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腾盛博药与健康元合作;迈瑞股东减持|21健讯Daily
Sou Hu Cai Jing· 2025-07-07 01:53
Policy Developments - The Ministry of Finance announced measures regarding the procurement of medical devices imported from the EU, stating that for procurement budgets over 45 million yuan, EU companies (excluding EU-funded enterprises in China) must be excluded if import products are required [1] Drug and Device Approvals - Weikang Pharmaceutical's Anruini capsules have been submitted for market approval, targeting adult and adolescent patients with specific solid tumors carrying NTRK fusion genes [2] - AstraZeneca's Imfinzi (Durvalumab) has received EU approval for use in muscle-invasive bladder cancer (MIBC) as an adjuvant treatment following radical cystectomy [3] Capital Market Activities - Micot announced the completion of over 100 million yuan in Series D financing, led by Zhejiang Merchants Venture Capital, with funds aimed at core pipeline development and the establishment of a formulation industrialization base [4] - Opcon Vision plans to use 334 million yuan to acquire 75% of Shanyang Qicheng Hospital Management Co., with part of the funds redirected from a community eye care service project [5] Industry Developments - Tengsheng Bo Pharmaceutical has reached a BD licensing agreement with Health元 for BRII-693, with Health元 responsible for development and commercialization in Greater China [7][8] - Nengte Technology has adjusted the listing price for the sale of its subsidiary, Ankang Shenqian Mining Co., to 114 million yuan, a 15% decrease from the previous listing price [9] - Ever Union, a shareholder of Mindray Medical, plans to reduce its stake by up to 0.41% through various legal means [10]
新里程董事长被实施留置;腾盛博药与健康元就在研药达成许可协议
Mei Ri Jing Ji Xin Wen· 2025-07-06 23:21
Group 1 - Lin Yanglin, the chairman of Xinlicheng, has been placed under detention and is under investigation, which may impact investor confidence despite the company stating the matter is unrelated to its operations [1] - Weiming Pharmaceutical's stock will be suspended for one day due to its trial progress not meeting expectations and its subsidiary's inability to resume normal operations within three months, affecting performance expectations [2] - Tengsheng Bo Pharmaceutical has signed a licensing agreement with Health Yuan Group for the exclusive rights to research, develop, and commercialize BRII-693 in China, providing cash flow and enhancing market expectations [3] Group 2 - China Resources Double Crane announced a cash dividend of 3.71 yuan per 10 shares despite a decline in revenue and net profit, indicating strong cash flow and commitment to shareholders [4] - InnoTech's subsidiary has obtained long-term product certification for a flu detection kit, which is expected to enhance market competitiveness and potentially increase revenue [5]
腾盛博药-B(02137.HK)与健康元集团携手推进BRII-693研发及商业化
Ge Long Hui· 2025-07-04 00:32
Core Viewpoint - The collaboration between Tengsheng Bo Pharmaceutical and Health元 Group focuses on the exclusive licensing and commercialization of BRII-693 in Greater China, addressing the urgent need for new antibiotics in the face of rising antibiotic resistance [1] Company Summary - Tengsheng Bo Pharmaceutical's subsidiary, Brii Biosciences, has signed a technology transfer agreement with Health元 Group for the development and commercialization of BRII-693 in Greater China [1] - Health元 Group will be responsible for the development, regulatory approval, and commercialization of BRII-693 in the specified regions [1] - The agreement includes an upfront payment and additional milestone payments based on the achievement of specific development and commercialization milestones, along with a sales revenue sharing arrangement [1] Industry Summary - The increasing threat of antibiotic resistance in Greater China highlights the urgent need for new hospital antibiotics, making the development of BRII-693 particularly timely [1] - The collaboration is expected to leverage Health元 Group's proven capabilities in the production and commercialization of hospital antibiotics, enhancing the prospects for BRII-693 [1] - The project is anticipated to address significant unmet clinical needs, with potential to become a Best-in-Class drug based on its therapeutic potential and pharmacological characteristics [1]
【健康元(600380.SH)】主业转型过渡,投入创新可期——更新点评(王明瑞/吴佳青)
光大证券研究· 2025-07-01 13:47
点击注册小程序 查看完整报告 保健品和OTC产品快速发展,驱动板块收入快速增长 24年健康元(不含丽珠集团、丽珠单抗)保健食品及OTC板块实现营业收入6.97亿元,同比增长约 53.91%。保健食品与OTC板块利用小红书、抖音、微信等新媒体内容渠道,通过达人推荐、健康科普、达 人直播带货等方式创作优质的内容触达用户,传递品牌理念,驱动品牌全渠道的销售增长。我们预计 25~26年板块发展势头良好,收入有望维持较快增速。 研发有序投入,创新转型可期 在创新药领域,公司正逐步推进"机制创新+多适应症覆盖"战略,向"抗感染+呼吸+镇痛"等多元协同方向 发展。其中:1)抗流感新药TG-1000已报产,预计2025年下半年获批上市,该新药具有较长的有效治疗 期;2)在高壁垒复杂制剂方面,沙美特罗替卡松吸入粉雾剂、丙酸氟替卡松雾化吸入用混悬液获得注册 批件,均实现国内首仿。3)在前沿靶点布局方面,TSLP单抗与IL-4R单抗均已进入Ⅱ期临床研究阶段。 在创新药加速向机制升级、适应症精准拓展演进的趋势下,公司在其呼吸系统疾病治疗主线之外,开始布 局多元化创新领域,Nav1.8作为外周神经系统疼痛信号传导的重要钠通道,具有机制 ...
健康元(600380):更新点评:主业转型过渡,投入创新可期
EBSCN· 2025-06-30 09:43
2025 年 6 月 30 日 公司研究 主业转型过渡,投入创新可期 ——健康元(600380.SH)更新点评 要点 吸入制剂收入有所波动,期待妥布霉素放量。 24 年公司呼吸制剂产品销售收入 10.97 亿元,同比下降 36.98%。吸入制产品收入有所波动主要是由于:1)妥布 霉素 24 年收入主要来自于 ICU 科室销售,放量较慢;2)左沙丁胺醇受集采政 策影响收入下滑;3)23 年呼吸疾病高发形成较高基数。整体来看,24 年收入 有所波动,随着集采等负面因素消退,预计 25 年有望依托妥布霉素、舒利迭、 TG-1000 等产品的逐步放量拉动吸入制剂板块收入增长。 保健品和 OTC 产品快速发展,驱动板块收入快速增长。24 年健康元(不含丽珠 集团、丽珠单抗)保健食品及 OTC 板块实现营业收入 6.97 亿元,同比增长约 53.91%。保健食品与 OTC 板块利用小红书、抖音、微信等新媒体内容渠道,通 过达人推荐、健康科普、达人直播带货等方式创作优质的内容触达用户,传递品 牌理念,驱动品牌全渠道的销售增长。我们预计 25~26 年板块发展势头良好, 收入有望维持较快增速。 研发有序投入,创新转型可期。在 ...
健康元(600380) - 健康元药业集团股份有限公司关于向控股子公司焦作健风提供委托贷款的进展公告
2025-06-25 09:45
关于向控股子公司焦作健风提供委托贷款的进展公告 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。 一、委托贷款概述 健康元药业集团 委托贷款进展公告 证券代码:600380 证券简称:健康元 公告编号:临 2025-052 健康元药业集团股份有限公司 2025 年 2 月 11 日,本公司通过招商银行向焦作健风发放委托贷款人民币 1,000 万元,其中 500 万元用于支付项目相关的构建费用,500 万元用于公司流动资金周 转。截至 2025 年 2 月 11 日,本公司在董事会审议通过的人民币 10,000 万元委托贷 款额度内,已向焦作健风发放委托贷款合计人民币 8,500 万元,其中 6,500 万元用于 支付项目相关的构建费用,2,000 万元用于公司流动资金周转,详见《健康元药业集 团股份有限公司关于向控股子公司焦作健风提供委托贷款的进展公告》(临 2025-009)。 2025 年 6 月 24 日,本公司通过招商银行再次向焦作健风发放委托贷款人民币 1,500 万元,全部用于支付项目相关的构建费用。截至本公告披露日 ...
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 ...