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九芝堂:控股子公司启动孤独症干细胞新药临床试验
Zhong Zheng Wang· 2025-08-27 07:37
Core Viewpoint - The company Jiuzhitang is advancing its research in stem cell therapy, particularly focusing on a new drug for treating Autism Spectrum Disorder (ASD) using human bone marrow mesenchymal stem cells, marking a significant milestone in clinical trials in China [1][2]. Group 1: Clinical Trial Developments - Jiuzhitang's subsidiary, Beijing Meike, has received ethical approval to initiate clinical trials for its human bone marrow mesenchymal stem cell injection project, specifically targeting ASD [1][2]. - The clinical trial for the stem cell injection has been approved by the National Medical Products Administration, making it the first of its kind in China for treating ASD [2]. Group 2: Product and Market Potential - The human bone marrow mesenchymal stem cell injection is classified as a Class 1 new drug and is aimed at treating Autism Spectrum Disorder, a complex neurodevelopmental disorder with no approved medications in China [2]. - Jiuzhitang is also making progress in other projects, including YB209, an innovative anticoagulant drug, and YB211, a new antibiotic targeting drug-resistant bacterial infections, both of which show promising market potential [3]. Group 3: Infrastructure and Recognition - Beijing Meike has established a large-scale stem cell drug research and production facility that meets GMP standards in China, the US, and the EU, positioning itself as a leading enterprise in the stem cell field in China [4].
九芝堂2025年上半年实现净利润1.44亿元 在中医药创新、干细胞领域取得积极进展
Mei Ri Jing Ji Xin Wen· 2025-08-21 10:05
登录新浪财经APP 搜索【信披】查看更多考评等级 在中医药行业稳步前行的浪潮中,九芝堂以其深厚的历史底蕴与前瞻性的创新战略,再次展现了其在传 统医学与现代医学的领导力。 8月20日晚,九芝堂披露2025年半年度报告。报告期内,公司实现营业收入12.65亿元,归母净利润1.44 亿元。值得注意的是,经营性现金流净额较去年同期上升191.72%,这一数据不仅反映了九芝堂良好的 盈利能力和经营效率,亦预示着公司在未来业务拓展和研发投入上将拥有更加坚实的资金基础。 自今年年初以来,九芝堂经历了重要的股权结构调整与人事调整:1月10日,黑龙江省国资委成为公司 的新任实控人;7月份,公司2025年度第一次临时股东大会通过审议,选举王立峰担任公司新任董事长 兼法人代表,九芝堂开启了新的发展阶段。 创新驱动 多款创新药进入临床阶段 在创新驱动发展战略的引领下,九芝堂在创新药和干细胞领域的探索取得了显著进展,为公司未来的可 持续发展奠定了坚实基础。中报显示,九芝堂正加速推进多个创新药物项目的研发进程,其中YB209和 YB211项目尤为引人注目。 YB209项目,作为一款拥有完全自主知识产权的首创性抗凝药物,以其高抗凝性与低出 ...
九芝堂: 2025年半年度报告摘要
Zheng Quan Zhi Xing· 2025-08-21 05:40
Core Viewpoint - The company, JiuZhiTang Co., Ltd., reported a significant decline in both revenue and net profit for the first half of 2025, attributed to external market conditions and internal reforms [6]. Financial Performance - The company's operating revenue for the reporting period was CNY 1,264,512,369.54, representing a decrease of 24.71% compared to the same period last year [6]. - The net profit attributable to shareholders was CNY 143,773,631.42, down 29.71% year-on-year [6]. - The net cash flow from operating activities showed a significant improvement, reaching CNY 213,061,017.36, an increase of 191.72% compared to a negative cash flow of CNY -232,303,029.43 in the previous year [6]. - Basic and diluted earnings per share were both CNY 0.1699, reflecting a decrease of 29.18% from CNY 0.2399 in the prior year [6]. Asset and Equity Position - Total assets at the end of the reporting period were CNY 5,025,993,962.59, a decrease of 3.56% from CNY 5,211,440,858.19 at the end of the previous year [2]. - The net assets attributable to shareholders were CNY 3,643,101,446.80, down 2.93% from CNY 3,753,212,418.98 [2]. - The weighted average return on equity was 3.84%, a decline of 1.31% from 5.15% in the previous year [2]. Shareholder Structure - The largest shareholder, Heilongjiang Cheneng Industrial Investment Co., Ltd., holds 24.04% of the shares, while the second-largest shareholder, Li Zhenguo, holds 18.91% [2]. - The company underwent a change in control, with Heilongjiang Cheneng becoming the controlling shareholder after acquiring shares from Li Zhenguo [5][6].
九芝堂上半年归母净利润1.44亿元 干细胞项目取得积极进展
Zheng Quan Ri Bao Zhi Sheng· 2025-08-20 14:11
资料显示,北京美科已建成符合中国、美国和欧盟GMP标准的大规模干细胞药物研发生产基地,并拥 有"国家高新技术企业""北京专精特新企业"等多项荣誉,是我国干细胞领域的领先企业之一。 半年报显示,九芝堂上半年持续优化公司组织架构,有序推进营销改革,并加快创新研发进度,在干细 胞项目及YB209、YB211等取得积极进展。 其中,YB209项目完成免疫原性研究的方法开发和验证,Ⅰ期临床收尾工作完成。YB209是一款拥有完 全自主知识产权的首创性抗凝药物,兼具高抗凝性与低出血风险的特性,拥有良好的市场前景。 此外,YB211项目完成临床样品制备、2段生殖毒性试验、PK-PD启动,现已全面启动临床Ⅱ期试验, 截至目前入组44例。YB211为针对耐药细菌感染的新型环脂肽类抗生素,同类替代品较少,临床需求空 间广阔。 在干细胞领域,九芝堂子公司九芝堂美科(北京)细胞技术有限公司(以下简称"北京美科")的缺血耐 受人同种异体骨髓间充质干细胞治疗缺血性脑卒中的临床试验,已完成IIa期45例全部受试者入组;人 骨髓间充质干细胞注射液治疗自身免疫性肺泡蛋白沉积症的临床试验,已完成10例全部受试者的入组。 在现有临床试验加速推进的同 ...
九芝堂上半年盈利1.44亿元 创新研发稳步推进
Zheng Quan Shi Bao Wang· 2025-08-20 13:59
在中成药业务稳步发展的同时,九芝堂积极投入创新研发,在创新药、干细胞领域取得积极进展。 8月20日晚间,九芝堂披露2025年半年度报告,公司半年度实现营业收入12.65亿元,归母净利润1.44亿 元,经营性现金流净额较去年同期上升191.72%。 今年1月,黑龙江省国资委成为九芝堂新任实控人。7月,公司2025年度第一次临时股东大会通过决议, 王立峰成为公司新任董事长兼法人代表。 中报显示,九芝堂上半年持续优化公司组织架构,有序推进营销改革,并加快创新研发进度,在干细胞 项目及YB209、YB211等取得积极进展。 其中,YB209项目完成免疫原性研究的方法开发和验证,I期临床收尾工作完成。YB209是一款拥有完 全自主知识产权的首创性抗凝药物,兼具高抗凝性与低出血风险的特性,拥有良好的市场前景。 此外,YB211项目完成临床样品制备、2段生殖毒性试验、PK-PD 启动,现已全面启动临床Ⅱ期试验, 截至目前入组 44 例。YB211为针对耐药细菌感染的新型环脂肽类抗生素,同类替代品较少,临床需求 空间广阔。 在干细胞领域,九芝堂子公司北京美科的缺血耐受人同种异体骨髓间充质干细胞治疗缺血性脑卒中的临 床试验,已 ...
九芝堂上半年盈利1.44亿元,创新研发稳步推进
Zheng Quan Shi Bao Wang· 2025-08-20 13:52
Core Viewpoint - Jiuzhitang (000989) is making significant progress in both traditional Chinese medicine and innovative drug development, particularly in stem cell therapy and new drug projects, as evidenced by its recent financial performance and ongoing clinical trials [1][2][3] Financial Performance - For the first half of 2025, Jiuzhitang reported a revenue of 1.265 billion yuan and a net profit attributable to shareholders of 144 million yuan, with operating cash flow increasing by 191.72% compared to the same period last year [1] Corporate Governance - In January 2025, the Heilongjiang Provincial State-owned Assets Supervision and Administration Commission became the new controlling shareholder of Jiuzhitang. In July, the company appointed Wang Lifeng as the new chairman and legal representative [1] Innovation and R&D Progress - Jiuzhitang is optimizing its organizational structure and accelerating marketing reforms while advancing its innovative research and development efforts, particularly in stem cell projects and drug candidates YB209 and YB211 [1] - The YB209 project, a novel anticoagulant drug with complete independent intellectual property rights, has completed method development and verification for immunogenicity studies, with Phase I clinical trials nearing completion [1] - The YB211 project, targeting antibiotic-resistant bacterial infections, has initiated Phase II clinical trials with 44 subjects enrolled, following the completion of clinical sample preparation and toxicity tests [1] Stem Cell Research - Jiuzhitang's subsidiary, Beijing Meike, has completed enrollment for 45 subjects in a Phase IIa clinical trial for ischemic stroke treatment using allogeneic bone marrow mesenchymal stem cells. Additionally, a clinical trial for treating autoimmune pulmonary alveolar proteinosis has enrolled 10 subjects [2] - Beijing Meike has received approval for a clinical trial using bone marrow mesenchymal stem cell injection for autism treatment, further expanding the application prospects of its stem cell technology [2] Commitment to Traditional Chinese Medicine - Jiuzhitang is actively engaged in the innovation and development of new traditional Chinese medicines, with ongoing research on classic formulas YB106 and YB107, and real-world studies for products like Shuxuetong injection [3] - The company is conducting clinical evidence-based research on several key products, which will clarify their therapeutic advantages and support the upgrade of its traditional Chinese medicine offerings [3]
九芝堂:YB211项目启动II期临床试验
news flash· 2025-05-26 08:51
Core Viewpoint - The announcement indicates that Jiuzhitang's subsidiary Youbo Pharmaceutical has initiated a Phase II clinical trial for the new drug YB211, which targets acute bacterial skin and skin structure infections caused by Gram-positive pathogens [1] Group 1: Clinical Trial Details - The clinical trial kickoff meeting was held on May 24, 2025, with 26 clinical trial centers, including Fudan University Huashan Hospital [1] - YB211 is a novel cyclic lipopeptide with a new chemical structure, and the trial will compare its efficacy against the control drug Daptomycin in adult patients [1] - The trial consists of two parts: dose exploration and pharmacokinetic studies [1] Group 2: Regulatory Approvals - Youbo Pharmaceutical received the clinical trial approval notice from the National Medical Products Administration on February 6, 2025 [1] - The company obtained the ethics review committee's approval by the end of April [1] Group 3: Impact on Company Performance - The initiation of the clinical trial is expected to advance the research and evaluation progress of the new drug YB211 [1] - However, it is noted that there will be no significant impact on the company's operating performance in the short term [1]