Chapter 235: Pfizer's Attention
Wu Zhou's equipment has been produced before Dr. Zhang's results come out, and the first prototype has come out in early May.
After that, the application was submitted to the National Medical Products Administration as normal.
Before Wu Zhou began to make efforts to speed up the approval, the leaders of the relevant departments took the initiative to contact him after seeing the detailed technical details.
After that, it will be listed as a key approval project and will be given priority for approval.
Of course, the relevant departments of the company are fully cooperative, provide sufficient materials and data, and actively communicate with the approval personnel.
In the area of data, because of the assistance of AI, except for a small part, most of them are passed over and over again, and the efficiency is unexpectedly high.
However, it still needs to go through several rounds of rigorous technical review and safety assessment.
This has the equipment 'procurement' of top hospitals like Liu Yang and Zhang Wei.
In fact, it is a prototype, which is used for practical testing and safety assessment.
Relevant data will be summarized regularly, and the Food and Drug Administration is also very concerned.
At the beginning of June, after nearly one million data verifications, the approval of the Food and Drug Administration accelerated again.
On the other hand, this equipment of Aiying Group has also been noticed by some other departments of the state.
Because of the current slow nucleic acid detection and the problem of detection accuracy error, it is easy to miss the diagnosis.
And then occasionally run to the social side for one or two
Time-consuming, laborious, and especially expensive.
Now Aiying Medical's equipment must be accurate and accurate, convenient and convenient, and efficient and efficient, and one device can top more than ten PCR equipment
Under the premise that the product has not yet obtained marketing authorization, the relevant departments directly ordered 10,000 pieces of equipment and distributed them to major provinces and cities with large population mobility.
On the other hand, the approval of Huaxia is accelerated, and the same is true of foreign countries, breakthrough technologies, special approvals, accelerated approvals, accelerated listings, etc.
The speed is not slower than that in China at all.
And the actual market demand on the foreign side, at least for the time being, is much more than that at home.
Because of this CRISPR nucleic acid detection equipment, Aiying Group has been popular during this time.
"MD, Wu Zhou's luck is too good, why don't you let him catch up." Someone couldn't help but say indignantly.
Envy, red eyes.
Because the domestic and foreign market demand is really large, the domestic market demand alone is at least hundreds of thousands of units, which is worth tens of billions.
Of course, in addition to this, there is another news that has once again sparked heated discussions.
"Recently, an inactivated mask vaccine developed by Huaxia Aiying Biotech has achieved encouraging results in phase 2 clinical trials. It has been reported that the vaccine uses the inactivated mask virus as an antigen, which can induce the body to produce neutralizing antibodies against the mask virus.
A total of 2,000 healthy volunteers were recruited in the phase 2 clinical trial and randomly divided into two groups, of which 1,000 received the inactivated mask vaccine and the other 1,000 received placebo. The results of the trial showed that more than 95% of the volunteers who received the inactivated mask vaccine developed high levels of neutralizing antibody titers after vaccination, and all volunteers did not experience serious adverse reactions.
It is worth noting that the inactivated mask vaccine is a traditional and mature vaccine technology, and its main advantage is the ability to retain the natural structure and immunogenicity of the virus. The success of this trial proves that the inactivated mask vaccine has good efficacy and safety in the prevention and control of mask virus infection.
Scientists said that the next step will be to carry out a larger phase 3 clinical trial to further verify the safety and efficacy of the vaccine in different populations, regions and variants, and optimize its preparation process and quality standards to provide a new weapon for the global defense against the mask virus. ”
As soon as this report is out.
A kind of melon-eating masses are even more dumbfounded.
"Is Aiying Biotech on the bar with the mask virus?"
"What is Ai Ying Biotech? How come I've never heard of it? Do they have formal qualifications and approvals? ”
"Aiying Biotech and Aiying Medical are both subsidiaries of Aiying Group."
"I'm not mistaken, it's Aiying again, it's all Aiying Group? Is there another Aiying Biotech in Huaxia?"
"Don't say anything, send me the stock code, I want all in."
"It's amazing! The success of the inactivated mask vaccine has added confidence to us to win the battle against the "epidemic"! Thank you to Huaxia Aiying Biotech and all the scientists involved in the R&D and trials! ”
"Hehe, the whole is to go around in the old technology, which should be the reason why our technology has been lagging behind Europe and the United States, mRNA vaccines are the future trend, we should keep up with the pace of the times, we should reflect."
"Why don't you reflect on it, you didn't get admitted to Tsinghua University and Peking University, you didn't make money, and you didn't carry the banner of Chinese scientific research"
"Everything is reflection, you know let others reflect, have you reflected yourself? And what's wrong with inactivated vaccines, why can't such a safe traditional vaccine route be used? JUST BECAUSE EUROPE AND THE UNITED STATES USE THE MRNA VACCINE ROUTE, THAT IS GOOD? The mRNA vaccine route has not been marketed so far, this kind of vaccine that the whole people need, with this technical vaccine that has not yet verified its safety to eat and test? Hehe. ”
"This trial is only 2,000 people, which is not large enough."
"Are you really stupid or fake stupid, 2,000 people are still less? The second phase is the second phase of clinical trials, and there are three phases, and the third phase is large-scale. ”
"Mr. Wu, you can't make a lot of money like this, the capital market is the king, hurry up and go public."
“+1”
Pfizer's CEO's office, at the moment Smith is browsing industry news.
As a manager of a company, it's not just about knowing what's going on inside the company.
Swiped his finger as usual, looking at the latest news and information in the industry, but his finger suddenly stopped.
Smith picked up the phone at hand and dialed Mike, the marketing manager. "Mike, come right here!"
"Yes, boss. What's wrong? Mike was surprised when he got the call. He is in the office discussing with his colleagues the latest market situation and preparing to develop the next stage of marketing strategy.
"Don't ask, come here!" Jack Smith urged, then hung up.
Mike felt a pang of unease and hurried out of the office. "I'm sorry, guys, I have to go. The boss looked for me. He said to his colleagues.
"What's wrong? Is everything alright? Colleagues looked at him curiously.
"I don't know, he sounds serious. Hopefully not bad news. Mike shook his head and said helplessly.
Mike walked to Smith's office door and knocked on the door. "Boss, I'm here. Can I come in? ”
"Come in, close the door." Smith's voice was a little low, but his face was still serious.
Mike walked into the office "Boss, what's wrong?" You look unhappy. ”
"Look at this and tell me what you think." Smith didn't answer him, just pointed to his computer and motioned for him to look at it himself.
Mike glanced at his boss suspiciously, then walked over, and after a while, his face became serious, and after about three minutes, he showed a look of surprise.
"Do you understand what this means for our company?" Smith frowned.
Mike pondered for a moment before he said seriously: "This is indeed a trouble, how can their R&D progress be so fast, even if it is accelerated approval, it should be a few months before the Phase II clinical trial ends, unless they are unusually smooth in the early stage of R&D, or have started earlier." ”
"Or they have some secret partners or investors that we don't know about, or maybe they have some breakthrough technology or approach that we haven't heard of." Mike frowned and said suspiciously.
"We need to investigate these later, and the top priority is that their product has entered the third phase, which is several months faster than us." Smith shook his head and said.
"Yes, according to what is said in this news, this vaccine is an inactivated vaccine, which is a traditional and mature technology that is easier to gain the trust and approval of the public and regulatory agencies than our company's current mRNA vaccine. Inactivated vaccines are also cheaper and easier to store and transport. This means that if they can successfully launch their products first, it will be really bad for us. Mike probably guessed some possibilities in his heart, after all, now that the problem of masks is getting more and more serious, many countries are looking forward to developing vaccines as soon as possible, and inevitably, some processes will be accelerated.
"I know all of this, Mike, and I'm going to have a solution." Smith said, banging on the table.
"It can be carried out in three steps at the same time, the company contacted the relevant departments in various countries, and asked them to strictly review the phase III clinical data of this Huaxia biopharmaceutical company, although the phase II clinical trial is very fast, but the phase III and the marketing approval process, we still have room to operate. In the second step, we can speed up the process of some of our company's mRNA vaccines now, and maybe eventually get them on the market before they do. Finally, the company needs to approve some marketing expenses, and we will contact some 'authoritative' people, as well as media channels, and we can give them some evidence and information, as long as we can convince the public not to trust this vaccine, even if it is on the market, not many people will be willing to take it, and the market will still be ours. Mike said seriously.
"Well, yes, then do as you say, explain this matter, I'll give you a day, make a detailed plan and budget, and then I will hold a meeting and invite all relevant departments to join us. Also, do a good job of investigating the background and resources of this Huaxia Aiying biological company. Smith's brow furrowed.
"Understood, boss." Mike nodded and said quickly.
(End of chapter)