Biotechnology

is China ready to lead?


For many people, when they hear China and genetic engineering in the same sentence, it is often synonymous with scandal, and gene-engineered babies probably come to mind.

And, while it’s true that nearly five years ago, researcher He Jiankui famously claimed he had created the first. gene-edited babiesbefore going to prison for three years, China continued to pour large sums of money into genetic engineering research, and aims to become a global leader in the field.

“The cumulative amount of financing in the field of gene therapy in China has exceeded $3.3 billion. Moreover, according to Frost & Sullivan research, it is estimated that by 2025, gene therapy will scale to 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 the country: “Gene editing has been listed as one of the key strategic goals in country-level strategic plans, including the 13th Five-Year Plan, 14th Five-Year Plan, and the plan for 2035. That means all financial support and resources (both public and private funds) will be put in place to prioritize these key strategic goals, including gene editing.”

Joy Zhang of the University of Kent, who is a global expert on the governance of gene editing in China, agrees with this, saying that gene editing is practiced, taught, researched, and implemented in universities across the country.

It is also, of course, being researched and practiced by biotech companies based in the country, such as BDgene and HuidaGene, which are working on gene therapy to treat diseases such as Duchenne muscular dystrophy (DMD) – a condition causing progressive muscle weakness – and herpes simplex virus (HSV) keratitis – a corneal infection caused by HSV.

the CRISPR revolution

China is currently using CRISPR gene editing tools for a wide range of applications, from agriculture, to gene editing in animals, to medicine.

In fact, when it comes to animal genome editing, Chinese researchers were actually the first to use CRISPR in monkeys, and the country now has several groups of researchers performing gene editing in large colonies of monkeys.

Harnessing the speed and precision of CRISPR, researchers have been able to create monkey models of muscular dystrophy, autism and cancer.

Researchers in the country have also used CRISPR on dogs, rats, mice, pigs and rabbits, with research that could potentially offer higher-quality meat, disease-resistant livestock, and medical treatments and new organs for transplant.

Push towards genetically modified crops

Another area where genetic engineering is really gaining ground in China is GM – or genetically modified – crops.

Previously, the country had considered a lot whether or not to allow the cultivation of GM crops, but, earlier this year, it was finally announced that China had approved the safety of its first gene-edited crop.

This is because the country wants to increase its agricultural production to overcome food insecurity and promote greater self-sufficiency.

The plant, developed by Shandong Shunfeng Biotechnology Company, is soybean and contains two edited genes that increase levels of the healthy fatty oleic acid in the plant.

Shandong Shunfeng Biotechnology Company is also working on other GM crops, such as high-yield rice, wheat and corn, and vitamin C-rich lettuce, and there are more companies working on similar projects.

Regulatory gap: room for improvement

Her gene editing scandal and subsequent convictions for ‘illegal medical practices’ led to the Chinese government tightening gene editing regulations, setting requirements for approval, supervision and ethical review.

However, some experts believe that this rule is insufficient; there are concerns around the fact that the rule may not apply to the private sector in the country, potentially allowing private entities to waive it.

Zhang explained that China used to be able to monitor scientific research, before the private sector was well developed in the country. But this is no longer the case.

“Back then, even when there were regulatory gaps, China could monitor all this research through its administrative channels – because it was almost like sending commissions to good scientists; You know who does what – but what has changed in the last 20 years is that you have a lot of very active companies that are growing outside of commercial institutions, and you don’t really have regulations in place to monitor – even to track – what’s going on. And that creates a problem,” he said.

Additionally, He has returned to the genetic engineering scene in China since his release from prison, and now claims to have set up his own lab, where he is trying to use CRISPR to find a DMD cure.

“Responsible scientific research is not just about good intentions – each of us has them – but not all of us are good scientists; we must have the skills and expertise, and more importantly, we must be careful and have the knowledge and expertise to be aware of the risks associated with individuals. This is something that I think is completely absent from his (Her) scientific reasoning,” said Zhang, who was one of the keynote speakers at an international human genome editing summit in London several months ago that highlighted He’s practice and the potential dangers of letting it slip away from his research.

There is some good news in sight, however, as Zhang said China’s ministry of science and technology recently proposed another draft of guidelines that provide an additional ethical review. Zhang explained that this is like a “catch-all” type of policy that would work to complement the rules they introduced earlier, and would take care of private entities.

Gao also noted that keeping the dialogue open and including China in high-level international discussions on the governance of gene editing would potentially help create consistent international standards in the field of gene editing.

Will China take the lead in genetic engineering?

There is hope in the scientific community in China that the country can bypass He’s actions, and that the gene editing in the country can succeed, eventually catching up with the US.

However, the road to the country is still long. “Currently, most of the 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 sometimes make new breakthroughs in this field,” commented Gao.

He noted that it might take a few years for China to catch up to the US, but a recent milestone put China on the map, when the CRISPR-Cas12i editing system developed by Chinese biotech HuidaGene was authorized by the US Patent and Trademark Office (USPTO).

So genetic engineering in China is definitely starting to take off, and with the large-scale investments being poured into genetic engineering and the amount of research being done using CRISPR technology, China could be poised to take the lead in the field in the near future, especially if they ensure their regulatory guidelines stay in line with international standards.



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