Illumina’s Inclusion in China’s Unreliable Entity List: Patent Wars, Geopolitical Risks, and Compliance Strategies

Jianwei (Jerry) Fang, Xiaoyu (Arthur) Jin and Haoyi Sun of Zhong Lun Law Firm discuss the reasons behind, and the implications of, Illumina’s inclusion in China’s Unreliable Entity List, as well as compliance recommendations for multinational corporations

Summary

  • China's Ministry of Commerce has added Illumina and PVH to its Unreliable Entity List—previously reserved for firms linked to arms sales to Taiwan—highlighting growing compliance risks for U.S. companies in China
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  • Analysts attribute Illumina’s listing not only to China's trade tariff responses but also to its litigation with domestic competitor MGI, lobbying for U.S. biosecurity measures, and cybersecurity concerns
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  • With domestic gene sequencing brands such as MGI rapidly expanding, the ban on Illumina imports is expected to further boost local substitution and reshape China's sequencing market
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  • In light of intensifying U.S.-China competition and geopolitical risks, the article outlines essential compliance strategies for multinational corporations to mitigate operational vulnerabilities
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