1类新药
Search documents
山东:“十四五”以来新获批9个1类新药
Zheng Quan Shi Bao Wang· 2025-11-20 10:43
人民财讯11月20日电,11月20日,山东省人民政府新闻办公室举行"高质量完成'十四五'规划"系列主题 新闻发布会。"十四五"以来山东新获批1类新药9个,相较"十三五"时期只有1个,实现巨大突破。目 前,正在进行临床试验的1类新药还有141个。 ...
上海浦东:已总体达到CPTPP和DEPA正文条款的开放水平
Di Yi Cai Jing· 2025-11-06 08:01
Core Viewpoint - Pudong is advancing its institutional openness by refining rules in various sectors, aiming to align with international standards and enhance its role as a global economic hub [1][2]. Group 1: Institutional Openness - Pudong has achieved a level of openness comparable to CPTPP and DEPA, focusing on expanding rules and standards in service, digital, and goods trade [1]. - The region has eliminated restrictive measures in the manufacturing sector and initiated pilot programs in value-added telecommunications and cell and gene therapy services, establishing 9 and 40 enterprises respectively [2]. - Pudong is aligning with OECD service trade restrictions and World Bank business environment assessments to improve its service and trade openness [1][2]. Group 2: Trade and Financial Services - Pudong is enhancing cross-border financial services by expanding free trade account functionalities and facilitating cross-border payments [2]. - The region has implemented the first customs special supervision area for bonded remanufacturing in China, allowing for 97 types of bonded repair services [2]. - A negative list for data export has been introduced, enabling compliant companies to bypass prior approval processes for data cross-border flow [2]. Group 3: Infrastructure and Connectivity - Pudong is positioned as a key gateway for international trade, with the Pudong International Airport projected to handle 3.78 million tons of cargo and mail in 2024, ranking second globally [3]. - The Shanghai Port continues to lead globally in container throughput, reaching 51.51 million TEUs [3]. Group 4: Business Cooperation and Support - The upcoming Oriental Hub International Business Cooperation Zone will facilitate business activities with a 30-day visa-free stay for international visitors [4]. - The "Overseas Enterprise Gathering Area" offers comprehensive support for companies venturing abroad, with over 80 professional service institutions and 270 global sites established [5]. Group 5: Technological Advancements - Pudong is focusing on high-tech industries, with significant increases in fiscal science and technology investment, rising from 4.2% in 2021 to 9.2% in 2023 [5]. - The integrated circuit industry has reached a scale of $41 billion, accounting for one-fifth of China's total, with a 7.4% increase in electronic component exports [6]. - The biopharmaceutical sector has over 4,000 companies, with significant contributions to global drug approvals and transactions [6].
科创板七周年:募资超万亿 点燃硬科技创新引擎
2 1 Shi Ji Jing Ji Bao Dao· 2025-11-05 10:37
Core Insights - The Science and Technology Innovation Board (STAR Market) has successfully gathered 592 listed companies by October 2025, with a cumulative IPO fundraising scale of 934.6 billion yuan and total financing exceeding 1.1 trillion yuan, becoming a key force in nurturing new productive forces and upgrading the modern industrial system [1][2] - Over the past five years, STAR Market companies have shown strong growth, with a compound annual growth rate of 18% in operating income and 9% in net profit attributable to shareholders, indicating robust growth potential [2][3] - The STAR Market has established a virtuous cycle ecosystem of "technology - industry - capital," effectively promoting the efficient allocation of innovative resources and attracting talent and investment [6][8] Group 1: Financial Performance - By October 2025, the STAR Market has raised a total of 934.6 billion yuan through IPOs, with total financing surpassing 1.1 trillion yuan [1] - The compound annual growth rates for operating income and net profit attributable to shareholders for STAR Market companies are 18% and 9%, respectively, since 2019 [2] - In the integrated circuit sector, 119 disclosed companies reported a revenue growth of 27% and a net profit growth of 83% year-on-year for the first three quarters of 2025 [3] Group 2: Industry Focus and Innovation - The STAR Market has maintained a focus on "hard technology," with over 80% of listed companies in emerging industries such as new-generation information technology, biomedicine, and high-end equipment manufacturing [3] - The STAR Market has seen significant advancements in key technologies, with companies like He Yuan Bio and Guo Dun Quantum achieving breakthroughs in innovative drugs and semiconductor technologies [4] - As of 2025, STAR Market companies have formed over 130,000 invention patents, with an average of 230 patents per company, showcasing a strong emphasis on innovation [4][5] Group 3: Ecosystem and Market Dynamics - The STAR Market has successfully attracted over 60% of its founding teams from scientific and engineering backgrounds, fostering a culture of innovation [6] - Approximately 90% of STAR Market companies received venture capital investment before going public, indicating strong investor confidence [6] - The STAR Market has developed a comprehensive index system with 33 indices, and the total scale of STAR Market-related index tracking products exceeds 330 billion yuan [6][7] Group 4: Regulatory and Institutional Innovations - The STAR Market has pioneered various institutional innovations, including multi-dimensional listing standards and a small-scale rapid financing mechanism, providing valuable lessons for other market segments [8] - Recent reforms, such as the "1+6" initiative, have further enhanced the inclusivity of the STAR Market, allowing for the expansion of standards to cover cutting-edge fields like artificial intelligence [8] - The Shanghai Stock Exchange aims to leverage the STAR Market's role as a "testing ground" to better identify high-quality technology enterprises and support their listing [9]
592颗星,1.1万亿活水:科创板激活中国创新伟力
中国基金报· 2025-11-05 04:48
Core Viewpoint - The Sci-Tech Innovation Board (STAR Market) has significantly enhanced China's innovation capabilities, with 592 listed companies and over 1.1 trillion yuan raised since its inception, marking a pivotal shift in the country's technological landscape [2][4]. Group 1: Institutional Flexibility - The STAR Market was established to address the "bottleneck" issues faced by tech companies, allowing firms with varying stages of development and governance structures to access capital markets [4]. - Notably, 57 companies listed without profitability, with 22 of them successfully turning profitable, demonstrating the board's inclusive approach [4]. Group 2: R&D Investment - In 2024, total R&D investment by STAR Market companies reached 168 billion yuan, more than three times the net profit of the sector, with a median R&D intensity of 12.44% [7]. - By the third quarter of 2025, R&D investment further increased to 113.35 billion yuan, reflecting a year-on-year growth of 9.01% [7]. - STAR Market companies have generated over 130,000 invention patents, averaging 230 patents per company, leading to significant technological advancements [7]. Group 3: Industry Cluster Development - The STAR Market has fostered a notable cluster effect, particularly in the integrated circuit sector, with 121 listed companies covering the entire industry chain [9]. - In the biopharmaceutical sector, 115 companies are actively involved in treating major diseases, with significant progress in drug approvals and international collaborations [9]. Group 4: Capital Market Dynamics - The STAR Market serves as a comprehensive ecosystem integrating technology, industry, capital, and talent, with over 60% of founding teams comprising scientists or industry experts [11]. - Approximately 90% of STAR Market companies received venture capital before listing, promoting a culture of early and substantial investment in hard tech [12]. Group 5: Policy Enhancements - The introduction of the "1+6" policy measures aims to further deepen reforms on the STAR Market, enhancing support for tech companies with significant breakthroughs and commercial potential [14]. - This policy marks a transition from a "testing ground" to a "demonstration field," facilitating growth for more hard tech enterprises [14].
浦东推动细胞基因等新兴赛道持续集聚 打造全球生物医药创新高地
Zheng Quan Shi Bao Wang· 2025-08-28 10:53
Group 1 - The core theme of the conference is "Source Without Boundaries," focusing on the innovative ecosystem and industrial strength in advanced therapies in Zhangjiang [1] - Since 2019, Pudong has approved 29 Class 1 new drugs, accounting for 78% of Shanghai's total, and 31 innovative medical devices, accounting for 57% of Shanghai's total [1] - In 2023, Pudong has seen the approval of 6 Class 1 innovative drugs and 4 innovative medical devices, covering multiple major disease areas with several "first" and "first-of-its-kind" breakthroughs [1] Group 2 - Pudong has gathered over 170 upstream and downstream enterprises in the cell and gene therapy field, achieving significant breakthroughs in first and first-of-its-kind cell gene drugs [1] - The Shanghai Zhangjiang Group aims to enhance the brand influence of Zhangjiang Medicine Valley by unifying the name to "Zhangjiang Medicine Valley+" and standardizing services [2] - Zhangjiang Medicine Valley has developed a complete ecosystem from basic research to industrial transformation, becoming a source and benchmark for China's cell therapy industry [2] Group 3 - Pudong will continue to integrate technological and industrial innovation, enhancing innovation capabilities and product carrying capacity while focusing on emerging fields such as cell gene therapy and brain-computer interfaces [3] - The goal is to establish Pudong as a global hub for biopharmaceutical innovation [3]
星耀科创板:从一块试验田到满园繁花
Shang Hai Zheng Quan Bao· 2025-07-21 19:58
Core Insights - The STAR Market has successfully transformed from a blueprint to reality, with 589 companies listed and significant contributions to innovation and capital markets [4][5] - Over 30% of STAR Market companies have pioneering products or projects, and more than 80% focus on import substitution and self-control [5] - The STAR Market has facilitated over 1.1 trillion yuan in equity financing, with over 60% of founding teams composed of scientists or engineers [5] - The STAR Market has become a model for reform in other markets, enhancing the legal framework and institutional improvements in capital markets [5][10] Company and Industry Developments - Junshi Biosciences, listed on the STAR Market, has raised over 8 billion yuan, accelerating the development of clinical and R&D projects, with its core products approved in over 35 countries [7][8] - The STAR Market has seen the launch of 20 innovative drugs since 2018, accounting for approximately 12% of all domestic innovative drugs approved during the same period [8] - The semiconductor industry on the STAR Market includes 120 companies, creating a complete and collaborative innovation ecosystem, enhancing the autonomy of the industry [10][11] - The STAR Market has significantly improved the financing environment for companies like Tuojing Technology, which achieved profitability in its first year post-IPO [9][11] Institutional Innovations - The STAR Market has established a multi-tiered and inclusive listing standard, allowing companies to go public even before achieving profitability [12][14] - Recent reforms include the introduction of a growth tier and the reactivation of the fifth set of listing standards, aimed at enhancing support for quality technology companies [17][18] - The STAR Market's ecosystem has been enhanced through precise institutional designs that facilitate the efficient flow and integration of technology, capital, and talent [16][17]
中国光谷出台措施加快发展生物医药产业
Zhong Guo Xin Wen Wang· 2025-07-15 07:29
Group 1 - The core viewpoint of the news is that Wuhan East Lake High-tech Zone, also known as "China Optics Valley," has introduced measures to accelerate the development of the biopharmaceutical industry, aiming to create a world-class biopharmaceutical industry cluster [1] - The life and health industry is one of the advantageous industries in Optics Valley, with an expected industry scale exceeding 200 billion yuan by 2024 [1] - The Wuhan National Bio-industry Base has formed a trillion-yuan industry cluster, highlighting the significance of the biopharmaceutical sector within the life and health industry [1] Group 2 - The measures include six major areas with 20 specific initiatives aimed at expanding the industry cluster scale, accelerating product R&D and industrialization, transforming platform systems, expanding application scenarios, enhancing resource supply, and optimizing industrial park ecosystems [1] - Financial incentives are provided, including up to 500 million yuan for major projects in key biopharmaceutical areas, up to 100 million yuan for the industrialization of new drugs, and up to 100 million yuan for top scientists and leading talents [1] - The measures encourage the development of artificial intelligence products tailored to application scenarios and support collaborative clinical research between hospitals and enterprises [1] Group 3 - The measures also focus on upgrading platform systems by supporting the construction of high-level innovation platforms and encouraging biopharmaceutical companies to develop large models in areas such as precision diagnosis, AI drug development, and rehabilitation management [2] - Wuhan is accelerating the creation of a trillion-yuan health industry cluster, with the total scale of the life and health industry expected to reach 554.6 billion yuan by 2024, ranking first in Central China [2]
科创板第五套标准重启凸显制度包容性 生物医药企业踊跃申报
Zheng Quan Ri Bao· 2025-07-07 16:07
Group 1 - The core viewpoint of the articles emphasizes the importance of the fifth listing standard on the Sci-Tech Innovation Board, which allows unprofitable companies with significant market potential and approved products to access capital markets, thereby enhancing market inclusivity [1][2][3] - Shanghai Hengrun Da Biological Technology Co., Ltd. plans to apply for listing on the Sci-Tech Innovation Board under the fifth standard, despite currently being unprofitable and not having products on the market [1] - Since the introduction of the fifth listing standard, 20 innovative biopharmaceutical companies have successfully listed, with 19 of them having launched core products, indicating a growing trend in China's biopharmaceutical innovation landscape [2] Group 2 - The fifth listing standard does not impose revenue or profit requirements but focuses on the approval of main products and significant market potential, facilitating access for companies with core competitiveness [2] - The recent optimization of the fifth listing standard aims to include emerging fields such as artificial intelligence and commercial aerospace, aligning listing criteria with industry innovation [3] - Experts suggest enhancing risk prevention mechanisms and improving information disclosure to ensure the healthy development of the Sci-Tech Innovation Board, including the introduction of third-party verification and advanced regulatory technologies [3]