Market Intelligence

Bio-Thera Solutions secures NMPA approval for BAT2306, China's first secukinumab biosimilar, while Biocon expands commercialization rights for its ustekinumab biosimilar YESINTEK across nine additional global markets. These developments mark significant milestones in the biosimilar landscape for autoimmune disease treatments.

本次修订草案共六章六十四条，较现行办法新增了十四条，重点针对医疗器械网络销售经营者、电商平台、直播营销、网络监测、监督检查及法律责任等方面对现行监管制度进行系统性完善，以适应“互联网+医疗器械”、直播电商等新型经营模式。

China's pharmaceutical and life sciences regulatory landscape underwent significant transformation in 2026, with major policy updates spanning drug approval processes, medical device quality standards, and healthcare facility management. The National Medical Products Administration introduced priority review pathways for chemical APIs and updated cosmetics registration requirements, while new medical device production standards took effect nationwide.

生物安全及人类遗传资源管理是医药企业开展研发、临床试验、生物制品生产及跨境科研合作时需要关注的重要合规领域。本文结合医药企业的主

China has rapidly emerged as a dominant force in early-stage biotech innovation, challenging traditional U.S. hubs like San Francisco and Boston through faster development timelines, lower clinical trial costs, and aggressive government support. As deal volume between Western biopharma companies and Chinese biotechs surges dramatically, industry leaders must navigate the complex balance between accessing China's growing scientific contributions and managing heightened geopolitical tensions and U.S. regulato

China's revised Good Clinical Practice for Drug Trials took effect on 1 September 2026, fundamentally reshaping the regulatory landscape for clinical trials by aligning domestic requirements with ICH E6(R3) standards. The new framework introduces streamlined regulations spanning just 54 articles across six chapters, while establishing comprehensive data governance requirements and clarifying ultimate accountability for sponsors, principal investigators, and clinical trial institutions. Companies conducting