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西安“学术金秋”聚焦外泌体前沿 细胞科技领域取得国际备案新进展
Huan Qiu Wang Zi Xun· 2025-10-15 03:09
Core Insights - The forum focused on the latest developments in exosome technology and the progress of local cell technology companies in achieving international compliance for related raw materials [1][3][5] Group 1: Event Overview - The forum, themed "Exploring Cell Messengers Leading the Future of Regeneration," was held in Xi'an and co-hosted by the Xi'an Science and Technology Association and the Xi'an High-tech Zone Management Committee [1][3] - It attracted participation from academic experts, government representatives, clinical researchers, and industry professionals, highlighting the application potential of exosomes in regenerative medicine and disease diagnosis [3][5] Group 2: Key Presentations - Renowned scientist Academician Pei Duanqing provided insights into the development trends, scientific value, and future prospects of exosome technology, emphasizing its potential in regenerative medicine, disease diagnosis, and new drug development [5] - He noted that the standardization and industrialization of exosomes are essential directions for the future [5] Group 3: Industry Developments - The forum announced that local company Medcell Biotechnology's exosome raw materials have received FDA DMF (Drug Master File) registration and have been included in the International Cosmetic Ingredient (INCI) list [5] - This FDA DMF registration indicates that the raw materials meet pharmaceutical-grade regulatory standards, facilitating their application in innovative drug development, while inclusion in the INCI list opens opportunities in the cosmetics sector [5] Group 4: Collaborative Efforts - A ceremony for "Building an Innovative Ecosystem for the Exosome Industry" was held, showcasing the collective commitment of academicians, university representatives, and business leaders to advance exosome technology from laboratory research to industrial application [7] - Collaborating institutions include Shaanxi Normal University and Northwestern Polytechnical University, contributing to the promotion of industry-academia-research cooperation in the biopharmaceutical frontier [7]
科兴制药外泌体原料通过美国FDA DMF备案
Zheng Quan Ri Bao Wang· 2025-09-16 07:13
Core Insights - Company has successfully registered its exosome raw materials with the FDA under the Type II Drug Master File (DMF), marking a significant achievement in meeting international standards for exosome technology [1] - The exosome technology is recognized for its low immunogenicity, strong penetration capabilities, and potential for targeted modification, making it applicable in various fields including drug delivery, regenerative medicine, and consumer markets such as aesthetics and anti-aging [1][2] - The successful DMF registration indicates that the company has passed rigorous international reviews regarding production processes, quality control, and safety data, which is a testament to its R&D capabilities and will facilitate market entry in high-end segments and other overseas markets [1] Company Developments - The exosome project is based on the K'Exosome delivery technology platform, which enables the large-scale and standardized manufacturing of clinical-grade exosomes, along with efficient loading of proteins/small nucleic acids and precise targeting capabilities [2] - The global market for exosome diagnostics, therapeutics, and research tools reached $227.5 million in 2023 and is projected to grow to $1.3 billion by 2028, reflecting a compound annual growth rate (CAGR) of approximately 42.2% [2] - The company is committed to an "innovation + internationalization" strategy, with significant progress in its overseas business and ongoing efforts to advance "R&D internationalization," positioning itself to penetrate the European, American, and emerging markets effectively [2]
合成生物中试平台的建设
synbio新材料· 2025-05-21 06:41
Core Insights - Synthetic biology and biomanufacturing have gained significant attention and support from various sectors, including government, academia, and industry, highlighting their role as new productive forces in the economy [1][15]. Event Overview - The SynBio China Third China Synthetic Biology "Scientists + Entrepreneurs + Investors" Expo will be held on August 1-2, 2025, at the Suzhou International Expo Center, featuring over 20,000 participants [3][36]. - The expo will include seven sub-conferences focusing on various aspects of synthetic biology, including health, food, and cosmetic applications [3]. Industry Challenges - Despite rapid concept dissemination, the synthetic biology industry in China faces challenges such as scaling production, realizing product value, market exploration, and innovation in core competitiveness [15]. Technological Innovations - Advances in synthetic biology are driving innovations in functional ingredients, next-generation food additives, and personalized health foods [9][12]. - The development of new protein sources and alternative foods, including sweet proteins and milk protein substitutes, is being facilitated by synthetic biology [10][12]. Applications in Beauty and Health - Synthetic biology is enabling innovations in effective raw materials for cosmetics, including recombinant collagen and bioactive compounds [13][16]. - The integration of synthetic biology in medical aesthetics is leading to advancements in clinical applications and product development [16]. Collaboration and Networking - The expo aims to foster collaboration among innovators, industry experts, and investors, providing a platform for project promotion and industry guidance [18].