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China proposes export ban on cell and gene therapy process technology
China is pursuing a proposal to place key process technologies for cell and gene therapies under an export ban. It plans exceptions or simplified procedures for licensing or contract research, development and manufacturing that do not transfer technology ownership.
China's Ministry of Commerce and Ministry of Science and Technology have published a draft revision of the catalogue of technologies prohibited or restricted from export. The proposal would add 40 technologies across three fields—artificial intelligence, biopharmaceuticals and solar power—with comments accepted until November 15.
The biopharmaceutical section includes five technologies related to cell and gene therapies, small nucleic acid drugs and pathogenic microorganisms. Two items were proposed for an export ban: cell and gene therapy process platforms with independently held Chinese intellectual property rights, and technologies involving gene synthesis and enhanced pathogenicity in high-risk pathogenic microorganisms.
Proposed export restrictions cover new target discovery and validation, key chemical modifications and high-yield synthesis processes for nucleic acid drugs, and lipid nanoparticle (LNP) delivery system manufacturing. They also include large-scale cultivation and purification technologies for viral and nonviral vectors carrying gene-editing tools.
The controls focus on technologies used to develop and manufacture medicines rather than finished drugs. Cell and gene therapies work by changing cell functions or delivering therapeutic genes, and vectors that carry genes into cells, along with cultivation and purification processes, affect product quality and safety.
The Chinese government cited biosecurity and preventing the inappropriate spread of technology as the policy rationale. It says the measures do not target a particular country or company and that normal international technology cooperation will be protected.
China's Ministry of Commerce said overseas licensing of the process platforms and contract research, development and manufacturing services using them would be excluded from the controls. It said licensing of the relevant target discovery and validation technologies would receive facilitation measures such as automatic approval, and products made using these technologies would also fall outside these technology export controls.
Temporary registration measures have already begun ahead of finalization of the regulations. Since the 16th, China has required covered technologies to be registered in a government system before export, including transactions that have begun but are not yet complete.
Registration covers not only overseas transfers of technology ownership but also overseas licensing and cases in which the technology owner or entity exercising actual control becomes a foreign entity. Required information includes the counterparty, destination country, intended use and expected transaction value; the scope of temporary registration is distinct from the exceptions and simplified procedures in the final catalogue.