Chapter 103 The Aura Of Scientific Research Against The Sky, The Approval Of New Drugs Is Accelerate
May 24.
Galaxy Medical Park.
A large conference room.
Hundreds of professors from various scientific research institutions gathered together.
They are here to report their respective drug research and development results.
The meeting begins.
Professor Qian Wei said with a smile: "Dean, selumetinib developed by our State Key Laboratory of Oncology Drugs has completed clinical trials.
The drug is the world's first innovative drug for the treatment of neurofibromatosis.
Those children aged 2 years and older with neurofibromatosis type 1 who had manifested symptoms could not be treated surgically for plexiform neurofibromas.
The new drug selumetinib developed by us can control the growth of cells, so as to achieve the purpose of treating neurofibromatosis type 1. "
hear this.
Lu Chen nodded in satisfaction.
600 scientific research institutions.
Not only the National Engineering Technology Research Center of Medical Nervous Drugs has developed new drugs.
Researchers from other institutions have made breakthroughs in their respective fields.
Professor Huang Hao said: "Dean, our State Key Laboratory of Congenital Deformities in Pediatrics has developed the farnesyl transferase inhibitor drug Zuojinwei, which has completed clinical trials.
The drug is the world's first innovative drug for the treatment of progeria and related syndromes.
People with progeria, a genetic disease, develop rapid aging and usually die before the age of 15.
And we developed Zojinwei.
Blocks farnesylation of progeria proteins.
Reduce the mortality rate by more than 60%. "
Hearing this, Lu Chen's eyes lit up.
Progeria, caused by a point mutation in the LMNA gene encoding lamin A, produces an abnormally farnesylated, toxic progeria.
Zuojinwei can block the farnesylation of progeria protein.
It is indeed the best drug for the treatment of progeria.
Professor Qiao Jian also said: "President, the drug Pemitinib developed by our National Engineering Center for Hepatobiliary Cancer has completed clinical trials.
The drug is the world's first targeted drug for cholangiocarcinoma.
Previously treated patients with locally advanced, metastatic cholangiocarcinoma carrying fibroblast growth factor receptor 2 fusions and rearrangements can be treated with pemitinib to relieve symptoms and prevent tumor growth and spread."
The voice fell.
Lu Chen nodded approvingly.
The birth of pemitinib will benefit many patients with cholangiocarcinoma.
next.
In the conference room, other professors spoke one after another.
In conclusion, our protein kinase inhibitor drug ripretinib can effectively treat advanced gastrointestinal stromal tumors!"
"Dean, the drug we developed, Teriparatide, has an extremely significant effect in the treatment of type 2 diabetes!"
"Dean, the drug we developed, Sepatinib, can effectively treat thyroid cancer and non-small cell lung cancer!"
"Luyuan, the drug Duvatinib developed by us has a remarkable effect in the treatment of psoriasis and psoriasis!"
"Yuan Lu, the drug we developed, veloxazine, can treat attention deficit hyperactivity disorder in children aged 6 to 17. It is the world's first new non-stimulant ADHD drug!"
Listen to the reports of the professors.
Lu Chen couldn't help but fall into the troubles of happiness.
The aura of academic research is really too heaven-defying!
Numerous professors have developed innovative drugs in various specialized fields, all of which are the first in the world!
At that time, these drugs required new drug declarations before they could be marketed.
He could have expected it.
After these new drugs are on the market, they will surely benefit countless patients every day!
early June.
Yanjing.
Drug regulatory agency.
Secretary Han Wen walked into the leader's office with the documents in hand.
She put the documents on the table and reported: "Leader, the new drug application documents for Yinhe Ganlu Capsule are all here.
Yuan Lide nodded and began to read.
In the document, the declaration information is very detailed.
The original data, clinical research data, pharmaceutical research data of Yinhe Ganlu Capsules, the approval letter of Suzhou Drug Administration Department, the approval letter of Suzhou Drug Inspection Institute, the field inspection report form and other documents are all available.
Each document is printed with the official seals of the Suzhou Provincial Drug Administration Department and the Suzhou Provincial Drug Inspection Institute.
All documents are in five copies.
After a while.
Yuan Lide ordered: "Han Wen, the application documents for Yinhe Ganlu should go through the fast-track approval channel immediately.
The Drug Approval Center is responsible for technical review, the Review Committee is responsible for review, and the Pharmacopoeia Committee is responsible for new drug quality standards and certification.
Within 60 days, I want to see the approval results of Yinhe Manlu Capsules!"
"Yes! Lead!"
Han Wen quickly responded.
The national drug regulatory agency, which encourages drug innovation and expedites review.
Decisions on new medicines needed to treat serious or life-threatening diseases can be made in as little as 60 days!
Yinhe Ganlu Capsule is the world's first new drug for the treatment of Alzheimer's disease that targets the brain-gut axis.
It can effectively treat mild, moderate and severe Alzheimer's disease and improve the cognitive function of patients.
A new drug with such a remarkable curative effect naturally needs to go through the fast-track approval channel.
Yuan Lide said with emotion: """ Statistics show that.
The annual cost of caring for and treating AD (Alzheimer's disease) patients worldwide has reached trillions of dollars.
The annual economic burden [over 1.2 trillion yuan] caused by AD in Xiaguo.
Now, AD has become the fifth most deadly disease in China, second only to stroke, ischemic heart disease, chronic obstructive pulmonary disease, and lung cancer.
Accelerated by population aging.
It is estimated that by 2050, there will be 40 million Alzheimer's patients in China.
The appearance of Yinhe Manlu Capsules will be good news for all AD patients in China!"
Han Wen nodded in agreement.
AD is irreversible.
And Yinhe Manlu Capsules have been proved to be effective in clinical trials!
Just as Han Wen was about to leave, she suddenly remembered something and said quickly, "Leader, there are already a backlog of 14,000 generic drug applications waiting for (Zhao Wangzhao)'s review. The review team in our department is short of manpower, should we recruit another one?" Batch of experts?"
"Understaffed?"
Yuan Lide thought about it and found that it was indeed the case.
Count the global new drug listing application time.
Australia, it takes 5 days.
In the United States, it takes 1 month.
Kimchi country, it takes 1 month.
Europe, 3 months.
Xiaguo took the longest time, with an average of 18 months.
After thinking for a moment.
Yuan Lide decided: "Then expand the team of experts in the Drug Approval Center.
From the current two to three hundred people, increase to 1,000 people to improve the speed of the new drug review and approval process.
We want to make the drug review system gradually in line with international standards.
Only in this way, more innovative drugs will be born, and even go abroad!"
"Yes, leader!"
Han Wen nodded solemnly. .