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微芯生物:西格列他钠二甲双胍缓释片临床试验申请获受理
Xin Lang Cai Jing· 2026-01-05 10:13
Core Viewpoint - The company and its wholly-owned subsidiary, Chengdu Microchip Pharmaceutical, have received a Notice of Acceptance from the National Medical Products Administration for the clinical trial application of its self-developed sustained-release formulation of Siglitazone Sodium and Metformin for the treatment of type 2 diabetes in adult patients, marking a significant step in its drug development pipeline [1] Group 1 - The clinical trial application was accepted on January 5, 2026 [1] - The drug is a fixed-dose combination sustained-release formulation of Siglitazone Sodium and Metformin, with no similar combination formulations currently in clinical trials globally [1] - The company can commence clinical trials if no negative or questioning opinions are received within 60 days from the acceptance date, although there is uncertainty regarding the ability to proceed [1]
微芯生物(688321.SH):西格列他钠二甲双胍缓释片临床试验申请获得受理
Ge Long Hui A P P· 2026-01-05 10:13
Core Viewpoint - Microchip Biotech (688321.SH) has received a clinical trial acceptance notice from the National Medical Products Administration (NMPA) for its self-developed metformin sustained-release tablets, aimed at treating adult patients with type 2 diabetes [1] Group 1 - The company and its wholly-owned subsidiary Chengdu Microchip Pharmaceutical Co., Ltd. have successfully submitted a clinical trial application for the drug [1] - The acceptance of the clinical trial application marks a significant step in the development of the drug for type 2 diabetes treatment [1]
21健讯Daily|去年我国创新药对外授权破千亿美元;益方生物递表港交所
Group 1: Innovation in Pharmaceuticals - In 2025, China approved a record 76 innovative drugs, significantly surpassing the 48 approved in 2024, marking a historical high [1] - The total amount of foreign licensing transactions for innovative drugs in China exceeded $130 billion in 2025, with over 150 transactions, also a historical high [1] - Among the 76 approved innovative drugs, 47 are chemical drugs, 23 are biological products, and 6 are traditional Chinese medicines, with a high proportion of domestic innovations [1] Group 2: Drug Approval and Clinical Trials - China Medical's subsidiary Tianfang Pharmaceutical received approval for clarithromycin tablets, which passed the consistency evaluation for generic drugs [2] - Microchip Biotech announced that its CS08399 tablets for treating tumors with MTAP deficiency have had their clinical trial application accepted [3] - Frontier Biotech's FB7013 injection, targeting MASP-2 for IgA nephropathy, received acceptance for its clinical trial application, marking it as a first-in-class drug [4] Group 3: Capital Market Activities - Yifang Biotechnology submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities as the exclusive sponsor [5] - Wanyi Medical also submitted a listing application to the Hong Kong Stock Exchange, with Guotai Junan International as the exclusive sponsor [6] Group 4: Corporate Investments and Acquisitions - Yunnan Baiyao plans to invest up to 45% of its net assets in financial products in 2026 [7] - Haili Biological's subsidiary intends to acquire 51% stakes in seven dental chain companies for 61.2 million yuan, expecting to increase revenue by approximately 100 million yuan [9] Group 5: Corporate Restructuring and Legal Matters - *ST Chang Pharmaceutical announced that its restructuring investors intend to terminate the restructuring investment agreement [10] - Zai Lab entered a global strategic cooperation and licensing agreement with AbbVie for the development and commercialization of ZG006, with potential milestone payments totaling up to $10.75 billion [11] - Tianyu Biotech's actual controller received a notice from the China Securities Regulatory Commission regarding an investigation into alleged illegal stock reduction [13]
中微公司拟购杭州众硅64.69%股权;天赐材料2025年净利同比预增超127%丨公告精选
Group 1: Company Announcements - Zhongwei Company plans to acquire 64.69% equity of Hangzhou Zhonggui through a combination of share issuance and cash payment, aiming to enhance its capabilities in CMP equipment and solutions [1] - Lixun Precision intends to repurchase shares worth between 1 billion to 2 billion RMB for employee stock ownership plans or equity incentives, with a maximum repurchase price of 86.96 RMB per share [2] - ZaiJing Pharmaceutical has reached a global strategic cooperation and licensing agreement with AbbVie for the development and commercialization of ZG006, receiving an upfront payment of 100 million USD [3] - Tianci Materials expects a net profit increase of 127% to 231% for 2025, driven by significant growth in lithium-ion battery material sales [4] - Meike Home plans to acquire 100% equity of Shenzhen Wande Technology through share issuance and cash payment, with stock resuming trading on January 5, 2026 [6][7] - ST KeliDa is planning a change in control, with stock suspension starting January 5, 2026, due to the transfer of 100% equity of its controlling shareholder [8] - Xinzhou Bang intends to invest approximately 260 million USD in a lithium-ion battery materials project in Saudi Arabia, enhancing its global capacity and supply chain [9] Group 2: Financial Performance - Kid's King anticipates a net profit increase of 51.72% to 82.06% for 2025 [9] - Guangku Technology expects a net profit growth of 152% to 172% for 2025 [9] Group 3: Mergers and Acquisitions - Xidi Micro plans to acquire 100% equity of Chengxin Micro for 310 million RMB [9] - Haili Biological's subsidiary intends to acquire 51% equity of seven dental chain companies for 61.2 million RMB [9]
微芯生物(688321) - 自愿披露关于CS08399片临床试验申请获得受理的公告
2025-12-31 10:31
证券代码:688321 证券简称:微芯生物 公告编号:2026-001 深圳微芯生物科技股份有限公司 自愿披露关于 CS08399 片临床试验申请获得受理的公告 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、准确性和完整性依法承担法律责任。 重要内容提示: 深圳微芯生物科技股份有限公司全资子公司成都微芯药业有限公司(以下简 称"公司")近日收到国家药品监督管理局药物审评中心(以下简称"国家药监 局药审中心")签发的境内生产药品注册临床试验的《受理通知书》,公司自主 研发的 CS08399 片用于治疗甲硫基腺苷磷酸化酶(MTAP)缺失的实体瘤和淋巴 瘤的临床试验申请获得受理。 本次申请为新药临床试验申请,在临床试验申请获得受理后,自受理之日起 60 日内未收到国家药监局药审中心的否定或质疑意见的,公司便可以按照提交 的方案开展临床试验。临床试验能否最终开展存在不确定性,敬请广大投资者注 意防范投资风险,谨慎决策。现将相关情况公告如下: 一、药品基本情况 1、产品名称:CS08399 片 受理号:CXHL2501515、CXHL2501516 受理日期:20 ...
微芯生物(688321) - 中证鹏元关于关注深圳微芯生物科技股份有限公司总经理、法定代表人变更事项的公告
2025-12-31 10:31
中证鹏元公告【2025】612 号 中证鹏元关于关注深圳微芯生物科技股份有限公司总经理、 法定代表人变更事项的公告 中证鹏元资信评估股份有限公司(以下简称"中证鹏元")对深 圳微芯生物科技股份有限公司(以下简称"微芯生物"或"公司", 股票代码:688321.SH)及其发行的下述债券开展评级。除评级委托 关系外,中证鹏元及评级从业人员与公司不存在任何足以影响评级行 为独立、客观、公正的关联关系。 | 债券简称 | 上一次评级时间 | 上一次评级结果 | | | | --- | --- | --- | --- | --- | | | | 主体等级 | 债项等级 | 评级展望 | | 微芯转债 | 2025-6-25 | A+ | A+ | 稳定 | 根据公司于 2025 年 12 月 24 日发布的《深圳微芯生物科技股份 有限公司关于聘任总经理、变更法定代表人的公告》,公司总经理由 XIANPING LU 博士变更为黎建勋先生,法定代表人由公司 XIANPING LU 博士变更为海鸥女士。XIANPING LU 博士仍担任公司董事长职务,为 公司实际控制人。 中证鹏元资信评估股份有限公司 根据公告,黎建勋先生历 ...
微芯生物(688321.SH):CS08399片临床试验申请获得受理
Ge Long Hui· 2025-12-31 10:00
Core Viewpoint - Micron Biomedical (688321.SH) has received the acceptance notice for the clinical trial application of its self-developed CS08399 tablets from the National Medical Products Administration (NMPA) for the treatment of solid tumors and lymphomas with methionine adenosine phosphorylase (MTAP) deficiency [1] Group 1 - The clinical trial application is specifically aimed at treating solid tumors and lymphomas associated with MTAP deficiency [1]
医药行业2026年度策略报告:产业趋势明确,创新药产业链是2026年医药板块主线-20251229
HUAXI Securities· 2025-12-29 12:01
Group 1 - The core investment theme for the pharmaceutical sector in 2026 is the innovation drug industry chain, with a clear trend towards international business development and accelerated commercialization of domestic products [2][3]. - The CXO sector is experiencing continuous improvement in performance and orders, supported by favorable financing conditions that benefit the industry's upward trajectory [3]. - The medical device sector is focusing on two main lines: international expansion and innovation [3]. Group 2 - The latest trends in medical insurance show a decline in total expenditure for the first ten months of 2025, amounting to 1,903.6 billion yuan, a year-on-year decrease of 1% [5][7]. - The total income of the medical insurance fund for the same period reached 2,352 billion yuan, with a year-on-year growth of 2%, indicating a slowdown in income growth [7][11]. - The number of medical insurance beneficiaries and hospitalization cases continues to grow, with 6.07 billion total beneficiaries in 2024, a year-on-year increase of 18% [11]. Group 3 - The average medical insurance cost per visit decreased in 2024, with the average cost for employees at 629 yuan (down 10%) and for residents at 351 yuan (down 12%) [15]. - The average hospitalization cost also saw a decline, with employees averaging 11,707 yuan (down 3.8%) and residents at 7,408 yuan (down 3.5%) [15]. Group 4 - The Chinese pharmaceutical industry is witnessing a significant increase in license-out transactions, with over 100 deals completed in 2025, totaling more than 110 billion USD [21][32]. - The number of license-out transactions involving upfront payments exceeding 100 million USD has also risen, indicating a growing interest from global pharmaceutical companies in Chinese innovations [21][32]. - The ADC (Antibody-Drug Conjugate) market is expanding rapidly, with a projected market size exceeding 16 billion USD in 2025, driven by several successful product launches [38]. Group 5 - The Chinese government is actively supporting the innovation drug sector through various policies aimed at enhancing accessibility and encouraging high-quality innovation [16][18]. - The proportion of medical insurance spending on innovative drugs is steadily increasing, with 149 innovative drugs included in the insurance coverage over the past seven years [90][94]. - The average price reduction for innovative drugs during negotiations with the national medical insurance has been around 60%, with some drugs seeing reductions as high as 94% [88][94].
年末换帅潮起!多家上市药企12月密集调整核心管理层
Zhong Guo Jing Ji Wang· 2025-12-29 09:15
Group 1 - In December, several leading pharmaceutical companies experienced significant executive changes, including Guoyao Holdings, BeiGene, and Zhendong Pharmaceutical [1][2] - Kexin Pharmaceutical announced the election of Li Hongfu as the chairman of its fourth board of directors on December 1 [1] - Kang En Bei reported that Jiang Yi resigned from multiple positions, including chairman, on December 6 due to work adjustments [1] Group 2 - WuXi AppTec appointed Tian Feng as the CEO and executive director, effective December 29, 2025 [2] - Alibaba Health announced the resignation of Zhu Shunyan as non-executive director and chairman, with current CEO Shen Difan taking over as chairman [2] - Sangfor Technologies reported the resignation of core technical personnel, Weng Zhibing, from all positions in its wholly-owned subsidiary on December 16 [2] Group 3 - Zhendong Pharmaceutical announced that Yang Lianmin resigned from his positions due to reaching retirement age on December 18 [2] - BeiGene appointed Dr. Wang Lai as president and global head of R&D, effective December 19 [2] - Guoyao Holdings announced Jin Bin as the new chairman on December 19, following the resignation of Zhao Bingxiang [2] Group 4 - Shijiazhuang Pharmaceutical Group reported that Zhang Cuilong stepped down from multiple roles, while Cai Lei was appointed as vice chairman and CEO on December 19 [3] - Weichuang Bio announced the appointment of Li Jianxun as general manager, while Chairman Lu Xianping stepped down from the general manager role on December 23 [3] - Shandong Pharmaceutical Glass reported that Chairman Hu Yonggang resigned from all positions due to age, with General Manager Zhang Jun taking over the chairman's responsibilities on December 24 [3]
微芯生物管理层调整,20年老将黎建勋掌舵经营接棒总经理,董事长鲁先平退居战略层
Mei Ri Jing Ji Xin Wen· 2025-12-24 12:53
每经记者|甄素静 每经编辑|黄博文 12月23日晚间,微芯生物(SH688321,股价28.72元,市值117.12亿元)公告称,拟聘任在公司任职超 20年的黎建勋为总经理,全面负责日常经营管理;董事长XIANPING LU(中文名为"鲁先平")辞任公 司总经理及法定代表人,仍保留董事长职务,工作重心转向企业战略规划、国际业务拓展等事务。 同日,微芯生物披露股份回购实施结果,以1500万元资金完成回购,达到方案上限,回购股份拟用于员 工持股计划或股权激励。 《每日经济新闻》记者注意到,此次人事调整与资本动作同步落地,正值微芯生物两款原创新药规模化 销售、业绩扭亏为盈的阶段。 对于此次人事调整和任命,微芯生物在接受记者采访时表示,本次任命是公司在前期探索基础上,为适 应新发展阶段需求而做出的制度化安排,旨在保障公司长期、稳健、高质量的发展。今后的分工将更为 专业、聚焦,决策链条更为清晰,执行效率有望进一步提升。 根据公告,微芯生物第三届董事会第十九次会议审议通过相关议案,同意聘任黎建勋为公司总经理,任 期自本次董事会审议通过之日起至第三届董事会任期届满之日为止。 对此,微芯生物表示,鲁先平不存在应履行而未履行的 ...