After being fired, I became the light of medicine
Chapter 240 Clinical Data of Ibetumumab Released
Chapter 240 Clinical Data of Ibetumumab Released
Tsingshan Pharmaceutical.
"Zhang, my friend, long time no see!"
Three days later, Lucas, vice president of GlaxoSmithKline, appeared in Zhang Yang's office.
Zhang Yang has always had a good impression of Lucas, and the two have been working together happily since the "ITG Myelopoietin" project.
Upon learning that Lucas was coming to visit, he even postponed his morning meeting.
"Lucas, it's been a long time! I remember the last time we met was two years ago. You finally came to see me again!"
"Zhang! I also want to visit you often, but as you know, I was transferred back to the UK headquarters from the Asia-Pacific branch two years ago, so I haven't been able to visit you in the past two years."
"Haha, I'm afraid that's not entirely the reason. I think it's possible that our Qingshan Pharmaceutical has not developed any new drugs that you're interested in in the past two years?"
Lucas's face suddenly turned red, and he said hurriedly:
"Zhang, it's definitely not what you think."
"Ha ha!"
Zhang Yang laughed. As soon as they met, he played a half-true, half-false joke on Lucas.
In fact, from the moment he received Lucas' call, he knew the real purpose of Lucas's visit.
But after the joke, he still warmly invited Lucas to sit down and directly helped Lucas out of the dilemma.
"Please sit down, Lucas. I was just joking. We have been friends for many years. I understand your difficulties."
Lucas's face lit up immediately, and then he breathed a sigh of relief, and said gratefully:
"Zhang, it's great that you can understand. I'm not the kind of person you think I am. I really don't have the opportunity to come to China!"
"If I had the chance, I would have come to see you a long time ago!"
But as he was speaking, his tone suddenly paused, and his face couldn't help but turn red again:
"But what you said is indeed correct. I came here this time because of the new medicine you developed..."
"The headquarters hopes to reach an exclusive European licensing agreement with you!"
"Ha ha!"
Zhang Yang laughed out loud. He had to admit that Lucas was indeed cute.
But soon, he stopped laughing and began to focus on the licensing cooperation that Lucas talked about.
Actually,
He was not surprised that GlaxoSmithKline was interested in "ibacterium tumefaciens", but... he had just started the Phase I clinical trial, and GlaxoSmithKline was so eager to discuss cooperation?
"Lucas, to be honest, I can understand your company's interest in our new drug 'Ibetumumab'."
"I thought you came here specifically to learn about the situation of 'Ibeumab' and the actual effect of the clinical trial. I didn't expect... Are you going to start discussing licensing cooperation with us right away?"
"You have so much confidence in us?!"
These words made Lucas blush again. He had asked President William similar questions in person three days ago.
But of course he couldn't tell Zhang Yang about President William's argument that he was "afraid of being beaten to the punch by other pharmaceutical companies", so he could only nod awkwardly:
"Zhang, we definitely have great confidence in you!"
"We believe that this 'ibukumab' will definitely pass clinical trials smoothly and will definitely be successfully launched on the market."
Zhang Yang laughed, and without thinking too much, he said:
"Well, since you all have such strong confidence, I can't just say No, right?!"
"Then let's talk about cooperation?"
"it is good!"
Lucas finally breathed a sigh of relief. After going around in circles, he finally got on the right track. He hurriedly said:
"Zhang, then I will tell you our ideas directly."
"We hope to continue the cooperation as before. We will first sign a letter of intent, and when your new drug has completed clinical trials, we will discuss the agency price and regional sales price of the new drug in detail."
"At the same time, after the initial signing of the contract, we immediately launched clinical trials of this new drug 'Ibetumumab' in Europe. Of course, all clinical trial costs and related work will be borne and taken care of by us!"
"Does that sound all right to you?"
Zhang Yang nodded slightly.
This is not the first time that Tsingshan Pharmaceutical and GlaxoSmithKline have collaborated. Whether it was the previous "liver cell activator" or the "kidney toxin clearing dialysis needle", they almost all adopted this type of collaboration.
only……
Zhang Yang felt that it was inappropriate to immediately launch clinical trials in Europe.
The previous "liver cell activator" and "kidney toxin clearing dialysis needle" were complete prescriptions provided by the simulator. Zhang Yang naturally had 100% confidence in conducting clinical trials simultaneously around the world.
He knew that it would be successfully launched on the market after just a few changes.
However, this time, "Ibetuzumab" was independently developed by Qingshan Pharmaceutical's R&D Center. He was not sure how many times it would have to be modified and how long it would take before it could be successfully launched on the market.
"Lucas, I have no objection to signing a letter of intent and negotiating the price after clinical trials!"
"It's just that 'Ibeumab' is currently undergoing phase I and phase II clinical trials in China, and I'm afraid the drug ingredients will need to be modified many times. If you conduct clinical trials at the same time... it would be a waste of resources!"
"How about this? Wait until we pass Phase III clinical trials in China before you start clinical trials. This will be more efficient and your expenses and patient resources will be less."
Lucas was slightly stunned, but after a little thought, he nodded in agreement.
"Okay, what you said makes sense, let's follow your plan!"
"Let's first sign a letter of intent. When you complete the Phase III clinical trial, we will start clinical trials in Europe and strive to introduce it to Europe as soon as possible!"
"Ok!"
In just a few words, Zhang Yang and Lucas successfully reached a cooperation agreement.
Zhang Yang was completely relaxed with a smile on his face, and Lucas was also relieved. However, just as Zhang Yang was about to reminisce with Lucas, Lucas suddenly interrupted:
"By the way, Zhang, there is one more thing I almost forgot."
“Before you came, our President William specially prepared a gift for you and asked me to bring it to you personally!”
"Oh? A gift?!"
Zhang Yang was a little surprised for a moment, and then he saw Lucas carefully put down the suitcase he was carrying, and then slowly took out a slender and exquisite small painting box from the suitcase.
He placed the small painting box on the coffee table and said as he opened it:
"This is an ancient painting that our President William bought from a collector. It is the famous 'Northern Qi Dynasty Book Reviewing Picture' in China!"
"This painting originated in the Song Dynasty and became part of the collection of the Qing Dynasty imperial palace. Later, it was purchased by a Japanese collector from a member of the Eight Banners family and then spread overseas."
"This time our president bought it specially for you as a gift. I hope you like it."
"Northern Qi Dynasty's Book Reviewing Map?"
Zhang Yang was stunned and couldn't help but smile bitterly.
To be honest, he had never even heard of the name of this famous painting. However, when he heard that it was a collection of the Qing Palace and that the Japanese bought it from the Eight Banners and it ended up overseas, he couldn't help but become more interested.
After Lucas carefully opened the scroll, which was about one meter long, he was suddenly attracted by the exquisite "Northern Qi Book Proofreading Picture" in front of him.
Although this ancient painting has gone through vicissitudes of life for a thousand years, the colors on the scroll are still as bright as new, with clear layers.
The most amazing thing is that the characters in the scroll have different expressions, each one is lifelike, beautiful and vivid, making people feel extremely comfortable at a glance!
"hiss……"
Although Zhang Yang doesn’t know much about collecting, even an outsider can tell at a glance that such truly good things are extraordinary!
"Lucas, this gift is too valuable. I can't accept it!"
"Zhang, it's not expensive. It's a little gift from our president. It's fine as long as you like it!"
"I like it..."
"That's it!"
Lucas interrupted Zhang Yang with a smile:
"Since you like it, if you have any cultural relics or calligraphy and paintings that you particularly want to collect, just tell us. Although we are a very influential company worldwide, we still have good connections in the UK and Europe."
"It's not a problem to collect some Chinese cultural relics!"
"This……"
Zhang Yang had just said it casually, but he didn't expect that Lucas had obviously misunderstood his meaning.
But on second thought, GlaxoSmithKline's attentiveness is simply to please me so that it can obtain authorization for more new drugs in the future.
In this case, if they want to give me some cultural relics, calligraphy and paintings, it would not be a bad thing to allow more national treasures lost overseas to return to the country.
"Okay, Lucas, thank you for your kindness then."
"You're welcome. It's just a small token of our appreciation."
Lucas was beaming with joy, he hadn't expected it to go so smoothly.
Moreover, Zhang Yang's answer also confirmed to him that Zhang Yang was indeed quite interested in Chinese cultural relics. Now he could give President William an accurate answer when he returned.
Next, Zhang Yang chatted with Lucas for about ten minutes, and then called Ren Xiaomin and Lucas to sign a letter of intent.
When Ren Xiaomin took Lucas out of the office, Zhang Yang suddenly thought of Novartis and Friedman.
Tsingshan Pharmaceutical's two best overseas partners are GlaxoSmithKline in Europe and Novartis in the United States.
The person who has always been in contact with Novartis is Friedman, a Jew.
"It's been a long time since I last saw Friedman."
"But this time Lucas has come in person to discuss cooperation on Ibeumab. Novartis must be interested as well. I'm afraid Friedman will come in person soon too."
Zhang Yang had expected Friedman to come to his house, but this time he was wrong.
In the next two or three days, he did not receive a visit from Friedman, nor did he receive a call from Friedman.
Just when he was somewhat surprised, the results of the first week of the double-blind clinical trial of the first batch of "Ibetuzumab" came out.
Zhang Yang quickly turned his attention to the clinical trial results of "ibukumab".
This time, "Ibetumumab" also belongs to a combined phase I and phase II clinical trial, and a total of 104 subjects were recruited.
Since acute leukemia is a major high-risk disease, the conditions of many subjects are already very critical. After obtaining Zhang Yang's permission, Director Hu applied for 32 people to receive independent medication, which means they would not participate in the double-blind test.
Among the remaining 72 subjects, their conditions were not too serious and they could barely maintain their condition with medication, so they set up a double-blind test, with 36 people in the test group and 36 people in the placebo group.
"Boss, the latest data from 32 patients who were given the drug independently came out, and the treatment effect is a little worse than we expected."
"The first is stability. According to the data from thousands of animal tests in our laboratory, the response rate of 'ibukumab' to leukemia cells in animals has reached more than 75%. When applied to humans..."
"After one week of medication, 50% of the patients had a cell response rate of only 51%, which means that at least half of the leukemia cells in the patients were not effectively identified and killed, which is far from the treatment effect we expected!"
"Of course, 30% of patients had a response rate of 70-80%, which basically met our treatment expectations. Even 5% of patients had a response rate of 90%. All leukemia cells in their bodies were suppressed and killed in just one week. The effect was far beyond our imagination!"
"This is clearly a strong phenomenon of 'individual differences'."
In the office, Zhang Yang listened carefully to Wei Tian's detailed report.
He couldn't help but frowned slightly, but soon relaxed his brows. This situation was actually within his expectations.
The previous "ITG Human Myelopoietin" and "Kidney Toxin Clearing Dialysis Needle" can be suitable for almost all patients because both drugs are produced by simulators and are truly first-line top drugs.
However, "Ibetumumab" independently developed by Tsingshan Pharmaceutical obviously cannot reach this level. Individual differences, side effects, and poor responses are normal. This is also a process that all pharmaceutical companies and all drugs must go through.
"Well, apart from the obvious individual differences, what about the double-blind situation? What about the universality of the drug?"
"The double-blind test went well! After one week of medication, we were able to basically identify which patients were in the experimental group and which were in the placebo group based on their blood test results."
"It can be confirmed that the universality of the drug is not a problem. Everyone who uses the drug will respond, but the treatment effect still fluctuates greatly!"
Hearing this, Zhang Yang let out a breath.
One of the most important evaluation values of a new drug is the drug’s universality.
It has strong universality and is effective for almost all patients, which proves that the drug's research and development ideas and targets are on the right track.
As for the floating factors that affect the treatment effect, there are many: for example, racial differences, disease differences, age and gender may all have an impact. The next step is to find the influencing factors through treatment differences and ultimately adjust the drug ingredients.
"Okay, I understand. Next, the first project team's primary goal is to find a way to find out the reasons that affect the treatment differences, and try to adjust the drug ingredients to be more precise and stable, so as to achieve at least 80% killing effect!"
"And the patient who showed a 90% treatment effect needs additional research to see if it was just a coincidence or if there was a specific cause!"
"Okay! I'll arrange it."
"Well, what about the side effects?"
Talking about the side effects, Wei Tian's expression eased a little:
"There are no new side effects, and they are still basically the same as what we saw in the laboratory before."
"Of course, it could also be that the medication was used for too short a time. After all, it was only a week, so many side effects did not appear so quickly."
Zhang Yang nodded.
"Well, okay, then upload the first week's clinical trial data to the National Clinical Trial Center website. Many patients are concerned about the specific effects."
"Okay! I'll upload it like this!"
Three hours later, the first week clinical data of Tsingshan Pharmaceutical's "Ibetuzumab" was uploaded to the national official website, which quickly attracted a lot of attention.
(End of this chapter)
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