Chapter 137 New Drug Launch

"Mr. Si, Robert sent a message that the phase II clinical trial was very successful, and we have applied for marketing." Si Mingyu received a call from Li Zhenyuan to report the good news.

"Is there a problem with the timing of the phase II clinical trial?"

Si Mingyu had received a thank you call from Baili Hongcheng before, saying that his wife Mu Lan had basically recovered, and he would have to observe for a while for the sake of safety, and he would come to thank him in person when he could leave, so he knew about the new drug. Now I listen to Li Zhenyuan talk about the time, it's not even a year.

"We're applying for federal marketing in fifty states. Because the success rate of many Europeans and Americans participating in the phase II clinical trial is very high, the Office of the Drug Regulatory and Compliance Agency over there has relaxed the requirements for the review. Li Zhenyuan explained.

Then he continued: "Of course, we came up with a special fund, and Robert found a lobbying firm that, in addition to persuading the administration, organized people with this rare disease in the 50 states to march several times in front of the office of the Drug Regulatory and Compliance Agency. ”

After Si Mingyu took over Guoxing Group, he allocated 7 billion Chinese dollars to the medical research institute in charge of Li Zhenyuan, and asked him to recruit researchers to open two more new drug research projects, increasing the number of projects currently in progress to six.

Of course, it is impossible and unnecessary to invest all this money at once, so at Robert's suggestion, such a special fund was taken out in order to allow the new drug to be marketed in advance.

It's not much, it's just a few million dollars, after all, it's not a big deal.

At the beginning, Li Zhenyuan had the right to decide how to use the funds of the medical research institute without reporting to Si Mingyu, so he decided on this trivial matter.

"How late will it be to go public in China?" Si Mingyu didn't care about the situation in the Fifty States Federation, it was the right thing to let the domestic patients use it first.

"At most, we have already said hello to the relevant departments, and if the 50 states get the listing procedures, they will apply for it immediately."

Because it is a joint development, it has been reported to the domestic drug administration agency since the establishment of the new drug project, and there are many reports that should be carried out during the period, so the relevant departments have a grasp of the situation of the new drug. At that time, with the approval of the 50 states of the federation, it will be no problem to shorten the clinical trial time and market it in China.

Besides, on the side of the fifty states, because everything is fine with new drugs, but the sales time is advanced, and it is not a problem for the Office of the Drug Regulatory and Compliance Agency, after all, they collect money, and it can be said that they do it for the sake of patients' lives.

"What about the pricing of medicines?"

"The original R&D budget was 7 billion Chinese dollars, but because the direction we chose was relatively accurate and there were many detours, which meant that a lot of money was spent, and the clinical trials conducted in India saved a lot, so the total investment did not exceed 4 billion Chinese dollars, which is still counting the special funds. After discussing with Robert, I decided that it would be better to price $300,000 per treatment. ”

Si Mingyu knew that the course of treatment that Li Zhenyuan said meant that the whole treatment process could cure a patient with mild or moderate symptoms, and the severe cases would have to be treated twice, and in the end, it would depend on their lives.

Of course, this fee is not cheap, even the middle class of the fifty states has to save for a few years without eating or drinking. But on the other hand, it is fitting that a few years of income can save lives.

"Okay, then according to the price you have negotiated." In this regard, Robert has a better understanding of the market situation of the Fifty States Federation, so there is no need for Si Mingyu to draw any more snakes.

After the new drug is marketed, the ingredients and chemical formulas are disclosed, which is why Indian pharmaceutical companies can successfully imitate them, but due to technical reasons in the process of raw material purification and synthesis, the generic drug will be worse than the original drug.

The effect is at least 80% or more, and this is also because it is imitated by Indian pharmaceutical companies, and the effect is the same when it is changed to European and American countries. But the price is hundreds or thousands of times worse, just at the price of 300,000 US dollars for a new drug, if it is a generic drug 3,000 US dollars, it is not expensive.

Of course, India's generic drugs are also mixed, and there are not a few people who go there to buy fakes, after all, there is no way to complain after buying them, and the local area does not care.

However, Li Zhenyuan kept an eye on it when he was researching, and this is the treatment process just mentioned. It's just that there is no medicine, but there must be a supporting treatment, which is confidential. However, with the increase in the number of uses, it will definitely leak out in the end, but it can also win a few years of monopoly market time.

Sure enough, things turned out as expected, and the relevant person in charge of the Office of the Federal Drug Regulatory and Compliance Agency of the fifty states carefully checked the report submitted by the medical research institute, especially after discovering that there was a large number of clinical data from Europeans and Americans, and there was basically no problem.

This is because due to different ethnic reasons, the same drug will have differences in treatment effect and possible sequelae, simply put, the drug that can cure Indians during clinical trials can achieve the same effect for Europeans and Americans without sequelae.

Now there is no problem with data support, plus the work of the lobbying company, it didn't take long for the procedures to be approved.

Production is not a problem, since Si Mingyu on the Huaxia side has already acquired and built a pharmaceutical factory, how can the fifty states federal side let it go, in fact, the first batch of drugs has already been produced, and it will be sold on the day of getting the approval procedures.

This is a huge boon for patients suffering from this rare disease, after all, early treatment and early recovery.

On the day when the new drug was put on sale, Si Mingyu took out 50 million US dollars as a bonus, and even the lowest-level researcher could get 100,000 US dollars, which made everyone extremely happy. As the head of the pharmaceutical research institute and the leader of new drug development, Li Zhenyuan also has an additional reward of 50 million US dollars.

The news that the new drug was listed on sale in the 50 states immediately came back to China, and domestic patients who have been concerned about this matter also got two pieces of good news.

The first good news is that the approval process will be fast, which means that they can get treatment faster, and the second good news is that the new drug is jointly researched, so it can be produced domestically and not imported drugs do not need to pay additional tariffs, which can save some money.

But even if the new drug is sold at the price of the 50 states, it will cost 2 million to convert 300,000 US dollars into Chinese dollars. But there is no way around it, any kind of drug that can treat rare diseases is expensive.

At least the disease has a chance to survive with drugs to treat it.