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悦康药业(688658) - 关于自愿披露子公司YKYY013注射液获得国家药品监督管理局临床试验批准的公告
2025-11-05 08:30
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、准确性和完整性依法承担法律责任。 证券代码:688658 证券简称:悦康药业 公告编号:2025-046 悦康药业集团股份有限公司 关于自愿披露子公司 YKYY013 注射液获得国家药品 监督管理局临床试验批准的公告 4、申请人:北京悦康科创医药科技股份有限公司、杭州天龙药业有限公司 悦康药业集团股份有限公司(以下简称"公司")子公司北京悦康科创医药 科技股份有限公司(以下简称"悦康科创")、杭州天龙药业有限公司(以下简 称"杭州天龙")于近日获得国家药品监督管理局(以下简称"NMPA")核准 签发的关于 YKYY013 注射液用于治疗慢性乙型肝炎病毒感染的《药物临床试 验批准通知书》,公司将开展本品 I 期临床试验。现将相关情况公告如下: 5、申报阶段:临床试验 一、临床批件主要内容: 3、通知书编号:2025LP02896 4、申请适应症:慢性乙型肝炎病毒感染 1、药品名称:YKYY013 注射液 2、受理号:CXHL2500882 6、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, 20 ...
悦康药业(688658) - 2025年第二次临时股东大会会议资料
2025-11-05 08:30
悦康药业集团股份有限公司 2025 年第二次临时股东大会会议资料 悦康药业集团股份有限公司 2025 年第二次临时股东大会 会议资料 2025 年 11 月 悦康药业集团股份有限公司 2025 年第二次临时股东大会会议资料 目 录 | 2025 | 年第二次临时股东大会会议须知 | 2 | | --- | --- | --- | | 2025 | 年第二次临时股东大会会议议程 | 4 | | 2025 | 年第二次临时股东大会会议议案 | 6 | 1 悦康药业集团股份有限公司 2025 年第二次临时股东大会会议资料 悦康药业集团股份有限公司 2025 年第二次临时股东大会会议须知 为了维护全体股东的合法权益,确保股东大会的正常秩序和议事效率,保证 大会的顺利进行,根据《中华人民共和国公司法》(以下简称"《公司法》")、 《中华人民共和国证券法》(以下简称"《证券法》")、《上市公司股东会规则》 以及《悦康药业集团股份有限公司章程》(以下简称"《公司章程》")的相关规 定,认真做好召开股东大会的各项工作,特制定本须知: 一、为保证股东大会的严肃性和正常秩序,切实维护股东的合法权益,除出 席会议的股东及股东代表、 ...
悦康药业:子公司药品YKYY013注射液获药物临床试验批准通知书
Core Viewpoint - Yuyuan Pharmaceutical (688658) announced that its subsidiary Yuyuan Kechuang and Hangzhou Tianlong have recently received approval from the National Medical Products Administration for the clinical trial of YKYY013 injection for the treatment of chronic hepatitis B virus infection [1] Group 1 - The company will initiate Phase I clinical trials for YKYY013 injection [1]
悦康药业子公司YKYY013注射液获临床试验批准
Zhi Tong Cai Jing· 2025-11-05 08:20
Core Viewpoint - YKYY013 injection, developed by the company and Hangzhou Tianlong Pharmaceutical, has received approval from the NMPA for clinical trials aimed at treating chronic hepatitis B virus infection [1] Group 1: Company Developments - The company's subsidiary, Beijing YK Pharmaceutical Technology Co., Ltd. (referred to as "YK Technology"), has been granted a clinical trial approval notice for YKYY013 injection [1] - The clinical trials will focus on the first phase of testing for YKYY013 injection [1] Group 2: Product Details - YKYY013 injection is a chemically synthesized double-stranded siRNA drug that utilizes an N-acetylgalactosamine (GalNAc) ligand [1] - The drug works through RNA interference to effectively silence the HBV genome's messenger RNA (mRNA), thereby inhibiting the production of hepatitis B viral proteins and replication [1] - The ultimate goal of YKYY013 is to achieve functional cure for hepatitis B by creating conditions for host immune reconstitution [1]
悦康药业(688658.SH)子公司YKYY013注射液获临床试验批准
智通财经网· 2025-11-05 08:18
Core Viewpoint - YKYY013 injection, developed by Yuyuan Pharmaceutical's subsidiary and Hangzhou Tianlong Pharmaceutical, has received approval from NMPA for clinical trials targeting chronic hepatitis B virus infection [1] Company Summary - Yuyuan Pharmaceutical's subsidiary, Beijing Yuyuan Kechuang Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical have jointly developed YKYY013 injection [1] - The drug is a chemically synthesized double-stranded siRNA that utilizes N-acetylgalactosamine (GalNAc) as a ligand [1] - The mechanism of action involves RNA interference to silence the HBV genome's messenger RNA, thereby inhibiting the production of hepatitis B viral proteins and replication [1] Industry Summary - The approval for YKYY013 marks a significant advancement in the treatment options for chronic hepatitis B virus infection [1] - The drug aims to create conditions for immune reconstitution in patients, potentially leading to functional cure for hepatitis B [1]
悦康药业:子公司YKYY013注射液获国家药监局临床试验批准
Xin Lang Cai Jing· 2025-11-05 08:12
Core Viewpoint - Yuyuan Pharmaceutical's subsidiary Yuyuan Kechuang and Hangzhou Tianlong have received approval from the National Medical Products Administration for the clinical trial of YKYY013 injection for the treatment of chronic hepatitis B virus infection, marking a significant step in the drug's development [1] Group 1 - The YKYY013 injection is a self-developed chemical-synthesized double-stranded siRNA drug [1] - Preclinical studies have shown significant HBV virus suppression activity and good safety profile for YKYY013 [1] - The drug has also received clinical trial approval from the U.S. FDA recently [1] Group 2 - The initiation of Phase I clinical trials is set to begin following the approval [1] - The company acknowledges that drug development involves long cycles, multiple stages, and high risks, which contribute to uncertainties [1] - There is no significant impact on the company's recent performance due to the drug's development status [1]
悦康药业股价涨5%,华安基金旗下1只基金重仓,持有1.05万股浮盈赚取1.08万元
Xin Lang Cai Jing· 2025-10-31 03:58
Group 1 - The core viewpoint of the news is that Yuyuan Pharmaceutical has seen a 5% increase in stock price, reaching 21.62 CNY per share, with a total market capitalization of 9.729 billion CNY [1] - Yuyuan Pharmaceutical focuses on the research and production of high-end chemical drugs, with significant revenue contributions from cardiovascular drugs, digestive system drugs, diabetes medications, and anti-infection drugs [1] - The main products contributing to the company's revenue include Ginkgo biloba extract injection, Tianma injection, Lansoprazole injection, Omeprazole enteric-coated capsules, Metformin sustained-release tablets, Cefuroxime sodium injection, and Ceftriaxone sodium injection [1] Group 2 - Huashan Fund has a significant holding in Yuyuan Pharmaceutical, with the Huashan CSI 1000 Index Enhanced A fund holding 10,500 shares, representing 0.4% of the fund's net value [2] - The Huashan CSI 1000 Index Enhanced A fund has achieved a year-to-date return of 25.63% and a one-year return of 28.95% [2] - The fund manager, Zhang Xu, has a tenure of 5 years and 168 days, with the best fund return during this period being 144.8% [3]
机构风向标 | 悦康药业(688658)2025年三季度已披露前十大机构持股比例合计下跌4.89个百分点
Xin Lang Cai Jing· 2025-10-30 01:19
Group 1 - Yuyuan Pharmaceutical (688658.SH) reported its Q3 2025 results, with 27 institutional investors holding a total of 262 million shares, representing 58.19% of the company's total equity as of October 29, 2025 [1] - The top ten institutional investors collectively hold 53.65% of the shares, with a decrease of 4.89 percentage points compared to the previous quarter [1] Group 2 - In the public fund sector, 12 funds increased their holdings, accounting for 3.94% of the total, including notable funds such as Fuqun Medical Innovation Stock A and E Fund Healthcare Industry Mixed A [2] - Two public funds decreased their holdings, representing a reduction of 0.26%, including China Merchants Medical Health Industry Stock and Fuqun Precision Medical Flexible Allocation Mixed A [2] - Six new public funds were disclosed this period, while 160 funds were not disclosed compared to the previous quarter, indicating significant changes in the public fund landscape [2]
悦康药业(688658) - 独立董事工作制度(2025年10月修订)
2025-10-29 15:07
悦康药业集团股份有限公司 独立董事工作制度 第一章 总则 独立董事应当独立履行职责,不受公司主要股东、实际控制人等 单位或个人的影响。 以会计专业人士身份被提名为独立董事候选人的,应具备较丰富 的会计专业知识和经验,并至少符合下列条件之一: 2 第一条 为进一步完善悦康药业集团股份有限公司(以下简称"公司")法 人治理结构建设,为独立董事创造良好的工作环境,促进公司规 范运行,根据《中华人民共和国公司法》(以下简称"《公司法》")、 中国证券监督管理委员会(以下简称"中国证监会")《上市公司 独立董事管理办法》(以下简称"《管理办法》")、《上市公司治理 准则》、《上海证券交易所科创板股票上市规则》(以下简称"《上 市规则》")、《上海证券交易所科创板上市公司自律监管指引第 1 号—规范运作》等法律、法规、规章、规范性文件及《悦康药业 集团股份有限公司章程》(以下简称"公司章程")的相关规定, 制定本制度。 第二条 独立董事是指不在公司担任除董事外的其他职务,并与公司及其 主要股东、实际控制人不存在直接或间接利害关系,或者其他可 能影响其进行独立客观判断关系的董事。 第三条 独立董事对公司及全体股东负有忠实与 ...
悦康药业:关于公司董事会换届选举的公告
证券日报网讯 10月29日晚间,悦康药业发布公告称,公司于2025年10月29日召开第二届董事会第二十 一次会议,审议通过《关于董事会换届选举暨提名第三届董事会非独立董事候选人的议案》及《关于董 事会换届选举暨提名第三届董事会独立董事候选人的议案》,同意提名于伟仕先生、于飞先生、于鹏飞 先生、宋更申先生、王霞女士为公司第三届董事会非独立董事候选人;于谦龙先生、蒋斌先生、谭勇先 生为公司第三届董事会独立董事候选人,其中于谦龙先生为会计专业人士。 (编辑 楚丽君) ...