CCTV Beijing, March 4 News (Reporter Sun Ruxiang Intern Yang Jiehui).Is 2023 the "first year of harvest" for China's innovative drugs? What does it mean for multinational companies to frequently "sweep goods" in China? How to break the dilemma of innovative pharmaceutical companies having new products without profits? Is it feasible to make reasonable profits at home and excess profits overseas? How to break the "last mile" when innovative drugs enter hospitals? ...
The third issue of "Asking Innovative Drugs" was recorded before the National People's Congress and the National People's Congress (NPC), and heavy questions were thrown out at the program site. The guests of the four leading innovative drug companies on the Science and Technology Innovation Board faced sharp questions.
The guests who participated in the recording included Zhu Yi, founder and chairman of Baili Tianheng, Zou Jianjun, executive director and CEO of Junshi Biosciences, Fang Jianmin, co-founder and CEO of Remegen, and Liu Datao, chairman and CEO of Mabwell. Luo Jiarong, chief analyst of GF** biomedical industry, served as the leading guest of this program.
Shanghai Market Hui Hard Branch Hard Ke" recording site.
Cutting-edge science and technology, hard customer forward-looking"! The column aims to build a space for all-round display and in-depth exchanges for the iconic soul of the development of "hard technology", so that entrepreneurial scientists can summarize experience, review the path, look forward to the industry and make suggestions, and further lead and help the ecology of the science and technology innovation board industry chain to continuously improve and achieve high-quality development.
What does it mean for multinational companies to "sweep goods" in China?
Starting in 2023, a new phenomenon has emerged in China's biopharmaceutical industry, that is, a number of multinational companies have reached product licensing cooperation with local enterprises. The industry presents a state of multinational companies coming to China to "sweep goods". At the beginning of the new year of 2024, overseas licensing transactions of domestic innovative drugs have accelerated, and a number of multinational pharmaceutical companies have reached product licensing cooperation with local Chinese innovative pharmaceutical companies, completing 12 transactions in the first two weeks of January.
Zhu Yi, founder and chairman of Baili Tianheng.
Regarding this phenomenon, Zhu Yi believes that this is a demonstration of the fruitful results of the development of China's biomedical ecology in the past ten years. It shows that Chinese have created innovative technologies and projects recognized by global multinational enterprises. Moreover, the world's second-largest biomedical innovation ecosystem after the United States has emerged in China.
Zou Jianjun, Executive Director and Chief Executive Officer of Junshi Biosciences.
This shows that the scientific and technological content of China's innovative drugs is increasingly recognized by more large enterprises, and more and more best-in-class or industry-first products made by Chinese pharmaceutical people will be able to enter the world stage in the future. Zou Jianjun said.
What is the position of China's innovative drugs in the world?
Looking back on the past 2023, it is generally considered to be a very important year in the industry, and it is known as the "first year" of a bumper harvest of domestic innovative drugs.
Datao Liu, Chairman and CEO of Mabwell.
2023 is a year of accumulation after years of accumulation. Liu Datao introduced that in 2023, the total number of approved innovative drugs in China will increase by 60% compared with 2022. In the past year, the whole industry has authorized about 22 billion yuan, which has exceeded the total amount of IPO funds raised by listed pharmaceutical companies.
Relevant data show that in 2023, China's Drug Administration will approve 40 innovative drugs for marketing, an increase of 74% over 2022.
Liu Datao said that 2023 can be called a fruitful year for Mabwell. As a start-up, Mabwell will have its first commercialized product in 2023, two innovative drugs will enter clinical trials, and an overseas licensing cooperation for an innovative product will be realized.
There is no doubt that for Baili Tianheng, 2023 will be full of harvest.
2023 is a lucky year for us, and it is also a really good year. Zhu Yi said that the first overseas transaction of joint development and commercialization of Baili Tianheng was realized, and the partner was BMS (Bristol-Myers Squibb).
According to public information, the total amount of the transaction is 8.4 billion US dollars, and the down payment is 800 million US dollars, which is the largest transaction in the history of the ADC field in terms of both the down payment and the total amount.
2023 is a very exciting milestone year not only for Junshi but also for China's innovative pharmaceutical companies. Zou Jianjun summed it up.
Zou Jianjun introduced that in this year, Junshi Biosciences independently developed and produced, completed all clinical studies and submitted a marketing application for the biological product PD-1, which was officially approved by the FDA for marketing, becoming the only drug approved in the United States for nasopharyngeal carcinoma; It has independently developed the world's first B and T lymphocyte attenuation factor monoclonal antibodies, which have been approved by the FDA and the Chinese drug regulatory authorities, and have carried out phase registration clinical studies around the world.
Fang Jianmin, co-founder and CEO of Remegen.
In the past ten years, China's biomedicine has made great progress, which can be summarized in four points. Fang Jianmin believes that first, the state's support for innovative drug innovation, especially the support of major national science and technology projects and new drug projects; Second, the regulatory reform has greatly improved the speed of review and approval, and a series of systems for new drug creation have been established; Third, the medical insurance policy solves the problem of the accessibility of drugs for the people, which is very important for the sales of innovative drugs; Fourth, the capital environment, especially the Science and Technology Innovation Board, plays a very key role.
So, while the industry is booming, what is the position of China's innovative drugs in the world?
Zhu Yi said that there are various signs that from 2023, the innovation of biomedicine in our country has begun to move to the front row of the world.
Zou Jianjun believes that on the one hand, the achievements are huge, but compared with Europe and the United States, there is still a distance in source innovation and commercialization. "In fact, many of our companies lack global commercialization capabilities," Zou added.
What the Chinese are really strong is technological innovation, but the discovery of truly scientifically innovative drug targets and the discovery of new disease mechanisms is still not small with the United States. Liu Datao said.
What is the role of the Science and Technology Innovation Board in the innovative drug industry?
The listing of many innovative pharmaceutical companies on the STAR Market is equivalent to being seen more widely by investors and being recognized and understood on a wider scale.
We listed on January 6, 2023 and got 9900 million, in exchange for the largest single asset transaction in ADC's history, 800 million US dollars in the down payment, 8.4 billion US dollars, played a key role for us. Zhu Yi further explained that Baili Tianheng completed the enrollment and evaluation of more than 800 sample sizes before making the above transactions. This data benefited from the listing on the Science and Technology Innovation Board, which raised funds for clinical research.
In less than 5 years from its incorporation to its listing on the Science and Technology Innovation Board, Mabwell has raised about 3.5 billion yuan from the capital market.
We are the beneficiaries of the STAR Market. R&D investment, sales team and factory establishment all rely on a large amount of resource investment, without the blessing of the science and technology innovation board, there would be no current development speed. Liu Datao said that in addition, the listing of the Science and Technology Innovation Board has strengthened corporate governance and standardized operation, so that the company has a better foundation for development.
Luo Jiarong, chief analyst of GF** biomedical industry.
Luo Jiarong believes that innovative drugs are an industry that has lasted a long time and has invested a lot. In fact, the launch of the Science and Technology Innovation Board has also built a complete ecosystem for the entire investment and financing industry chain in China, from the primary market to the secondary market, and has played a great catalytic role in the development of the industry.
Why is the pricing gap between China and the United States dozens of times?
Taking Junshi Biosciences' PD-1 as an example, the product was launched in the United States, and its sales ** were 33 times that of China!Why is there such a big gap?
Indeed, this product is about 1,900 yuan in China and about 64,000 yuan in the United States. Zou Jianjun said that before there was no domestic PD-1, cancer patients used foreign PD-1 for about 150,000 US dollars a year. At present, the annual cost of domestic drugs is between RMB 30,000 and RMB 50,000. It is also the social responsibility of China's innovative pharmaceutical companies to let our Chinese people get the best with affordable products.
One of the main reasons for the pricing difference between China and the United States is that the payment system is not exactly the same. China has a relatively simple payment system, and if there is no medical insurance, the patient will pay out of pocket. But in the U.S., it has a more integrated payment system, including commercial insurance and health insurance.
Liu Datao explained this difference from the perspective of "per capita".
China's main payment end is medical insurance, which accounts for about 7% of GDP in China and 17% in the United States. The per capita investment of Chinese is about 6,000 yuan, and the per capita investment conversion of the United States is 970,000, which is 15 times that of China. From this point of view, the price of medicine in China is 1.15 in the United States, which is a very normal phenomenon. Liu Datao said that Mabwell's own slogan is to develop good drugs that people can afford in China, and go to developed countries to earn our excess profits.
Liu Datao further said that only the United States has such drugs in the world**, and American innovative drugs account for half of the world's innovative drug profits. This also reminds us that the high investment and high drug prices like the United States cannot be replicated in other parts of the world, and China has its own way to go.
How to break the dilemma of innovative pharmaceutical companies having new products without profits?
There is another important problem associated with **, which is also a common dilemma faced by innovative pharmaceutical companies, that is, it is difficult for Chinese biopharmaceutical companies to make profits, and the products are on the market but the companies are not profitable.
Even if we don't pursue high drug prices, we always have a reasonable **. We often say that grain cheapness hurts farmers, but our drug prices are too low, which actually hurts the industry. It is very necessary to separate the first-class system of innovative drugs from generic drugs, and allow enterprises to have a certain degree of autonomy to set prices, especially innovative drugs that have significant value to solve clinical needs and have breakthrough identification. Fang Jianmin suggested.
Zhu Yi believes that we can try to solve the problem in two directions.
First, can innovative drugs be priced in the market, and basic medical insurance will pay part of the basic costs? Second, if we have a population of 1.4 billion, assuming that there are 200 million wealthy people, they can afford to pay for their own expenses, can we make innovative drugs for these 200 million people without a threshold, and can be approved at any time, enter the hospital at any time, and be prescribed at any time? There is no need for major changes in the system, but only to give some policy support, so that enterprises can survive and form a sustainable situation. Zhu Yi said.
Liu Datao believes that the issue related to pricing is also the issue of drug accessibility, including several aspects.
First, does the patient have access to the drug? After the drugs in China are approved and marketed, even if I enter the medical insurance, I have to go to the hospital one by one. This is the biggest problem for enterprises, in fact, as long as a certain scale is guaranteed, it is beneficial.
Second, there need to be some innovative attempts in business models, such as a certain drug** is relatively high, and it is not good to treat it with this drug, and half of the money or even no money will be charged. At the same time, patients are provided with commercial insurance to provide part of the support.
Third, China's previous main battlefield was still public hospitals, which had many restrictions. However, many private hospitals have emerged in some specialized fields, and the mechanism is relatively simple, as long as it is suitable and can have a curative effect on patients, it will be easier to accept.
Zhu Yi believes that China's drug economy should be a low-price market, and it should be a low-cost business model that greatly controls costs in marketing.
How to break the "last mile" of innovative drugs into the market?
When it comes to how drugs enter the market, there are still some obstacles. Fang Jianmin said that China's advantage is that it can concentrate on big things and solve problems, but you have to find this problem in time to solve it. Pharmaceutical companies do a good job of pharmaceutical companies, relevant departments and institutions should take responsibility and perform their duties, and just lowering the first is not a long-term solution.
Zou Jianjun also said that going to the hospital to get medicine one by one is the same dilemma faced by many companies.
For the "last mile", Zou Jianjun said, for example, the hospital's pharmacy department decides which drugs can enter the hospital, but some hospitals only open them once a year. If you miss this opportunity, you'll have to wait another year or more.
Regardless of whether the pricing is high or low, it is ultimately necessary to solve the problems of clinical demand, clinical accessibility, or whether the drug has entered the hospital or not, and whether it can be prescribed in the hospital. All of these need to be supported at the policy level to actually solve the plight of enterprises. Zou Jianjun said.
Zhu Yi believes that this problem is not just a problem of medical insurance, but requires the coordination of the National Health Commission and even the National Health Commission.
The guests unanimously agreed that in fact, our country does not have too many medicines, but too few useful medicines and too many useless medicines.
There are voices saying that the 2024 track belongs to medicine, do you agree with this statement?
Regarding the statement that "the track in 2024 belongs to medicine", Liu Datao categorically denied it.
I don't think it's medicine. Liu Datao said that the pharmaceutical industry accounts for a small proportion of the entire economy and cannot become the protagonist of the capital market. To put it pessimistically, the cycle of capital enthusiasm for China's pharmaceutical development has passed, at least for the time being, it may be at a relative low ebb, and the low tide may continue for several years.
Many people say that winter has passed, and I think that the pharmaceutical industry has just entered winter, and it really needs to be psychologically prepared for a long period. Liu Datao added.
Fang Jianmin basically agrees with Liu Datao's judgment, he said that the epidemic in the past two years has made medicine a relatively hot field for investment. "It is precisely because of the investment in the past few years that we have seen some results, so many overseas authorizations, new product launches, etc., the drive of capital for innovation is very obvious, and the fluctuations of the capital market are cyclical, which is very easy to understand. Fang Jianmin said.
Fang Jianmin believes that the current development of Chinese society, the improvement of health requirements, the aging of the population, and the increasing proportion of tumors will bring demand for drugs to the market. And as an investor, the time of the trough is precisely the opportunity to invest. Investors still need to believe that they can find products and companies with potential.
Which tracks in the field of innovative drugs are worth focusing on in 2024?
I think that 2024 belongs to the subdivision of ADC (antibody drug conjugate), and ADC must be an outlet among life drugs, which is worth paying attention to. From my personal research on drug types, this drug type will completely change the current pattern of tumor ** in the next 10 or 20 years. Zhu Yi is very sure about this.
Liu Datao said that ADC is a targeted chemotherapy, but it has a very good synergy with immunity. It can release some new antigens for immune cells to recognize, and that's where its real value lies.
I think that in the next few years, ADC may indeed be a very good track, but from my experience, the failure of a large number of ADC projects will be a high probability event in the near future. Liu Datao said.
Maybe in the next 5 years, 10 or even 20 years, we still have a lot to do ADC, of course, you don't know which target, which tumor will have a breakthrough, but there will definitely be one after another, endless products will come out. It can be said that ADC binding immunity** has a promising future. Fang Jianmin said. (CCTV Capital Eye).