China: Life Sciences, Biotechnology & Nanotechnology

China's regulators intensified anti-corruption enforcement in the life sciences sector during the first half of 2026, introducing stricter oversight of medical data security, sales representatives, and public procurement processes. New administrative measures and judicial interpretations have lowered thresholds for criminal liability while expanding corporate accountability for employee misconduct.

Patent applications for biomarkers in disease diagnosis are rapidly growing, yet many fail to meet patent law requirements. While screening experiments can identify correlations between biomarkers and diseases, they alone cannot prove diagnostic value. This analysis examines why validation experiments demonstrating sensitivity and specificity are essential for patent approval, and how their absence leads to rejection under Chinese Patent Law Articles 26(3) and 26(4).

The US Department of Health and Human Services has launched Operation TrialBlazer to address China's growing dominance in clinical research and restore American leadership in biomedical innovation. As Chinese clinical trials now surpass US trials in both speed and volume, this comprehensive initiative aims to modernize regulatory processes, reduce administrative burdens, and reverse the trend of research investment flowing overseas.

China's national intellectual property administration (CNIPA) has released ten typical cases from 2025 involving patent reexamination and invalidation. These cases were selected because they are highly relevant...

In 2026, Chinese regulators have continued their focus on anti-corruption enforcement in the life sciences industry.

特拉华州衡平法院在SRS诉Alexion案中，就跨境医药BD交易中的里程碑付款争议、商业合理努力义务及预期损失量化作出了详尽裁判。本文深入剖析该案判

The fourth amendment to the Patent Law of the People's Republic of China (hereinafter, the "Patent Law") came into effect on June 1, 2021. In July of the same year, the Measures for the Implementation...

在生物医药领域，对于涉及氨基酸序列和/或核苷酸序列的发明专利申请，通常需要制作符合特定标准的序列表...

Chinese authorities have launched a special "Hundred-Day Campaign" to target misconduct relating to China's state-run medical insurance program and issued a new Ethical Code for Healthcare Professionals...