人民财讯1月7日电，微芯生物(688321)1月7日公告，近日，中华人民共和国澳门特别行政区药物监督管 理局(简称"ISAF")官方网站公示，ISAF批准公司的西达本胺片上市。 ...

Core Viewpoint - Microchip Biotech (688321.SH) has received approval from the Macao Special Administrative Region's Drug Regulatory Authority (ISAF) for the marketing of Chidamide tablets, marking a significant milestone for Chinese innovative drugs in the global market [1] Group 1: Product Approval - ISAF has officially approved the marketing of Chidamide (brand name "Epidaza") [1] - Chidamide is the world's first subtype-selective histone deacetylase (HDAC) inhibitor [1] - This approval represents a pioneering achievement for Chinese innovative drugs in obtaining license-out agreements with Europe and the United States [1] Group 2: Indications and Clinical Trials - Chidamide has been approved for three indications in mainland China: peripheral T-cell lymphoma, breast cancer, and diffuse large B-cell lymphoma [1] - In Japan, it has been approved for adult leukemia and peripheral T-cell lymphoma [1] - In Taiwan, it has been approved for breast cancer [1] - The company is currently conducting Phase III clinical trials for follicular helper T-cell phenotype peripheral T-cell lymphoma (PTCL-TFH), colorectal cancer (CRC), and melanoma (MM) in China and overseas [1]

微芯生物公告，近日，中华人民共和国澳门特别行政区药物监督管理局（ISAF）官方网站公示，ISAF 批准公司西达本胺片上市。西达本胺是全球首个亚型选择性组蛋白去乙酰化酶（HDAC）抑制剂，开创 了中国创新药对欧美专利授权的先河。西达本胺在中国大陆已获批外周T细胞淋巴瘤、乳腺癌、弥漫大 B细胞淋巴瘤三个适应症、在日本已获批成人白血病和外周T细胞淋巴瘤两个适应症、在中国台湾已获 批乳腺癌适应症，目前正在中国及海外开展滤泡辅助T细胞表型外周T细胞淋巴瘤（PTCL-TFH）、结直 肠癌（CRC）、黑色素瘤（MM）的III期临床试验及其它临床探索研究。 ...

Core Viewpoint - Microchip Biotech (688321.SH) has received the acceptance notice for the clinical trial application of its self-developed drug, Siglitazone Metformin Sustained-Release Tablets, for the treatment of type 2 diabetes in adult patients from the National Medical Products Administration [1] Group 1 - The company and its wholly-owned subsidiary, Chengdu Microchip Pharmaceutical Co., Ltd., have recently received the acceptance notice for the clinical trial application [1] - The Siglitazone Metformin Sustained-Release Tablets are a fixed-dose combination formulation of Siglitazone and Metformin, developed by the company [1] - This drug aims to provide better blood glucose control for patients with type 2 diabetes through different mechanisms of action [1]

Core Viewpoint - Microchip Biotech (688321) has received acceptance for its clinical trial application for the combination drug of Siglecatin Sodium and Metformin Hydrochloride for treating adult patients with type 2 diabetes from the National Medical Products Administration [1] Group 1 - The company and its wholly-owned subsidiary Chengdu Microchip Pharmaceutical Co., Ltd. have recently received the acceptance notice for the clinical trial application [1] - The clinical trial application is for a self-developed drug, which is a combination of PPAR full agonist and Metformin [1] - Currently, there are no PPAR full agonist and Metformin combination formulations in clinical trial stages globally [1]

●累计转股情况：截至 2025 年 12 月 31 日，"微芯转债"累计 有人民币 404,000 元已转换为公司股票，转股数量为 15,957 股，占 "微芯转债"转股前公司已发行股份总额的 0.0039%； ●未转股可转债情况：截至 2025 年 12 月 31 日，"微芯转债" 尚未转股的可转债金额为人民币 499,596,000 元，占"微芯转债" 发行总量的 99.9192%。 一、可转债发行上市概况 经中国证券监督管理委员会"证监许可[2022]1234 号"文同意 注册，公司于 2022 年 7 月 5 日向不特定对象发行可转换公司债券 500.00 万张，每张面值为人民币 100 元，发行总额为人民币 | 证券代码：688321 | 证券简称：微芯生物 | 公告编号： 2026-002 | | --- | --- | --- | | 转债代码：118012 | 转债简称：微芯转债 | | 深圳微芯生物科技股份有限公司 关于可转债转股结果暨股份变动的公告 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 ...

获得受理的公告 证券代码：688321 证券简称：微芯生物 公告编号：2026-003 深圳微芯生物科技股份有限公司 自愿披露关于西格列他钠二甲双胍缓释片临床试验申请 治疗的 2 型糖尿病成人患者，以改善此类患者的血糖控制 申请事项：新药临床试验申请 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（以下简称"公司"）及全资子公司成都微 芯药业有限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 主研发的西格列他钠二甲双胍缓释片治疗 2 型糖尿病成人患者的临床试验申请 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：西格列他钠二甲双胍缓释片 ...

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]