Because the application and approval process for relevant procedures is complicated and the time required is difficult to predict, and the construction of a preparation workshop cannot be completed in a month or two. Regarding the clinical trials of generic drugs, Xu Xin suggested splitting up efforts. On the one hand, Hongxing Pharmaceutical Relevant departments of the factory should seize the time to prepare for preparation production. In addition, they should cooperate with a pharmaceutical company with complete procedures to launch generic pharmaceutical preparation products as soon as possible and strive to conduct clinical trials as soon as possible.
Fang Hanmin fully agreed with Xu Xin's suggestion. He gave Xu Xin the task of finding partners, "You are the sales section chief and know the most about outside companies. Which company do you think is the most suitable partner for Red Star Pharmaceutical Factory?"
"Director Fang, I don't know which company is suitable to be our factory's partner. This matter cannot be decided by me. I think the cooperative unit should be determined through a method similar to bidding."
"The bidding method is certainly good, but when bidding for the same industry across the country, from the issuance of bids, screening and review, to final confirmation, the workload is not small! Not to mention time-consuming and troublesome, I am afraid that the final result will be counterproductive."
Fang Hanmin’s worries are all justified. Domestic peers basically know the market value of this generic drug. If the national bidding is held, there will be at least 20 or 30 pharmaceutical companies willing to cooperate with Red Star Pharmaceutical Factory. It is necessary to choose one among so many companies. Partners can only make judgments through analysis and comparison. Neither Fang Hanmin nor anyone else has the time or energy to do this work.
After some discussion, everyone believed that the bidding should be controlled to a smaller scope, and only familiar units or pharmaceutical companies that have done business with Red Star Pharmaceutical Factory should participate in the bidding.
At the meeting, Fang Hanmin also made divisions and arrangements for other matters, and urged everyone to take their own responsibilities, act vigorously and resolutely, and take practical actions to bring generic drugs to the market as soon as possible.
As Mr. Xia said, Hongxing Pharmaceutical Factory has always been engaged in the production of raw materials and has not directly faced the preparation products of medical institutions. It has never dealt with medical institutions and is seriously lacking resources in this area. Although the decision has been made, Fang Hanmin encountered The first problem is to find a medical institution willing to conduct clinical trials. This is a task he shares.
Without social resources, Fang Hanmin could only try his luck. He wrote to several pharmaceutical experts he met at academic exchange meetings, stating his ideas and asking them to help recommend or contact medical units that were willing to cooperate.
Ten days later, Fang Hanmin received replies from experts one after another. The results disappointed him because several experts who responded frankly admitted that although they were engaged in pharmaceutical research and were somewhat famous in the industry, they had little contact with medical institutions. Fang Hanmin faced There is nothing they can do about the difficulties.
At around three o'clock in the afternoon that day, the staff sent another letter to Fang Hanmin. The postal signature at the bottom of the envelope showed that the letter was sent from a well-known domestic medical research institute. When I opened the envelope and unfolded the letter paper, I saw that the letter read :
Hello, Comrade Hanmin!
First of all, congratulations to Hongxing Pharmaceutical Factory for taking the lead in successfully developing this generic drug in the country!
Sorry for the late reply. The matter you entrusted me was very difficult for me. Although I have been doing drug research all my life, I have never dealt with any well-qualified medical institutions. However, I didn’t want to let down your trust, so I mobilized my relatives and friends to help. As a result, I An old classmate of mine actually found such a medical institution. It is said that it not only has high qualifications, but also has conducted many clinical trials and has rich experience. After preliminary contact, the other party expressed its willingness to cooperate with you, but the conditions and details of cooperation need to be negotiated by both parties.
The letter was signed by Fei Liangyong. Professor Fei is a well-known drug synthesis expert in China and highly respected in the industry. Fang Hanmin’s hydrogenation reduction process is the scientific and technological achievement that Professor Fei presided over. At the academic exchange meeting the year before last, he praised the other party. Hanmin spoke highly of the papers he read and the keynote speech he delivered. He admired Fang Hanmin's talent very much and had a close relationship with Fang Hanmin.
This letter from Professor Fei gave Fang Hanmin, who was extremely frustrated, hope. He immediately called Professor Fei. In addition to expressing his gratitude to Fei, he also decided to go to City S as soon as possible to interview people from the clinical trial institution.
The factory office staff booked a train ticket for Fang Hanmin for the next day. Two days later, Fang Hanmin arrived in City S. He decided to visit Professor Fei first. On the phone, the two agreed to meet at a hotel near Fei's workplace.
At about six o'clock in the evening, Fang Hanmin waited for a while in a small private room on the second floor of the hotel. Lao Fei pushed the door in. Fang Hanmin stood up to greet him, held the guest's hand and said excitedly: "Professor Fei, we meet again. Nice to meet you!"
"Yes, we haven't seen each other for more than two years, but you have changed so much in the past two years! I heard that you not only became the director of Red Star Pharmaceutical Factory, but also took the lead in copying this drug nationwide. You are indeed young and promising. !”
"Professor Fei won the award. In fact, I am not interested in administrative management. Although I became the director of the factory, my main energy is still in scientific research." As he spoke, Fang Hanmin moved the guests to the dining table.
"That's right. You have talents in scientific research. Don't waste your talents because of administrative matters. Try to leave administrative work to your deputies."
"It's not about talent, I'm just interested in scientific research. Professor Fei, we can't just talk. Let's order the dishes first. You are a local, and you will arrange the dishes." Fang Hanmin placed an exquisite menu in front of the guest.
"I don't know how to order. Wherever I go to eat, I follow other people's arrangements. Don't make things difficult for me." Professor Fei handed the menu to Fang Hanmin again.
Senior technical experts like Lao Fei generally don't care about certain details in life. Fang Hanmin felt that he was not being polite on purpose, so he followed the waiter's suggestion and ordered four of the restaurant's special dishes, plus a soup, because he knew that Fei The professor didn't drink liquor, so Fang Hanmin ordered another bottle of higher-grade dry red.
"As far as I know, the patent protection of this drug is about to expire. Including our unit, there are five or six scientific research institutions and relevant universities in the country who want to imitate this drug. No one expected that now it is your place. The company took the lead in imitating it, and this news will definitely cause shock in the industry. With you as the technical leader, I don’t doubt the technical strength of Red Star Pharmaceutical Factory, but what I want to know is, how could you think of imitating this drug?" Professor Fei Although he did not admit it, he still had some doubts about the results achieved by Red Star Pharmaceutical Factory.
At this time, the dishes had been served, the wine had been poured, and the two of them were chatting while eating.
Fang Hanmin explained the original intention of developing this generic drug, "Red Star Pharmaceutical Factory only has three or four products in total. We believe that the company's products are single and its ability to resist risks is poor. The purpose of developing new products is to increase the company's ability to resist risks. After confirming the development of this Before making a generic drug, we conducted research and found that this drug has a good reputation in the market and its patent protection is about to expire, making it an ideal target for new product development.”
If he had not personally heard Fang Hanmin’s speech at the academic exchange meeting the year before last, Professor Fei would not have believed that a local enterprise with thousands of people could have such advanced awareness and keen sense of smell.
Lao Fei believes that even top medical experts like him at the famous national medical research institute where he works have only realized the importance of this drug. However, due to the cumbersome decision-making mechanism and slow action, it was not until the end of this year that If this drug is included in next year's scientific research and development plan, even if the development process goes smoothly, based on the work efficiency of their unit, it is impossible to achieve any results in less than two years.
For those low-level scientific research institutions and large pharmaceutical manufacturers, they don't even have such awareness!
As the leader of the expert group specializing in synthesis of the Institute of Medicine, Professor Fei originally wanted to discuss some synthesis process issues of generic drugs with Fang Hanmin. Considering the sensitivity of technical secrets, Professor Fei gave up the idea and asked instead: "You guys It’s an API production unit, why do you suddenly want to do clinical trials?”
"Because the company's product categories are too small, it is not conducive to participating in market competition. The next step for Hongxing Pharmaceutical Factory is to develop a product chain and increase product categories. We believe that generic drugs are just an opportunity, and we decided to produce preparations as well as raw materials. Therefore, We want to conduct clinical trials using our own preparations to compare them with products from patent-holding companies."
"This is a bold idea." Professor Fei nodded slightly, "But I want to remind you that clinical trials are a very serious matter, and the therapeutic effects obtained are real results. If the clinical data are not ideal, it will not be good for you. Both the preparations and APIs produced can have adverse effects.”
Fang Hanmin said slightly mysteriously: "To be honest with Professor Fei, we conduct clinical trials for a purpose that is not convenient for disclosure to the public."
"Oh, do you have other purposes? I wonder if you can reveal some information to me?" Driven by curiosity, Lao Fei couldn't help but ask.
"Based on the original patent, we have improved the synthesis process. At least from the raw material testing data obtained, the active ingredients of the drug have increased by two to three percentage points compared with the original patent, and the corresponding harmful ingredients have also been reduced a lot."
Lao Fei felt unbelievable, "What? The laboratory in your factory not only improved the original patented process technology? It also achieved such good results?"
"Professor Fei, although the scale of the newly built laboratory in our factory is not too big, it is not like the old one you saw when you went to us to host the hydrogenation process technology appraisal meeting. In recent years, the laboratory has not only purchased new instruments and equipment, and the newly purchased instruments and equipment are very advanced.”
Lao Fei seemed dissatisfied with Fang Hanmin's explanation, "I'm afraid things are not that simple, right? Hardware facilities such as instruments, equipment and laboratories can be purchased at any time as long as there are funds, but to achieve results, in addition to modern instruments and equipment, the key Talent is needed!”
The drug research institute where Lao Fei works has gathered hundreds of professionals related to drug research. They have just realized the importance of copying this drug. Fang Hanmin and the others have not only successfully developed it, but also made major improvements based on the original patent. , which was completely beyond Professor Fei’s expectation.
Through his past understanding of Fang Hanmin, Lao Fei knew that Fang Hanmin's technical level was very high, but he did not believe that Fang Hanmin alone could achieve such great results. In addition, Professor Fei has read the patented technical information of this drug. Even based on his level, he believes that its synthesis is not easy and involves multiple processes. Could it be that Fang Hanmin is a technical all-rounder?
Although he heard the implication of Professor Fei, Fang Hanmin could not tell the truth. He could only respond perfunctorily, "Professor Fei, although our unit's overall technical strength is relatively weak, it does not have nothing. We have gathered all the technical elites in the factory to make imitations." The development of pharmaceuticals solves the problem of insufficient talent.”
Lao Fei was noncommittal about this explanation, "Centralize the entire factory's technical elite? This may be a way."
