Professor Chang Junbiao of Henan Normal University invented the first anti -new crown oral medicine in my country

Author:Henan High Education Time:2022.07.15

Azfdin, who has been approved for more than two years of phase III clinical trials, is expected to become my country's first oral anti -new crown drug with completely independent intellectual property rights!

On July 15th, Henan Real Biotechnology Co., Ltd. (hereinafter referred to as "real creature") announced that it has officially submitted a listing application for the treatment of new coronary virus indications to the National Drug Administration for the treatment of new coronary virus.

Since April 2020, Azf has been approved at home and abroad to conduct phase III clinical trials. The clinical trial results show:

(1) Significant improvement of clinical symptoms: Azf's fixed tablet can significantly shorten the moderate new type of coronary virus infection with pneumonia patients, improve the proportion of patients with improvement of clinical symptoms, and achieve clinical excellent results. On the first 7th day of the administration, the proportion of the subjects of the clinical symptoms improved 40.43%, and the placebo group was 10.87%(P value <0.001). There are very significant statistical differences with the placebo group (P value <0.001). (PPS set)

(2) Inhibit the role of new coronal virus: Azf will definitely have the activity of inhibiting the new coronary virus, and the virus clearance time is about 5 days.

(3) In terms of safety: The overall tolerance of Azf's fixed decision is good, and the incidence of adverse events has no statistical differences with the placebo group, and the risk of the subject does not increase.

Dr. Du Jinfa, the chief scientist of the real biology, said: "We are very happy to usher in this important moment. I look forward to Azf's early approval and provide a force for the prevention and control of domestic and global epidemic conditions."

Professor of Azf's drug inventor and Professor Chang Junbiao said: "We break through traditional ideas, develop new strategies for nucleoside drug design, and innovate the characteristics of micro -environment RNA polymerase in the process of virus replication, so that the drugs can make the drugs inside the target cells Specific 'locally' activation and play a role in situ. In addition, further research has proved that the half -life of Azf in CD4T cells is greater than 120 hours, and its drug is targeted and long -term. "

Jiang Jiandong, an academician of the Chinese Academy of Engineering and the dean of the Beijing Academy of Pharmaceutical Research, Chinese Academy of Medical Sciences, said: "Azf has obvious anti -new coronal virus effects, which is effective for patients with clinical enlightening. The new crown of mechanism, this is its distinctive biological characteristics. "

It is understood that in order to prevent the prevention and control of the epidemic, as early as January 31, 2020, the Henan Provincial Department of Science and Technology launched the first batch of emergency research research projects. The drug screening (201100311500) was approved.

After the project task was issued, Professor Chang Junbiao led the relevant units to find that Azf had a certain anti -new coronal virus activity through the screening of anti -new coronal virus drugs. After reviewing the Hospital Medical Ethics Committee, it is used for clinical trials. On February 29th, the first batch of project progress of the first batch of project progress in the first batch of project progress in the prevention and control of the new crown pneumonia in Henan Province was reported. After preliminary clinical trials, the results were exciting. Among the 10 patients in the experimental group, the first nucleic acid ride yin rate within 4 days reached 90%, while the conventional treatment group was only 10%of the first nucleic acid ride yin rate within 4 days; especially in the experimental group, a patient was admitted to the hospital for treatment 20 For many days, the nucleic acid detection was used in multiple treatment schemes. None of them did not switch to yin. On the 5th day of taking Azf's fixed drug, nucleic acid testing was tested. Other clinical data is currently in statistics, and there will be more comprehensive clinical results in the near future.

Azvudine (FNC) 1.1 New drug 1.1 is jointly developed by the National Major New Drug Special support, Professor Chang Junbiao, Henan Real Biotechnology Co., Ltd., Zhengzhou University, Henan Normal University, and Henan Academy of Sciences. Internationally the first anti -HIV dual -target innovation drug, compared with the listed nucleoside reverse transcription enzyme inhibitors, FNC has a unique mechanism and strong inhibitory virus replication function. The scope is applied for patents and authorized. As the world's first dual -target anti -AIDS innovation medicine, Azfdin appeared in the national "13th Five -Year Plan" scientific and technological innovation achievement exhibition in 2021. The advent of its adventure marks that in the field of AIDS therapy, China's first nucleoside innovation drug was born!

The native scientist in Henan has led the team for 18 years and once again achieved a breakthrough in "from 0 to 1" to embed a bright star for the innovative medicine territory. Today, this innovative medicine will contribute to the new crown.

"This road 'Ninety Dead Life'"

Chang Junbiao, male, born in October 1963, from Henan Province, Henan Province, a second -level professor, winner of the National Outstanding Youth Science Fund, outstanding professional and technical personnel in the country ...

Behind the profile of calm restraint, there is a unknown story.

In 2006, Chang Junbiao established the "New Drug Creation and Drug Safety Evaluation Henan Provincial Coordinated Innovation Center". This is the first drug research and development professional laboratory in Henan.

Here, Chang Junbiao team developed three innovative drugs -AIDS AIDS Azfdin, the treatment of sodium sodium in the treatment of a new drug of cerebrovascular disease, and the treatment of non -small cell lung cancer new drugs.

What does 3 innovative medicine mean?

Although the level of science and technology in the field of pharmaceuticals in my country has made great progress, it is still a major generic drug, and there are very few real innovation medicines. Just like a pyramid, the largest proportion of the tower foundation is occupied by various types of generic drugs. The most dazzling tower spire belongs to the innovative drug of independent intellectual property, that is, the original research drug. Authoritative data show that from 2017 to 2020, there were only 41 innovative medicines approved by my country. The development of new drugs has always been regarded as a high -risk and time -consuming technology research field. From the perspective of international experience, the birth of an innovative medicine usually takes more than ten years, and costs billions of dollars. Behind it, there are many links such as drug design, pharmaceutical synthesis, pharmaceutical experiments, safety experiments, and clinical trials of phase I -III. Anyway, there is a problem with the stagnation of research and development, and even declare failure.

It is difficult to produce results. It is difficult to "monetize" the results and cross the "Valley of Death". In the eyes of the "insiders", in the life of his life, you can have a research on an innovative medicine to be listed and comfortable.

This road is not only long, but also dangerous. The higher the climbing, the more levels you need to break.

Seven years ago, Brozuo sprayed sodium to a powerful pharmaceutical company in Zhejiang at a price of 45 million yuan, setting the highest record for the transfer of single patent results in Zhengzhou University.

But Azf would not be so smooth. After the technology transfer, due to the restrictions of various conditions, especially the funding, each link is helpless. Afraid of the results of the results, Chang Junbiao's team chose to stand up with the enterprise firmly and complete a series of experimental work.

"I finally gave birth to a healthy baby, and it depends on him to upgrade the monsters all the way until he grew up." Chang Junbiao was so joking.

Yu Xuejun, a researcher at the High -tech Research Center of Henan Provincial Academy of Sciences, is Chang Junbiao's old partner. In 2005, the two were going to a security evaluation center outside the province to set a safety evaluation for Azf. As a result, the other party asked for more than 1 million yuan.

At that time, the project initiated fund was only 150,000 yuan. More than 1 million yuan, it is undoubtedly an astronomical number!

Studies were trapped. They are as open as possible, while raising money, looking for help, finding a way to "蹭" laboratory, overcome difficulties, and continue to promote research.

One step and one step, step by step. Looking for the road in the way, solve the problem in the problem.

"This road is not 'Nine Dead Life', but‘ Ninety Dead Life ’. Most people have trek their lives for a lifetime and have not reached the top of the mountain.” Yu Xuejun said with emotion.

"Do not selfish thoughts for doing medicine"

"Medicine is used to save people's lives. It is a special product."

"It is necessary to be quiet and calm for medicine, and you can't have selfish thoughts, otherwise you will deviate from your original intention."

Before obtaining the patent and approved listing, the results must not be announced in advance for some kinds of interests. For more than 20 years, the people in the team have come, but everyone knows that this is the bottom line of research with Chang Junbiao.

"Everyone who chooses medicine should ask themselves, can they be responsible for social needs? Do you like it from the inside?"

In this sentence, Chang Junbiao became a current questioner from the listener in school.

Only when you really like it can you resist boring and fatigue.

Only when Chang Huai's heart is benevolent, can you be able to make a lifetime once.

In 1982, Chang Junbiao admitted to Henan University from Rural Rural in the County and studied organic chemistry. Although he saw the train for the first time after going to college, he had no time to forget to return to the outside world. He was soaked in the classroom and library all day. There are more than 120 students in the whole year, but there are only a few people who receive scholarships, but he has him every year.

After graduating from college, several units wanted him, and he chose to continue studying. First, I was admitted to the Institute of Chemistry of Henan Provincial Academy of Sciences, studied for a master's degree in science, and then won a doctorate degree in the Institute of Pharmaceutical Research Institute of China Union Medical University (now Beijing Union Medical College), and became a postdoctoral post -doctoral of the School of Pharmacy of the University of Georgia.

"Tao Sanxing Si Pear for five years, I want to eat ginkgo for a hundred years." The rural baby who has been familiar with the old saying from an early age knows that although the pear tree grows slowly, once it is in the high yield, it is out of control. There are many.

Quiet, quiet. Quiet.

As long as you do n’t have a business meeting, you will be soaked in the laboratory every Saturday and Sunday; you arrive before 8 am, and leave after 7 pm -he has persisted for many years.

Doing experiments is his biggest hobby and the only hobby in his life. When you are tired, go downstairs to take a walk, the eyebrow lake, the birds are groaning, how much the small puppets in the thoughts, in the walking more than 10,000 steps a day, went smoothly and unlocked.

There is no shortcut to climb the peak of science. He usually speaks not high and quite gentle. He heard the names of "Xueba" and "Medicine God", and immediately frowned:

"How can there be no god in scientific research? Do it always first."

When Chang Jun read his Ph.D., he studied with Xie Jingxi, a famous drug chemist in my country. Mr. Xie is 97 years old. Since his retirement, he will come to Zhengzhou once a year before the age of 90. It is more than 20 days to stay. He lived in Chang Junbiao's house at night, stuck into the laboratory during the day, and continued to guide the "disciples and grandson" to do experiments and discuss academic issues.

These scientists are simple and pure, and sometimes make people cry.

On the first day of the New Year, Chang Junbiao and the internationally renowned structural biologist in Germany Chai Jijie called. After the video was turned on, neither of the two people worshiped the New Year, and they began to discuss the progress of the subject.

Chang Junbiao's wife Qi Xiuxiang remembers very clearly that for so many years, the opportunity of the couple traveling together has three times. These three times are "mandatory tourism" invited by experts and talents. "For them, it is nothing more than changing the study." Qi Xiuxiang said with a smile. Others usually see where they are worth visiting, but their husbands are looking for a conference room first to discuss topics in the last group of colleagues.

He didn't pay attention to him at all, even simple. Some clothes were washed too much, and the collar cuffs were rotten. He called him to buy, and he always said that he had no time. Qi Xiuxiang had to compare his old clothes and buy a few pieces at one time at one time.

Even now, when a person is in a residence, the "fast food" he mostly does is still a bowl of corn batter according to his hometown. Sometimes when I return to Zhengzhou, the most wanted to eat is the dumplings that his 80 -year -old lady wrapped in hand.

Qi Xiuxiang, who loves to laugh, sometimes "aggrieved". The husband was originally the boss at home and had a strong ability to take care of himself. After marriage, he became the pillar of the family and was forced to learn a lot of things.

No way, there are too many things he wants. There are more than 30 people in the team, and everyone's research progress is clear. The data reported by the student can blurt out a few months later.

"Only simplicity and purity can maintain that focus and enthusiasm." The wife actually understood him best.

"He taught us to give everything to the truth"

In essence, innovation is the process of pursuing truth.

For the development of innovative drugs, drug design and synthesis are the first step of innovation. Chang Junbiao compares this "Long March first step" to "series", which means that every link is important, and each problem cannot be detoured. Each step is the basis and premise of the next step:

"Once you take this first step, you can only go to the results that you want to want, you can't stop, and you can't get back."

The wonderfulness of nature is amazing! There are only a hundred types of chemical elements known, but on the experimental table between square inches, they jump and move, and they can become an endless form. From the colorful and beautiful elves, the one you want, this search and harvest can bring people a great happiness.

However, the process itself means trying again and again. Most of the time, it is difficult for researchers to get the results they want. During the research process of Azf, thousands of compounds have been synthesized, and countless experiments have been conducted. During this huge number of numbers into the 18 -year research journey, each step is immersed in the salty astringent of sweat.

Some response consumption is long, and you need to stare without sleep. Afraid of young people sleeping a lot, Chang Junbiao usually asked them to stare at the middle of the night, set the alarm clock itself, and take over the middle of the night.

At the beginning, there were only a few people in the Azf's research team. Qi Xiuxiang, who was in the same major as Chang Junbiao University, often played the role of assistant role at any time.

What is more common is the failure of the experiment, but the person who rushed on the road was not frustrated. "With the training of Teacher Chang, everyone has formed a conditional reflection. When you encounter a problem, find the reason until you think of a new way to solve it." Said Meng Yonggang, a doctor of organic chemistry at Zhengzhou University.

The top is often hidden in the clouds. Even in the fall of falling — climbing — falling again, you have to aim at the target and re -revive the spirit to climb up again and again.

Sometimes scientific researchers even need to "ask for hard work". After Azfdin entered the phase II clinical trial, it was found that the effect of the drug was not obvious. It was necessary to further study its mechanism to see the actual distribution of drugs in the human body. In order to get the results as soon as possible, Chang Junbiao decided to recruit the test volunteer independently. He first reported his name.

Qi Xiuxiang was a little worried at first, but she knew too much about Chang Junbiao. This person not only had an opinion, but also was very stubborn. Once determined, nine cows couldn't pull.

"I also report!"

"Count me in!"

Including Meng Yonggang, Song Chuanjun, a professor at the School of Chemistry and Molecular Engineering of Zhengzhou University, and Wang Qingduan, an old retired professor, eight laboratory members reported. Chang Junbiao's brother and nephew also volunteered. The 12 places were full soon.

In this way, after the scientific research ethics assessment and comprehensive physical examination, at the clinical trial center of the First Affiliated Hospital of Zhengzhou University, the subjects took Ozfdin orally, and compared the results of the concentration of blood Chinese drugs before and after taking the medicine to further conclude:

Azf is targeted at a single nuclear cell (PBMCS) of the peripheral blood, and the active metabolites are effectively maintained for 4-5 days after the medication; the single nuclear cell targeted coefficient is more than 140 times that of another commonly used drug.

This conclusion provides a reliable basis for Azf as a long -term oral antiviral drug, and also gives a reasonable explanation to the results of clinical trials.

"Dedicated everything for the truth. Teacher Chang asked so, and we did this." Meng Yonggang said.

"I want to tell a story about innovation and persistence"

Song Chuanjun always remembered the scene 10 years ago.

One day before the Spring Festival, a dozen major members of the Brozo Sodium R & D team gathered at a white table at the laboratory.

At that time, the atmosphere was stagnant. Like the temperature of that day, it could freeze people into a hard group.

Just before this meeting, the research and development of the ride -the medicines made are not good in water, it is difficult to absorb in the body, and the biological utilization is low. Drops and capsules. Everyone tried to make the drugs into various preparations. I could think of all the ways, and they could do all the efforts, and they still could not solve the problem.

After a few hours of discussion, there was still no result. Almost everyone thinks that there is no way and fails. The study of more than ten years has given up like this, and it is really reluctant. There must be a way, but I haven't found it for the time being. Chang Junbiao's two thick eyebrows twisted together. Seeing that everyone didn't speak anymore, he waved his hand: "Persist for half a year!"

Do not solve the problem of water solution in potassium salt? Inspired by a similar drug, Chang Junbiao put forward new ideas.

However, the research team found that although the problem of water solution was solved, it encountered new difficulties: the stability of the synthesis made is extremely low, and the crystallization was not obtained.

"Potassium salt is not good, how about sodium salt?" Chang Junbiao suddenly proposed a bold idea.

"How can this do? How can the medicine for the treatment of thrombosis make sodium salt?" "Sodium ions high will increase blood pressure, and patients with cerebral infarction are dangerous. Isn't this not common sense?"

Native

The proposal was immediately refuted.

"Compared with daily diet intake, the sodium salt intake from drugs is much less dosage, and safety can be guaranteed. Try it!" Chang Junbiao insisted.

After about 3 months, the bottleneck was finally broken when the wicker was green. This time, the safety, solubility, and stability of the drug have been realized, and it is successful!

Strong will and dare to innovate. This is where Song Chuanjun admires Chang Junbiao most. Over the years, the laboratory "Bird Gun changed cannon" and bought a new conference table, but the simple white table of that year, Song Chuanjun has been reluctant to throw. Every student comes, and he will take them to the corridor west to see it, rubbing the mottled table along the paint, telling this story about innovation and persistence.

"Not because of hope, but because of persistence, he saw hope." Chang Junbiao said that this was a concentration that he had experienced more than 20 years of research.

It is difficult to leave the homeland, so the soil is difficult to leave

In 2015, with the "first shot" of my country's drug supervision reform, the innovative light was lit. Gradually, light is getting stronger and stronger, and more and more climbers come together.

For many years before, "making the original medicine in your own country" is the dream of Chang Junbiao.

In 1998, after the post -doctoral study, in the face of an invitation to stay in the United States, he refused without thinking.

Indeed, the traffic, residence, and research conditions there are very good, and wages can be obtained 10 times that of domestic. But that kind of wandering sense is always lingering, making him feel that it is "other people's country".

Back to China! Back to Henan!

After discussed with Mr. Song Maoping, Zhengzhou University who worked in the United States, the two decided to bring their wives and return to China together. Breaking the ice in the development of new medicines and engraving the Chinese names, this is by no means high -profile for scientists, but a dream castle built a little bit at school.

"Our country has a treasure!" When he was a PhD in that year, Chang Junbiao had been thinking about Professor Xie Jingxi. He also visited traditional Chinese herbal medicine like Mr. Xie and looked for the source of innovation.

When reading the blog, he found from Schisandra that this common Chinese herbal medicine rooted in China has a strong activity in regulating the central nervous antiviral antiviral, but the content of useful ingredients is too small to develop into new drugs. He synthesized these compounds, and for the first time in international bionic synthesis of natural products, split -flavored sub -alcohol armor.

Despite the "snail house" Henan, Chang Junbiao has not been alone over the years. Before him, a group of like -minded people shoulders next to their shoulders and ran together on the way to achieve their goals. This goal is to allow China to have more innovative drugs with independent intellectual property rights.

Taking Azf as an example, not only in China, the United States and Europe have obtained patent authorization. Its unique "dual target" technology. In terms of image, there are two sets of "annihilation" viruses, like missiles, accurately entering target cells, compared with those imported drugs that are peripherals peripherals. The dose is only one percent, and the toxic side effects are greatly reduced.

To maximize the patient's illness, relieve pain, and reduce his negative, this is the goal of Chang Junbiao, and this is the medicine he wants to make.

Scientific research is not the victory of a person. In recent years, Henan's innovation environment has become better and better. He has been doing various efforts to bring more and more excellent young people back, retain more new forces for the future industry of life and health science.

Wang Xiaona, an associate professor at the School of Pharmacy of Zhengzhou University, is a member of the Chang Junbiao team. After completing her studies from the University of Wisconsin at the University of Wisconsin in 2014, she decided to return to Henan to teach with Chang Junbiao.

On the first day of Zheng Da's report, a teacher in the same office told her that the wall she leaned on her desk was originally peeled off. It was professor that Professor Chang found putty and tools by herself.

After returning to China for more than two months, she published a paper on the top international journal "JACS". Because the main research was completed abroad, she didn't think much, so she entered the name of herself and foreign mentors. Later, an acquaintance told her: Professor often promoted your paper on several occasions, saying that it was the first "JACS" of the School of Pharmacy of Zhengzhou University. He was very proud and happy, just like his own article.

"Professor Chang is particularly willing to see young people surpass him, which makes people respect." Wang Xiaona said.

From studying abroad from the University of Bristol in the United Kingdom, after working in Zhengda, Song Chuanjun did not apply for the funding for a few years. Money is worried.

Not to mention the difficulties of the subject research, as long as he asked Chang Junbiao, he would give suggestions for his heart, without reservation. From a junior, Meng Yong just followed Chang Junbiao for research. , Dare to put forward new theories, open up new areas, explore new paths, do not be chicks under the wings of hens, be tigers, leopards, and take your own way in the jungle of scientific exploration.

Chang Junbiao, who usually does not like to laugh, has a tender side. On the day of the Mid -Autumn Festival, many students stayed for experiments. He set more than 30 pizza at once and accompanied the young people to have a happy lunch.

"It is very lucky to meet such a leader. It is very happy to study such a pure and harmonious team." This is the voice of young people from the heart.

"Good medicine, but the disease can be willing."

For drug research and development, this is an old saying that is familiar. It is deep and dignified, and it is also burning.

Breaking through the fog, it is a kind of innovative medicine to harvest independent intellectual property rights from the tens of millions of stitching of the structure.

It is greater sweet to develop more new medicines and good medicines to help patients regain health.

As long as there is pain in the world, developers will open up new adventure routes. Looking for sweetness in the bitter travel, although it is difficult to regret it.

The new and higher peaks are waiting for him to climb with them.

Source: Henan Normal University, Henan Daily

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