Wang Ju PAI AN | Lianhua Qingwen attacks FDA, is it true?

A few days ago, a friend overseas called me and said, “Director Wang, do you know what our embassy sent us for epidemic prevention supplies? Lianhua Qingwen capsules!”

He was a bit suspicious at the time, not knowing if Lianhua Qingwen capsules could be sold as medicine locally. He had doubts and continued, “Director Wang, Lianhua Qingwen capsules have not only obtained indications for the treatment of COVID-19 in China, but have also applied for clinical trials with the US FDA (US Food and Drug Administration), preparing to enter the US market. Can you check it out? If Lianhua Qingwen really enters the US market, that would be amazing, and we can feel at ease taking it.”

When I heard this, I thought it was indeed worth investigating. So, I checked and found that Lianhua Qingwen capsules had indeed applied to the US FDA, which is really big news.

Everyone should know that FDA is the abbreviation for the US Food and Drug Administration. All drugs in the world that want to be listed in the United States must apply to the FDA. So how many drugs does the FDA approve in a year? On average, it approves about 10 drugs a year, a very small number. But if a drug is approved by the FDA, the price of the drug can be set freely after it is listed in the United States, and you can set the price as much as you want.

Everyone knows that Lianhua Qingwen capsules currently cost more than ten yuan a box in China. If the FDA approves it, proving it is effective and listing it, the price can be set at 10,000 US dollars a box, or even 1 million US dollars a box. If it can really enter the US market, it will not only bring glory to the country, but also make a lot of money from Americans. The epidemic is raging in the United States now, and the government doesn’t care much, and many people still die every day. If Lianhua Qingwen is listed, and Americans take it and are all cured, wouldn’t that be a way to promote traditional Chinese medicine and also promote Chinese culture? This is much more effective than the Confucius Institute. If a Chinese medicine can be listed in the United States, then all doubts must be silenced.

More importantly, if the FDA approves it, it can not only be listed in the United States, but also automatically obtain approval in many countries, because many countries do not have the ability to organize clinical trials themselves, and basically follow the decisions of the US FDA. As long as the FDA approves it, other countries can directly sell it. Therefore, if Lianhua Qingwen is really successful in being listed in the United States, it can not only be sold in the United States, but also be directly sold in many countries, then it will make a lot of money. Academician Wu Yiling of Yiling Pharmaceutical may really become a billionaire by then.

You must know that if a drug sells well, it is not a problem to make 10 billion US dollars, especially for diseases like COVID-19. Therefore, this matter is of great significance.

The listing procedures of the US FDA are extremely strict and usually go through several steps. To list a drug, you must first do animal experiments, such as feeding small monkeys and small mice, mainly to do safety experiments to see if there is any toxicity. The pharmacokinetics (the metabolic process of drugs in the body) of some drugs will also be carried out on animals, such as creating tumors on mice and then testing the effects of tumor drugs.

After the animal experiments are completed, it enters human trials, which are divided into four phases.

The first phase is safety experiments, generally recruiting 20 to 80 healthy volunteers, asking them to take the drug and test for safety hazards and possible side effects.

The second phase mainly studies the pharmacokinetics of the drug, that is, to see if it works, usually on a scale of several hundred people.

The third phase is the most important and the most difficult, requiring large-scale randomized double-blind experiments. Sometimes, if there is a drug approved for listing in the United States for this disease, then the new drug must conduct a “head-to-head experiment”. That is to say, you cannot just prove that your drug is effective, but also prove that your drug is better than the existing drug, otherwise the FDA will not approve it.

This “head-to-head experiment” is extremely expensive for many pharmaceutical companies. For example, a 5,000-person experiment may cost tens of millions of US dollars, or even hundreds of millions of US dollars, just to purchase the control drugs. If you don’t have real skills, you don’t dare to do the third phase of the experiment.

If the third phase is completed, you can apply for listing. Sometimes, the FDA will also require a fourth phase of clinical trials to track the long-term situation of patients, to prevent the drug from not finding problems in the early experiments, but adverse reactions appearing after listing.

So, if Lianhua Qingwen can pass the strict review of the FDA and be listed, what does that mean? It means that all the controversies surrounding whether Lianhua Qingwen is effective must be silenced. The FDA’s review process is the best way to “put the horse out and let it run”.

So, has Lianhua Qingwen really successfully entered the US market? We checked the progress, and the results were surprising.

Lianhua Qingwen capsules obtained the drug approval for the treatment of COVID-19 in China in April 2020 and were officially listed. In July of the same year, they applied for clinical trials in the United States, which was very fast. However, this experiment was withdrawn in August 2020 because “the chief researcher could not be found”.

This is very strange. It stands to reason that it is not difficult to find a chief researcher for the first phase of clinical trials. There are many CRO (contract research organization) companies in the United States. If you can’t find a researcher yourself, you can委托cro company to do it, which is completely fine. Even if you can’t find it in the United States, it is also feasible to find a CRO company in China to help apply for experiments in the United States. The level of Chinese CRO companies is very high worldwide, and they can easily handle this kind of thing. So, why can’t Yiling Pharmaceutical find a chief researcher? This important experiment was stopped simply because the researcher could not be found, which is really a pity.

That’s not all, Lianhua Qingwen also has a second experiment – pharmacokinetic research. This is a phase I clinical safety trial to study the therapeutic effect of COVID-19. This experiment started in January 2022 and was scheduled to be completed in July. However, we checked and found that the experiment is still in the “recruiting volunteers” stage.

It stands to reason that it is already July, and the experiment should have been completed. How come even volunteers haven’t been found?

Phase I clinical trials usually only require 20 to 80 people, and there are countless COVID-19 patients in the United States, with hundreds of thousands of infections every day. Why can’t you find experimental subjects? This is also very strange, but Yiling Pharmaceutical has not explained it.

So, in general, Lianhua Qingwen has indeed applied for FDA clinical trials, but the first experiment was withdrawn because “the chief researcher could not be found”, and the second experiment is still recruiting volunteers, with slow progress.

This makes people wonder if Lianhua Qingwen really has the confidence to enter the US market? Or is it just a gimmick of “applied for FDA” to increase its domestic market value?

This question is worth pondering.