For many people, when they hear China and genetic engineering in the same sentence, it is often synonymous with scandal, and gene-edited babies may spring to mind.
And, although it is true that nearly five years ago, researcher He Jiankui infamously claimed he had created the first ever gene-edited babies, before going to prison for three years, China has continued to pour a lot of money into genetic engineering research, and aims to become a global leader in the field.
“The accumulative amount of financing in the gene therapy field in China has exceeded $3.3 billion. Also, according to a Frost & Sullivan study, it is estimated that by 2025, gene therapy will reach a scale of nearly $17.89 billion in China,” said Fiona Gao, founding partner of Chinsiders.
Gao also said that gene editing has been listed as a key strategic goal for China: “Gene editing has been listed as one of the key strategic goals in the country-level strategic plans, including the 13th Five-Year Plan, the 14th Five-Year Plan, and the plan for 2035. That means all support and financial resources (both public and private funds) will fall into places to prioritize these key strategic goals, including gene editing.”
Joy Zhang of Kent University, who is a global expert on the governance of gene editing in China, concurred with this, and said that gene editing is being practiced, taught, researched, and applied in various universities across the country.
It is also, of course, being researched and put into practice by biotech companies based in the country, such as BDgene and HuidaGene, who are working on gene therapies to treat diseases like duchenne muscular dystrophy (DMD) – a condition causing progressive muscle weakness – and herpes simplex virus (HSV) keratitis – an infection of the cornea caused by HSV.
The CRISPR revolution in China
China is currently using the gene-editing tool CRISPR for a wide range of applications, from agriculture, to editing genes in animals, to medicine.
In fact, when it comes to animal genome-editing, Chinese researchers were actually the first to harness CRISPR in monkeys, and the country now has several groups of researchers conducting gene editing in large colonies of monkeys.
Exploiting CRISPR’s speed and precision, researchers have been able to create monkey models of muscular dystrophy, autism, and cancer.
Researchers in the country have also used CRISPR on dogs, mice, rats, pigs and rabbits, with the research potentially being able to offer higher quality meats, disease-resistant livestock, and new medical treatments and organs for transplantations.
China’s push towards genetically modified crops
Another area in which genetic engineering is really beginning to advance in China is GM – or genetically modified – crops.
Previously, the country had very much deliberated about whether or not to allow the planting of GM crops, but, earlier this year, it was finally announced that China had approved the safety of its first gene-edited crop.
This came as the country is looking to boost its agricultural production in order to tackle food insecurity and push for greater self-reliance.
The crop, developed by Shandong Shunfeng Biotechnology Company, was a soybean and contains two edited genes that increase the level of healthy fat oleic acid in the plant.
Shandong Shunfeng Biotechnology Company is also working on other GM crops, such as higher yield rice, wheat and corn, and vitamin C-rich lettuce, and there are more companies working on similar projects.
China’s genetic engineering regulatory gaps: room for improvement
He’s gene editing scandal and subsequent conviction for ‘illegal medical practices’ led to the Chinese government tightening the regulations on gene editing, setting requirements for ethical approval, supervision, and inspection.
However, some experts believe that these rules do not go far enough; there is concern around the fact that the rules may not apply to the private sector in the country, potentially allowing private entities to bypass them.
Zhang explained that China used to be able to monitor scientific research, before the private sector properly developed in the country. But this is no longer the case.
“Back then, even when there was a regulatory gap, China could monitor all this research through its administrative channel – because it’s almost like sending commission to good scientists; you know who is doing what – but what has changed in the past 20 years is that you have a whole lot of highly active enterprise that is burgeoning outside of commercial institutions, and you don’t really have regulations that are in place to monitor – even to trace – what’s happening. And that creates a problem,” she said.
Furthermore, He is back on the genetic engineering scene in China since his release from prison, and now claims to have set up his own lab, where he’s attempting to use CRISPR to find a cure for DMD.
“Responsible scientific research is not just about good intentions – every one of us has good intentions – but not all of us are good scientists; we have to have the skills and expertise, and more importantly, we have to be cautious and have the knowledge and expertise to be cautious of the associated risk with individuals. This is something that I think is completely absent from his (He’s) scientific reasoning,” said Zhang, who was one of the main speakers at an international human genome-editing summit in London a few months ago that shone a light on He’s practices and the potential dangers of allowing him to get away with his research.
But, there is some good news in sight, as Zhang said that China’s ministry of science and technology has recently proposed another draft guideline that provides additional ethics reviews. Zhang explained that it is like a “catch-all” kind of policy that will work in complement to the rules they introduced before, and that it will address private entities.
Gao also noted that keeping the dialogue open and including China into high-level international discussions in the governance of gene editing would potentially help to create consistent international standards in the gene editing field.
Will China lead the way in genetic engineering?
There is hope within the scientific community in China that the country can move past He’s actions, and that gene editing in the country can prosper, ultimately catching up to the U.S..
However, there is still a long way to go for the country. “At present, the vast majority of core patents for gene editing come from western countries. Gene therapy companies in China rely on in vitro therapy (based on gene editing and hematopoietic stem cell transplantation). Chinese companies have only occasionally made groundbreaking discoveries in this field,” commented Gao.
She noted that it will probably take a few years for China to catch up with the U.S., but a recent milestone put China on the map, when the CRISPR-Cas12i editing system developed by the Chinese biotech HuidaGene was authorized by the U.S. Patent and Trademark Office (USPTO).
So, genetic engineering in China is definitely starting to take off, and with the large-scale investment being poured into genetic engineering and the amount of research being done using CRISPR technology, China could be poised to lead the way in the field in the near future, especially if they ensure their regulatory guidelines stay in line with international standards.