Core Viewpoint - The Chinese pharmaceutical industry is experiencing positive changes driven by policy optimization and innovation, with a focus on internationalization and high-quality development [2][3]. Group 1: Industry Development - China's pharmaceutical industry has become a global leader in the production of active pharmaceutical ingredients (APIs) and small to medium-sized medical devices, playing an increasingly important role in the global pharmaceutical landscape [1][2]. - The industry is transitioning from exporting intermediates and APIs to a comprehensive export of innovative products, marking a significant shift in the internationalization of Chinese pharmaceuticals [2][3]. Group 2: Policy and Regulatory Environment - Recent reforms in drug and medical device regulation have enhanced the safety and effectiveness of products while stimulating innovation within the industry [4][5]. - The acceleration of drug review and approval processes, along with China's membership in the International Council for Harmonisation (ICH), has created a "fast track" for innovative drugs to enter international markets [2][3]. Group 3: Market Strategies and Internationalization - Companies are encouraged to adopt differentiated and refined market entry strategies by analyzing regional market characteristics, disease profiles, payment capabilities, and competitive landscapes [3][4]. - Successful case studies highlight the importance of collaboration, local production, and building partnerships to penetrate target markets effectively [5]. Group 4: Challenges and Future Directions - Despite the progress, the industry faces various internal and external challenges that require modernization of the regulatory system and governance capabilities to ensure high-quality development [3][5]. - The industry must maintain confidence and focus on enhancing innovation capabilities and quality control to navigate complex international environments and competition [5].

近年来，合成生物学技术迭代更新迅猛，与生物医药产业深度融合，在 药物研发、疾病诊疗和绿色可 持续生产 等关键领域展现出巨大潜力与广阔市场空间。在疾病诊断方面，合成生物学为早期、精确诊 断提供了创新思路与技术支撑；在疾病治疗方面，基于合成生物学原理的细胞疗法、细菌疗法、新型疫 苗和生物医学材料等前沿成果不断涌现，为患者带来新希望。据相关数据显示，2023年全球合成生物学 市场规模已突破 170亿美元 ，其中医疗健康领域约 64亿美元 ，占比近 40% 。未来合成生物学在医疗健 康领域的应用规模有望持续攀升，预计到2028年将达到 133亿美元 。随着基因编辑、高通量测序、生物 信息学和人工智能等技术的不断进步，合成生物学在医药领域的应用场景将不断拓展，为医药产业的转 型升级提供强大动力。 2025第二届合成生物制造创新发展大会 将于 2025年5月22-23日 在 上海浦东喜来登由由大酒店 盛大启 幕。本次大会以" 合成新'基'遇，智造赢未来 "为主题，邀请全球生物制造领域的专家、企业家和科研 机构，聚焦合成生物技术在 医药、食品、化妆品、新材料、AI方向 的应用，共同探讨生物制造技术的 发展趋势、市场机遇与挑 ...