It was precisely because he realized that the other party might have encountered something very difficult that Wei Liang was not angry at the time of the other party's lateness.
On the contrary, he nodded with great understanding and said politely: "Mr. Smith is fine, I have nothing else to do, so don't worry."
"Thank you!" James Smith thanked, smiled politely, and then sat in front of Wei Liang.
The two ordered some meals at will, and James Smith asked Wei Liang: "Is there anything important about Mr. Wei coming from China so far?"
Wei Liang smiled and said, "Mr. Smith must have heard of us Jiuxuan Pharmaceuticals?"
"I've heard of it." Smith nodded and said, "You have a drug for review in our FDA, right?"
"Yes." Wei Liang hurriedly said: "The review cycle has been a long time and has not yet entered the next stage, so I would like to ask if there is any way to speed up the pace."
Smith said in embarrassment: "Now FDA has been very strict in reviewing imported drugs. This process is indeed very long, and I cannot tell you clearly whether it meets our standards after completing all the processes and whether it can be approved for market launch.
.”
Wei Liang explained: "Mr. Smith, our Chinese patent medicine has very safe ingredients and no toxic side effects. It is very effective. It can be said that it will be immediate. Will this medicine be rejected by FDA?
?”
Smith nodded and said, "We have been receiving drug applications from Eastern countries in recent years, and most of them are the Chinese patent medicines you mentioned. Not only China, Japan and South Korea have submitted a lot, but most of them are
Rejected."
Wei Liang asked in confusion: "Why is this?"
Smith said very seriously: "Mr. Wei, our Western drug testing and review requirements are very different from traditional Eastern medicine. One very important point is that there must be clear pharmacokinetic tests."
"You must tell us clearly what the effective ingredient of this drug is, what reasons, and what role it plays. And you must also tell us whether this drug is in the body and on all organs, especially the liver and kidneys, has it.
The toxic side effects, how long is the metabolization cycle of its components in the body? If we don’t understand these, we will not be able to obtain permission to enter the Chinese market for sale.”
Wei Liang hurriedly said: "Many Chinese prescriptions and medicines have very complex prescription composition, so the internal components are also very complex. Unlike Western medicines, most of them are chemical drugs, there is often only one active ingredient, such as penicillin, aspirin, and a molecular formula can reflect it.
Its actual ingredients and composition are difficult for all Chinese patent medicines to meet the requirements of the West, but shouldn’t we seek common ground while reserving differences?”
Smith shook his head and said, "Sorry, Mr. Wei, we cannot seek common ground while reserving differences in this regard. The regulations are regulations that all drugs that want to enter the US market must in principle comply with all our rules, otherwise they will not be available for sale.
”
Wei Liang hurriedly said: "Our medicine has excellent effect, which is recognized by all patients. It is a best-selling drug in many countries. As far as I know, many American patients buy our Jiuxuanwei San through purchasing agents, but
This method not only takes a long time, but also has a much higher cost. They also hope that FDA will be allowed to enter the US market as soon as possible."
Smith shook his head and said, "Many patients themselves can't tell whether your medicine has a clear therapeutic effect or a strong superficial symptom relief effect. If it is the former, it is okay, but if it is the latter, it is very likely.
It will also delay the treatment of actual lesions."
Speaking of this, Smith said: "This is like a very popular hemorrhoid tumour in China. Some patients in the United States bought it through online shopping and black market channels. It feels good after using it. And it has always hoped to be able to use it through FDA.
Review, but we haven't passed its application, do you know why?"
Wei Liang asked in confusion: "Why is that?"
Smith said: "Because in our opinion, some cool and analgesic ingredients are used in the hemorrhoid tumour. This ingredient can relieve pain, but it can only relieve pain. In our opinion, these ingredients are
Not only can the lesions be truly treated, but it is also likely to cover up the condition, which delays the patient's scientific treatment. Therefore, we also issued a warning some time ago, reminding patients who use this drug to pay attention to screening and not because of
Relieving surface symptoms and ignoring core issues.”
"In addition, we have also studied something that was once very popular in China and combined with tablets. It is said to be a special cold medicine made of honeysuckle, forsythia and some Western medicine ingredients."
"But our research has found that among those drugs, there are two Western medicine ingredients that really play a therapeutic role. One is the common medicine for fever and analgesia, acetaminophen; the other is specially used to relieve allergies.
, drugs for rhinitis, sneezing, runny nose and other symptoms, primrine, combined with the two, can just treat fever, cold and runny nose."
Speaking of this, Smith spread his hands and said seriously and helplessly: "Mr. Wei, I am not deliberately targeting you, or traditional medicine in the entire East."
"But think about it, if you Jiuxuan Pharmaceuticals also use some plant ingredients, and match them with the Western medicine ingredient metformin that can control blood sugar, and then you will declare that this is a Chinese patent medicine that can effectively reduce blood sugar.
Do you think we may approve this drug on the market?”
"This is why we have always been very cautious about Oriental medicines. Medicine is a very rigorous discipline. We must be clear and clear, and we must not piece together irresponsibly."
Wei Liang also felt a little embarrassed and said, "Mr. Smith, I don't deny that the things you just said are a few so-called Chinese medicine or medicines that combine things. They are indeed suspected of selling dog meat with sheep's head.
But I think you can’t kill all traditional oriental medicines with one blow just because of such a case. There are still many excellent medicines in traditional oriental medicine.”
Smith nodded: "Of course I don't deny this, but what I want to say is that even excellent traditional oriental medicines must meet all our requirements to enter the Chinese market. So, you
If the medicine wants to enter the US market, we must first understand all its ingredients, as well as the uses and potential dangers of each ingredient."
Wei Liang asked back: "If the ingredients of many Chinese patent medicines are too complicated, they may not be explained clearly by just a few ingredients, and even dozens or hundreds of them are needed, so how can we do it
Are you sure one by one?"
Smith shrugged: "If we can't determine one by one, then we can only fail."
Wei Liang asked again: "Even though I know that this medicine is very effective, Is it because I cannot completely determine the ingredients and effects, so will you refuse it to be sold?"
"Yes." Smith said firmly: "This is our attitude. Even if the medicine is really effective, it will never be available until we understand it."
Wei Liang couldn't help asking: "Don't you think this is also a loss to the American people?"
"Loss?" Smith heard this and said in a somewhat contemptuous tone: "Mr. Wei, to be honest, we in the United States have a large number of alternatives to all the Oriental medicines I know so far, and it is safer and more efficient.
A substitute!”
"Whether it is related to headache, brain fever, or all organs, blood vessels and nervous systems, including the heart, liver, spleen, lungs and kidneys, you have them in traditional Eastern medicine, and we have Western medicine, and our Western treatment methods are better than your Eastern medicine.