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浙江医药股份有限公司 关于XC2309注射液获得药物临床试验批准通知书的公告
Group 1 - The company has received approval from the National Medical Products Administration for the clinical trial of XC2309 injection, which is intended for treating gastrointestinal ulcer bleeding [1][2] - XC2309 injection is classified as a Class 1 chemical drug with a specification of 5ml:10mg [1] - The clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and bioavailability of XC2309 in healthy adult subjects [1][2] Group 2 - The company has invested a total of 83.96 million yuan in the development of the XC2309 project, which includes costs for both the injection and the tablet form of the drug [2] - The global sales of a similar drug, Fumaric Acid Vonoprazan Tablets, are projected to reach 936 million USD in 2024, with domestic sales in China estimated at 825 million yuan [2] - There are 23 domestic companies, including Takeda Pharmaceutical, that have received production licenses for similar oral solid dosage forms [2]
易明医药实际控制人变更;新疗法实现细菌与病毒协同抗癌
Policy Developments - The State Council has agreed in principle to the "Biopharmaceutical Industry Chain Open Innovation Development Plan" for the China (Jiangsu) Free Trade Zone, aiming to create a globally influential biopharmaceutical industry hub and enhance international competitiveness [1] Industry Initiatives - The National Health Commission has issued guidelines to promote the application of artificial intelligence in ear and hearing health, focusing on the development and transformation of cutting-edge technologies in the field [2] Medical Pricing Guidelines - The National Medical Insurance Administration has released two project guidelines for medical service pricing, including the "Hernia and Thyroid Medical Service Pricing Project" and the "Digestive System Medical Service Pricing Project," integrating existing pricing projects into 25 and 150 items respectively [3] Medical Device Approvals - Zhonghong Medical's subsidiary, Shenzhen Maide Rui Na, has obtained a medical device registration certificate for an infusion pump, valid until August 19, 2030 [4] - Zhejiang Medicine has received approval for clinical trials of XC2309 injection, a first-class chemical drug intended for treating gastrointestinal ulcer bleeding [5] Financial Performance - Maipu Medical reported a 29.28% increase in revenue to 158 million yuan and a 46.03% rise in net profit to 47.3 million yuan for the first half of 2025 [6] - Sainuo Medical achieved a 12.53% increase in revenue to 240 million yuan and a remarkable 296.54% growth in net profit to 13.8 million yuan in the same period [8] - Baihua Medicine reported a revenue of 202 million yuan, a 2.95% increase, and a net profit of 25.5 million yuan, up 12.45% [9] Capital Market Activities - Linuo Pharmaceutical plans to acquire a 30% stake in Suzhou Chuangyang New Materials Technology Co., Ltd. for 84 million yuan [10] Industry Innovations - Researchers from Columbia University and Rockefeller University have developed a new therapy using bacteria to deliver viruses directly to tumors, enhancing cancer treatment efficacy [11] - Sanbo Brain Science has begun using surgical robots in certain neurosurgical procedures to improve service quality and surgical outcomes [12] Corporate Changes - Yiming Pharmaceutical announced a change in its actual controller to Yao Jinbo, following a share transfer from the previous controller [13] - Tiantan Biological received a commitment from its actual controller to resolve newly created competition issues due to a recent acquisition [14]
浙江医药:获得XC2309注射液《药物临床试验批准通知书》
Mei Ri Jing Ji Xin Wen· 2025-08-21 08:45
Group 1 - Zhejiang Medicine Co., Ltd. received approval from the National Medical Products Administration for the clinical trial of XC2309 injection [2] - The company's revenue composition for the year 2024 is as follows: human nutritional products account for 50.1%, pharmaceuticals account for 48.85%, other businesses account for 0.64%, and additional services account for 0.41% [2]
浙江医药(600216) - 浙江医药关于XC2309注射液获得药物临床试验批准通知书的公告
2025-08-21 08:45
证券代码:600216 证券简称:浙江医药 公告编号:2025-034 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个别及连带责任。 近日,浙江医药股份有限公司(以下简称"公司")收到国家药品监督管理 局核准签发关于XC2309注射液的《药物临床试验批准通知书》,经审查,XC2309 注射液临床试验申请符合药品注册的有关要求,同意本品开展临床试验。现将相 关情况公告如下: 一、药品基本情况 药物名称:XC2309注射液 剂 型:注射剂 规 格:5ml:10mg(按C21H22FN3O3S计) 注册分类:化学药品1类 通知书编号:2025LP02083 浙江医药股份有限公司关于 XC2309 注射液 浙江医药股份有限公司董事会 2025 年 8 月 22 日 二、药品研究及相关情况 根据 Pharmarket 数据库,其同类药物富马酸伏诺拉生片 2024 年全球销售额 9.36 亿美元。米内数据查询,武田制药的富马酸伏诺拉生片 2024 年国内销售额 8.25 亿元人民币。伏诺拉生片的国内上市企业为武田 ...
浙江医药:XC2309注射液获得药物临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2025-08-21 08:44
(文章来源:每日经济新闻) 每经AI快讯,浙江医药8月21日公告,公司近日收到国家药品监督管理局核准签发关于XC2309注射液的 《药物临床试验批准通知书》,经审查,XC2309注射液临床试验申请符合药品注册的有关要求,同意 本品开展临床试验。申请的适应症:本品临床拟用于各种情况引起的消化道溃疡出血。 ...
浙江医药(600216.SH):XC2309注射液获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-08-21 08:43
格隆汇8月21日丨浙江医药(600216.SH)公布,收到国家药品监督管理局核准签发关于XC2309注射液的 《药物临床试验批准通知书》,经审查,XC2309注射液临床试验申请符合药品注册的有关要求,同意 本品开展临床试验。 ...
浙江医药:XC2309注射液获药物临床试验批准通知书
Xin Lang Cai Jing· 2025-08-21 08:38
浙江医药公告,近日公司收到国家药品监督管理局核准签发关于XC2309注射液的《药物临床试验批准 通知书》。XC2309注射液临床试验申请符合药品注册的有关要求,同意本品开展临床试验。该药品用 于各种情况引起的消化道溃疡出血。截至目前,公司为开展XC2309项目已累计投入研发费用8396.07万 元。 ...
浙江医药上周获融资净买入1613.40万元,居两市第494位
Jin Rong Jie· 2025-08-18 00:31
Core Viewpoint - Zhejiang Medicine has shown a net financing inflow of 16.134 million yuan last week, ranking 494th in the market, indicating a moderate interest from investors [1] Financing and Investment Summary - The total financing amount for Zhejiang Medicine last week was 265 million yuan, while the repayment amount was 249 million yuan [1] - Over the past 5 days, the main capital outflow was 9.0568 million yuan, with a decline of 0.52% in this period [1] - In the last 10 days, the main capital outflow reached 134 million yuan, reflecting a decline of 3.43% [1] Company Profile - Zhejiang Medicine Co., Ltd. was established in 1997 and is located in Shaoxing City, primarily engaged in the pharmaceutical manufacturing industry [1] - The company has a registered capital of 961.63775 million yuan, which is also its paid-in capital [1] - The legal representative of the company is Li Nanhang [1] Business Activities - Zhejiang Medicine has made investments in 28 enterprises and participated in 83 bidding projects [1] - The company holds 190 trademark registrations and 27 patents, along with 46 administrative licenses [1]
浙江医药(600216)8月13日主力资金净流入2984.38万元
Sou Hu Cai Jing· 2025-08-13 09:12
浙江医药最新一期业绩显示,截至2025一季报,公司营业总收入22.55亿元、同比增长0.28%,归属净利 润4.09亿元,同比增长273.08%,扣非净利润4.02亿元,同比增长279.23%,流动比率2.854、速动比率 1.999、资产负债率19.51%。 天眼查商业履历信息显示,浙江医药股份有限公司,成立于1997年,位于绍兴市,是一家以从事医药制 造业为主的企业。企业注册资本96163.775万人民币,实缴资本96163.775万人民币。公司法定代表人为 李男行。 金融界消息 截至2025年8月13日收盘,浙江医药(600216)报收于15.83元,上涨1.54%,换手率 2.89%,成交量27.81万手,成交金额4.38亿元。 资金流向方面,今日主力资金净流入2984.38万元,占比成交额6.82%。其中,超大单净流入1799.32万 元、占成交额4.11%,大单净流入1185.06万元、占成交额2.71%,中单净流出流出1895.08万元、占成交 额4.33%,小单净流出1089.30万元、占成交额2.49%。 通过天眼查大数据分析,浙江医药股份有限公司共对外投资了28家企业,参与招投标项目83次 ...
浙江医药股份有限公司 关于股份回购实施结果暨股份变动的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 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: 三、回购期间相关主体买卖股票情况 2025年4月15日,公司首次披露了回购股份方案,具体内容详见公司在上海证券交易所网站披露的《浙 江医药股份有限公司关于以集中竞价交易方式回购股份方案的公告》(公告编号:2025-008)。 ■ 一、回购审批情况和回购方案内容 浙江医药股份有限公司(以下简称"公司")于2025年4月14日召开第十届四次董事会会议,审议通过了 《关于以集中竞价交易方式回购股份方案的议案》,同意公司使用自有资金或自筹资金以集中竞价交易 方式回购公司股份,用于后续实施员工持股计划或股权激励,回购价格不超过人民币20.83元/股 (含),回购资金总额不低于人民币1亿元(含)且不超过人民币2亿元(含),回购期限自董事会审议 通过回购股份方案之日起不超过12个月,即2025年4月15日-2026年4月14日。本次回购股份事项的具体 内容详见公司于2025年4月19日在上海证券交易所网站披露的《浙江医药股份有限 ...