Wei Kang did not know this resentment coming from the distant Eagle Country FDA.
He is currently receiving a special group of visitors.
Just a few days ago, the clinical phase III trial report of Sanxin’s new hemostatic spray came out.
The effect is very good, far better than other products on the market. As long as it is sprayed on the bleeding wound, it will immediately stop the bleeding in 3 seconds, and then quickly bond the wound, which can greatly save the lives of emergency patients.
However, with the submission of this report, what was waiting was not the usual approval notice from the Food and Drug Administration.
It is an approval document for special medicines required by the military issued by the Department of Logistics and Support of the Central Military Commission (Health Bureau of the Ministry of Logistics and Support of the Central Military Commission).
A subsequent phone call solved Wei Kang's doubts.
The voice on the phone was calm and rich: "Hello, I am Du Cheng from the Rear and Security Department of the Military Commission. I am responsible for the registration and approval of special drugs. Sanqing Pharmaceutical's new drug under development, a special hemostatic spray, has passed our approval. It has become a special drug for the military."
"This hemostatic spray has outstanding efficacy in the treatment of war injuries, far exceeding the similar products we use now, and can greatly meet the needs of treating wounded people. However, military drugs have their own particularities, which are very different from ordinary prescription drugs on the market, so Sanqing may need to make some improvements in many aspects to meet our special R&D requirements."
Wei Kang was stunned for a moment, then reacted immediately and nodded in agreement: "No problem, just tell us what improvements we need to make."
"Okay, I will bring someone here to discuss this matter in a few days. Thank you!"
Wei Kang put down the phone and was thoughtful. He didn't expect that this hemostatic spray would attract the attention of the military, and it would quickly be approved as a special drug for military use.
Special medicines for the military are special medicines used by the military to reduce casualties and prevent and treat diseases. They have separate military drug approvals and are usually limited to internal use within the military.
However, generally speaking, this will not affect the civilian market of hemostatic spray. If a military drug wants to be converted to civilian use, it can be put on the market as long as it is approved by the Food and Drug Administration and obtains a national drug approval number.
However, there may be two versions for military and civilian use.
We can only wait for the people from the rear security department to come and see if there are any special requirements.
Three days later, several strong men in green military uniforms arrived at the Sanqing headquarters. The leader was a calm middle-aged man in his early forties with a tough temperament and a resolute expression. It was Du Cheng who was on the phone.
Du Cheng held Wei Kang's hands and said enthusiastically: "Haha, I finally met the famous Sanqing Wei. We know that Sanqing's anti-cancer drugs and anti-Alzheimer's drugs are famous, but we didn't expect that the research and development of hemostatic drugs would be so good." sharp."
"The ministry attaches great importance to this hemostatic spray. Judging from the clinical trial report, its efficacy is really good. So when I come here this time, firstly, I want to see its effect with my own eyes and bring some samples to the army. Do experiments in different scenarios. Secondly, we also put forward some special requirements, which I hope Sanqing can meet as much as possible."
Wei Kang was also smiling and felt a little excited. As a patriotic entrepreneur, he felt very accomplished when he could provide special medicines to the military, especially when he thought that his medicines could treat the wounded on the battlefield and save countless lives. A soldier's life was devoted to protecting his home and country, and a sense of pride immediately surged in his heart.
"Yes, we will do our best to meet the special requirements of the troops."
Du Cheng saw Wei Kang's extremely cautious look and smiled and patted his shoulder: "Don't be so serious. In fact, our requirements are not particularly difficult. They are all about potency, dosage form, packaging and expiration date. , as long as you follow the rules, that’s enough.”
Soon, both parties sat down in the conference room and had a lively discussion with each other.
Military drugs are a relatively special category, mainly aimed at preventing and treating damage caused by various weapons, such as nuclear weapons, chemical weapons, biological weapons, and kinetic energy weapons. There are also treatments for diseases caused by special military environments, such as high temperature, high cold, aviation and navigation.
Sanqing's hemostatic spray belongs to combat injury treatment drugs. Drugs in this category mainly refer to anti-shock, anesthetic drugs, analgesics and other drugs used for battlefield first aid and treatment.
As for the special requirements, it is neither difficult nor easy to say.
The first is the particularity of drug efficacy. Since military drugs are often used in special situations such as battlefield first aid, the requirements for drug efficacy are very high. They require a short onset of action and a long medication interval, so as to achieve high efficiency, quick effect, and long-term effect. .
This is not easy for ordinary drugs, and such requirements are much higher than those for civilian drugs.
But this is nothing to Sanqing. This hemostatic spray perfectly meets the three requirements of high efficiency, quick effect and long-lasting effect.
The second is the particularity of the dosage form. In order to facilitate self-rescue and mutual rescue during wartime, the dosage form of military drugs must be convenient to use. Injections, aerosols, oral tablets, etc. are preferred. At the same time, controlled and sustained-release preparations must be used as much as possible to prolong the drug effect and meet the needs of medical personnel. The need for graded evacuation for treatment. Moreover, special-shaped tablets should be used to improve the cognitive ability and identification of drugs by non-medical personnel.
Sanqing's hemostatic medicine uses a spray form, which is easy to use and easy to identify, which perfectly meets this requirement.
After that, the validity period must be long, generally reaching the standard of 5 years, and the stability must be higher than that of civilian drugs to meet the needs of rotation and update of war storage materials.
Finally, there is the particularity of packaging, labels and instructions. These introductory texts must be easy to understand so that non-medical personnel can use the drugs correctly through labels and instructions in an emergency. At the same time, the packaging should be suitable for wartime, making it easy to carry, store and use.
These requirements were very easy for Sanqing, no wonder Du Cheng said they were just ordinary requirements and there were no special difficulties.
The two parties quickly reached a consensus, and Sanqing promised to make improvements in these aspects as soon as possible, and then provide samples that meet the needs for clinical trials.
At the same time, Wei Kang also asked tactfully, what is the appropriate gap between military drugs and civilian drugs?
Du Cheng laughed and said directly: "The coagulation time of normal people is usually about 5 minutes. Commonly used hemostatic drugs take effect in 2-3 minutes, but bleeding from large arteries and the like takes longer. So. It's very simple. The military version of your hemostatic spray can stop bleeding in 3 seconds, and the civilian version can stop bleeding in 5 to 10 seconds. It is considered miraculous and beats all current hemostatic drugs."
Wei Kang suddenly knew what he would do, and quickly thought about the effect of the civilian version: "Okay, we can adjust it as soon as possible and make it a civilian version, and then apply for national drug approval from the Food and Drug Administration again."
"The efficacy of the medicine is that it starts to stop bleeding in 5-10 seconds, and the glue contained in the spray adheres to the skin within 15 seconds, forming a sealing layer on the skin surface, and it has a complete hemostasis effect within 30 seconds. In this way, even if the skin surface is covered with blood, It will not affect the hemostatic effect.”
Seeing that the meeting ended perfectly, he sent an invitation to Du Cheng: "Now that the discussion has ended, let's go to the laboratory and see the most intuitive effect in person."
A group of people came to the laboratory.
A little pig is ready.
Du Cheng and others gathered in a circle to carefully watch the researchers' operations.
A 6 mm diameter iron pipe was inserted straight into the piglet's heart, instantly forming a penetrating wound.
Blood spurted out like an arrow from a string, splattering on the researchers' protective clothing.
The researchers immediately picked up the hemostatic spray and quickly sprayed a thick layer of hemostatic spray on the pig's heart wound.
Within a few seconds, the gushing blood was stopped.
Within five seconds, the massive bleeding from the penetrating heart injury completely disappeared.
The wound is bonded with glue and closes quickly without suturing.
The little pig's whole body was trembling slightly, and nothing abnormal could be seen.
"The size and structure of a pig's heart are closest to that of a human heart, and bleeding from a beating heart is currently the most difficult type of bleeding. As long as it can stop the bleeding from this wound, it will definitely be effective on humans."
The researcher explained in detail to the guests, and everyone nodded.
Looking at the nonchalant little pig, the shock on the faces of the guests became more intense, and they all whispered to each other and had a heated discussion.
After a while, the guests asked the researchers carefully about various experiments.
In addition to massive bleeding from penetrating cardiac injuries, aortic injury is also a common and troublesome massive bleeding.
The technician quickly demonstrated the miracle of hemostasis of the aorta again, which attracted admiration.
Wei Kang stood aside, keeping a faint smile on his face and not disturbing them.
Suddenly, Du Cheng turned around and asked, "Mr. Wei, do you have any other new drugs under development? We are very interested and want to know more about them."
"Yes, we are very optimistic about Sanqing's R&D capabilities. It would be best if we could reach a long-term strategic cooperation with each other." The man in military uniform who was traveling with him couldn't help but echoed.
Wei Kang nodded, waved his hand, and led the way: "We do have several new drugs under development. One of them, I feel you may also be very interested in."
