这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 国家药监局：优化临床急需境外已上市药品审评审批 央视新闻消息显示，为加快临床急需境外已上市药品在境内上市，满足患者临床用药迫切需求，国家药 监局进一步优化这类药品审评审批。 国家药监局表示，坚持以临床价值为导向，鼓励申请人在中国开展全球同步研发、同步申报上市；鼓励 临床急需境外已上市的原研药及仿制药在境内申报，对于符合要求的可纳入优先审评审批范围。 药械审批 亿帆医药：全资子公司收到易黄汤颗粒境内生产药品注册受理通知书 1月7日，亿帆医药公告称，公司全资子公司宿州亿帆药业有限公司于2026年1月6日收到国家药品监督管 理局签发的易黄汤颗粒境内生产药品注册上市许可申请《受理通知书》。易黄汤颗粒是公司申报注册的 第一个经典名方品种，其功能主治为固肾止带，清热祛湿。 正海生物：公司获得医疗器械注册申请《受理通知书》 1月7日，微芯生物(688321.SH)公告称，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。西达本胺是全球首个亚型选择性组蛋白 ...

证券代码：688321 证券简称：微芯生物 公告编号：2026-004 近日，中华人民共和国澳门特别行政区药物监督管理局（以下简称"ISAF"）官方网站公示，ISAF批准 深圳微芯生物科技股份有限公司（以下简称"公司"）的西达本胺片上市，现将相关情况公告如下： 深圳微芯生物科技股份有限公司 自愿披露关于澳门药物监督管理局批准西达本胺上市的公告 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： 一、药品基本情况 名称：西达本胺片 药品类别：1类新药 持有人：深圳微芯生物科技股份有限公司 西达本胺（Chidamide；商品名为"爱谱沙/Epidaza"）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（License-out）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） ...

中科蓝讯：2025年净利润同比预增366.51%-376.51% 1月7日晚，中科蓝讯(688332)发布公告称，公司预计2025年归属于母公司所有者的净利润为14.00亿元到 14.30亿元，与上年同期相比增加366.51%到376.51%。业绩大幅增长主要系公司投资摩尔线程和沐曦股 份取得的公允价值变动收益显著增加，导致非经常性损益同比大幅上升。 川金诺：2025年净利润同比预增144.24%–172.64% 1月7日晚，川金诺(300505)1月7日晚间发布业绩预告，预计2025年归母净利4.3亿元—4.8亿元，同比增 长144.24%—172.64%。 北方导航：在商业航天领域无相关业务 也未取得相关订单 1月7日晚，北方导航(600435)发布股票交易异常波动公告，近期，部分网站、股吧将公司股票纳入商业 航天板块。本公司从未发布过相关公告，且公司在商业航天领域无相关业务，也未取得相关订单。 光启技术：签订2.64亿元超材料产品批产合同 1月7日晚，光启技术(002625)发布公告称，近日收到全资子公司深圳光启尖端技术有限责任公司（简 称"光启尖端"）的通知，光启尖端与某客户签订了合计2.15亿元的超 ...

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。 ...

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。 ...

Audit Opinion - The audit report states that the financial statements of Shenzhen Micu Biotechnology Co., Ltd. (referred to as "Micu Bio") fairly reflect its financial position as of December 31, 2024, in accordance with the accounting standards issued by the Ministry of Finance of the People's Republic of China [1][2]. Key Audit Matters - Capitalization of development expenditures amounted to RMB 125,271,997.57 for the year 2024, with a cumulative balance of RMB 152,216,111.48 as of December 31, 2024. The audit identified this as a key audit matter due to significant management judgment involved in determining whether the expenditures meet the capitalization criteria [1][2][3]. - The audit procedures included evaluating internal controls related to the capitalization of development expenditures, obtaining relevant approvals and feasibility reports, and assessing the technical feasibility of the projects [1][2]. Company Overview - Shenzhen Micu Biotechnology Co., Ltd. was established on March 29, 2018, and is primarily engaged in drug technology development, new drug research, and production of pharmaceuticals and health food [5][6]. - The company operates under the accounting standards set by the Ministry of Finance and adheres to the disclosure requirements of the China Securities Regulatory Commission [5][6]. Financial Reporting Basis - The financial statements are prepared on a going concern basis, indicating that the company has the ability to continue its operations for at least 12 months from the reporting date without significant uncertainties [5][6]. Accounting Policies - The company has specific accounting policies for recognizing and measuring bad debt provisions, inventory valuation, and the capitalization of research and development costs, which are tailored to its operational characteristics [6][7]. - The financial statements comply with the requirements of the Ministry of Finance and reflect the company's financial condition and results of operations accurately [6][7]. Financial Instruments - The company classifies its financial assets and liabilities based on their management business model and cash flow characteristics, with initial recognition at fair value [10][11]. - Financial assets are subsequently measured at either amortized cost or fair value, depending on their classification [10][11].

Core Insights - Guangdong Province has approved a list of 107 innovative drug and medical device products, including 46 innovative drugs, to enhance the application of these products in public medical institutions [1][5] - Among the approved innovative drugs, 10 are anti-cancer drugs, representing 22% of the total, showcasing Guangdong's strength in cancer treatment research and manufacturing [3][5] Summary by Category Innovative Drug List - The list includes 107 innovative products, with 46 classified as innovative drugs [1] - The anti-cancer drugs cover various prevalent malignant tumors, indicating significant research capabilities in this area [3] Anti-Cancer Drugs - The 10 anti-cancer drugs listed include: - Aorebatinib for chronic myeloid leukemia - Sapalizumab for cervical cancer and Hodgkin lymphoma - Socazolimab for cervical cancer - Sidabenzamide for diffuse large B-cell lymphoma - Cardunilimab for cervical cancer and gastric adenocarcinoma - Acetate injection for prostate cancer - Trelizumab for multiple cancers including Hodgkin lymphoma and non-small cell lung cancer - Panitumumab for multiple cancers including non-small cell lung cancer - Obinutuzumab for adult lymphomas - Ivorilumab for lung cancer [4] Industry Development - Guangdong pharmaceutical companies are accelerating their internationalization, exemplified by the approval of Panitumumab for the U.S. market [5] - The integration of industry, academia, and research has been pivotal in the development of these innovative drugs, with local scholars leading significant research efforts [5] - The comprehensive innovation capability from research to clinical application is being established, enhancing Guangdong's competitive edge in the global biopharmaceutical industry [5]