Chapter 677 New liver medicine! Liver disease savior!
When the exposure is 0.12-0.27 times the recommended dose for humans, male dogs can see too few testicular spermatogenic epithelial cells and shed spermatogenic epithelial cells in the epididymis.
The same damage can occur when the data is 0.02-0.09 times in lenvatinib.
In monkeys and rats, ovarian follicle atresia can be seen in monkeys and rats when the exposure is 0.4-1.91 times and 60-131 times the clinically recommended dose, respectively.
The data for lenvatinib are 0.2-0.8 times and 10-44 times.
This result excited all researchers.
Even compared with lenvatinib, which is twice as expensive as sorafenib, compound No. 7 has less impact on fertility and less damage to the human body!
Subsequent embryonic developmental toxicity studies, studies on toxicity of young animals, carcinogenicity, and various acute toxicity, mutagenicity, hepatotoxicity, cardiotoxicity, etc., were all unexpectedly good.
Pharmacokinetic results were also released soon after.
Compound No. 7 underwent four groups of pharmacokinetic experiments, including healthy adult subjects, subjects with impaired liver function, subjects with impaired kidney function, and adult subjects with solid liver cancer tumors.
The data showed that compound No. 7 was rapidly absorbed after oral administration and reached its peak within one to four hours after administration.
Moreover, food did not affect absorption and could hardly slow down the absorption rate.
Material balance study data showed that the absolute bioavailability of the compound was about 95%.
This figure is 75% for lenvatinib!
Compound No. 7 also performed well in terms of distribution performance after absorption. It has a high in vitro binding rate with human plasma proteins, ranging from 98% to 99%, mainly binding to albumin, and can also slightly bind to α1-acid glycoprotein and γ-globulin...
In vitro transporter studies, safety pharmacology, elimination, and other data were released one after another.
Compound No. 7 performed exceptionally well!
Although it is inferior to sorafenib, lenvatinib and other high-priced miracle drugs in general, it has more outstanding performance in some aspects, such as side effects and utilization...
This has surprised Han Chang and others.
Sorafenib is a long-established miracle drug for liver cancer, costing more than 10 billion yuan, and it took ten years to finally come out.
As for lenvatinib, Eisai Co., Ltd. has been devoted to research and development for 15 years, stopping all projects just to sharpen this sword, and finally took part of the kingdom from sorafenib.
In contrast, what about compound No. 7?
In less than four months, it only cost 3.9 billion Daxia coins, which is not even a fraction of the opponent, but it has successfully qualified to benchmark sorafenib and lenvatinib, which is simply a miracle!
...
In a week, compound No. 7 quickly completed preclinical experiments.
Xu Qiu quickly submitted an application for clinical research on new drugs.
The relevant materials have been prepared.
Including materials used in previous experiments, where and when human experiments are planned, as well as the structure of new compounds, methods of administration, toxicology research reports, etc.
As soon as this document left Baiyu Pharmaceutical Factory, it was immediately labeled confidential and escorted by a special person to Tiandu on a special plane that day.
In Tiandu, the Drug Administration, the Ethics Review Committee, etc. were already ready.
Also attending the meeting were the Minister of Health and the Director of the Health Commission.
The conference room was not calm at this time. The bigwigs who could determine the direction of the medical community whispered to each other and discussed this matter.
"It actually worked?"
"Clinical human experiments have begun. What are the results?"
"I don't know. The new liver drug R\u0026D department is all Xu Qiu's researchers. We don't know the inside news..." The speaker glanced at the Minister of Health.
With what he said at the beginning, no one dared to interfere with Xu Qiu, let alone insert personnel to collect information.
Therefore, everyone knew nothing about the various results and data of Compound No. 7.
Even the code name "Compound No. 7" was learned by the Drug Administration from the last experimental new drug approval.
"It's sent..."
As soon as the voice fell, the commissioner of the Ministry of Health entered the meeting room with a briefcase.
Bang.
The heavy briefcase was placed in front of the Minister of Health.
He nodded, entered the password, unlocked the layers, took out the innermost file, checked Xu Qiu's signature on the seal, and then nodded.
All the internal secrets of Compound No. 7 were sent to the headquarters. Once leaked, the consequences would be disastrous.
They can't afford to be careless!
"No problem, everyone review it."
The Minister of Health took out the most critical compound structure, manufacturing process, etc.
If it was just an ordinary generic drug or original drug, there was no need to be too vigilant, after all, those who could attend the meeting were all their own people.
But Compound No. 7 was too important, and they were unwilling to gamble!
Therefore, only he, the director of the Drug Administration, and a few others could read these documents.
…
The conference room was silent, and everyone carefully examined the data submitted by the new liver drug department.
The expressions of the crowd changed from curiosity to solemnity, and finally to a solemn look, even with a hint of confusion.
“Is this…really the pre-experimental data of compound No. 7?”
“How is it possible? It’s comparable to sorafenib. This is the result of more than four months?”
“Not just more than four months, he only spent 5 billion! No, the 5 billion has not been used up yet!”
"No, is he serious? Really 5 billion?"
"Xu Qiu clearly agreed to make a safe version of Gan An Ning, how come he quietly beat the other party by a wide margin... This data is countless times better than Hui Ning's ideal Gan An Ning!"
The eyes of everyone in the venue fell on the Minister of Health and the Director of the Health Commission.
That look seemed to be questioning: This is the person you two recommended, give a reasonable explanation quickly...
The smile on the corner of the Minister of Health's mouth was almost unstoppable. He lay back and his tense emotions relaxed. He said: "I can't explain it. This is Xu Qiu!"
The Director of the Health Commission also smiled and said with emotion: "Yes, this is Xu Qiu!"
...
The next day, an expedited approval was sent back to Linhai City.
After certification, the Drug Administration, the Ethics Approval Committee, etc. all passed the review and allowed the seventh compound to start clinical trials!
Xu Qiu was even faster. An hour later, the recruitment notice for the first phase of clinical trials was released on the official websites of Linyi, Linhai City, Baiyun Province, etc.!
"Liver cancer is a serious disease with a high recurrence rate and a grim prognosis. The five-year survival rate of patients with lymph node metastasis is only 11%; after metastasis to other organs, it is less than 3%.
"As a country with a high incidence of hepatitis B, my country's liver cancer incidence rate remains high. Among men, liver cancer is the third most common cancer after lung cancer and gastric cancer.
"But at present, our effective treatment methods for liver cancer are still extremely limited!
"The existing systemic therapies for liver cancer are divided into two categories, one is immunotherapy, and the other is multikinase inhibitors (MKI). However, MKI drugs such as sorafenib and lenvatinib are priced very high, with a single box price of more than 20,000 yuan, and a month's treatment costs about 50,000 yuan, or even higher!
"Not long ago, the new drug independently developed by Daxia showed great potential in the targeted treatment of liver cancer. Domestic liver cancer, especially hepatocellular carcinoma patients, are expected to usher in new treatment options!"
