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2025新实施标准盘点:医疗制药篇——共有476份新标准实施
仪器信息网· 2025-12-29 09:03
Core Viewpoint - The implementation of new pharmaceutical standards in 2025 significantly enhances the application of scientific instruments, with chromatography, mass spectrometry, and spectroscopy technologies becoming core methods to promote high-quality regulation of drugs, medical devices, and instruments [1][3]. Group 1: Scientific Instrument Applications - In 2025, a total of 476 new pharmaceutical standards will be implemented, marking a new height in the breadth and depth of scientific instrument applications [3]. - The new standards notably strengthen the use of chromatography, mass spectrometry, and spectroscopy technologies, with methods like gas/liquid chromatography-mass spectrometry (GC-MS/LC-MS) becoming essential for identifying hundreds of toxic substances and drug components in blood, urine, and biological samples [3]. - Inductively coupled plasma mass spectrometry (ICP-MS) has been established as a key standard for detecting 32 trace elements in biological samples and evaluating the performance of medical mass spectrometers [3]. Group 2: Pharmacopoeia Upgrades - The 2025 edition of the "Chinese Pharmacopoeia" promotes innovation in domestic instruments by revising standards for mass spectrometry and nuclear magnetic resonance spectroscopy, significantly enhancing detection efficiency [3]. - The introduction of advanced technologies such as near-infrared spectroscopy and atomic fluorescence spectroscopy replaces traditional toxic reagent testing, embodying the concept of green regulation [3]. Group 3: Focus on Advanced Medical Devices - In the newly implemented medical device standards, high-precision instruments such as artificial intelligence imaging devices, surgical robots, and digital X-ray detectors are highlighted, driving the precision and intelligence of diagnostic and treatment processes [3]. - Scientific instruments are no longer merely auxiliary tools but are now core technological supports for achieving high-quality regulation and ensuring the safety of drugs and devices in the pharmaceutical industry by 2025 [3].
合肥冲出百亿IPO:复旦校友造出“黑科技屏”,打破索尼垄断
创业邦· 2025-10-30 03:34
Core Viewpoint - The article highlights the entrepreneurial journey of Gu Tie, a prominent figure in the tech industry, who is on the verge of achieving his second IPO with his company, Shiya Technology, which specializes in silicon-based OLED microdisplays and has made significant strides in breaking foreign monopolies in high-tech fields [3][16]. Company Overview - Gu Tie, a graduate of Fudan University, has founded three technology companies: Yisui Technology, Guangwei Technology, and Shiya Technology, focusing on high-tech sectors and achieving domestic replacements for imported technologies [3][9]. - Shiya Technology is recognized as the third-largest global supplier of digital X-ray detectors and the leading supplier in China, having successfully listed on the Sci-Tech Innovation Board [3][9]. - Shiya Technology's silicon-based OLED microdisplays are crucial components for AR/VR devices, with the company positioned as the second-largest player globally, following Sony [4][15]. Market Position and Performance - Shiya Technology's silicon-based OLED microdisplays have achieved a market share of 35.2%, while Sony holds 50.8%, indicating a strong competitive position in the industry [15]. - The company has established partnerships with major clients, including DJI, ByteDance, and Lenovo, and is currently in the process of an IPO application on the Sci-Tech Innovation Board [5][33]. Financial Performance - Shiya Technology has shown steady revenue growth, with projected revenues of 1.90 billion, 2.15 billion, 2.80 billion, and 1.50 billion yuan from 2022 to the first half of 2025, respectively [26]. - The company has been operating at a loss, with net losses of 2.79 billion, 3.64 billion, 3.08 billion, and 1.43 billion yuan during the same period, primarily due to high R&D expenditures and investments in production capacity [29][30]. Future Outlook - The company anticipates achieving profitability by 2026, driven by the expected increase in demand for silicon-based OLED microdisplays [30]. - Shiya Technology plans to raise approximately 2.015 billion yuan through its IPO, with funds allocated for expanding production lines and building a research center [33].