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万邦德石杉碱甲口服溶液启动Ⅰ期临床 适应症为重症肌无力
Xin Lang Cai Jing· 2025-12-30 10:41
Group 1 - The core focus of the news is the initiation of a Phase I clinical trial for Wanbangde Pharmaceutical Group's oral solution and injection of Huperzine A, aimed at comparing their pharmacokinetic characteristics in healthy Chinese subjects [1] - The clinical trial is designed as a single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover study, with a registration number of CTR20255231 and the first public information date set for December 30, 2025 [1] - The primary objective of the trial is to compare the pharmacokinetic profiles of the oral solution and injection of Huperzine A under fasting conditions, while secondary objectives include assessing the relative bioavailability of the oral solution and the safety of both formulations [1] Group 2 - The main endpoints of the trial include pharmacokinetic parameters such as Cmax, AUC0-t, and AUC0-∞, while secondary endpoints include Tmax, λz, t1/2, AUC_%Extrap, CL/F, Vz/F, relative bioavailability F, physical examinations, vital signs, 12-lead ECG, laboratory tests, and adverse events [2] - The current status of the trial is ongoing, with a target enrollment of 20 participants, although recruitment has not yet started [2]
中药板块12月30日跌0.32%,*ST长药领跌,主力资金净流出2.31亿元
Market Overview - The Chinese medicine sector experienced a decline of 0.32% on December 30, with *ST Changyao leading the drop [1] - The Shanghai Composite Index closed at 3965.12, down 0.0%, while the Shenzhen Component Index closed at 13604.07, up 0.49% [1] Stock Performance - Notable gainers in the Chinese medicine sector included: - Taiji Group (600129) with a closing price of 18.25, up 2.07% [1] - Wanbangde (002082) at 13.89, up 1.98% [1] - Fangsheng Pharmaceutical (603998) at 11.29, up 1.62% [1] - Conversely, *ST Changyao (300391) saw a significant drop of 19.49%, closing at 0.95 [2] Trading Volume and Value - The trading volume and value for key stocks were as follows: - Taiji Group: 87,200 shares traded, with a transaction value of 159 million [1] - Wanbangde: 164,400 shares traded, with a transaction value of 227 million [1] - Fangsheng Pharmaceutical: 48,000 shares traded, with a transaction value of 53.82 million [1] Capital Flow - The Chinese medicine sector experienced a net outflow of 231 million from institutional investors, while retail investors saw a net inflow of 280 million [2] - The capital flow for specific stocks included: - Wanbangde with a net inflow of 48.79 million from institutional investors [3] - Taiji Group with a net inflow of 18.53 million from institutional investors [3] - *ST Changyao had a net outflow of 19.49% [2]
万邦德医药控股集团股份有限公司关于子公司药品WP107获得伦理批件的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:002082 证券简称:万邦德 公告编号:2025-068 万邦德医药控股集团股份有限公司 关于子公司药品WP107获得伦理批件的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误导性陈述或重大遗 漏。 英文名称:Huperzine A Oral Solution 剂型:口服溶液 规格:0.22mg 注册分类:美国505(b)1/中国2.2类新药 适应症:重症肌无力 临床研究阶段:I期 临床研究单位:温州医科大学附属第二医院 伦理审查委员会审查意见:同意临床试验 万邦德医药控股集团股份有限公司(以下简称"公司")全资子公司万邦德制药集团有限公司的新药 WP107治疗重症肌无力的I期临床试验获得了温州医科大学附属第二医院 温州医科大学附属育英儿童医 院医学伦理委员会的审查批件,批准项目开展。现将相关情况公告如下: 一、药品及获得伦理批件基本情况 药品名称:WP107 口服溶液 公司于2023年12月获得美国食品药品监督管理局(FDA)授予的石杉碱甲治疗重症肌无力的孤儿药认 定,于2025年1月WP107口服溶液用于治疗全身 ...
万邦德:在研新药WP107获得伦理批件
Core Viewpoint - Wanbangde's new drug WP107 (Huperzine A oral solution) for treating myasthenia gravis has received ethical approval for its Phase I clinical trial, indicating progress in its drug development pipeline [1][3]. Group 1: Clinical Trial and Regulatory Approvals - Wanbangde's subsidiary has obtained ethical approval from the medical ethics committee of Wenzhou Medical University for the Phase I clinical trial of WP107 [1]. - The company has received orphan drug designation from the FDA for Huperzine A in treating myasthenia gravis and has been granted clinical trial permission for WP107 in January 2025 [3]. - The clinical trial aims to compare the pharmacokinetic characteristics of the oral solution and the injectable form of Huperzine A in healthy subjects [3]. Group 2: Product Development and Market Position - Wanbangde is the sole manufacturer of Huperzine A injection, holding a 24.37% market share in the Huperzine A formulation market, reflecting its technological authority and market exclusivity [2]. - The company is expanding its product matrix with ongoing clinical trials for Huperzine A controlled-release tablets for Alzheimer's disease and other formulations for various neurological conditions [2]. - WP107 is designed to address swallowing difficulties in some myasthenia gravis patients and improve medication adherence in pediatric patients [2]. Group 3: Company Overview and Focus Areas - Wanbangde is headquartered in Taizhou, Zhejiang, focusing on pharmaceutical manufacturing and medical devices across multiple therapeutic areas, including cardiovascular, neurological, respiratory, digestive, and mental health [1]. - The core component of Huperzine A, a novel drug, has received multiple patents globally, including in the US, Europe, and Japan, and has won national awards for its technological innovation [1].
贵州茅台控股股东完成30亿元增持;*ST熊猫涉嫌信披违规被证监会立案丨公告精选
Key Points - Guizhou Moutai's controlling shareholder, Moutai Group, has completed a share buyback plan, acquiring 2,071,359 shares for a total of 3 billion yuan, increasing its stake to 56.63% of the total share capital [1] - Juneyao Airlines plans to purchase 25 Airbus A320 series aircraft for a total of 4.1 billion USD, with deliveries scheduled between 2028 and 2032 [1] - ST Panda is under investigation by the China Securities Regulatory Commission for suspected violations of information disclosure laws [1] - Huali Co. has terminated its plan to acquire a 51% stake in Zhongke Huilian due to a lack of consensus on key transaction terms [1][2] - China Duty Free Group's subsidiary has signed a contract for a duty-free project at Beijing Capital International Airport, covering an area of 10,646.74 m², with a guaranteed operating fee of 480.27 million yuan in the first year [3] - Haisheng Pharmaceutical's invested company has initiated Phase II clinical trials for NWRD06, a novel RNA drug targeting GPC3 for liver cancer, marking a significant milestone in cancer treatment [3] - WISCO Development is planning to acquire stakes in WISCO Mining and Luzhong Mining through asset swaps and cash payments, leading to a temporary suspension of its stock [4] - Yonghui Supermarket intends to publicly sell a 28.095% stake in its subsidiary Yonghui Cloud Gold Technology [5] - Shanxi Expressway plans to acquire a 15% stake in Shanxi Transportation Industry Development Group for 74.8 million yuan [5] - China Energy Construction's subsidiary has won a 6.864 billion yuan ecological comprehensive governance project [5]
万邦德子公司药品WP107获得伦理批件
Bei Jing Shang Bao· 2025-12-29 10:55
Core Viewpoint - Wanbangde's subsidiary has received ethical approval for the Phase I clinical trial of WP107, a new drug for treating myasthenia gravis, indicating progress in its drug development pipeline [1] Group 1: Clinical Trial Developments - Wanbangde's subsidiary, Wanbangde Pharmaceutical Group, has obtained approval from the ethics committee of Wenzhou Medical University for the Phase I clinical trial of WP107 [1] - The trial aims to compare the pharmacokinetic characteristics of oral and injectable forms of huperzine A in healthy Chinese subjects under fasting conditions [1] - The company received orphan drug designation from the FDA for huperzine A in December 2023, and has been granted clinical trial approval for WP107 in January 2025 [1] Group 2: Regulatory Approvals - The FDA granted clinical trial permission for WP107 in January 2025, with further approval from the National Medical Products Administration for a Class 2 new drug trial in July 2025 [1] - The ethical approval is a significant step in the drug development process, allowing the company to officially commence the Phase I clinical trial [1]
万邦德(002082.SZ)子公司药品WP107获得伦理批件
智通财经网· 2025-12-29 09:20
Core Viewpoint - Wanbangde (002082.SZ) has received approval from the medical ethics committee of Wenzhou Medical University for its Phase I clinical trial of the new drug WP107, aimed at treating myasthenia gravis [1] Group 1: Clinical Trial Progress - The company’s wholly-owned subsidiary, Wanbangde Pharmaceutical Group Co., Ltd., has officially commenced the Phase I clinical trial after obtaining the clinical trial approval notice from the National Medical Products Administration [1] - The trial will compare the pharmacokinetic characteristics of oral and injectable forms of Huperzine A in healthy Chinese subjects under fasting conditions [1] - The objective is to evaluate the relative bioavailability of the oral solution of Huperzine A and the safety of both formulations in a fasting state [1]
万邦德(002082) - 关于子公司药品WP107获得伦理批件的公告
2025-12-29 09:15
证券代码:002082 证券简称:万邦德 公告编号:2025-068 万邦德医药控股集团股份有限公司 关于子公司药品WP107获得伦理批件的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚 假记载、误导性陈述或重大遗漏。 万邦德医药控股集团股份有限公司(以下简称"公司")全资子公司万邦德 制药集团有限公司的新药WP107治疗重症肌无力的I期临床试验获得了温州医科 大学附属第二医院 温州医科大学附属育英儿童医院医学伦理委员会的审查批件, 批准项目开展。现将相关情况公告如下: 一、药品及获得伦理批件基本情况 药品名称:WP107 口服溶液 英文名称:Huperzine A Oral Solution 剂型:口服溶液 规格:0.22mg 注册分类:美国 505(b)1/中国 2.2 类新药 适应症:重症肌无力 临床研究阶段:I 期 临床研究单位:温州医科大学附属第二医院 伦理审查委员会审查意见:同意临床试验 二、药品临床试验进展情况 公司于 2023 年 12 月获得美国食品药品监督管理局(FDA)授予的石杉碱甲 治疗重症肌无力的孤儿药认定,于 2025 年 1 月 WP107 口服溶液用于治 ...
万邦德(002082.SZ):子公司药品WP107获得伦理批件
Ge Long Hui A P P· 2025-12-29 09:09
Core Viewpoint - Wanbangde (002082.SZ) announced that its wholly-owned subsidiary, Wanbangde Pharmaceutical Group Co., Ltd., has received approval from the Medical Ethics Committee of Wenzhou Medical University Second Affiliated Hospital and Wenzhou Medical University Affiliated Yuying Children's Hospital to conduct Phase I clinical trials for its new drug WP107, which is aimed at treating myasthenia gravis [1] Group 1 - Wanbangde's new drug WP107 is specifically designed for the treatment of myasthenia gravis [1] - The approval for the clinical trial was granted by two medical institutions affiliated with Wenzhou Medical University [1]
万邦德医药控股集团股份有限公司关于控股股东部分股份质押及解除质押的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:002082 证券简称:万邦德 公告编号:2025-067 万邦德医药控股集团股份有限公司关于控股股东部分股份质押及解除质押的公告 公司控股股东、实际控制人及其一致行动人保证向本公司提供的信息内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证信息披露内容的真实、准确、完整,没有虚假记载、误导性陈述或重大遗 漏。 四、控股股东及其一致行动人股份质押情况 1.公司控股股东及其一致行动人本次质押与上市公司生产经营需求无关。 万邦德医药控股集团股份有限公司(以下简称"公司")近日收到公司控股股东万邦德集团有限公司(以 下简称"万邦德集团")的通知,获悉其所持有公司的部分股份办理了质押及解除质押手续,具体事项如 下: 一、股东股份质押基本情况 ■ 二、股东股份解除质押基本情况 ■ 三、股东股份累计质押情况 截至本公告披露日,万邦德集团及其一致行动人所持质押股份情况如下: ■ 2.公司实际控制人庄惠女士质押的691万股于半年内到期,除此之外,控股股东及实际控制人不存在未 来半年内或一年内到期的质押股份。 3.公司控股股东及其 ...