China Planning To Ban Gene Editing Technology Exports
Hindrance To Growing Sector?
Executive Summary
Beijing’s latest proposal to ban gene editing is viewed as a direct response to Washington’s tightening grip over the transfer of US technology to China.
China’s Ministry of Commerce issued in January its draft catalogue of Banned Technology for Export, in which Beijing added seven new items, including gene editing techniques such as CRISPR.
The ministry is gathering public comments and the standout addition to the annual catalog was cell cloning and gene editing technology. This was defined as including stem cell cloning such as nucleus extraction, withdrawal and transfer, embryotic cell transplant and cell activation enzyme technology. The gene editing ban includes ZFN (zinc finger nucleases) and TALEN (transcription activator-like effector nucleases) technology, along with CRISPR (clustered regularly interspaced short palindromic repeats).
Despite China not holding a leading global position in gene editing, the ban indicates Beijing’s intention of becoming a frontrunner in the revolutionary technology, which has wide potential applications.
Gene editing gained worldwide attention when in 2020 Jennifer Doudna from the University of California, Berkeley and Emmanuelle Charpentier shared the Nobel Prize in Chemistry for their contributions to the CRISPR editing technology, a breakthrough expected to bring fundamental changes to treating medical conditions caused by gene mutation, including rare diseases.
Although China is a latecomer to the gene editing race, researchers in the country have been catching up quickly. Junjiu Huang, a researcher at Sun Yat-sen University in Guangzhou, was the first in the world to introduce CRISPR to human embryos. Five years before the technology gained worldwide attention, Huang and his team used CRISPR/Cas9 on non-viable embryos to modify genes causing β-thalassaemia, a rare blood disorder.
Others soon followed with more controversial studies. Jiankui He, then associate professor at the China Southern Institute of Technology in Shenzhen, shocked the world in 2018 by conducting the world’s first publicly disclosed gene editing modifications to human embryos.
Up to then, scientists had voiced strong caution over so-called “designer babies,” in which embryos are genetically modified to produce a baby with specific traits. He’s work led to the birth of twin gene-edited baby girls and then a third girl Amy and he was later sentenced to three years in prison.
Growing Domestic Sector
On the corporate side, China has a growing gene editing sector led by EdiGene Inc and BRL Medicine, which are both devoted to rare disease treatments.
Beijing-based Edigene raised $100m in funding and has entered its β-thalassaemia treatment into clinical studies after obtaining Chinese investigational new drug approval. The company told Scrip it would not comment on the planned new China export ban given the proposal is still under official review.
BRL Medicine also obtained IND clearance to study its candidate BRL-101 for β-thalassaemia in China, making it the second gene therapy targeting sickle cell disease.
More prevalent in the country is investigator-initiated research, in which physicians conduct experiments with patients who need treatment. Many companies also use such studies to quickly gather clinical data towards a regulatory filing.
Any export ban on gene editing technology would mean such therapies would be largely limited to the Chinese domestic market and cross-border collaboration and deals discouraged.
WHO And Off-Target Risks
Following the He Jiankui scandal, the World Health Organization established a framework for gene editing’s human use, which mainly focused on major risks associated with one of the technology's unintended adverse effects: off-target editing.
The highly uncertain risk of editing non-target cells prompted the WHO to propose the set-up of an expert committee to monitor a gene editing clinical trial registry and conduct cross-border reviews within a three-year framework.
In China, the Ministry of Science and Technology has already banned the use of gene editing in humans, including embryos.
Biosecurity Tightening
Given China’s relatively novice gene editing sector, the proposed export ban for the technology also indicates a biosecurity concern. Already, since the COVID-19 pandemic first hit the country in late 2019, authorities have set biosecurity as a goal to secure the safe handling, storing and transfer of research results in biological laboratories.
China’s Biosecurity Law specifically bans the export of human genetic materials such as blood, saliva and genomic information, essentially putting gene and gene editing research off-limit to foreign entities. The latest proposal would also serve to clip domestic researchers' wings and ambitions to move beyond China.
That puts those working in the field in a delicate position. How can cutting-edge, first-in-class research be conducted without stepping over the red line of unethically abusing technology to attract attention and personal gain? Scientists found to have crossed the line could be sentenced to three to 10 years in prison.