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Since the 18th National Congress in 2016, it has been proposed that China's future development should be driven
by scientific and technological innovation.
So far, the 20th National Congress of the Communist Party of China pointed out: improve the scientific and technological innovation system and adhere to the core position
of innovation in the overall situation of China's modernization construction.
Accelerate the implementation of innovation-driven development strategies
.
Accelerate the implementation of a number of major national science and technology projects with strategic and overall foresight, and enhance the ability of
independent innovation.
"Innovation-driven" is still the national development strategy and main theme
.
What stage is China's innovative drugs at now, what obstacles have they encountered, what is the underlying logic, and how should they go in the future? With these questions in mind, GBI interviewed Mr.
Song Ruilin, Executive Chairman of China Association for the Promotion of Pharmaceutical Innovation.
Exclusive interview with GBI • Guest guest
Exclusive interview with GBI • Guest guest
Song Ruilin
Song RuilinExecutive Chairman of China Association for the Promotion of Pharmaceutical Innovation
He is currently the executive chairman of the China Association for the Promotion of Pharmaceutical Innovation, a special expert of the talent pool of the National Committee of the Chinese People's Political Consultative Conference for political participation and discussion, and an expert of the Central Committee of the Peasants' and Workers' Party to participate in and discuss politics; He received a bachelor's degree in law from China University of Political Science and Law, a master's degree in business administration from China Europe International Business School and a doctorate degree in social and management pharmacy from China Pharmaceutical University.
Visiting scholar
at the University of Sydney, Australia.
He has been engaged in health and drug policy and legal research in the Legislative Affairs Office of the State Council for a long time, and was responsible for the drafting and review of laws and regulations in the field of health and medicine; In recent years, he has mainly engaged in the research
of China's pharmaceutical innovation policy.
Other social positions: Executive Deputy Director of the National Drug Policy and Industry Development Research Center of China Pharmaceutical University, Visiting Researcher of Shanghai Jiao Tong University, Member of the Expert Advisory Committee on Strategic Decision Making of Traditional Chinese Medicine Management of the State Food and Drug Administration, Member of the Biotechnology Advisory Group of the Hong Kong Stock Exchange, Vice Chairman of the China Rare Disease Alliance, Honorary Director of the Chinese Pharmaceutical Association, Director of the Chinese Pharmacists Association, and Director of
the Bethune Public Welfare Foundation.
"In recent years, the state has made a series of support policies to support the development of innovative drugs, and innovative drugs have ushered in unprecedented development dividends
.
Later, with the reform of the medical payment system, the return of innovative drugs did not seem to usher in the expected outbreak
.
”
GBI
GBIThis year's health insurance negotiations are about to begin, in your opinion, how should we ensure the value of innovative drugs in terms of payment for innovative drugs?
This year's health insurance negotiations are about to begin, in your opinion, how should we ensure the value of innovative drugs in terms of payment for innovative drugs?Chairman Song: We can think of this situation as a relatively complex game between the payer and the drug provider, both sides want to maximize the interests of the party they represent, but the market will present a more objective reflection, when the value of the product can be displayed, the supply of the market will be more sufficient; Conversely, the supply will weaken.
Of course, this may not be an immediate change, but it is inevitable from the perspective of long-term trends, which is also an economic law
.
China's innovative drugs have actually made due contributions
to the entire Chinese market.
Although there are still few drugs with a new mechanism of first-in-class in China, due to China's innovation and development in the past 10 years, through the continuous increase of domestic innovative drugs, the problem
that China has long relied on imported high-priced drugs and medical insurance has no negotiating power.
However, in this process, the contradictions have been differentiated, and in the process of the development of innovative drugs in China, innovative enterprises have found that this market does not seem to fully show the value of innovative drugs, that is, the payment price of medical insurance is relatively low
.
Because China's medical insurance reimbursement system was established in the 90s of the twentieth century, when China actually did not have any innovative drugs to speak of, nor did it have any innovative ability, our basic medical insurance system was not set up to meet China's innovative drugs, or to adapt to China's innovative drugs, so the goal pursued was more how to stabilize prices and ensure patient access
.
.
Of course, as the payer, it is completely understandable that the payer wants to buy high-quality and low-cost goods, but there may be a conflict in this process, if the other party is only an ordinary buyer, of course, the pursuit of low prices is beyond reproach; But if it is a strategic purchaser representing the country, then the strategy lies in the long-term, that is, whether we stand on a strategic high ground and look at the positive impact
that this industry can bring to the overall strength of the country in the future with strategic vision and strategic thinking.
Therefore, medical insurance is not simply a question of price, but whether China needs to innovate the industry, and whether China needs to innovate
.
The political report of the 20th National Congress has clearly shown that in order to improve the scientific and technological innovation system and accelerate the implementation of the innovation-driven development strategy, then there is no doubt at this point that what changes is not the overall national strategy, but what we should think about what kind of guarantee system
to establish.
At present, basic medical insurance is an important member of the security system, but it is obviously not the only single system to assume the responsibility of protection, but should establish a diversified multi-party payment system
.
GBI
GBIChina has produced many innovative drugs over the years, but the original motivation is still insufficient
.
Although China's overall GDP is not low, the proportion invested in health care is not as high
as that of the United States.
How should we stimulate the driving force of innovation in Chinese medicine?
.
Although China's overall GDP is not low, the proportion invested in health care is not as high
as that of the United States.
How should we stimulate the driving force of innovation in Chinese medicine?
President Song: These are different historical stages
for different countries.
China's innovation is first of all from scratch, and we are now entering the 2.
0 stage, that is, from something to excellent
.
In the process of starting from scratch, as long as there is a product, the original purpose has been achieved; But when we really have a product, we will find that our innovation is actually more follow-up innovation
.
0 stage, that is, from something to excellent
.
Now China's pharmaceutical innovation has also entered the stage of 2.
0 (or a new stage), that is, we must be guided by clinical value, rather than solving the problem
of whether there is any.
In fact, if I were to say that there are two realms of innovation, one realm is to fill clinical gaps, and the other realm is to implement effective substitution
.
Roughly speaking, China's 1.
0 era is to implement an effective substitution of import dependence, which is me-too/me-better to achieve so-called fast-follow innovation, then it is characterized by looking at what drugs are available in the world and China does not, so this innovation is called staring at drug innovation, then the next step we need to focus on the innovation of the disease, that is, which diseases do not have medicine, how to meet this demand, so these are two different stages
。 Therefore, we need to have strong primary care, basic medicine and basic drug research and development capabilities, and now we must enter a stage to fill the clinical gap, which is where translational medicine needs to play a role
.
Translational medicine must first be able to identify needs, because only by discovering such needs can we find ways to meet them
.
The discovery needs mainly come from the clinical frontline
.
In public health and clinical care, we find out which diseases are clinically understood but have no cure, which is the discovery process
of clinical needs.
Now we have established dozens of national medical research centers, and these research centers actually bear the heavy responsibility of future basic research, so our country is paying more and more attention to basic research, laying the foundation
for possible transformation in the future.
"Innovation is inseparable from the support of
capital.
In 2020, biotech raised more than HK$90 billion in IPOs on the Hong Kong Stock Exchange, and 600 in 2021
More than 100 million, but by 2022 (as of October) only more than 4 billion, showing a cliff-like decline
.
”
GBI
GBIRecently, the primary market has been sluggish, and capital has suddenly become cautious from crazy investment before
.
China's biotech valuation seems to be falling exceptionally fast, why do you think China's biotech is not favorable?
.
China's biotech valuation seems to be falling exceptionally fast, why do you think China's biotech is not favorable?
President Song: I think there are multiple factors, both internal and external
.
First of all, our own problems, China's biotech is mainly some original drugs me-too, that is, the originality is relatively weak, which is a hard injury, indicating that it is difficult to form a single monopoly in the market, and there are competing products as soon as the drug is made, which is one aspect
.
On the other hand, there is involution, because everyone does me-too, so it forms a crowd
on the same track.
The result of congestion is that the total market value of the product is averaged, or fragmented, so the value of the product is declining
.
The trend toward fragmentation, or averaging value, has also led to health insurance negotiations that can take advantage of payers' advantageous positions to allow companies to significantly reduce prices and profits
.
So everyone seems to be doing innovative drugs, but they have not maximized real innovation, but have minimized the price, which is a problem
that cannot be ignored by Chinese biotech.
that cannot be ignored by China's biotech.
Looking at the external reasons, on the one hand, the investment community has doubts about China's biotech, and it does have a lot to do with our current geopolitics, including the economy
.
In previous years, the United States had been engaged in quantitative easing, and a large amount of hot money poured out, causing capital to run
after projects at that time.
However, success is capital, failure is also capital
.
The reason why we have a lot of me-too products is also fueled by capital
.
After capital investment, they require the product to be made, but after making it, they do not seriously think about how big the market
is.
Just like tumors, with the targeting of tumors, tumors are divided more and more finely, a lung cancer distinguishes several targets, from the past to say that the number of tumor patients in China is millions per year, now each target has become only hundreds of thousands of patients, more and more in the direction of rare diseases, so its market carrying capacity is different from the original design, and the disorder of capital also promotes the generation
of value bubbles.
On the other hand, the United States this time seeks to decouple science and technology between China and the United States, and the relevant bills require that these funds cannot be invested in China's biomedical field, so at this time the tide of capital suddenly recedes, so the entire IPO market value we see now has fallen
sharply.
This also makes all of us wake up
.
I thought that when there are peaks, there will be troughs, and when the troughs come, everyone can keep a rational and sober mind, carefully analyze how big the market is, and how much value
they can create for the entire medical service.
That's when we found that investors are rational and developers are rational, so I don't think that's a bad thing
in the long run.
"The proportion of self-developed new drugs approved in China has increased from 2% in 2016 to 35.
8% in 2021 (not including license-in), but the vast majority are me-too on a global scale
or me-better, rarely first-in-class, or even best-in-class
.
”
GBI
GBIBeiGene and Legend Biologics are representative companies of innovation in China, and innovative drugs have been successfully approved
in the United States.
There are also many companies that plan to promote their products to the world, but are frequently frustrated
on the way to sea.
What do you think should be the path for these companies that are preparing to go to sea, especially those planning to go to developed countries?
in the United States.
There are also many companies that plan to promote their products to the world, but are frequently frustrated
on the way to sea.
What do you think should be the path for these companies that are preparing to go to sea, especially those planning to go to developed countries?
Chairman Song: Going overseas is a new topic
for China.
In the past, our pharmaceutical industry mainly met the medical services of our country, and now it is facing internationalization, which is also an inevitable road
.
BeiGene is an international company founded in the United States, so it's normal
for him to go relatively smoothly on the road to sea.
On the other hand, domestic companies seek to go overseas, and there is a problem
of integrating Chinese and international clinical trial evidence systems.
If a country has cheap and good medicine, I don't think any country will say no, because it is good for its socio-economic development, but we have to get the other party to recognize
it.
China joined the ICH in 2017, and with the implementation of ICH guidelines in China, our registration regulations and clinical evidence requirements are becoming more aligned
.
Because there are many Chinese and the number of sick people, we use more clinical evidence
from China.
So to go abroad, there needs to be a clinical evidence of different races or countries, and Chinese companies need to go abroad to carry out clinical trials, which has two levels of problems, one is a scientific problem, and the other is a political problem
.
The scientific aspect is that we do answer all concerns in the right proportions, i.
e.
to find more objective scientific evidence
.
On the other hand, we do not rule out that with the sharp geopolitical confrontation now, it will lead to a different view of Chinese products, and I think it is inevitable
.
At the end of the day, as long as we are more adequate in terms of scientific evidence, we will have no problem
going out.
On the other hand, our international market can not only focus on Europe and the United States, we also have a vast number of developing country markets, there are "Belt and Road" countries, as well as the SCO, Southeast Asia, South America and Africa, so for China, we attach importance to the US and European markets, but we can not only look at the US and European markets, which requires us to comply with the relevant standards and regulations
of the WHO.
At the same time, as a member of the management committee of ICH, China is actively implementing ICH's international standards in China, so I believe that with the gradual unification of these standards, China's drugs will be around the corner
.
GBI
GBIWhat trend and status do you predict will become in China's innovative drugs or innovative models in the next 5~10 years?
What trend and status do you predict will become in China's innovative drugs or innovative models in the next 5~10 years?Chairman Song: In the next 5~10 years, China's innovation policy will continue to change and improve, and these 5~10 years will still be the process
of policy infrastructure.
I don't think 5 years will make a huge difference in the ability of pharmaceutical innovation, but we have been steadily moving forward and steadily improving, there is no doubt about it
.
In 2015, China launched the reform of the drug approval system (the first year of drug supervision reform), and at present, drug regulatory reform will also enter the 2.
0 stage; after the establishment of the National Medical Insurance Administration in 2018, a lot of reforms have also been carried out, but the reform is not yet fully in place
.
For an emerging power like China, there are still many institutions that need to be established or continuously improved
.
I believe that today's China has the ability to continuously optimize policies and systems, and promote China's transformation
from a pharmaceutical power to a pharmaceutical power.
from a pharmaceutical power to a pharmaceutical power.
GBI
GBIFinally, could you please introduce the CPPCC, what are the current matters and future plans?
Finally, could you please introduce the CPPCC, what are the current matters and future plans?Chairman Song: CPC is a platform-based industry organization
composed of local drug research, R&D, production, manufacturing, service and even investment-related institutions.
We have always taken innovation as the core point, and we have been adhering to the concept
of "innovation, industrialization and internationalization".
The Association has been committed to promoting the close integration of scientists, entrepreneurs and investors, and we have held six consecutive sessions of the China Pharmaceutical Innovation and Investment Conference (the seventh session was postponed to December due to the epidemic this year), which has become the largest cooperation platform
for pharmaceutical innovation and investment in China.
At the conference, you can see the latest achievements of China's pharmaceutical innovation, allowing investors to know what innovations
China is currently making.
If there are projects that need to find investment here, then those who need to find funds can also come here, and the slogan of our conference is "innovation gives investment opportunities, investment supports innovation"
.
The Association regards promoting innovation as our own responsibility, promoting innovation on the one hand, and serving innovation
on the other.
In September this year, we will jointly host the SCO Conference on the Development of Pharmaceutical Cooperation with the Secretariat of the Shanghai Cooperation Organization and the Committee for Good-Neighborly Friendship and Cooperation of the Shanghai Cooperation Organization of China, and we will also establish a mechanism to promote cooperation with the pharmaceutical industry in ASEAN countries, so that China's innovative drugs can make due contributions
to the establishment of a community of human health.
of "innovation, industrialization and internationalization".
Policy research is another important work of the CPPCC, and we have been paying attention to China's drug research, approval, medical insurance and even medical drug related policies
.
We have many topics every year, some of which cooperate with government departments, such as the Ministry of Science and Technology, to analyze the innovation capabilities of Chinese pharmaceutical innovation enterprises; working with health authorities to assess the research capacity of our current research hospitals/research wards; Cooperate with relevant institutions to study how China's medical insurance should develop next, etc.
, this series is all around the theme of innovation, and strive to push China's pharmaceutical innovation industry to a higher level
.
So we have been working tirelessly, not worrying that no one will listen to us, but especially worrying that no one in society will study these potential and existing problems
.
I believe that as long as we work down-to-earth, everything we do will ultimately contribute to society and produce its due value
.
