Chapter 1062 The Ordinary Road (Second update, please subscribe)
As usual, Li Shun turned on the car radio as soon as he got in the car and listened to the music program broadcast by the broadcasting company. A few minutes later, his car drove onto the highway, which was only ten minutes away from his work. After the music finished playing, the sound of news came again.
Most of them are domestic and foreign news. After hearing the news that "the Navy's First Fleet is about to end its special military operation in Suez and will return to Nanyang soon", although I have no idea about current affairs. There was nothing special about it, but Li Shun still nodded and said.
“It seems that the canal crisis should be over soon.”
Many things have signals. If it weren’t for the fact that the crisis was about to be resolved, the fleet would never have withdrawn to Nanyang. Soon The news was changed to music again, and Li Shun couldn't help but hum a few times while listening to the music.
After just a few songs, the car pulled into the parking lot of the Food and Drug Administration. There were more cars here than in the past, and more and more colleagues bought their own cars. Maybe one day, the parking lot will definitely be filled with cars. Who would have thought that a few years ago, this parking lot was still empty?
"Good morning, Master Zhao."
As usual, after saying hello to Zhao Deliang, Li Shun entered the office building.
After passing the lobby, step directly into the elevator.
The elevator stopped on the seventh floor. The porch light illuminates the beige floor and is lined with white walls. The entire corridor looks extremely neat. It also smells of lab reagents and cigarette smoke. Twenty frosted glass doors lined the corridor. This is the laboratory of the Food and Drug Administration, and Li Shun's office is here.
Even though it's not yet eight o'clock, some doors are ajar, and the sound of typewriters or phones ringing can be heard inside. This place is very busy every day, and a large amount of food and medicine are sent here for testing every day.
Li Shun's job was to be the person in charge of this laboratory. He opened a door and turned on the light. His office looked like a dark place, without even windows, but it was very rare to have an independent office, and one wall was turned into a bookshelf. A leather-bound hardcover book, a drug manual, a large atlas, a street guide to Chang'an, a phone book,
A large number of labeled case file boxes, mostly reports of drug testing experiments, Li Shun's here The job is very simple - it is to provide a "birth certificate" for every drug entering the market to ensure that every Nanyang person can use safe drugs.
And his job is to review materials provided by pharmaceutical companies and ultimately decide whether their drugs can enter the market. And that's where he works as a reviewer for new drug applications at the Center for Pharmacology.
The job seems simple, but in fact his work is related to the lives and safety of tens of millions of Nanyang people.
In the quiet office, Li Shun, a new drug application review officer at the Center of Pharmacology, is burying his head under the desk lamp. His eyes are focused and sharp, like a falcon staring at its prey.
In his hand he held a thick stack of pharmaceutical company information. Each page carried the hope of saving lives in the future, but also lurked unpredictable dangers.
Faced with pharmaceutical company application reports, what Li Shunjiao needs is to carefully read every report and data. Then decide whether they can be marketed.
Although Nanyang’s drug approval process is much improved compared to many countries, there are still no formal rules governing the data submitted to support new drug applications. At least in part, the process is routine—if the Food and Drug Administration raises no objections to a drug's marketing application within a certain period of time, the drug is automatically approved.
This is almost the case all over the world.
The drug Li Sun was reviewing was a report on the new drug "Thalidomide" provided by the German company Merrell. As long as it passes his review, this new drug that has just been invented to suppress morning sickness in pregnant women can enter the Nanyang market.
However, as the reading progressed, Li Shun's brows gradually furrowed. There are many hidden dangers hidden in the application materials for this new drug.
“This drug has not been tested prospectively?”
As a pharmacologist, Li Shun knows very well that this means that its potential risks and side effects have not yet been fully revealed. What shocked him even more is that this drug has not been tested on pregnant animals. This is undoubtedly a huge problem for a drug that is targeted at patients, including pregnant women, and has the function of suppressing morning sickness in pregnant women. loopholes.
The most disturbing thing is that he did not find any fatal dose of this drug in his report.
"Is it possible that this drug does not have a lethal dose?"
Li Shun's tone was full of doubts, but he knew that there is no perfect drug in the world without risks, and any drug has more or less risks. There are few side effects and risks.
Although this experiment only injects drugs into mice and observes whether the mice can survive. If they survive, this drug is "harmless".
But there are no such simple test results. This is amazing!
“The safety of this drug is “perfect” and so extraordinary!”
While sighing, Li Shun felt an indescribable uneasiness.
Li Shun had already made up his mind about this initial application.
Immediately, Li Shun resolutely rejected Merrell's application and clearly requested the company to provide more data on toxicity, efficacy and purity of the preparation in his reply.
Soon, Li Shun arrived in the director's office. Cheng Enci, the director of the Pharmacology Center, frowned as he read his reply.
"The problem is that this data is too positive. It seems to pursue superficial perfection while ignoring the potential risks that the drug may bring."
"Potential risks?"
Cheng Enci's brows twitched slightly. Wrinkled and said.
“What risk?”
Li Shun said truthfully.
"Intuition."
His answer stunned Cheng Enci.
"Is it intuition?"
"Yes!"
Li Shun nodded.
"All the drugs I reviewed in the past clearly stated their toxicology, but this drug did not. I believe there is no such perfect drug in this world. It is basic common sense that drugs are three parts poisonous! So, I rejected Merrell's request to market thalidomide. If they want to pass the review, they must provide more comprehensive and true data so that I can make a more accurate and fair review decision."
Looking at the director, Li Shun asked.
"Director Cheng, is there anything else?"
"Well! Safety is no small matter. Since you have decided, then reject it!"
Wei Wei Nodding, Cheng Enci said.
In fact, he is just curious. Even if he is the director, he does not have the right to require Li Shun to pass the drug review and issue a marketing authorization. He does not even have the power to change the review officer, because the chief responsibility system is implemented here, and the review officer decides. Whether a drug is eligible for marketing. He can use his own judgment to decide whether the drug can be marketed. As for him as the director, he just coordinates various tasks.
Soon Li Shun left the director's office and wrote a reply rejecting the application in the office.
Although Merrell is an important partner of Jianmin Pharmaceutical, Li Shun knows better that as a new drug application reviewer, his responsibility is to protect the public's health and safety. He cannot allow any drug with hidden dangers to pass review easily.
On this day, when Li Shun rejected the marketing application of Merrell's new drug "Thalidomide", this drug began to be reviewed in Germany, the Netherlands, France, Australia and other countries. The exception passed the review. After all, the drug seemed harmless, and Nanyang's rejection had no impact on Merrell. This was just one of the countries.
In the silence of the manager's office of Jianmin Pharmaceutical Company, Zhu Huayun's face darkened slightly with a piece of news. When he learned the news that the drug project had been rejected, his brows wrinkled unconsciously.
"Let Meirel explain more." He ordered in a deep voice.
"Okay, I'll have someone send a telegram to Germany."
"Let them prepare more complete information and don't always make such low-level mistakes."< br>
After the secretary left the office, Zhu Huayun put the matter aside for the time being. After all, he still had a more important matter in his mind - the patent period of streptomycin had quietly passed ten years.
Ten years is already halfway through the patent period of a drug. Jianmin Pharmaceutical is known as "the world's largest gold mine" by virtue of its patent monopoly on streptomycin. Although the price of streptomycin has been reduced several times in recent years, and it has even been authorized to be produced by many European and American companies, its "gold content" is no longer what it was in the past, but it is still an important pillar of the company's profits.
"There is only less than ten years of patent period left..." Zhu Huayun murmured to himself, with a hint of indescribable worry between his brows. He knew that the glory of streptomycin was coming to an end, and where would the company go in the future?
"New drugs..." He once again turned his attention to the piles of research and development materials on new drugs. Every year, the company invests huge amounts of money in the research and development of new drugs and has achieved some good results. However, none of these new drugs can have a specific therapeutic effect on certain diseases like streptomycin. They may bring huge profits, but they cannot become new "gold mines" for the company.
"It's difficult..."
Zhu Huayun sighed softly. The information in front of him seemed to have turned into insurmountable mountains, making him feel unprecedented pressure and challenges. He knows that if Jianmin Pharmaceuticals is to continue to maintain its leading position in the future, it must find new breakthrough points and develop more effective and innovative drugs.
However, this is easier said than done?
But no, how can the company support its future profits with such huge profits from streptomycin?
(End of this chapter)