Small molecule drugs are like finding a needle in a haystack to screen out a promising new drug from thousands of compounds, and then optimize it on the research and development track, which costs a lot of money, and "one billion dollars in a decade" and two billion dollars are common。Biopharmaceutical is to fully understand the molecular mechanism of disease under the premise of using the tools provided by molecular biology, bold and reasonable design of drugs, high success rate, short time, relatively low cost is logical, has been proven。
China's pharmaceutical industry has been tracking biologic drugs in the hot areas of MAB or CAR-T anti-tumor,Now mRNA drugs have become the new darling of the biopharmaceutical field (some people also count them as gene therapy technology)!But biopharmaceuticals aren't just about tracking and copying,As long as biopharmaceutical talents have bold and reasonable innovative thinking,We can open up new areas for patients' needs,Develop original new drugs with low cost and high efficiency。
The age of biopharmaceuticals is upon us, and the odds are fair。But also to realize and take the initiative to embrace this opportunity, time is not waiting for me, time is no longer, biopharmaceutical companies in Europe, the United States and Japan are actually on the same starting line with us, it is a good opportunity for China's pharmaceutical industry to work hard, and the world's big pharmaceutical companies to compete on the same stage and develop differentiation。We can no longer hesitate to waste this opportunity given to our pharmaceutical industry.
Although biopharmaceuticals have been developed for more than three decades, the transformation of the pharmaceutical industry has been slow and gradual, and development is still highly uneven。The vast majority of pharmaceutical companies are still in the era of small molecule drugs and are in the stage of continuing to wait and see。After all, the number of European and American pharmaceutical companies with relatively good transformation and development of biopharmaceuticals is limited。
In addition to a variety of popular anti-tumor antibody class biologic drugs, there are many opportunities to treat many diseases in those patients with relatively simple, low-cost solutions。Enterprises can choose or avoid the differentiated development path of direct competition with international large enterprises, accumulate strength and gradually form an advantage field with their own characteristics。This is the dividend of the era to biopharmaceutical pioneering innovators, wait until these simple problems are solved, and it is likely that only hard bones will be left to chew after 20 or 30 years (refer to Pfizer's Phase II clinical success rate jumped from 17% in 2017 to 53% in 2020).。
For example, there is no elevator in the 20-floor tall building, and Jingdong little brother has 10 yuan income regardless of the delivery to that floor。Delivery to the bottom, second and third floors, the income is 10 yuan;He's still only got 10 bucks to carry it to the 20th floor。Now the transformation is equivalent to choosing the bottom customer order, at most two or three layers;I don't have a choice in a few days. I only have orders for the 20th floor。From the perspective of large pattern and enterprise development strategy, is it right now to transform biopharmaceutical?
Although biologic drugs with new mechanisms often produce surprising therapeutic effects on previously incurable diseases, they are not necessarily associated with high costs for pharmaceutical companies and patients。Think of the innovation of the era when penicillin was discovered, even today is not a huge cost, but it is not that era, there is no opportunity: simple antibiotics have long been everyday medicine, and today, you want to screen out competitive new antibiotics even if the cost is not necessarily able to do it。
Biopharmaceutical imitation does not necessarily cost small, take the original road is not necessarily risky!If we do not carry out the research and development of original drugs, generic drugs can only be consumed at low prices in the domestic market, and naturally lose the qualification to compete in the broad international market。The development of enterprises under the new policy should conform to the trend of The Times, look at the global drug market, and differentiate research and development products in international competition;The transformation of small and medium-sized pharmaceutical companies for the local market is similar。
For many years, the world's innovative talents (including graduates of Tsinghua University and Peking University of Science and Technology) have flowed to the United States, and the United States also pays attention to the positive impact of different sources of R & D personnel on innovation, and actively absorbs people with different backgrounds to join the innovation team。
In contrast, China's innovation system has many worthy of improvement, here the author only put forward a few of the current system does not understand, this is the current biopharmaceutical development facing obvious institutional pain points, I hope everyone to discuss。
1. Why do biopharmaceutical job recruitment and participation in innovation competitions have to set conditions such as return time and age?
Not in the field of hard technology, such as artificial intelligence (data mining), Didi Taxi-hailing, financial software and other single technical fields that require data collection, analysis and processing, or the establishment of market digitization that directly communicates with buyers and sellers, innovation needs young scholars to lock in their goals and move forward, and young age is an advantage。
But when it comes to biopharmaceutical ideas and technologies, such as monoclonal antibodies, cell therapy, gene therapy, etc., are the comprehensive application of complex knowledge under the premise of understanding the mechanism of disease, not to mention the original biological drug mechanism and production technology。To really do original drugs to meet the needs of patients as the goal, do not follow the trend, do not track hot spots, original innovation to lead the trend of biopharmaceutical times, older is the advantage。
Fu Xinyuan, chairman of Health Axis Biology, said in an interview: "Most of the Chinese entrepreneurs are originally in the European (American) big companies, they understand the operation of big companies, understand all aspects, and investors are also very like this kind of people, they have made a great contribution in the past 30 years.。However, they lack the source of their own innovative drug IP, so they most commonly use the introduction, which gradually formed a business model in the Chinese investment community: relying on the License in, doing the follow, and following the micro innovation。”
The phenomenon described by Professor Fu Xinyuan can be observed in society, at least in the field of biomedicine, studying abroad and working location and years abroad can indeed help imitation tracking, but can not be equated with original ability。It is often seen that research units set various conditions for recruitment: academic title, whether to study abroad, study years, whether to do management in large companies in Europe and the United States, return time, whether the alumni of famous universities at home and abroad are very difficult to understand。
Recently, the conditions for many entrepreneurship competitions are: "The intention to start a business in China recently or have started a business in China for less than 4 years."。How about four years or two more? Why not five?Why do domestic original biological drugs not support, why must follow Europe and the United States, leading the trend?Why the innovation of "foreign personnel age can be relaxed to 60 years old", graduate from domestic universities, study abroad to get a green card and return to work, what is the relationship with the original?
China's top leaders recently stressed at the 20th Academician Conference of the Chinese Academy of Sciences, the 15th Academician Conference of the Chinese Academy of Engineering and the 10th National Congress of the China Association for Science and Technology that "to achieve high-level scientific and technological self-reliance, in the final analysis, depends on high-level innovative talents.。”
Encourage innovation, do not artificially set up barriers, suppress talent restrictions!Regardless of gender, age, ethnicity and nationality, innovators should be supported to unleash their talents to produce products that meet market needs and are competitive enough to serve patients around the world。Such similar recruitment conditions for research positions or the threshold for participating in innovation competitions, which appear fair and fair, are actually hindering innovation and strangling innovative talents in the cradle。Fully shows that those who formulate personnel policies do not understand the characteristics of the industry, too take it for granted。
2. Original innovation must have a "soul", and seeds can germinate and eventually become towering trees
Original innovation must have a soul, it is expressed as a kind of intuition, inspiration, concept and confidence, so that it can overcome all human obstacles and difficulties given by nature, and move forward。With such an innovative soul may not succeed, but without such an innovative soul will not succeed!
Jobs is recognized as the soul of Apple, his intuition, inspiration made him have a firm belief, let Apple computer and Microsoft together shape the computer hardware technology, software development, the human data processing world today, changed everything in the office。Jobs also had a firm belief in the earliest period of mobile phone development, moving everything from computers to mobile phones, so that humans have mobile offices。Although he did not imagine the development of the mobile network can be today's level, and today's mobile world is far beyond the imagination of Jobs, but we also know that it is in the ideas and technology of Jobs's generation to develop。
Think of Steve Jobs as a teenager,The idea for the computer was born in his father's humble garage,He revolutionized computer hardware and software with Bill Gates.As for "Jobs came first,After the phone "needless to say;Musk doesn't know everything, does he,But his original rocket recycling and electric cars are also very good examples。Therefore, even if you graduated from famous universities such as Harvard, Massachusetts, read a few books or have a variety of high-end academic titles, have the foundation of innovation, improve along a road that has been developed or forge ahead toward the established goal, you are good scientific and technological talents, but not necessarily original innovative talents。
3. Innovative biopharmaceuticals do not wait, do not copy tracking, rely on innovative talents to open up new areas
Original ideas come with or without them。A good industry system should select talents with advanced consciousness and original ideas to lead the development of the entire industry across The Times。
It is hard to imagine that there is an intermediate state, and if there is an intermediate state, it is an imitation tracking。Even professionals with various titles, especially those who only study and write SCI papers in universities, and even experts with experience and qualifications in traditional drug research and development, rarely have a deep understanding of biopharmaceuticals, and it is difficult to make any forward-looking recommendations。Participating in the innovation pharmaceutical conference or every speech before the competition is to emphasize that China's basic investment is insufficient, the discovery of "new targets" is not enough, the innovation time is not arrived, and the "neck" is helpless in front of。
For them, innovation must come after spending huge sums of money and many years on par with the United States in basic research。This has resulted in a lack of original thinking, unable to make breakthroughs in scientific research and technology, forming a general situation of seniority and formalism, in fact, there is no deep understanding of the development trend of the industry, and the development of the industry not only has no guiding role, but is harmful。
Basic scientific research requires high investment,Spend time;Training future generations of scientific and technological personnel should also be patient,But that is no reason why biopharmaceutical innovations cannot be developed immediately: from the 1940s to the 1980s,The development of molecular biology has provided a solid theoretical basis for biopharmaceutical research and development, production tools;Subsequently, the theories and methods of molecular biology entered the field of medicine,Maximal low has promoted the understanding of the molecular mechanism of disease,These are publicly available academic results。It has not kept up with the progress of the era of science and technology, can not understand physiological and pathological processes from the molecular level, and therefore can not put forward original views and drug mechanisms in the field of biopharmaceutical, are their own knowledge aging, knowledge is shallow and can not keep up with The Times caused by, where can blame others or even other countries。
The industry system is not adapted to the development of biopharmaceutical first of all in the knowledge can not keep up with The Times,Including authoritative scholars, professional universities and research institutes,Reports of optimal times for important meetings often recall work from 20 or 30 years ago,Speaking of the current work is mostly imitation,At best, tracking is very close,There is no claim of differentiated development as a professional。The second point is the selection of talents, choose famous primary schools and universities one by one, SCI papers published the most "genius", government departments will give the world's academic circles are good, far more than ordinary scientific and technological workers of life and work treatment, hoping that biopharmaceutical science and technology leading the world。
Science and technology talents need to grow in fertile soil,But can not be promoted!Choice is subject to the laws of nature,Starting to grow fast in the greenhouse does not necessarily end up growing the tallest, strongest, fruity!Let a large number of seedlings under the same conditions to withstand the test of wind and rain,Standing out is the real talent;Talent is not the number of NSC papers published,Instead, we need to have a broad vision and a broad pattern,And solve specific problems,Keep moving towards your goal。Such talents can lead the trend and take on the responsibility!
4. Policymakers with the money and the voice don't understand why biopharmaceuticals are the only way to follow suit
National leaders also said: "China's original innovation capacity is not strong and a series of problems need to continue to make great efforts to solve.。”
It is said that the number of doctors trained in life sciences in China every year is the first in the world, but why is it not reflected in the original biopharmaceutical aspect, and it is also the first in the world?
At present, some stakeholders inside and outside the system say that China's biopharmaceutical has embarked on the road of originality, and is the second in the world。To say that generic drugs are not bad, and original drugs are second is too fantastic, and few people believe it。It is said that the land area is only more than 40,000 square kilometers, the population is close to Hangzhou, there are innovative drug giants Novartis Novartis, Roche led a number of original drug small and medium-sized enterprises in Switzerland,Don't even dare to say the world's second!And we look around,Most small and medium-sized pharmaceutical companies in China need to be transformed,But the way forward is not yet known;There are many tracking, generics and expansion drugs,But how to innovate the second achievement?
Various biopharmaceutical project competitions are constantly invited and hot, but every time they participate in the project roadshow, those well-known people who sit on the judging table do not understand the professional problems of biopharmaceutical, and have never seen any valuable problems in science and technology。In particular, those who have more or less money in their hands that can influence the development of the project openly require innovative drug development to follow their "logic" for the sake of so-called "performance" : imitation tracking is best, not innovation, especially not original。Such a system will only applaud copycat tracking projects, and innovations will be ignored or ignored and eliminated。
It is hard to understand the "logic" of investors and businesses that "spend a lot more on marketing than on research and development.。May I ask how much money is needed for hundreds of investment projects to invest in the same target, and isn't it throwing money into the sea to follow the trend of investment in the fierce Red Sea?Such a swarm of funds wasted investment just do not have to assume responsibility, performance will be good?Why can't we bring a little original drug development?Besides, it is a bad way to talk about economic value without the medical value of the project itself to the patient's disease。These people are used to fighting, internal friction, generic drugs know some, hope that they have a deep understanding of the original project and can be forward-looking, make intelligent recommendations, which is too difficult for them。It is not unusual to ask questions every time the project has progressed to that stage, several clinical stages。
Biopharmaceuticals can also act through the mechanism of targets, but innovative biopharmaceuticals can not adopt the "target" first strategy of traditional small molecule chemical drugs, and the overall idea and path of research and development can be completely different。If you do not know the characteristics of this era of the pharmaceutical industry, you can not correctly control the development direction of biopharmaceutical, how to do biopharmaceutical project competition judges?
And if the original project does clinical, but also seek them to invest a little money?No wonder Ma Yun was looking for investment all over the world is met with cold eyes。Consider that investors may have asked Ma similar questions at that time, but why SoftBank Group Son Masayoshi can decisively invest in Alibaba?
It is common for investors to enter the investment field through the college entrance examination and fight "pedigree", they follow the investment rules and those financial indicators they have learned, do not speak about the value judgment and the real needs of patients, or only use outdated knowledge to measure today's new and original biopharmaceuticals, and do so without any risk。But Masayoshi Son is not such a person, his vision allows him to reap the dividends of historical development at a very low price: he has brought changes to the way consumer goods are produced and sold in China, gave birth to the Alibaba of the world, and he has been rewarded with amazing rewards。
This article should put forward its own views and suggestions on the development of China's pharmaceutical industry under the premise of drug collection and price reduction, not to offend the judges of the competition。The judges are also the enforcers of specific rules, and they can't help it。What needs to be changed is the industry system, to separate the original and investment production, and to unify the interests represented by investors and the innovation needs。
Biopharmaceutical investment invests in the same target projects, swarms to the science and technology board listing, playing word games are said to be original, and it is actually a serious "internal volume" consumption behavior。PD-1/PD-L1 isn't that a lesson?Now monoclonal antibodies, bispecies, and even more specificity are also foreseeable: although there are good reasons for improvement and innovation under the premise of such a platform, the cost is minimal, but almost all in the highly competitive track of anti-tumor monoclonal antibodies, the essence is to track the performance of serious imitation。Recently, a similar scenario with MAB drugs has appeared in the field of CAR-T and gene therapy, and various science and technology development parks have rushed to invest heavily in the same target or technology platform, especially expensive CAR-T therapy is not known who will pay for it, whether it can be fruitful?At present, the fierce competition in the research and development of KRAS G12C inhibitors in China is no less than that of PD-1/PD-L1 antibodies, and there is a high probability that the historical scene will be repeated!When will the "internal" civil war end?This will not only waste a huge amount of money, but also miss the opportunity for the development of the pharmaceutical industry。
Low-cost tracking imitation can quickly meet the needs of the vast number of patients and is urgently needed by our society, which is not rich。Therefore, it is not that we cannot imitate or innovate on the basis of imitation,It emphasizes that mainstream and large pharmaceutical companies should develop innovative biological drugs for diseases and patients that have no medicine in the past in this surging era,Set an example for small businesses to transform and develop talent,In the process of transformation, the innovation of the enterprise itself extends to the outside,Become a strong competitor in the international pharmaceutical market。
If most of the country's industries can do the same, it is only a matter of time before the low - and middle-income trap is overcome!
The main body of innovation in Europe and the United States is small and micro enterprises led by scientists. In fact, the domestic system is not linked, and the idea of innovation will not have financial support。
5. Academic exchanges should be equal and promote innovation, and nepotism and suppression of differences by title and status should not be allowed
What is creative talent?Of course, to be able to innovate is innovative talent。Regardless of whether there is a title of "innovative talents", innovation needs appropriate working conditions and environment to exert energy, and innovative talents will contribute to society with innovative theories or products。
In recent years, a new industry has emerged, the intermediary company。There are many good intermediary companies, which is no doubt, firmly in the government departments, investors and no market experience between the research and development personnel to build a bridge of communication, praise need not say much。
But there are also many intermediaries,Keen to make friends,Eat at all levels of government and parks,Kill the average tech guy,Each event is a show of rank: give the "big guys" all kinds of superhuman treatment,Flattering each other in the spotlight,Bad speculation concept,Chasing international hot spots (CAR-T, gene therapy, hot targets).....), there is no project scientific principle, reasoning logic and technical details that we need;Ordinary researchers have to pay the travel fees even if they speak on road shows, not to mention the expensive attendance fees as ordinary listeners。Tech events that are supposed to be open, encouraging people to participate, make it a closed-door conversation that requires a certain status。Online and offline, there are only a few translated articles and a few sentences of industry news, and there is never any expression of their own views, speeches and debates in pursuit of the truth, real discussions and collisions of views。How can such an academic atmosphere become a trend in the field of science and technology characterized by openness?
The emerging, integrated science and technology fields such as biopharmaceuticals do not and do not need any authority, only need a path of visionary original ideas and technological innovation, and need to make progress in continuous learning and exploration。The phenomenon of showing colorful academic hats, superior status, and pressure on people can only hinder the development of innovative biopharmaceuticals, and hinder and suppress the ability of truly original talents。Even if the truly beautiful young people have wonderful ideas, if they are not given the opportunity and occasion to fully express them, they will gradually "vanish into the masses".。
Only people speak freely,Only by discussing problems on the basis of fairness and justice can innovation and originality be stimulated;The fake talents who are appreciated by the leadership and wear various academic laurels naturally dare not appear on the stage (unfortunately, domestic conferences are polite first),Few challenge authority);The whole industry can flourish,The role of truly original talents in leading the trend can be shown and played out。
6. It is hoped that the state will reform the industry investment system and bring strong development momentum for real innovation in biopharmaceuticals
The innovation capability of our country is far from that of the United States. If we add various unreasonable restrictions on innovation and completely control investment by amateurs, the result will be nothing original。Management, investors, wearing a variety of "innovative" academic officer hats together will find a variety of reasons for not innovating, and then follow the trend of investment, play concepts, speculation themes, at most only micro innovation, or even pseudo-innovation。
Now is not the early stage of biopharmaceutical exploration in the 1980s, most industry resources to transform biopharmaceutical trend has been clear。The current industry system some practices,It's a blind man trying to manage an elephant if he doesn't know anything about technology.,The immediate consequence is to bypass the path of original biopharmaceuticals,We-too一窝蜂选择抗肿瘤同靶点单抗仿制药项目; 第二个副作用就是由此产生了生物制药风险大、耗时长、成功率低的错误观念。These make it difficult for small and medium-sized pharmaceutical companies that are looking for transformation opportunities to make correct decisions, dare not step into new areas like biopharmaceuticals, and stay in the wait-and-see stage, which obviously hinders the development of the national and local pharmaceutical industry。
Therefore, in order for the national pharmaceutical industry to adapt to The Times on a larger scale and scope, transform biopharmaceutical, and at the same time expand employment channels for low -, medium - and high-tech talents, management and R&D personnel who have grown up under the traditional small molecule drug system need time to understand the biopharmaceutical process。It is hoped that people with experience in traditional drug research and development can take the initiative to accept new ideas and shorten this time as much as possible。And the drug has to be safe and effective regardless of whether it's a small molecule or a large molecule or anything else, and that doesn't change, right。Therefore, the experience of traditional pharmaceutical personnel can also play a major role in the biopharmaceutical process, especially at the animal testing and clinical stages。
In particular, it is hoped that the country can improve the industrial system and rules that are not conducive to the development of productivity,Let people who understand both biopharmaceutical and investment join the ranks of judges;Let people with innovative ideas and traditional practical experience combine,So that our pharmaceutical companies innovative products in the next hundreds of years can be everywhere,Cures all skin colors regardless of yellow, white or black。
Innovation has always been a nine-die life, but we must have the pride of "also the good Xi, although the nine dead have no regrets"。
Fortunately, doing biopharmaceutical now does not require the self-sacrifice spirit of Professor Tu Youyou's ancestors to test drugs,The success rate of well-designed biopharmaceutical projects in reality is also higher than the probability of "near-death" (10%),Living in such turbulent times,Not "to the world's scientific and technological frontier, to the main economic battlefield, to the major needs of the country, to the people's lives and health.,"Innovate and start businesses now,When do we have to wait?!
We should be full of confidence and pride, take the big ship of this era of biopharmaceutical, fully participate in international competition, strengthen China's pharmaceutical industry, and move forward to meet the expectations of human health in the magnificent blue ocean of original new drugs。
We are also well prepared to lead the next pharmaceutical industry transformation。