Back To The Age Of The '80s

"Promote the listing of erlotinib in China?" All the top figures in the domestic biological circle were present, and they couldn't help but look at each other when they heard Li Zheng's words.

"Yes, Erlotinib, as the first anti-cancer targeted drug, is of great significance to the history of human medicine and the market. FDA has made it clear that it will speed up the drug approval process, and I hope that China can also keep up. "

Changing Huaguo's new drug approval system and speeding up the connection between Huaguo's drug market and the international market is one of the most important reasons why Li Zheng gave up Xiangjiang's favorable experimental environment and returned to Huaguo.

And erlotinib will become the starting point for him to leverage the stubborn stone of new drug approval.

In Li Zheng's last life, Huaguo's new drug approval system seemed to have become a great shackle for the development of Huaguo's biopharmaceuticals.For example, when the CFDA was still the SFDA, the Department of Drug Registration, as the key department of the SFDA, held a lot of power.

Huaguo SFDA does not require clinical trials for new drug registration of drugs that have been listed in the Pharmacopoeia, and the approval time is generally between 1 year and 18 months, while the US FDA's approval time for real new drugs may last for 6-8 years.

From this point of view, it seems that Huaguo's new drug approval system has greatly promoted the research and development of new drugs, and is conducive to the rapid transformation of scientific research results into productivity.

However, is this really the case?

Li Zheng has seen a data that in 2004 Huaguo SFDA accepted 10009 new drug applications for approval, while the US FDA accepted 148 new drug applications for approval in the same period.The huge data discrepancy made Huaguo's biopharmaceutical industry a joke for a while.

Among the so-called new drugs submitted for approval, there are no more than 20 first-class new drugs approved in China, and the rest are all generic drugs. And there are many drug research institutes.

They don't have much research strength, and their daily job is to find information, make declarations, get approval documents, and then use the country's preferential policies for new drugs to make huge profits.

This market phenomenon, while greatly destroying the ecology of the domestic new drug research and development market and dampening the enthusiasm of researchers, has caused real new drugs to be mixed with such fake drugs and cannot be released for a long time.

Drawing on blank paper is far easier than drawing on paper that has been smeared. The current Huaguo new drug approval process has not yet been fully solidified. When it comes to drug research and development, for them, completing the research and development is equivalent to completing the task.

"This...you can apply to the relevant department, it shouldn't be difficult to get it approved." Tian Lao said naturally.

He had seen Li Zheng's clinical data, which was very detailed. In his opinion, this problem should not be a big one.

"The problem is really not big. Two days ago, I had received the rule that the drug entered the approval process."

Everyone was stunned for a moment, and then realized that with Li Zheng's current reputation, it is not surprising that such a thing happened.

"Isn't this great? I've seen your clinical data. It's very detailed, and there's nothing wrong with it. Life-saving medicine needs to be dealt with specially!" Mr. Tian was full of optimism.

On the other hand, Mr. Yang, who always showed his impulsive image, frowned and never let go.

"Li Zheng, did you have someone say hello?" Elder Yang asked suddenly.

Li Zheng raised his eyebrows and didn't hide it, "Yes, when I submitted the new drug for approval, I asked someone to help clear it up."

When everyone heard the words, there was a bit of tangled expression on their faces, but in the end, most people's opinions were just like what Elder Tian said just now, life-saving medicine is a special case, and it is not a major event that breaks the rules.

From this, everyone's concept of the drug approval system can be seen.

This is the top group of people in the current Huaguo biology circle.

Li Zheng didn't go around in circles with them, "Seniors, don't you think there is something wrong? Watson, Berger, and Gilbert are all Nobel Prize winners, world-class biologists, and there are three of them. Guaranteed, the accelerated approval time given by the FDA is 1-3 years. In these three years, what the FDA needs to do is clinical approval of drugs.”

"In China, we don't even have clinical approval standards. From a long-term perspective, this is not a good phenomenon for biopharmaceutical people." Li Zheng, who is 21 years old, has a serious look on his face.

drug approval?Zhao Depei's expression is a little subtle, and this is not just a scientific matter.But he had to admit that what Li Zheng said was indeed reasonable.

Compared with these biological people of the older generation who are immersed in the laboratory, Zhao Depei is the most senior president of Huaqing, and he still has some contact with the officialdom. In the current drug registration department, there are only a few dozen people engaged in front-line drug approval, and the highest education is only a few. It is too embarrassing for the university to ask for clinical medicine and so on.

However, Li Zheng is right. If the domestic drug market is to be truly regulated and in line with the international market, it is essential to establish a sound clinical trial standard.

Only a sound clinical trial specification can ensure the scientific nature of the drug access mechanism, promote the healthy and stable development of the domestic drug R&D market, and provide institutional guarantees for the smooth entry of foreign drugs into the Chinese market.

However, it makes sense to make sense, but after all, this is not just a scientific matter, and it is not easy to do.

Everyone at the scene also heard Li Zheng's implication, "Why, Li Zheng, are you interested in new drug approval?" Old Yang was smiling. One of the highest approvers of Huaguo new drugs entering the market.

He had some vague concepts and ideas about the drug approval system in Huaguo, but they never became concrete. Li Zheng's words were like enlightenment, which made him see a lot more clearly.

However, as a biologist, he has always regarded himself as a scientist. He didn't pay much attention to such trivial matters as the system and approval. In the eyes of this old man, this is not doing business properly!

"Li Zheng, you are a natural scientist, don't let other things distract you." Yang Laoyu said earnestly.

The lofty arrogance of the older generation of scientists is also an important reason why drug approval in Huaguo is controlled by a group of laymen, and drug clinical standards have not been established for a long time.

"Old Yang, what is the significance of our study of biology?" Li Zheng's eyes became a little serious.

Old Yang was obviously taken aback, "Meaning, to explore the mysteries of life science."

Li Zheng smiled. He raised his head, glanced at a group of old scientists who had dedicated their lives to biological science, and said word by word: "I am different. The purpose of my research on biology is very simple. It can be transformed into productivity, and the Each of my projects has been transformed into visible productivity."

Li Zheng's statement is as if in the ancient times when everything was inferior but reading was high, a scholar shouted out that I was studying for the purpose of getting promoted and getting rich, which shocked the world.

Li Zheng didn't mean to stop. In his mind, the scene when he met Chen Anbang for the first time in Huaqing in his previous life. At that time, Chen Anbang was over 50 years old, and his long-term laboratory career made him look younger than his peers. People are much thinner.

However, Li Zheng will never forget his powerful words in two lifetimes.

"Exploring the mysteries of life and pursuing the essence of life is a very noble thing. But the current state of the country does not allow us to be noble. These are the original words of an old man, and because of his words, I I gave up molecular biology, which I was good at, and devoted myself to biopharmaceuticals." This is the first time Li Zheng has taken the initiative to bring up his original work.

This made all the old seniors in Huaguo's biological circle look at each other in blank dismay. The old senior Li Zheng was talking about should also be from their generation. How could anyone among them have such a great influence on this talented biologist?

"Medicine is not a work of art, it is for people to appreciate. Only when a medicine is used on people and truly plays a role in curing diseases and saving lives, can it live up to the days and nights in our research laboratory. The sooner a real good medicine is on the market, the better it will be." Saving one more life, reforming the drug approval system, and strengthening the drug transfer mechanism are imperative now."

There was silence in the meeting room. This meeting was initiated by Li Zheng. Everyone thought it would be a meeting about the Human Genome Project, but they didn't expect Li Zheng to drop a blockbuster on everyone when the meeting started.

Reforming the drug approval system is both difficult and easy to say.

Because everyone present is the most influential group of people in the biological field of Huaguo. Their peaches and plums are all over the world, and many of them are powerful officials in the health department.

Even several of them, like Mr. Yang, have the National Drug Regulatory Commission on their heads. Many of them don't care much about this title, but if it is really used, it can change the status quo of drug approval in Huaguo .

The National Drug Regulatory Commission is the highest power opportunity of the drug regulatory department directly under the State Council. The committee has 24 permanent members. Every major decision-making related to drugs must be voted on by [-] members present, and it is passed with more than half of the votes.

The members of the committee are elected and born, and the officials of the Ministry of Health and other related departments and the biologists are divided into half and half.It's just that the old scholars in Huaguo have always been impatient with these mundane things.

Therefore, the committee has been established for so long, and these biologists with the title of committee member have seldom attended the committee. In other words, officials from the Ministry of Health and other relevant departments voted on major matters such as drug approval and drug listing in Huaguo.

"Li Zheng, you mean to change the status quo of drug approval in Huaguo?" Someone asked.

"No, this goal is too broad. The first step I have to do now is to establish a relatively complete drug clinical specification."