Zhang Dan
This article is the sixth issue of the "Science and Technology Innovation Academician Lecture Hall" co-sponsored by Shenzhen Innovation and Development Research Institute, Boyan Business School, Shenzhen Enterprise Federation, etc. On September 9, Zhang Dan, a foreign academician of the Russian Academy of Engineering, chief scientist of Xingwan Biology and co-founder of Kunling Pharmaceutical, visited the lecture hall of academicians of science and technology innovation and delivered a speech on China's "opportunities and challenges of new drug research and development".
On September 9, Zhang Dan, a foreign academician of the Russian Academy of Engineering, chief scientist of Xingwan Biology and co-founder of Kunling Pharmaceutical, was a guest of the academician lecture hall of science and technology innovation. Courtesy of the organizer
The following content is based on the transcript of Academician Zhang Dan's speech and has not been reviewed by the speakers
Today's topic is "Opportunities and Challenges of New Drug Development", which is a big topic. A look back at some of the biggest changes in the biomedical field in our country.
Dramatic changes in China's biomedical field
In 2015, the Opinions of the State Council on Reforming the Review and Approval System for Pharmaceutical Medical Devices basically reshaped the biomedical market. This document is very important, first of all, it took more than a year to digest and complete the 36,000 NDA (new drug listing application) audit approval documents that were backlogged at that time, and in 2018, the approval within the prescribed time limit was realized, which accelerated the approval process and speed of new drugs. Second, all the generic drugs before 2007 need to be re-tested for bioequivalence, when 90% of our country was generic. Third, take the initiative to withdraw the application for approval and do not pursue it, and the next time it is reported again, it will accelerate the approval.
At that time, China enforced the strictest standards in the world. Many people disagreed, and as a result, 12 of the 13 items were checked for the first time. Find out that you have counterfeiting and other violations, three or five years are not allowed to report drugs, on the blacklist. As soon as the results came out, everyone automatically withdrew, and 83% of the applications of domestic enterprises were withdrawn. That was the reality at the time, and later, China quickly recovered from that trough.
In March 2016, the State Food and Drug Administration issued the "Announcement on issuing the Work Plan for the Reform of the Registration classification of Chemical Drugs", which clearly put forward the registration classification, the first category is innovative drugs, and the innovative drugs that have not been listed at home and abroad refer to drugs that contain new structures with clear structure, have pharmacological effects, and have clinical value. This provision changed the definition of new drugs, and "national new" became "global new". The impact of this change is enormous. Before it was changed, a drug was approved in the EU for 20 years, and as long as China did not approve it, it was a new drug in China. So much so that at that time, many of the world's expired generic drugs had the highest price in China, because China still treated it as a new drug. As soon as the definition of new drugs was changed, the problem was eliminated, and in China, the threshold for new drugs was rapidly raised.
In 2017, China joined the ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). H (Harmonisation) here means "harmony", which actually refers to the consistency of technical standards for clinical trials, production standards and animal experiments reviewed and approved by member countries, and the result of harmonization is global mutual recognition of data. This is effectively equivalent to the WTO in the field of biomedicine.
In 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices (Hall Zi [2017] No. 42). The basis for the revision of China's new drug administration law is Circular 42. Document No. 42 has a total of 36 articles, of which the first 14 are clinical, which shows that the state attaches great importance to clinical practice, which is a fundamental change for generating data, supporting declarations, and accelerating innovation.
In 2019, the collection began, and the price of Generic Drugs in China began to decrease, but China is not the lowest price in the world, and the United States is lower than China. Because generic drugs are a fully competitive market.
Immediately after, me-too drugs (also known as derivative drugs) were included in the collection. This is very important, the vast majority of our country's current innovative drugs are me-too drugs. That is to say, China is facing a market of about two major factors, the first is to set up a desperate competition between pharmaceutical companies, and the second is that the mutual recognition of data under the ICH conditions makes external resources quickly enter China.
2016 was the last year before our country joined the ICH, that year approved 6 new drugs, 3 domestic, 3 imports; on June 15, 2017, China joined the ICH, this year, approved 40 imports, 1 domestic; in 2018, 40 imports were approved, 9 domestic; in 2019, almost, 52 were approved, of which more than 40 imports. Covid-19 will be in 2020. This year has done a good job, the ratio of imports to domestic production has reached almost 1:1.
China's pharmaceutical market is currently the international market, data mutual recognition, foreign original research drugs have come in. The most typical impact is the bivalent and nine-valent HPV vaccines, which took 11 years for GSK (GlaxoSmithKline) to get the foreignly approved bivalent vaccine in China before China joined the ICH, because China did not recognize its overseas data. In China, it had to do a new phase I, PHASE II, and PHASE III trial, and as a result, it could only be listed in China after ten years, and it was withdrawn half a year after the listing, because the nine-valent vaccine was listed, and the nine-valent HPV vaccine was approved when China had just joined the ICH. After joining the ICH, the state accelerated approval, from the declaration of NDA to the approval, it took only 8 days, and the data used were all overseas data. So that Merck, who produces HPV vaccines, was surprised, did not expect to batch so fast, did not produce for the Chinese mainland market, so after the batch is actually myrrh, many people go to Hong Kong to look for drugs.
What is China's current market? The collection market plus the world market produced by ICH. Is this phenomenon unique to China? No. Many countries have experienced it in history.
Taking Japan as an example, Japan used to be more than 1,700 pharmaceutical companies, which were reduced to more than 200 through a slow and similar collection method, and about a dozen or so companies used ICH to go to the world.
On January 15, 2020, the first part of the U.S.-China trade agreement was signed, which has a clause specifically for biomedicine, for the protection of "patent links" and patent compensation data. The patent link links the patent office and the drug office, and now go to the Food and Drug Administration to report that the new drug is listed, and you have to do a choice of four: 1, the patent is mine. 2, the patent is not mine, but the original patent has expired. 3, the patent is not mine, the original patent has not expired, but I promise that it will never be listed before the patent expires. 4, the patent has not expired, the patent is not mine, but I am ready to challenge the patent and prove that someone else's patent is invalid. The fourth is the most ruthless, you sign this statement, the FOOD and Drug Administration will give the information to the patent office, the patent office notified the patent holder, saying that someone wants to challenge you, ready to fight, this is the patent link system, under this system you can not sneak around, everything is on the table.
What is Patent Compensation? This starts with a logic of our medicine.
The researchers found an active substance in the laboratory, did some clarification on the mechanism, did some experiments in vitro and in vitro, and applied for patents. Almost 10,000 patents approve 1 drug for marketing, one in 10,000. Why do you fail so much, you go from having a patent to do a bunch of pre-clinical accumulation, optimization, to doing animal toxicology, animal toxicology has a lot of CRO (pre-bed research outsourcing services), to apply for clinical IND (submit a new drug for experimental use) approval, after approval, go to the clinic, phase I, phase II, phase III, and then apply for NDA marketing authorization, and finally start selling. From having a patent to forming a sale, the return on the patent takes longer than the long march, so a large number of our patents are invalid.
So in 1984, the United States launched a bill Hatch-Waxman (Drug Price Competition and Patent Term Compensation Act), saying that patents are very important to enterprises, and rely on the exclusive monopoly operation of patents to make money to supplement research and development. In the past, after the approval of drugs, the term of patent protection was only two or three years, three or four years, and if it could not be sold, the patent would be gone. Therefore, the state decides that the loss of patent time caused by the administrative process of the state shall be compensated by the national patent office, which is patent compensation. How much is compensated? For example, the United States has an algorithm, which is quite complicated. The compensation for large molecules does not exceed 14 years, and the patent duration is generally 20 years. Small molecules range from 5 years to 7 years.
How valuable are patents? The average weekly sales of a drug in the United States is $3 million, which is the value of the patent. Patents are actually monopolies that the state allows. So sometimes monopoly is not a bad thing. Why allow monopolies? Because human life is at stake, the high value of human life, the state would rather allow patents to monopolize operations, so as to attract everyone to use their insights and financial resources in biomedicine.
In 2021, a series of changes have taken place in Sino-US relations, and digitalization and artificial intelligence have begun to intervene in biomedical systems on a large scale. Over the years, we have seen a continuous stream of dramatic changes in the biomedical field that have reshaped the entire market. For the development of the biomedical industry, the new crown epidemic is a sudden trillion market for God, but it is a reshaping and blowing blow to the whole society.
In the first half of this year, global investment in biomedicine has concentrated sharply, reaching an all-time high. Biomedicine patent application is long, 1/10000 success rate, the success rate is so low, why do so many people invest money in it? The conclusion is that the rate of return is really high, to what extent? I give you an index, if since the birth of the US stock market, looking for the stocks of pharmaceutical companies, three years of investment returns, any three years, the return of the pharmaceutical industry is always the highest. The reason is that patents, the state allows you to monopolize the operation, so there is such a high return.
Under the new crown epidemic, the return rate of the biomedical industry has reached a peak that has never been seen in the world, from the first clinical trial to the listing approval, this time is an average of 6-8 years, and during this time you can not earn a penny, constantly invest money, hundreds of millions, billions of continuous investment.
During the COVID-19 epidemic, major countries, including China, have said that they can cut corners in emergency situations and use authorized EUV (Emergency Use Authorization) urgently. The visible hand and the invisible hand are simultaneously activating, accelerating the application of new technologies in this industry and the interpretation and overcoming of new diseases. From clinical trials to marketing, it has changed from 7 years to 7 months. This rate of return, not a 10-fold relationship, is a change of dozens of times.
What will happen in the years and decades after China joins the ICH? The most important thing is at the very bottom, 40,000 technical sequences lay the technical standards for the review and approval level of all member countries, the guiding principle of ICH is QSEM, Q (quality) is "quality", including stability, verification, impurities, specifications, etc.; S (Safety) is "safety", including pharmacology, toxicology, drug generation and other trials; E (Efficacy) is "effectiveness", including design in clinical trials, research reports, GCP M (Multidisciplinary) is an "integrated discipline" that includes terminology, managing communications, etc., spanning into other series.
Since its birth in 1990, ICH has issued more than 60 technical requirements and guidelines, basically planning the scope of drug approval and review. I myself was the global industry chief representative for the Series E Drug Safety Group and participated in the development of this guideline. The ICH currently has eight regulatory member institutions, namely the United States, the European Union, Japan, Canada, China, South Korea, Brazil and Switzerland. The ICH has also established a large number of observers who are not eligible to participate in rule-making but are willing to automatically comply with the rules established. There are observers from India, Russia, Australia, and the United Kingdom, which automatically lost its membership and became an observer after Brexit.
Before joining ICH, none of China's innovative proprietary medicines had entered the mainstream Western market. It is estimated that some people may say that our artemisinin has won the Nobel Prize, but it is an API not a finished medicine.
A real Chinese company that entered the U.S. market with arsenic cream for leukemia, Baekje's zebutinib, was later marketed in the United States. After China joined the ICH, the United States recognized China's clinical data, and its phase II key data all came from China, and the first phase was done in the United States and Australia. ICH is very important for China's innovative drugs to enter the U.S. market in history.
Hehuang Pharma's fruquintinib (the first anti-cancer drug independently invented by Chinese, researched by Chinese doctors, and developed by Chinese companies. On September 5, 2018, the State Drug Administration approved it for colorectal cancer. Unlike BeiGene, zebutinib was approved by the United States and approved by China seven or eight months later. And Huang Pharmaceutical is the first batch in China, and then to the United States. Recently, many companies in China have made PD-1 and PDL-1 immunotherapy products, and several companies have lined up to approve listing in the United States.
Why can't we just think about the Chinese market? The conclusion is that the United States makes more money. On the one hand, the US government does not allow collective procurement. On the other hand, commercial insurance in the United States is the largest type of insurance, government insurance is the second largest, and China is the opposite. I am not opposed to China's collection, because China has its own practical problems. In fact, no country can afford all innovative drugs only by relying on government insurance, it must be commercial insurance + government insurance.
The United States has given a series of special policies for innovative drugs. The U.S. agency that approves innovative drugs is probably the most experienced review body in the world. In the past two years, 80% of the world's new drugs have been launched in the US market. This is the "invisible hand" at work. If you can't enter the US market, the economic benefits of your drug will be hit by a question mark.
ICH, can recognize data mutually, accelerate review, and avoid duplication of experiments and duplicate data. However, the approval and adoption of drugs on the market, this national drug agency should be established separately.
The United States has launched a seven-nation alliance, the United States, Canada, Australia, Switzerland, Singapore, the United Kingdom, New Zealand, in the field of oncology drugs at the same time to approve the listing, one piece, one batch, I call it "super ICH". This is very good for our pharmaceutical companies, the market is very large at once, and the rate of return is very high.
Now we do innovative drugs, whether in Shenzhen, Shanghai, or Beijing, we must "bear in mind the motherland and look at the world". In the case of BeiGene, the fastest approval is the United States, after the United States has promoted the Chinese market, even if you target the Chinese market, in some cases, you can also take advantage of the differences between the Chinese and American systems, use the ICH data mutual recognition, may have to go to other countries to walk around and then come back. For the sustainable development of innovative drugs, China's way out is only internationalization, and only in this way can we produce "Huawei" in the field of biomedicine.
Some products really have to consider going to Japan and the United States for approval, such as stem cells, and now Shenzhen uses stem cells to do medical beauty, but I have not seen a formal approval, nor have I seen any formal clinical trial data. What is its safety and effectiveness?
Stem cells have not yet been approved as a wide range of products in China, but more than a dozen drugs have been approved overseas, and Japan, the European Union, and the United States have all approved. In this case, Chinese companies will have to try in countries that have already been approved because their path is clear.
Similarly, can innovative drugs accelerate the process in other countries? We did it. For example, in Australia, now take a clinical program into Australia to start clinical trials, if it is done well, it will start in 6 weeks, and it will accept non-GMP (Good Manufacture Practice of Medical Products) procedures from China. More than 90% of the products can not have GMP clinical approval, as long as there is an ethical approval, which is still difficult in the Chinese market.
The U.S. oncology products are reported to the NDA (New Drug Application) products on the market, once you find that clinical trials have good results, two pages of paper first report, rolling submission. At present, we still need a relatively long process to submit it, and there is a lag of almost one year or half a year.
ICH gives us the opportunity to go down this path. There was not much chance to go before, because the United States did not recognize our data. Now it is mutual recognition, and the premise is to prove that there are no ethnic differences, similar treatment methods and other series of conditions. This door will be opened to further develop China's innovative drugs and technologies.
After China joins the ICH, how will it affect the future?
First, China is now the international market, which means that our original strategy of attracting investment in the pharmaceutical field should be rethought. Previously, China's investment promotion strategy was the first generic drug, and whoever imitated the fastest was the boss. Before 2016, the country had a classification, called 3.1 drugs, who were the first to imitate it in The country, the state gave data protection, as a new drug, the pricing is relatively high. Therefore, at that time, biomedical pharmaceuticals mainly looked for the most powerful enterprises with the first generic drugs. I jokingly call this stage Biomedicine 1.0, which is the concept given by my partner Dr. Tian Yuan.
Later, it evolved to 2.0 to make new drugs around the world. Before 2016, our country did a lot of global new drugs, but after all, our country's new drug discovery ability and innovation ability are weak, so we have made a series of slight modifications on the basis of overseas innovative drugs, bypassing patented innovative drugs, we call me-too drugs (derived drugs). You target PD-1, and I also do a target for PD-1, make slight structural changes, and then patent this. Dozens, hundreds of PD-1 patents in our country have come from this way.
Chinese learning ability is super strong, me-too drugs have become "we-too", you can learn I can also learn, these dozens of hundreds of are dry, shengsheng made innovative drugs into generic drugs, are new drugs. I reckon it was also difficult for policy at the time to predict how quickly Chinese would react. There is an English word called "Fast Follow-On", which is a rapid follow-up of innovative drugs, and I have a batch of you immediately.
This strategy was particularly good before joining ICH. At that time, it took 7 years or 10 years for overseas original research to be approved to enter China, and at that time, China engaged in its own follow-up innovation, not only obtained patents in China first, sold for a few years to earn almost when foreign original research could enter China, and he also needed to do a phase I, phase II, and phase III in China, and the time was consumed.
The 2.0 version of the global new drug has also allowed innovative drug companies based on me-too drugs to flourish, which is the main symbol of the success of the biomedical 2.0 park, and now the mainstream pharmaceutical parks in China are mainly doing this.
After joining the ICH, the rate of return is quickly questionable, taking O drug (Opdivo, nivolumab) and K drug (Keytruda, pembrolizumab) PD-1 as an example, the current flagship product of tumor immunotherapy, dozens of Chinese companies engaged in PD-1, PDL-1, the first approved is 0 drug and K drug, there are Bristol Squibb (BMS) and Merck (MSD/Merck) two first batch, China's Junshi Biological, Innovent Biologics, Innovent Biologics, Hengrui Pharmaceutical, BeiGene, etc., were approved later. The first batch, the second batch, the third batch, the fourth batch, how much difference in returns? The West has this data, the first batch of drugs accounted for almost 50% of the market, the second batch of drugs accounted for more than 20%, the third accounted for 10%, the fourth accounted for 2%-5%, and after the fifth, it was not out.
After joining the ICH, the state approves foreign investment to enter China, what should we do if our country re-enters the innovative drug? Price cuts, price wars, so that now the price of PD-1 in China is 1/20 of that in the United States.
Why are so many companies struggling to support such low returns? The system of various countries is different, in the United States you do not enter the top four dare not do, because the market does not sell. But the Chinese system has produced the "wool out of the dog" thing. For example, this PD-1 can be a piece of land in the local area, because it is an innovative enterprise, I am doing it slower, but my drug now has patents, a team, and no risk, and it can definitely prove success scientifically. You say that a single drug is not enough, let's join forces with the old medicine. Talent policies, high-tech enterprises, tax policies, and land policies are all in place, and even if the products are not listed, the others have arrived.
On July 2, the Drug Review Center (CDE) of the State Drug Administration issued a draft of the Guidelines for clinical value-oriented Clinical Research and Development of Antineoplastic Drugs (hereinafter referred to as the Draft for Comments). After the release of the Draft for Comments, the market value of many enterprises was cut off, and the effect was unexpected by the State Food and Drug Administration. Because of the future of me-too drugs, the threshold for clinical trials will gradually increase.
If pharmaceutical companies want to be internationalized, they must do it in accordance with ICH standards. We do clinical trials in China, do a production, do an animal, after we use these data, the United States, the European Union, Japan, Southeast Asia and many places can use, this return is high. At the beginning of the COVID-19 outbreak, the ICH was holding a meeting, which proposed many new changes, such as constantly revising technical guidelines, adding new technical guidelines, and coordinating global drug research and development. This requires that our businesses have someone to track these changes and implement them.
The second is multi-country and multi-center clinical trials, which must now be oriented to the world, and it is best that our products can be sold in various countries, so that the market caused by China's collection and procurement can be temporarily reduced, so that we can be compensated in the global market. From the first phase of the clinic, it is necessary to consider whether it is possible to multi-country and multi-center, rather than only in one country and one institution to do clinical trials. In this way, the product can be recognized in many countries. ICH has specially formulated the "epidemic period guidelines", that is, to encourage everyone to globalize from the early stages, which most of our companies have not done, we have a new drug, from the beginning of the backward. Future market returns are not laid out in advance, which is a very important matter.
In fact, during the covid-19 epidemic in our country, both Traditional Chinese medicine and Western medicine have made many attempts, some of which have clinical effects, but we have not carefully designed and collected this information in accordance with ICH standards. Of course, now I'm saying this in hindsight. In the future, when we encounter similar situations, we have to prepare in advance, not like this time, we were the first to have the largest number of cases in the world, but we did not produce relevant high-quality global clinical data first, and this resource is a bit wasted.
It's a two-sided thing, the Chinese government controls it too well, there are no patients, so later we have to go overseas to do vaccines. But this has also produced an unprecedented good phenomenon. Previously, the vast majority of countries were skeptical of China's clinical data. But this time China has fought a turnaround battle, vaccines we go to the world to do, Europe, South America, the Middle East, Central Asia, we all do it. People's doctors, people's patients, people's regulatory agencies, we can't fake, data to the scene to collect. Even though the best of the mild and ordinary types is not as high as other people's "me-too" drugs, the data on severe mortality are very good. This time proved that China's data is reliable, and it has won glory and increased trust in our entire biomedical industry.
By coincidence, this has created a new market – the market for the Belt and Road countries. In the past, the "Belt and Road" countries were also reluctant to accept Chinese biomedical products. The first approval of the COVID-19 vaccine produced by inactivation technology was not in China, but in countries such as Brazil and Turkey, because the data was there for them. China also approved it after collecting data from all over the world. This time, China has been very successful in letting go of the world, and because of Its huge production capacity, China has become the only country that can mass-produce vaccines for the world in the short term. I believe that China's current way out is to enter the market of the rich countries in the West with international standards, and at the same time to enter the "Belt and Road" countries, which is a rigid demand.
I also suggested to the state whether we could establish a "Belt and Road" national pharmaceutical coordination organization. Because the "Super ICH" is basically a rich country coordination organization, can we be a "Belt and Road" country coordination organization and achieve mutual recognition of data and products internally. If these countries can accept China's vaccine products, why can't they accept China's PD-1 and Chinese medicine products, if we have real data to prove, I think the difficulty of acceptance will be greatly reduced.
The requirements for vaccines are very high, because you are vaccinating healthy people, you can't turn healthy people into patients. Comparatively speaking, it should be easier to accept that you already have an incurable disease. Therefore, we call on our country to take advantage of this opportunity to establish a "Belt and Road" national pharmaceutical alliance, and recognize each other's products and data, so that the internal volume generated by our current domestic collection will become an "outer volume", so that our excess biomedical production capacity will flow abroad.
Following the principle of ICH, taking two-wheel drive with two wheels, internal market and external market collection, it is possible for our enterprises to have room for survival and development in the environment of collection and ICH.
Zhou Siyuan, deputy director of the Drug Evaluation Center of the State Drug Administration, who is in charge of the ICH Office, pointed out that for the series of guidelines for ICH, the state has also formulated a series of issues to be introduced to enterprises. I come from a corporate background, and I know it's impossible to have so many experts and so many guides in business day and night.
So, can the government level help enterprises to establish a mutual learning and mutual aid agency to guide enterprises to learn, accept and implement the ICH guidelines? In fact, one of our responsibilities in Xingwan to Shenzhen is to establish an ICH park, and enterprises entering the park must understand ICH, and now we do not understand, after entering the park, we have the responsibility to teach and understand. Because this park is going to benchmark the global market, if you don't have this ambition, don't come here. This is the "Biomedical Park Version 3.0" that we want to create.
Version 1.0 is the first generic drug, version 2.0 is a me-too drug, and version 3.0 is a drug that can kill the world. We hope that Shenzhen can take the lead in building a complete supporting policy in the country that will help to go to the world and form a 3.0 version of the biomedical system.
Shenzhen often talks about being an international metropolis, and if international standards cannot become mainstream standards in Shenzhen, then at least in biomedicine, it is impossible to become an international metropolis. There is an opportunity, China has been re-elected as a member of the ICH management this year, and enterprises in various regions are almost at the same starting line to learn ICH, which is a bit of a "and now step forward from scratch" feeling.
The challenge we encountered in ICH is first and foremost training, and we now find that translating ICH regulations and guidelines into Chinese, regulatory agencies, cooperative units, such as commissioned production units, clinical institutions, pharmaceutical companies and CRO (pharmaceutical research and development contract outsourcing service agencies), have different understandings. We need to reach a consensus on the understanding of technical guidelines, so training is particularly important.
How can China narrow this gap after joining the ICH, and what can Shenzhen do?
First, make full use of Shenzhen's policy advantages of being the first to try first. We are able to apply in bulk for the national first-in-the-first-mover reform regulations. For example, can we take the lead in conducting multi-ethnic research in Shenzhen? Hong Kong, Singapore and Australia can do it, why can't Shenzhen invite foreigners to do clinical trials? Why do companies have to go overseas to do clinical trials? This requires the government to carry out a series of institutional reforms, for example, experiments with foreigners do not need to be submitted to the Human Genetic Resources Management Office for approval. Second, can you give him a special visa to allow him to come to Shenzhen to do experiments, neither a tourist visa nor a work visa. Third, the relevant medical institutions in Shenzhen are required to achieve a comprehensive interpretation of international standards, can they accept overseas commercial insurance? A series of institutional reforms such as these need to be made. If you recognize the internationalization, it is best to help domestic enterprises enter the international market at the lowest cost, rather than forcing enterprises to run all over the world. Can Shenzhen use the Qianhai and Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zones to do this?
Second, take advantage of Shenzhen's location. Shenzhen is close to Hong Kong, not far from Macao, not far from Southeast Asian countries, the country has given so many special first to try, can we engage in a small alliance with neighboring countries and regions, first recognize the clinical trial data. The state has just announced that there is a cooperation area such as Hengqin in the middle of the two ports of Zhuhai and Macao, how can these resources be coordinated to accelerate the development of our products to the world.
Our country's "Eleventh Five-Year Plan", "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" support for major new drugs have jumped from the third echelon to the second echelon. According to McKinsey's calculations, the first echelon is the United States, the second echelon is Japan, China, Britain, Germany, Switzerland, and the rest are the third echelon. However, although China has entered the second echelon, the competition to get close to the first echelon is still quite large.
If we do that, we may be closer to the first echelon. Chinese average VC venture capital institutions are probably Shenzhen, but the VCs that invest in biomedicine are a little worse. How to make Shenzhen's huge technical resources more accurately dock with the biomedical health industry depends on the power of the market and the promotion of the government.
From a global perspective, there are several cities that have been successful in biomedical innovation, and we all recognize several. The first was San Francisco and the second was Boston. If we compare their model with Shenzhen, we have a lot to think about. Shenzhen has invested in many universities, there are also medical schools under construction, and I hope that Shenzhen will also support the construction of global research institutes, that is to say, we recruit people here not only Chinese, but also recruit old foreigners to do research.
Referring to San Francisco, san Francisco property owners first discovered these intellectual property rights on the East Coast of the United States, right in Boston, Harvard, MIT (Massachusetts Institute of Technology) scientists, but at that time in Boston could not find money, so they ran to the West Coast with technical information to find money, and started a business on the West Coast. After Boston's state of Massachusetts discovered the problem, the government invested $2 billion to keep those resources, forming the current pattern.
This is a good enlightenment, Shenzhen has strong resources, connected to the biomedical field, so that the 7-year, 10-year investment period, can be uninterrupted investment, laying a strong foundation for biomedical innovation and entrepreneurship in Shenzhen.
The third is the cultivation of talents. If we go to the United States to report and sell drugs, how can you let the Chinese be the main hit, the Chinese are in the minority there. So to the world, we must prepare talents, we have a talent platform in Shenzhen, so that our enterprises can easily find these international experts in Shenzhen, so that talents who speak more languages can gather together for the development of Shenzhen.
The last item is to build a new system of medical sciences based on the city. This is what Shenzhen is doing and it is also very remarkable. Shenzhen has the vigor and courage, and this matter will inevitably form a healthy dynamic micro-environment. On March 25, 2021, the General Office of the Shenzhen Municipal Government issued the "Construction Plan of Shenzhen Academy of Medical Sciences", and the Shenzhen Academy of Medical Sciences is located in Pingshan District, and the Pingshan Park of Shenzhen National High-tech Zone and Shenzhen National Biological Industry Base are also located in Pingshan District.
Let's talk about Shenzhen, which is not only concentrated in IT companies, but also a city of great health and life science innovation and entrepreneurship.
In terms of talent introduction, investment, going abroad and introducing foreign technology, Shenzhen can be a comprehensive first-mover city. If you do this, what internal volume, what collection, what ICH, all the solution lies in globalization.
China's production capacity is super strong, if we do the clinical experiment capabilities up, the "two ends outside" are strong in all aspects, And the environment of China's biomedical enterprises and biomedicine is promising.
(Finishing: Wang Miaomi)
Editor-in-Charge: Tian Chunling
Proofreader: Luan Meng
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