"Mr. Si, Robert sent a message saying that the second phase of clinical trials was very successful and we have already applied for market launch." Si Mingyu received a call from Li Zhenyuan announcing the good news.
"Is there any problem with the timing of the Phase II clinical trial?"
Si Mingyu had previously received a thank-you call from Baili Hongcheng, saying his wife, Mulan, had essentially recovered. To be on the safe side, he planned to observe her for a while longer and then return to thank her in person once he was free. So he knew about the new drug. Now, after hearing Li Zhenyuan's comment, he calculated the time, and it hadn't even been a year.
"We applied for marketing approval in all fifty states. Because many Europeans and Americans participated in the Phase II clinical trial and the success rate was very high, the drug supervision and compliance office there relaxed the requirements in the review. After all, the sooner it's on the market, the sooner it can save lives," Li Zhenyuan explained.
He then continued, "Of course, we set aside a special fund, and Robert found a lobbying firm. In addition to persuading the regulatory authorities, this firm also organized several marches in front of the Drug Administration Compliance Agency offices for people with this rare disease in all fifty states."
After taking over Guoxing Group, Si Mingyu allocated 7 billion Chinese yuan to the Medical Research Institute in charge of Li Zhenyuan, allowing him to recruit researchers to start two more new drug research projects, bringing the number of ongoing projects to six.
Of course, it was impossible and unnecessary to invest all this money at once, so at Robert's suggestion, such a special fund was set aside to allow the new drug to be launched on the market earlier.
It’s not much, just a few million US dollars. It’s not a big deal after all.
It was agreed that Li Zhenyuan had the right to decide how to use the funds of the Medical Research Institute without reporting to Si Mingyu, so he made the decision on this small matter.
"How long will it take for the drug to be launched in China?" Si Mingyu didn't care about the situation in the Fifty State Federation. The important thing was to let domestic patients use it first.
"It will take at most a month. We have already contacted the relevant departments. Once the Fifty State Federation obtains the listing procedures, we will apply immediately."
Because this is a joint development project, the drug was registered with domestic drug regulatory authorities from the moment it was initiated. During this period, all required interim reports were submitted, ensuring the relevant authorities have a complete overview of the new drug. With federal approval from all fifty states, shortening the clinical trial period and securing domestic marketing approval will be straightforward.
As for the Fifty-State Federation, since there is no problem with the new drug and the sales time has just been brought forward, it is not a problem for the Office of Drug Administration and Compliance. After all, they have received the money, and they can also say to the outside world that they did it for the sake of patients' lives.
“What about the pricing of medicines?”
"The original R&D budget was 7 billion Chinese yuan, but because we chose a more accurate direction, we avoided many detours, which meant we spent significantly less money. Furthermore, conducting clinical trials in India saved even more money, so the total investment is no more than 4 billion Chinese yuan, even after accounting for the special funding. Robert and I discussed it and decided that a price of 300,000 US dollars per course of treatment would be a good price."
Si Mingyu knew that the one course of treatment that Li Zhenyuan mentioned was the entire treatment process that could cure a patient with a mild or moderate illness. Severe cases would require two treatments, and the final outcome would depend on fate.
This cost is certainly not cheap; even the middle class in the fifty states would have to save for several years without eating or drinking. But on the other hand, it is perfect to think that saving a life by paying only a few years' income is enough.
"Okay, then let's follow the price you agreed on." Robert knew more about the market conditions in the Fifty State Federation in this regard, so there was no need for Si Mingyu to add anything unnecessary.
After a new drug is put on the market, its ingredients and chemical formula are made public, which is why Indian pharmaceutical companies can successfully imitate it. However, due to technical reasons in the raw material purification and synthesis process, generic drugs may be inferior to original drugs.
Even if it's not as good as the original, it's still at least 80% effective. This is because it's a generic product from an Indian pharmaceutical company. If it's manufactured in Europe or the United States, the effect will be the same.
The effects are similar but the prices differ by hundreds or thousands of times. For example, a new drug costs $300,000, while a generic drug costs $3,000, which is not considered expensive.
Of course, the quality of generic drugs in India varies, and many people buy fakes there. After all, there is no way to complain after buying them, and the local authorities don't care.
However, Li Zhenyuan kept a careful eye on the treatment process he'd just discussed. Just having the medicine wasn't enough; there needed to be a supporting treatment method, and this was kept secret. While the information would undoubtedly leak out as usage increased, it would at least buy him a few years of market dominance.
Sure enough, things developed just as expected. After the relevant person in charge of the Fifty State Federal Drug Administration Office carefully checked the report submitted by the Medical Research Institute, especially after discovering that it contained a large amount of clinical data from Europeans and Americans, he found that there was basically no problem.
This is because due to racial differences, the same drug may have different therapeutic effects and possible sequelae. Simply put, whether the drug that can cure Indians in clinical trials can achieve the same effect on Europeans and Americans and whether there are any sequelae.
Now that we have data support, there is no problem. Coupled with the work of the lobbying company, the procedures were approved in a short time.
Production is not a problem at all. Since Si Mingyu in China has already acquired and built a pharmaceutical factory, how could the Fifty State Federation miss out? In fact, the first batch of drugs has already been produced and sales began on the day the approval procedures were obtained.
This is great news for patients suffering from this rare disease. After all, early treatment means early recovery.
On the very day the new drug was released, Si Mingyu, as promised, offered a $50 million bonus. Even the lowest-level researcher received $100,000, which delighted everyone. As the head of the pharmaceutical research institute and a leader in new drug development, Li Zhenyuan received an additional $50 million.
The news that the new drug was on the market in the fifty states spread back to China immediately, and domestic patients who had been paying close attention to this matter received two pieces of good news at the same time.
The first good news is that the approval process will be very fast, which means they can get treatment faster. The second good news is that because the new drug is jointly researched, it can be produced domestically. It is not considered an imported drug and does not need to pay additional tariffs, which can save some money.
Even if the new drug were sold at the same price as the 50 states, $300,000 would still cost two million Chinese dollars. But there was no other way around it; any drug that could treat a rare disease was expensive.
At least there is a drug to treat this disease, and patients have a chance to survive.
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