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After the trough caused by the storm of drug registration and verification in 2006, the declaration of domestic innovative drugs began to grow slowly from 2009; After the implementation of the new policy on pharmaceutical R & D in 2015, the R & D of innovative drugs has entered an outbreak period, and the number of new drug applications has reached a new high every year. By 2020, only 909 registration application acceptance numbers and 835 approval acceptance numbers of chemical innovative drugs (Class 1 new drugs) will be accepted (on average, there are 2 acceptance numbers for a variety, which is equivalent to more than 400 new drugs), The number of innovative chemical drugs approved for clinical and production in the year may be more than that in the United States.
When can innovative drugs rot on the street? Is China's R & D strength world-class?
From September 18 to 19, 2021, the "2021 high quality development conference of health industry and the Sixth China Pharmaceutical R & D Innovation Summit (PDI)" was officially held. The theme meeting entitled "key technologies of innovative drug R & D" was held in the form of sub forum of the conference. At the same time, it is worth noting that the round table forum with the theme of "when me too becomes we too, where should innovative drugs go" brought together a number of experts from the investment community, academia and business community to deeply analyze the reasons behind the event and future trends.
How to treat the phenomenon that me too becomes we too?
When they first started to make new drugs, people were confused and didn't know what to do and how to start with real innovative drugs; After five years of development, there are too many me too in the existing countries. Is this situation unique to our country? Or are there other countries, and what are the reasons behind the emergence of so many me too?
He Juying, chief analyst of medicine at CSC securities, said that the path of innovation and transformation of Chinese enterprises is basically in line with the development law of the industry. For example, Wuxi apptec's transformation from global business to Chinese business is an important change in the development of innovative drugs in China. It is obviously unrealistic to blindly require all enterprises to make differentiated targets in a short time, or to make differentiated schemes on a mature target. In other words, at the current time point, driven by various policies, there may be a concentration or surplus of targets, but this must also be an inevitable process of evolution. The government is also actively guiding the changes of the whole industry.
Li Xiaohui, a professor of the Army Military Medical University and a national expert on new drug evaluation, said that the reason why there will be a situation of enterprise cluster innovation at present may be due to the difficulty of innovative drugs themselves. At present, there is still a lot of work to be done in basic research in China.
Hou Yu, chief expert of pharmaceutical intelligence data and President of Kangzhou pharmaceutical big data research institute, said that the R & D of innovative drugs is nothing more than capital, talent and time. The first two are not inferior to the overseas market in terms of the existing situation. However, in terms of time, some enterprises place too much emphasis on short-term profitability. In fact, the correct approach should be to temper patiently and take a long-term view, In this way, we can make me too in the real sense.
Fang Yi, director of the phase I clinical trial research office of the national drug clinical trial Institute of Peking University People's Hospital, said that the reason why there are a lot of me too and few first in class in the Chinese market is actually "capital". Making me too is also for the accumulation of original capital. Only after the accumulation of original capital, he has the ability to resist risks, He dared to do a little innovative work. In addition, Professor Fang Yi also stressed that in addition to target innovation, innovation work also has multi-dimensional innovation. All innovative work that can make up for clinical defects should be respected.
Lei Huangshu, chief scientist of Chongqing Yaoyou Pharmaceutical Co., Ltd., believes that we too has no problem and should do so. However, when making me too drugs, we should also strive to make more me better for the purpose of advantage. As for the avoidance method of low-end repetition and centralized clustering, the best method is "not to innovate for the sake of innovation", rather than the cowardice that even clinical trials dare not start at present.
Li Zhenghai, vice president of Kangchen Pharmaceutical Group and general manager of pharmaceutical research center, believes that since the phenomenon exists, it must be reasonable. The reason why most enterprises use we too is actually to survive. Today, with the decline of generic drug revenue, metoo is still the best choice from the perspective of game, and the resulting we too situation is also the situation expected by the country, Because only when a large number of enterprises get together and innovate can there be a basis for drug price reduction and benefit the people.
Liu Yongsheng, director of haijinger medicine, said that China has its own unique national conditions. First solve the problem of food and clothing, then live a well-off life, and then reach the common prosperity of developed countries. The same is true for enterprises. From me too to we too and then to first in class, this is the choice of the market and the only way for Chinese innovative drugs.
How will China's pharmaceutical industry break through the homogenization barrier in the next three to five years
Since the we too situation is the only way for the development of China's pharmaceutical industry at present, can we make further progress in the we too situation in the next 3-5 years, and what is the best way to make progress?
He Juying said that in the next three to five years, mainstream innovative drug companies may make more and more breakthroughs in internationalization, which will also be the breakthrough of most enterprises.
Li Xiaohui also said that regardless of supervision and trend, the road of enterprise innovation will be difficult to avoid. It is difficult for enterprises to occupy the absolute market without taking the innovation probability. At the same time, the state should also lead the sharing of R & D costs to drug prices, so as to make innovation more dynamic and more future.
Hou Yu admitted that it is an inevitable trend from me too to we too and then to me better, but it is also a relatively long process.
Fang Yi said that if you want to break through the barrier, you must not innovate for innovation, but do a solid job in scientific research. Many enterprises have been aware of this, and many potential innovative products will emerge in the next 3-5 years. At the same time, it is emphasized that innovative medicine, as an industrial chain, needs the joint efforts of many members to correct the current chaotic situation in the pharmaceutical circle.
Li Zhenghai put forward a new viewpoint of "managing the boss well". For some bosses who do not understand R & D, correct the idea of maximizing short-term income, and make solid research and move forward steadily under the condition of ensuring the development of the enterprise.
Liu Yongsheng emphasized that another element of breakthrough comes from the improvement of scientific research transformation efficiency and increasing the actual output of R & D, which is one of the elements of breakthrough in the next 3-5 years.
summary
To sum up, many experts basically agree that we too stage is the only way for the development of innovative drugs in China, and its existence is also the manifestation of market rationalization. With the efforts of the state and many practitioners, the seemingly chaotic situation at this stage will be basically alleviated in the next 3-5 years. There will be more enterprises with international influence in the future, and the overall situation is still bright.
In addition, in terms of pharmaceutical research and development, without basic research, there will be no discovery of new mechanisms and new targets. Without these findings, there is no real innovative drug.
The whole process is expected to pick up the ready-made unsustainable resources from European and American countries, closely follow the forefront of world life science and look for opportunities.
To optimize the market environment of innovative drugs, the invisible hand of the market is the real baton!
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December 13, 2022
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Author:
Ms. Yi
Phone/WhatsApp:
December 13, 2022
December 06, 2022
November 16, 2022
November 16, 2022
June 17, 2022
June 01, 2022
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