西达本胺
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微芯生物(688321.SH):澳门药物监督管理局批准西达本胺上市
Ge Long Hui· 2026-01-07 08:28
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)、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。 格隆汇1月7日丨微芯生物(688321.SH)公布,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 批准公司的西达本胺片上市。 ...
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].
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 ...
“安永企业家奖”2025出炉,十二位企业家上榜
Di Yi Cai Jing Zi Xun· 2025-12-15 01:32
2025年12月5日,第二十届"安永企业家奖"评选结果揭晓。今年是"安永企业家奖"落地中国内地、香港 及澳门的第二十年,二十年间,这个舞台先后走出了232位中国商业精英,而今年的获奖者阵容尤为引 人注目——12位来自中国内地和香港/澳门的获奖者中,既有在生命科学领域攻克原创药研发难关的科 学家型企业家,也有在精密制造领域深耕数十年的实业家,更有在人工智能、芯片设计等前沿赛道开拓 疆域的创新者。 其中,深圳微芯生物科技股份有限公司创始人、董事长兼总经理鲁先平,东江集团(控股)有限公司主 席兼执行董事李沛良,分别获得"安永企业家奖"2025中国内地大奖以及"安永企业家奖"2025中国香港/ 澳门大奖。 "让中国人用得起全球竞争力的原创新药。"二十多年前,面对被仿制药主导的中国,作为科学家的鲁先 平看到的是患者"无药可用"或"天价用药"的困境。"我们有责任去改变这种现状",一颗原创新药的种子 自此埋下。 带着技术和人才,鲁先平回到深圳创办微芯生物,自此踏上中国创新药"从0到1"的拓荒之路。如今,这 家初创企业已孕育出西达本胺、西格列他钠两款全球首创药物,成为中国医药创新史上的标杆。 从诞生起,微芯生物就锚定"源头创 ...
“安永企业家奖”2025出炉,十二位企业家上榜
第一财经· 2025-12-15 01:21
2025 年 12 月 5 日,第二十届 " 安永企业家奖 " 评选结果揭晓。今年是 " 安永企业家奖 " 落地中国 内地、香港及澳门的第二十年,二十年间,这个舞台先后走出了 232 位中国商业精英,而今年的获 奖者阵容尤为引人注目 ——12 位来自中国内地和香港/澳门的获奖者中,既有在生命科学领域攻克 原创药研发难关的科学家型企业家,也有在精密制造领域深耕数十年的实业家,更有在人工智能、芯 片设计等前沿赛道开拓疆域的创新者。 其中,深圳微芯生物科技股份有限公司创始人、董事长兼总经理鲁先平,东江集团(控股)有限公司 主席兼执行董事李沛良,分别获得"安永企业家奖" 2025 中国内地大奖以及"安永企业家奖" 2025 中 国香港 / 澳门大奖。 " 让中国人用得起全球竞争力的原创新药。 " 二十多年前,面对被仿制药主导的中国,作为科学家的 鲁先平看到的是患者 " 无药可用 " 或 " 天价用药 " 的困境。 " 我们有责任去改变这种现状 " ,一颗 原创新药的种子自此埋下。 带着技术和人才,鲁先平回到深圳创办微芯生物,自此踏上中国创新药 " 从 0 到 1" 的拓荒之路。如 今,这家初创企业已孕育出西达本胺、西 ...
安永企业家奖2025获奖企业家介绍专辑(一)
Sou Hu Cai Jing· 2025-12-09 08:28
Group 1: EY Entrepreneur Of The Year 2025 Awards - The EY Entrepreneur Of The Year 2025 awards were announced on December 5, recognizing twelve outstanding entrepreneurs from mainland China and Hong Kong/Macau [2] - Dr. Lu Xianping, founder and CEO of Microchip Biotech Co., Ltd., and Li Peiliang, Chairman and Executive Director of Dongjiang Group (Holdings) Limited, won the Grand Prize, representing mainland China and Hong Kong/Macau respectively [2] - Both winners will compete for the EY Global Entrepreneur Of The Year 2026 award [2] Group 2: Dr. Lu Xianping and Microchip Biotech - Dr. Lu Xianping is a prominent scientist and entrepreneur in China's innovative drug sector, holding a Ph.D. in Molecular Biology from Peking Union Medical College [4] - He founded Microchip Biotech in 2001 with a mission to develop affordable innovative drugs, focusing on first-in-class drugs with new mechanisms of action [4] - Under his leadership, the company developed the first original chemical drug for cancer in China, which has been included in the national medical insurance, significantly reducing patient burdens [4][5] Group 3: Li Peiliang and Dongjiang Group - Li Peiliang is recognized for integrating philosophical thinking into business practices, leading Dongjiang Group from a small mold factory in Hong Kong to a global leader in precision injection molding solutions [8] - The company was listed on the Hong Kong Stock Exchange in 2013 and has become the largest exporter of injection molds in China [8] - Li emphasizes a business philosophy focused on risk control and professionalism, and has implemented Industry 4.0 smart production lines to enhance operational efficiency [8]
第20届“安永企业家奖”结果揭晓!12位获奖者脱颖而出,多数来自科技公司
Zheng Quan Shi Bao Wang· 2025-12-08 00:33
安永表示,今年的获奖者中,来自科技行业、生命科学与医疗健康、制造业及服务业的企业家,无一不 通过科技赋能,革新产品和营运模式,在创新的道路上筑梦前行。 其中,云天励飞董事长兼CEO陈宁,于2014年创立云天励飞,带领团队自主研发神经网络处理器(NPU) 架构,打造国际领先的多模态大模型与NPU平台,承担六项国家级人工智能重大专项,构建起纯国产工 艺的NPU产业生态。在他的带领下,云天励飞成功推出四代自研NPU芯片,率先实现国产高算力AI推 理芯片商业化,2023年公司成功登陆科创板,成为中国AI芯片领域的领军企业。 (原标题:第20届"安永企业家奖"结果揭晓!12位获奖者脱颖而出,多数来自科技公司) 日前,第20届"安永企业家奖"评选结果揭晓,12位来自中国内地、香港及澳门的企业家脱颖而出,获得 殊荣。其中多位来自科技类上市公司,包括来自云天励飞、云知声、赤子城科技、东芯股份、威胜信 息、微芯生物等上市公司的企业家。 "安永企业家奖"是全球最具影响力的国际商业奖项之一,自1986年创办以来,已扩展至全球79个国家和 地区。该奖项旨在表彰那些以非凡远见、卓越领导力和创新精神,对行业发展和社会进步产生深远影响 的 ...
2026-2032年HDAC、PI3Kα双靶向抑制剂行业发展现状与投资战略规划可行性报告-中金企信发布
Sou Hu Cai Jing· 2025-12-04 01:59
报告发布方:中金企信国际咨询 项目可行性报告&商业计划书专业权威编制服务机构(符合发改委印发项目可行性研究报告编制要求)-中金企信国际咨询:集13年项目编制服务经验为各 类项目立项、投融资、商业合作、贷款、批地、并购&合作、投资决策、产业规划、境外投资、战略规划、风险评估等提供项目可行性报告&商业计划书编 制、设计、规划、咨询等一站式解决方案。助力项目实施落地、提升项目单位申报项目的通过效率。 (1)HDAC/PI3Kα双靶向抑制剂作用机制介绍: PI3K(Thephosphatidylinositol3-kinase)是一类高度保守的酶家族,是胞内PI3K-Akt-mTOR信号通路的重要组成部分。PI3K-Akt-mTOR信号通路中信号转导 的很多成员分子,都是癌症、免疫及控制血栓形成等过程中的关键药物靶点。PI3K本身具有丝氨酸/苏氨酸(Ser/Thr)激酶的活性,也具有磷脂酰肌醇激酶 的活性。PI3K可分为3类,其结构与功能各异。其中研究最广泛的为I类PI3K,此类PI3K为异源二聚体,由一个调节亚基和一个催化亚基组成。 当接受来自酪氨酸激酶和G蛋白偶联受体的信号后,PI3K的p85调节亚基即被募集到临 ...
大股东完成减持套现超3亿元!微芯生物同步推进9.5亿元定增融资 拟投入创新药研发和制造基地建设
Mei Ri Jing Ji Xin Wen· 2025-11-26 16:32
Core Viewpoint - The major shareholder of Microchip Biotech, Boao Biological Group, has completed a share reduction plan, selling 12.23 million shares, which is 3% of the company's total equity, for approximately 322 million yuan. This reduction will not significantly impact the company's governance structure or operations [2][7][8]. Group 1: Shareholder Actions - Boao Biological Group, the largest shareholder of Microchip Biotech, held 34.71 million shares (8.51% of total equity) before the reduction [7]. - The share reduction was initiated on September 11, 2025, due to strategic funding needs, with a plan to sell up to 12.23 million shares through a combination of centralized bidding and block trading [7][8]. - The reduction was executed between October 14 and November 26, 2025, with a total of 407.80 million shares sold through centralized bidding and 815.59 million shares through block trading, at prices ranging from 23.59 yuan to 31.10 yuan per share [8]. Group 2: Company Financing Plans - Microchip Biotech is advancing a plan to issue A-shares to specific investors, aiming to raise up to 950 million yuan for innovative drug research, the construction of a new drug manufacturing base, and to supplement working capital [9]. - The fundraising plan has been approved by the company's board and shareholders, pending approval from the Shanghai Stock Exchange and registration with the China Securities Regulatory Commission [9]. - The funds will be allocated as follows: 350 million yuan for innovative drug research, 350 million yuan for the first phase of the new drug manufacturing base, and 250 million yuan for working capital [11]. Group 3: Research and Development Focus - Microchip Biotech is focusing on multiple key Phase II and III clinical trials, including a Phase II study for a combination treatment for advanced pancreatic ductal adenocarcinoma and a Phase III study for a colorectal cancer indication [11][12]. - The company reported significant revenue growth for its products, with a 125.7% year-on-year increase for one drug in the first half of 2025 and an 18.8% increase for another in the same period [11][12].
大股东完成减持套现超3亿元!微芯生物同步推进9.5亿元定增融资,拟投入创新药研发和制造基地建设
Sou Hu Cai Jing· 2025-11-26 16:21
Core Viewpoint - The major shareholder of Microchip Biotech, Boao Biological Group, has completed a share reduction plan, selling 12.23 million shares, which is 3% of the company's total shares, for approximately 322 million yuan. This reduction will not significantly impact the company's governance structure or operations [1][5][6]. Group 1: Shareholder Actions - Boao Biological Group, the largest shareholder of Microchip Biotech, has reduced its holdings from 8.51% to 5.51% after selling 12.23 million shares [6]. - The share reduction was executed between October 14 and November 26, 2025, with a total sale amount of 322 million yuan, and the share price ranged from 23.59 yuan to 31.10 yuan [6][5]. - The market reaction to the share reduction was minimal, with only a 0.32% decline in the stock price during the reduction period [6]. Group 2: Fundraising and Investment Plans - Microchip Biotech is advancing a plan to issue A-shares to specific investors, aiming to raise up to 950 million yuan for innovative drug research, the construction of a new drug manufacturing base, and to supplement working capital [7][8]. - The fundraising plan has been approved by the company's board and shareholders, pending regulatory approval from the Shanghai Stock Exchange and the China Securities Regulatory Commission [7]. - The allocation of the raised funds includes 350 million yuan for innovative drug research, 350 million yuan for the first phase of the new drug manufacturing base, and 250 million yuan for working capital [7][8]. Group 3: Drug Development Progress - Microchip Biotech is focusing on multiple key Phase II and III clinical trials, including a Phase II study for a combination treatment for advanced pancreatic cancer and a Phase III trial for a colorectal cancer treatment [8][9]. - The company reported significant revenue growth for its drugs, with a 125.7% increase for one drug in the first half of 2025 and an 18.8% increase for another in the same period [8][9].