Chapter 183 Difficulty in Approval of Gene Drugs
With the support of Chen Changan, Wang Jia and Yunheng's new projects were both launched!
Both of them were not polite at all. It cost 50 million to purchase new scientific research equipment in advance. Wang Jia also dug up several experts in optic nerve research from his alma mater, Sun Yat-sen University.
Yun Heng was even more ruthless. With a waste of money, he directly dug up six researchers who had participated in their project from the scientific research team at Jiangcheng University that studied CRISPR-Cas9 gene editing!
The main reason is that the research team at Jiangcheng University, which focuses on gene editing, is too short of funds. In recent years, Jiangcheng University's research funding has been very tight and cannot allocate funds to them, which has led to their research stagnation for a long time.
In this case, Yun Heng waved a lot of money, as well as Ruikang Medical and Chen Changan's signature to poach people, it was simply too easy.
He just mentioned his project and immediately poached six backbone members of the research on gene editing technology from Jiangcheng University. And a few people were still hesitating and might join Yunheng's scientific research team in the future.
Money is really a good thing. Without shortage of money, the two of them soon built the R&D team. They were short of talents and equipment, so they could do whatever they wanted.
After gathering the team, the two of them did not delay anything and started R&D work in a busy manner. However, the project was just the beginning and there would be no signs in the short term in one or two months, and the humanoid paper library of Chen Changan would not be used for the time being.
But he was not idle either.
The clinical trial work of the biopacifier project is almost over.
After several fine-tunings, the gene agent used to transform pacemaker cells has been derived, which are suitable for four different genomic populations in the north and south. Basically, except for some patients suffering from severe diseases such as blood diseases and cancer, it is suitable for most Chinese people.
This genetic agent has already met the standards for listing in China, but the Drug Administration and the Health Commission have not agreed to the listing approval for listing for a long time, and have not refused, but have just been delaying and refused.
Chen Changan was still a little confused. Eighty-most because genetic drugs are involved in too wide and have high risk. Genetically modified foods have been delayed in being approved for marketing in China, let alone drugs that modify cell genes?
However, the thousands of clinical data submitted by Ruikang Medical are really excellent, which makes the leaders of the Drug Administration and the Health Commission very moved. They always feel that it would be a pity to not approve it.
Therefore, the senior management has been arguing about this. The number of leaders who support the listing of genetic agents and those who oppose the listing of genetic agents is similar. There was no satisfactory result in several internal meetings.
Only when the listing approval matters will be delayed without a reply.
.....
In the office building of the Beijing State Food and Drug Administration.
Another meeting on genetic agents for Ruikang Medical was held today.
This is not the first time the State Administration of Drug Administration has held a meeting on this matter. It has held seven or eight meetings in the past half month. It is basically a debate over the issue of disagreeing with Ruikang's genetic agents.
"I think it is completely approved for listing. The clinical data submitted by Ruikang and the safety surveys given by several medical institutions have already made it clear. This genetic agent applied to the heart is very effective, which can restore the self-discipline of the human heart and perfectly replace the role of a pacemaker."
"Compared to the cardiac pacemaker that needs to be implanted into the human body, this genetic agent is the direction of future medical development. Such an advanced medical method is no reason not to be approved!"
"Ruikang Medical has 4,852 clinical cases, of which dozens of patients failed due to the impact of other diseases they carry. The remaining nearly 4,800 patients have recovered their hearts after injecting genetic drugs. The heart has recovered their self-discipline function, heart arrhythmia, pacing disorders, atrioventricular block and other problems have been cured!"
"And no sequelae were found. This superficial gene editing technology can be used in clinical practice!"
Several young and more radical leaders of the Drug Administration are part of the supporter of Ruikang's gene drug launch!
In their eyes, the progress of medical methods requires support. New gene editing technologies have appeared for more than ten years. Some new treatment methods developed by major scientific research institutions around the world based on gene editing technology are basically very promising.
If you want to completely cure some diseases in the cellular field, you can only use gene editing technology to repair it, otherwise you can only consider cloning and transplanting, or organ cultivation and other more unrealistic methods.
Compared with the illusory in vitro cultivation of human organs, cloning and other technologies that are still in the conceivable stage, it is obvious that gene editing technology, which has reached the clinical stage, is more reliable and has more hope to become a new generation of therapeutic technology.
It is inevitable that China's medical development will lag behind in the traditional field, and it is even difficult to catch up with the international front-line level. Only by increasing investment in emerging gene editing can we overtake in the medical field.
After all, the current field of gene editing is basically at the same level in the world, and the development of the domestic gene editing field is not inferior!
In traditional medical methods, it is impossible to repair lesions or dead cardiomyocytes, and it is an irreversible disease and cannot be cured.
Ruikang's genetic agent used for heart treatment is undoubtedly a very cutting-edge and advanced treatment method. It only takes two injections of genetic agents to give birth to new self-disciplined cardiomyocytes and restore the heart's self-discipline.
Such powerful medical methods must be vigorously promoted. How can it hinder development?
However, some older and more stable leaders do not think so.
The deputy director of the State Administration for Drug Administration, who was sitting in the first seat of the left hand of the conference room, retorted: "A new technology, and a technology that involves human genes, can't guarantee the safety of gene changes!"
"At present, we have not even figured out how many genes there are in the human body. We rashly modify the cell genes. Perhaps it seems to be very effective now and can cure diseases, but who can guarantee that there will be no problems in the future?"
"If a gene mutation occurs five years later, ten years later, or changes the patient's genetic genes, causing the next generation to have genetic defects, the consequences will be unimaginable!"
"Let's take a step back, even if this impact does not involve the next generation, if the patient who has received gene therapy undergoes genetic changes, how can he solve it?"
"A large part of the disease in the human body is caused by a little mutation in the gene, and there are genetic problems. The current medical level cannot be treated at any time."
"If this genetic agent is used in large quantities and hundreds of millions of patients use this genetic agent, how will they deal with it if there is a subsequent genetic defect or mutation?"
"Since the current implantation of mechanical pacemakers can also achieve the ability to maintain patients' lives, why should we take the risk of genetic treatment?"
The views of the Agree faction are very reasonable, but the arguments of the Opposition are not unreasonable. Both sides' ideas are correct in a sense.
This made Director Kang, who was sitting in the main seat, very impressed.
Ruikang's genetic agent has great benefits and great risks.
This made him a little dilemma!
Chapter completed!