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]

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]

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]

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]

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 ...

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 ...

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]

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].

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]

Core Viewpoint - Micron Biomedical announced the appointment of Li Jianxun as General Manager, while Chairman Lu Xianping will focus on strategic planning and international business expansion, coinciding with the company's new drug sales and profitability turnaround [1][2] Management Changes - Li Jianxun has been with Micron Biomedical for over 20 years and has held various positions, indicating the company's recognition of his management capabilities [2] - Lu Xianping will remain as Chairman and will not affect the company's normal operations despite resigning as General Manager [2][3] Share Buyback and Financial Performance - The company completed a share buyback of 15 million yuan, reaching the plan's upper limit, intended for employee stock ownership plans or equity incentives [1] - For the first three quarters of 2025, Micron Biomedical reported revenue of 674 million yuan, a year-on-year increase of 40.12%, and a net profit of 70.77 million yuan, marking a turnaround from losses [3] Product Sales and Market Expansion - The sales of core products, Xidabena and Xiglitazone, have significantly contributed to revenue growth, with Xiglitazone's sales increasing by 136.13% year-on-year [3][5] - Xidabena has become the only oral innovative drug for DLBCL under national medical insurance, enhancing its market position [5] Strategic Focus - The management restructuring aims to optimize the management hierarchy and enhance focus on R&D and international market opportunities [3] - The company is actively pursuing global development for its innovative drugs and expanding its business team to attract interest from overseas enterprises [5]