Chapter 1782

Precisely because he realized that the other party might have really encountered a significant difficulty, Wei Liang was not angry at all because of the other party's lateness.

On the contrary, he nodded very understandingly and said politely: "It's okay, Mr. Shi Misi. I don't have anything else to do, no rush."

"Thank you!" James Shi Misi thanked him, smiled politely, and then sat down in front of Wei Liang.

The two ordered some food casually, and James Shi Misi asked Wei Liang: "Mr. Wei came all the way from China, is there any important matter?"

Wei Liang laughed: "Mr. Shi Misi should have heard of our Nine Mysteries Pharmaceutical, right?"

"Heard of it." Shi Misi nodded and said: "You have a drug that is currently under review by our FDA, right?"

"Yes." Wei Liang said hurriedly: "The review cycle has passed for quite a long time, and it still hasn't entered the next stage, so I wanted to consult if there is any way to speed it up."

Shi Misi said very embarrassedly: "The FDA's review of imported drugs is very strict now. This process is indeed very long, and I cannot explicitly tell you whether it meets our standards and can be approved for listing after going through all the processes."

Wei Liang explained: "Mr. Shi Misi, the ingredients of our kind of traditional Chinese medicine are very safe, and there are no toxic side effects. Moreover, the efficacy is very good, and it can be said to be immediate. Could it be that this kind of drug will also be rejected by the FDA for listing?"

Shi Misi nodded and said: "In recent years, we have been receiving drug applications from Eastern countries, and the vast majority are this kind of traditional Chinese medicine you mentioned. Not only China, but Japan and South Korea have also submitted quite a few, but the vast majority have been rejected."

Wei Liang asked in confusion: "Why is this?"

Shi Misi said very earnestly: "Mr. Wei, our Western testing and review requirements for drugs are very different from Eastern traditional medicine. A very important point among them is that there must be a clear pharmacodynamic test."

"You must clearly tell us what the effective ingredients of this drug are, why, and what kind of role they play. Moreover, you must also tell us whether this drug has toxic side effects in the body, especially on the liver and kidneys, and what the metabolic cycle of its ingredients in the body is. If these cannot be clarified, we have no way to approve it to enter our country's market for sale."

Wei Liang said hurriedly: "Many traditional Chinese medicines have very complex prescriptions, so the internal ingredients are also very complex. Unlike Western medicines, which are mostly chemical drugs, the effective ingredients are often only one, such as penicillin, aspirin, a molecular formula can reflect its actual ingredients and composition. All traditional Chinese medicines are very difficult to meet the requirements of the West. But shouldn't we seek common ground while reserving differences?"

Shi Misi shook his head and said: "Sorry, Mr. Wei, we cannot seek common ground while reserving differences on this point. Rules are rules. All drugs that want to enter the US market must, in principle, meet all our rules, otherwise they cannot be listed for sale."

Wei Liang said hurriedly: "Our drug's effect is extremely good, which is recognized by all patients. It is a best-selling drug in many countries. As far as I know, many American patients purchase our Nine Mysteries Stomach Powder through purchasing agents. But this method not only takes a long time, but the cost is much higher. They also very much hope that the FDA can approve this drug to enter the US market as soon as possible."

Shi Misi shook his head and said: "Many patients themselves cannot distinguish whether your drug has a clear therapeutic effect or a very strong effect of relieving surface symptoms. If it is the former, it is easy to talk about, but if it is the latter, it is very likely to delay the treatment of the actual lesion."

Speaking of this, Shi Misi added: "This is like a kind of hemorrhoid suppository that is very popular in China. Some American patients bought it through online shopping and black market channels, and it felt very good to use. Moreover, it has always hoped to pass the FDA's review, but we have never passed its application. Do you know why?"

Wei Liang asked in confusion: "Then why is that?"

Shi Misi said: "Because in our view, that kind of hemorrhoid suppository uses some cooling and analgesic ingredients. This kind of ingredient can relieve the patient's pain, but it can only relieve the pain. In our view, these ingredients not only cannot truly treat the lesion, but are also very likely to cover up the condition, thereby delaying the patient's scientific treatment. So, some time ago, we also issued a warning to remind patients using this drug to pay attention to screening and not to ignore the core problem because of the relief of surface symptoms."

"Besides this, we have also studied a certain combination tablet that was once very popular in China, which is said to be a special cold medicine made of honeysuckle and forsythia combined with some Western medicine ingredients."

"But after our research, we found that the ingredients that really play a therapeutic role in that drug are two Western medicine ingredients: one is a common drug for fever and pain relief, acetaminophen; and the other is a drug specifically used to relieve allergies, rhinitis, sneezing, runny nose, and other symptoms, chlorpheniramine. The combination of the two happens to be able to treat fever, cold, and runny nose."

Speaking to this point, Shi Misi spread his hands, seriously and with some helplessness, said: "Mr. Wei, I am not deliberately targeting you, or targeting the entire Eastern traditional medicine."

"But think about it, if your Nine Mysteries Pharmaceutical also casually uses some plant ingredients, and then matches them with metformin, a Western medicine ingredient that can control blood sugar, and then claims to the outside world that this is a traditional Chinese medicine that can effectively lower blood sugar, do you think we are likely to approve this drug for listing?"

"This is why we have always been very, very cautious about Eastern drugs. Medicine is a very rigorous discipline. It must be clear and understandable. You cannot irresponsibly piece things together wantonly."

Wei Liang also felt a bit embarrassed and bit the bullet and said: "Mr. Shi Misi, I don't deny the things you just said. A few so-called traditional Chinese medicines, or drugs that combine East and West, indeed have the suspicion of hanging a sheep's head and selling dog meat. But I think you cannot beat all Eastern traditional medicine drugs to death just because there have been such cases. In Eastern traditional medicine, there are still many, many excellent drugs."

Shi Misi nodded: "I certainly don't deny this point, but what I want to say is that even excellent Eastern traditional medicine drugs must enter our market under the premise of meeting all our FDA requirements. So, if your drug wants to enter the US market for sale, you must let us first understand all its ingredients, as well as the use and potential danger of each ingredient."

Wei Liang asked back: "Then if, as you just said, the ingredients of many traditional Chinese medicines are too complex, and it may not be explained by a few ingredients, and even up to dozens or hundreds, then how can we determine them one by one?"

Shi Misi shrugged: "If we cannot determine them one by one, then we can only not pass."

Wei Liang asked again: "Even if it is clearly known that this drug is very effective, but just because it cannot fully determine the ingredients and role, you refuse it to be listed for sale?"

"Yes." Shi Misi said decisively: "Our attitude is like this. Even if this drug is really very effective, but before we have figured it out, it absolutely cannot be listed."

Wei Liang couldn't help asking: "Then don't you think this is also a loss for the American people?"

"Loss?" Hearing this, Shi Misi said with a somewhat contemptuous tone: "Mr. Wei, to tell you the truth, all the Eastern drugs I know of currently have a large number of substitutes in the United States, and they are safer and more efficient substitutes!"

"Whether it is about headaches and brain fever, or about all organs, blood vessels, and nervous systems including the heart, liver, spleen, lungs, and kidneys, what you have in Eastern traditional medicine, we have in Western medicine. And our Western treatment methods are much, much better than your Eastern treatment methods!!"