance rate of 51.11% [1] - The cash dividend proposal received overwhelming support, with 99.91% approval from shareholders holding more than 5% of the shares [1] Summary by Categories Profit Distribution - The profit distribution plan for 2024 was approved with a support rate of 97.9% from minority investors, and 98.39% from shareholders with a market value below 500,000 [2] Financing Guarantees - The proposal for credit financing and providing guarantees for subsidiaries was approved with a 97.66% approval rate, although there was significant disagreement among minority investors, with only 44.38% in favor [2] Audit Reappointment - The reappointment of Deloitte Touche Tohmatsu as the auditing firm for 2025 was approved with a 99.74% support rate [2] Key Data - A total of 935 million shares were voted, representing 51.11% of the company's total share capital [3] Non-Operating Fund Usage - The special report on non-operating fund usage was approved with a 99.87% support rate [4] Subsidiary Loan Guarantees - The loan guarantee proposal for the subsidiary Jinguang Electric was supported by 99.83% of the votes [5] Compliance and Legality - The meeting procedures complied with the Company Law and the company's articles of association, presided over by director Lin Nanqi, with all board members and supervisors present [6] Impact - The resolutions clarified the company's financial distribution for 2024 and the financing guarantee framework for 2025, enhancing risk control for subsidiaries and maintaining audit stability, signaling robust operations to investors. Minority investors significantly benefited from the dividend plan but showed low participation in the financing guarantee matters [7]
健康元: 健康元药业集团股份有限公司关于第二期中长期事业合伙人持股计划锁定期满的提示性公告
Zheng Quan Zhi Xing· 2025-06-06 12:19
根据《关于上市公司实施员工持股计划试点的指导意见》及《上海证券交易所上 市公司自律监管指引第 1 号——规范运作》等相关规定,本公司中长期事业合伙人持 股计划之第二期员工持股计划(以下简称"本期持股计划")锁定期将于 2025 年 6 月 一、本期持股计划的基本情况和锁定期 本公司于 2022 年 5 月 18 日召开 2021 年年度股东大会,审议并通过《关于公司< 中长期事业合伙人持股计划之第二期持股计划(草案)>及其摘要的议案》及相关议案, 同意公司实施中长期事业合伙人持股计划之第二期持股计划并授权公司董事会办理相 关事宜。 截至 2022 年 6 月 7 日,本公司第二期持股计划已通过二级市场集中竞价交易的方 式累计购买公司股票 6,275,372 股,占公司总股本(1,911,733,078 股)的比例为 0.33%, 成交金额合计为 75,740,661.60 元,成交均价约为人民币 12.07 元/股。至此,公司第二 期持股计划已完成标的股票的购买。2022 年 6 月 8 日,本公司披露了《健康元药业集 健康元药业集团 第二期中长期事业合伙人持股计划锁定期满的提示性公告 团股份有限公司中长期事 ...
健康元: 健康元药业集团股份有限公司2024年年度股东大会决议公告
Zheng Quan Zhi Xing· 2025-06-06 12:14
证券代码:600380 证券简称:健康元 公告编号:临 2025-048 健康元药业集团股份有限公司 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: ●本次会议是否有否决议案:无 一、会议召开和出席情况 集团大厦二号会议室 (1)出席会议的股东和代理人人数 485 (2)出席会议的股东所持有表决权的股份总数(股) 935,025,484 (3)出席会议的股东所持有表决权股份数占公司有表决权股份总数的比例(%) 51.1095 本次会议由公司董事会召集,经半数以上董事推举,董事林楠棋先生主持本 次会议。本次会议以现场投票及网络投票相结合的方式进行表决,会议的召集、 召开和表决方式符合《公司法》 、《上市公司股东大会规则》及《公司章程》的有 关规定,本次会议决议有效。 (1)本次会议采用现场加视频会议形式召开,其中部分董事以视频方式参 会。公司在任董事9人,出席9人,其中董事兼总裁林楠棋先生、董事兼副总裁、 财务负责人邱庆丰先生、董事兼副总裁幸志伟先生、独立董事覃业志先生、沈小 健康元药业集团 2024 年年度股东 ...
健康元: 北京德恒(深圳)律师事务所关于健康元药业集团股份有限公司2024年年度股东大会的法律意见书
Zheng Quan Zhi Xing· 2025-06-06 12:14
北京德恒(深圳)律师事务所 关于健康元药业集团股份有限公司 法律意见 深圳市福田区金田路 4018 号安联大厦 B 座 11 层 电话:0755-88286488 传真:0755-88286499 邮编:518026 北京德恒(深圳)律师事务所 关于健康元药业集团股份有限公司 北京德恒(深圳)律师事务所 关于健康元药业集团股份有限公司 法律意见 德恒 06F20240039-026 号 致:健康元药业集团股份有限公司 本所律师得到如下保证:公司已提供了本所律师认为出具本法律意见所必需 的材料,所提供的原始材料、副本、复印件等材料、口头证言均符合真实、准确、 完整的要求,有关副本、复印件等材料与原始材料一致。 在本法律意见中,本所律师根据《股东会规则》及公司的要求,仅对公司本 次会议的召集、召开程序是否符合有关法律、行政法规、《公司章程》以及《股 东会规则》的有关规定,出席会议人员资格、召集人资格是否合法有效和会议的 表决程序、表决结果是否合法有效发表意见,不对本次会议审议的议案内容以及 这些议案所表述的事实或数据的真实性及准确性发表意见。 健康元药业集团股份有限公司(以下简称"公司")2024 年年度股东大会 ...