重组人白蛋白注射液(水稻)

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首个重组人白蛋白注射液(水稻)在汉上市
Jing Ji Guan Cha Bao· 2025-09-05 13:04
据禾元生物方面介绍,该重组人白蛋白注射液(水稻)是利用水稻胚乳细胞表达,经提取、纯化的重组 人血清白蛋白产品。2024年9月,该产品获得国家药监局NDA受理,被纳入优先审评审批程序。2025年 7月18日,获得国家药监局批准上市,是全球首个获批上市的植物源重组人白蛋白注射液。 禾元生物董事长杨代常在论坛致辞中表示,奥福民获批上市并已完成首批患者临床应用,是我国生物医 药领域的一项重大突破,更是解决临床"救命药"供应安全问题的里程碑事件。禾元生物将加产业化基地 建设,早日投产实现自主研发的国产替代,保障国家药品供应安全。同时启动在FDA法规下的国际多中 心三期临床试验,拓展适应症研究,让全世界患者用上安全、可及的"中国造"重组人白蛋白。 据禾元生物官网介绍,人血清白蛋白广泛用于肝硬化腹水、脑水肿,失血性休克、严重烫伤烧伤、术后 扩充血容量和癌症的放化疗等治疗,还在药物辅料、干细胞、细胞治疗、培养基添加剂、细胞冻存保护 剂与疫苗赋形剂等具有广泛用途,在我国市场需求约为1000吨/年,据2024年中检院批签发数据,进口 占比达到69%。传统人血白蛋白依赖血浆提取,潜藏血源安全风险,同时在人口老龄化加剧、献血率走 低 ...
中国生物产业大会上的“黑科技”目不暇接
Chang Jiang Ri Bao· 2025-09-05 00:45
9月4日,第十七届中国生物产业大会在光谷科技会展中心开幕,本届大会以"生物科技 赋能未来 生物制造重塑世界"为主题,立足"高端化、专业化、国际化、市场化"。众多知名 企业带"黑科技"亮相展会,集中展示全球最前沿的新技术、新产品、新应用,让人目不暇 接。 联影医疗展示的5T磁共振成像系统。 编辑:宗夏 禾元生物展示的重组人白蛋白注射液(水稻)。 华大智造展示的组织切片在时空芯片的应用。 光谷生物城展区展示的光学脑机接口,近红外脑功能成像装置,吸引外宾的关注。 ...
人民日报头版关注 “武汉造”
Ren Min Ri Bao· 2025-08-17 13:19
Core Viewpoint - The article emphasizes the importance of developing new quality productivity in Wuhan, highlighting the city's efforts in traditional industry transformation, emerging industry growth, and future industry layout, driven by technological innovation and government support [14][15][17]. Group 1: Traditional Industry Transformation - Wuhan's Dongfeng Motor Corporation has developed a new energy vehicle equipped with a domestically produced high-performance microcontroller chip, set to be mass-produced next year [15]. - The city's automotive industry has seen significant growth, with new energy vehicle production reaching 168,000 units in the first half of the year, a year-on-year increase of 152% [15]. - Traditional industries in Wuhan are undergoing revitalization, with examples such as the transformation of the old WISCO plant into a green super factory and the digitalization of the century-old pharmaceutical brand, Mayinglong [15][16]. Group 2: Emerging Industry Development - Wuhan's optical electronics industry, particularly in the "China Optics Valley," is expanding with a focus on innovation and industry chain improvement, aiming for over 20% annual growth [16]. - The scale of the optical fiber and cable industry in Wuhan has surpassed 600 billion yuan, showcasing the city's strength in this sector [16]. - Companies like Changfei Optical Fiber and Huagong Technology are leading advancements in optical technology, enhancing signal transmission speeds and precision manufacturing capabilities [16]. Group 3: Future Industry Layout - Wuhan is making strides in the field of brain-computer interfaces, with the first clinical application and surgery completed in the region, indicating rapid advancements in this cutting-edge technology [17]. - The city is focusing on 13 key areas, including humanoid robots and new energy storage, to establish a competitive future industry landscape [17]. - The local government is committed to integrating technological innovation with existing industries to enhance productivity and quality, aligning with national development goals [17].
奋勇争先,决战决胜“十四五”|因地制宜发展新质生产力——“武汉造”攀高逐新活力足
Ren Min Ri Bao· 2025-08-16 04:06
Core Insights - Wuhan's He Yuan Biotechnology Co., Ltd. has received approval from the National Medical Products Administration for its recombinant human albumin injection, which is aimed at treating liver cirrhosis with hypoalbuminemia, showcasing the city's innovation capabilities [1] - The high-tech manufacturing sector in Wuhan experienced a 15.7% year-on-year increase in added value in the first half of the year, accounting for 24.6% of the total industrial added value [1] - Wuhan is focusing on transforming traditional industries and nurturing emerging sectors, with a goal to build a modern industrial system and enhance competitive advantages [1][5] Traditional Industry Transformation - Dongfeng Motor Corporation, headquartered in Wuhan, has developed a new energy vehicle equipped with the DF30 chip, which has passed cold climate testing and is set for mass production next year [1] - The automotive industry is a pillar of Wuhan's economy, with new energy vehicle production exceeding 168,000 units in the first half of the year, marking a 152% year-on-year increase [2] Emerging Industry Development - Wuhan's optical electronics sector is a key strength, with the East Lake High-tech Development Zone expanding its innovation and industrial chains [2] - Changfei Optical Fiber and Cable Co., Ltd. has launched air-core optical fibers, significantly enhancing signal transmission speed [2] - The "Optical-Core-Screen-End-Network" industry in the East Lake area has surpassed 600 billion yuan in scale [2] Future Industry Layout - Wuhan is making strides in the field of brain-computer interfaces, having launched medical service pricing for this technology and completed the first implant surgery in Central China [4] - The city is targeting 13 sub-sectors, including brain-computer interfaces and humanoid robots, to establish a competitive future industry development hub [4] Government Support and Vision - The government is actively supporting the automotive industry's technological advancements through collaborative efforts among various stakeholders [2] - Wuhan aims for an annual growth rate of over 20% in emerging industries, reflecting its commitment to enhancing quality and efficiency [3] - The local government emphasizes the importance of technological innovation in building a modern industrial system and achieving high-quality development [5]
奋勇争先,决战决胜“十四五”丨“武汉造”攀高逐新活力足
Ren Min Ri Bao· 2025-08-16 02:15
Core Viewpoint - Wuhan's biotechnology and high-tech manufacturing sectors are experiencing significant growth and innovation, exemplified by the approval of a recombinant human albumin injection and advancements in electric vehicle technology [1][2]. Traditional Industry Transformation and Upgrading - Dongfeng Motor Corporation's new energy vehicles equipped with the DF30 chip have passed cold climate testing, with plans for mass production next year [2]. - The automotive industry in Wuhan has seen a 152% year-on-year increase in new energy vehicle production, exceeding 168,000 units in the first half of the year [2]. - Traditional industries are revitalizing, with examples such as the transformation of Wuhan Iron and Steel's old factory into a green super factory and the digitalization efforts of Ma Yinglong Pharmaceutical [2]. Emerging Industry Development - The optical electronics information sector is a key strength for Wuhan, with the East Lake New Technology Development Zone expanding its industrial chain and innovation capabilities [3]. - Longhua Fiber Optic Cable Co., Ltd. has launched air-core optical fibers, significantly enhancing signal transmission speed [3]. - The "Optical Core Screen End Network" industry in Wuhan has surpassed a scale of 600 billion yuan, with a target growth rate of over 20% annually [3]. Future Industry Focus and Layout - Wuhan is making strides in the field of brain-computer interfaces, with the first implant surgery completed in Central China, marking a significant advancement in clinical applications [4]. - The city is targeting 13 sub-sectors, including brain-computer interfaces and humanoid robots, to establish a competitive future industry landscape [5]. - The local government emphasizes the importance of technological innovation in driving the modernization of the industrial system and improving development quality [5].
人民日报:因地制宜发展新质生产力—— “武汉造”攀高逐新活力足
Ren Min Ri Bao· 2025-08-16 01:38
Core Viewpoint - The article emphasizes the importance of developing new productive forces in Wuhan, highlighting the city's efforts in promoting high-quality development through technological innovation and industrial transformation [15][16]. Group 1: Economic Development and Policy - The article discusses the significant role of private enterprises in China's economic reform and development, emphasizing the need for policies that support their growth and ensure equal opportunities in the market [2][3]. - It highlights the favorable political, economic, and social environments for the development of private enterprises, encouraging them to seize opportunities for growth [2][3]. Group 2: Technological Innovation and Industry Transformation - Wuhan's high-tech manufacturing industry saw a year-on-year increase of 15.7% in added value, accounting for 24.6% of the total industrial added value [15]. - The article mentions the successful development of a new energy vehicle by Dongfeng Motor Corporation, which is set to launch next year, showcasing the city's advancements in automotive technology [16]. - The article also highlights the growth of the optical electronics industry in Wuhan, with significant investments and innovations leading to a robust industrial ecosystem [17]. Group 3: Future Industry and Emerging Technologies - Wuhan is focusing on the development of future industries, particularly in the field of brain-computer interfaces, with significant breakthroughs in clinical applications [18]. - The city aims to establish itself as a national leader in 13 key areas, including brain-computer interfaces and humanoid robots, through targeted technological advancements and application expansions [18].
“武汉造”攀高逐新活力足(奋勇争先,决战决胜“十四五”)
Ren Min Ri Bao· 2025-08-15 22:11
Core Viewpoint - Wuhan's biotechnology company He Yuan has received approval for its recombinant human albumin injection, which will benefit patients with liver cirrhosis and low albumin levels, reflecting the city's vibrant innovation in manufacturing [1] Traditional Industry Transformation and Upgrading - Dongfeng Motor Corporation, based in Wuhan, has developed a new energy vehicle equipped with the DF30 chip, which has passed cold climate testing and is set for mass production next year [1] - The high-tech manufacturing sector in Wuhan saw a 15.7% year-on-year increase in added value in the first half of the year, accounting for 24.6% of the total industrial added value [1] New Industry Development - Wuhan's optical electronics industry is thriving, with the East Lake High-tech Development Zone expanding its advantages in this sector, achieving a scale exceeding 600 billion yuan [2] - Changfei Optical Fiber and Cable Co., Ltd. has launched air-core optical fibers, significantly enhancing signal transmission speed [2] - Huazhong University of Science and Technology has developed intelligent equipment for laser etching, capable of creating precise textures on various materials [2] Future Industry Layout - Wuhan is making strides in the field of brain-computer interfaces, having launched medical service pricing for this technology and completed the first implantation surgery in Central China [4] - The city is focusing on 13 sub-sectors, including brain-computer interfaces and humanoid robots, to establish a competitive future industry development hub [4] Government Support and Strategic Vision - The establishment of a collaborative innovation consortium for automotive-grade chips in Hubei province highlights the government's support for technological advancements in the automotive sector [2] - Wuhan aims for an annual growth rate of over 20% in emerging industries, reflecting a commitment to enhancing quality and efficiency [3] - The local government emphasizes the importance of technological innovation in building a modern industrial system and improving development quality [5]
因地制宜发展新质生产力—— “武汉造”攀高逐新活力足(奋勇争先,决战决胜“十四五”)
Ren Min Ri Bao· 2025-08-15 22:00
Core Viewpoint - Wuhan's biotechnology company, He Yuan Bio-Tech, has received approval for its recombinant human albumin injection, which will benefit patients with liver cirrhosis and low albumin levels, reflecting the city's vibrant innovation in manufacturing [1] Traditional Industry Transformation and Upgrading - Dongfeng Motor Corporation, based in Wuhan, has developed a new energy vehicle equipped with the DF30 chip, which has passed cold climate testing and is set for mass production next year [1] - The high-tech manufacturing sector in Wuhan saw a 15.7% year-on-year increase in value added, accounting for 24.6% of the total industrial value added in the first half of the year [1] New Industry Development and Expansion - Wuhan's automotive industry is a pillar sector, with new energy vehicle production exceeding 168,000 units in the first half of the year, marking a 152% year-on-year increase [2] - The optical electronics industry in Wuhan, known as "China's Optics Valley," has seen significant advancements, with the optical fiber industry reaching a scale of over 600 billion yuan [2][3] Future Industry Focus and Layout - Wuhan is making strides in the field of brain-computer interfaces, having launched medical service pricing for this technology and completed the first implant surgery in Central China [4] - The city aims to establish a competitive future industry development hub by focusing on 13 key areas, including brain-computer interfaces and humanoid robots [4] Government and Policy Support - The establishment of a joint innovation consortium for automotive-grade chips in Hubei province highlights the collaborative efforts between government, industry, and academia to drive technological advancements [2] - Wuhan's government emphasizes the importance of technological innovation in building a modern industrial system and aims for high-quality development [5]
武汉造全球首款 “稻米造血”创新药获准在美开展三期临床试验
Chang Jiang Ri Bao· 2025-08-09 03:12
Core Viewpoint - Wuhan Heyuan Biotechnology Co., Ltd. has reached a consensus with the FDA on the global multi-center Phase III clinical research design for the world's first "rice-derived" recombinant human albumin injection, marking a significant milestone in the biopharmaceutical field [1][2]. Group 1: Company Developments - Heyuan Biotechnology's recombinant human albumin injection (rice) has been recognized by FDA experts as a "Historical innovation," indicating strong support for its global multi-center clinical trials [1]. - The FDA confirmed that upon successful completion of the international multi-center Phase III clinical study, the product will be eligible for all clinical indications approved for existing human serum albumin, benefiting patients with clinical needs [1]. - The company has initiated preparations for the global multi-center Phase III clinical research, with plans to launch the study soon [2]. Group 2: Industry Context - The approval of Heyuan Biotechnology's recombinant human albumin injection by the National Medical Products Administration in July 2025 will make it the first approved recombinant human albumin product in China, filling a gap in the global biopharmaceutical market [2]. - This development signifies a transition for China from "catching up" to "leading" in the recombinant human albumin sector, providing a solution for global blood product alternatives [2]. - The competitive landscape of the global pharmaceutical market is intensifying, prompting domestic pharmaceutical companies to expand internationally to enhance their global competitiveness and participate in the restructuring of the global pharmaceutical industry [2].
产经观察丨武汉:剑指国际消费中心城市第六城
Sou Hu Cai Jing· 2025-08-04 20:41
Core Insights - The innovative drug sector in Hubei is lagging behind the national average in terms of approved varieties and market promotion, despite recent improvements in the approval rate of innovative drugs [3][14]. Group 1: Market Performance and Trends - Since 2025, the innovative drug sector has seen a strong recovery in the capital market, with several innovative drug-themed funds rising over 100% and multiple stocks doubling in price, indicating a gradual release of value potential in the industry [3]. - Hubei has approved a total of 15 national Class 1 innovative drugs over the past six years, ranking 6th nationally and 1st in Central China, with 3 Class 1 innovative drugs approved in the current year [7][9]. Group 2: Key Developments and Innovations - Wuhan Heyuan Biotechnology Co., Ltd. received approval for its recombinant human albumin injection, becoming the first domestically approved product of its kind, addressing a significant clinical demand for human serum albumin in China [4]. - Renowned domestic anesthetic drug leader, Renfu Pharmaceutical, has had its Class 1 innovative drug application accepted for review, focusing on severe limb ischemia treatment, with no similar products currently available in the market [5]. Group 3: Policy Support and Investment - Hubei's innovative drug development is supported by strong policy measures, including the implementation of a notification commitment system for clinical trial approvals and initiatives to accelerate the growth of the biopharmaceutical industry [9][10]. - The favorable business environment in Hubei has attracted external innovative drug companies, such as Shenzhen Fowo Pharmaceutical, which invested 2 billion yuan to establish a research and production base in Wuhan [10]. Group 4: Challenges and Recommendations - Despite the positive trends, Hubei's innovative drug sector faces challenges, including a weak conversion of scientific research achievements into clinical applications and a limited number of approved innovative drugs compared to developed regions [14]. - Experts suggest that Hubei should learn from regions like Jiangsu and Zhejiang to create green channels for local innovative drugs in public hospitals to enhance market access [14].