Health & Beauty

Watson & Band Import and Export Data Observation reports that the current COVID-19 epidemic is still raging, and the world's worst public health crisis in recent years has not gone away. The continuous introduction of new crown vaccines has won an effective prevention and control situation, and at the same time, the demand for drugs against the new crown virus has become more and more urgent.

"The research and development of special drugs for the new crown is not only the needs of a company or an industry, but has actually risen to the needs of the country. If an innovative drug can be developed to control the new crown like the flu, it will greatly enhance its international influence." At the 12th China (Taizhou) International Pharmaceutical Expo held recently, Li Jia, director of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, said that new drug creation is the core driving force for the innovation and development of biomedicine, not only a people's livelihood issue, but also a national It is also the frontier of world science and technology, and the most important starting point for people's health.

The importance of new drug research and development is self-evident, whether it is in the field of infectious diseases, or in other fields such as tumors and rare diseases. At present, my country's new drug research and development has developed from the stage of tracking and imitation to the stage of imitation and innovation, and toward the stage of original innovation, facing new situations, showing some new characteristics, and also facing new opportunities and challenges.

According to Huacheng Import and Export data observation report, the failure rate of new drug research and development is as high as 95%. The industry's innovation pressure is increasing, and innovation is a must for the entire biopharmaceutical industry.

At the same time, the innovation of biomedicine requires high technology and high investment, which also means that the entire industry will coexist with risks.

"The failure rate of new drug research and development is as high as 95%, and it is often difficult to predict early. Many major clinical phase III clinical trials fail every year. But innovative drugs are the eternal theme of pharmaceutical companies, because only innovative drugs can achieve high profits and affordability. A company’s real innovative research and development.” Li Jia said that the current research and development of new drugs faces many challenges, such as higher and higher costs, longer and longer cycles, and at the same time, the gold content (effectiveness) of new drugs is declining, peak sales are reduced, and the golden sales period is shortened. Wait.

First of all, it is becoming more and more difficult to develop new drugs. Li Jia introduced that the failure rate of new drug research and development is very high. Twenty new drugs entered the clinic, and the success rate was only 5%. Based on the number of screening compounds, the success rate is only one in a million to one in 10,000. Entering the clinical research stage, the success rate of the second phase is about 18%, and the third phase is less than 50%.

Second, the cost of new drug research and development is getting higher and higher. The average cost of developing a new drug was $802 million in 2001 and $2.6 billion in 2014, according to the Tufts Center. A statistic shows that the world's 12 largest pharmaceutical companies spend more, with an average of $6.28 billion, of which AstraZeneca has the highest cost of $12.4 billion, and the lowest spend, Amgen, is as high as $3.7 billion.

In addition, the development cycle of new drugs is getting longer and longer. According to Li Jia, original innovative drugs often require proof-of-concept and larger-scale clinical research, which often takes more than 10 years.

"Although the investment is getting bigger and bigger, the risk is getting bigger and bigger, but the enthusiasm of the whole industry for biomedicine has not decreased in any way." Li Jia said.

According to Huacheng Import and Export Data Observation Report, collaborative innovation is becoming more common, and drug research and development is more refined. More and more capital is entering the "golden track" of biomedicine, and the biomedical industry is constantly changing.

Li Jia mentioned that there are four trends in the current research and development of new drugs. One is to pay more attention to the effectiveness of the target; the second is to pay more attention to the predictability of the efficacy; the third is to pay more attention to the drugability of the drug;

"All the high and new technologies in the world are being combined with the direction of biomedicine. Life sciences, bioomics, disease omics, gene editing, etc., as well as chemistry, physics, information science, and materials science, are all concentrating on biomedicine. Li Jia believes that the development of biomedicine is not only in pharmaceuticals, but also represents an all-round change in the field of big health.

In terms of cooperation with pharmaceutical companies, multinational pharmaceutical companies pay more attention to open innovation and R&D cooperation networks and alliances to carry out collaborative innovation, and cooperation with small and medium-sized enterprises and academia is becoming more and more common and frequent.

At the same time, the biopharmaceutical industry is also developing in a more refined direction.

Li Jia said that, on the one hand, the division of labor in the entire biopharmaceutical industry is becoming more and more refined, such as CRO, CMO, CXO, etc., from R&D to production, OEMs can be found. On the other hand, the diseases targeted by drug development are more refined. "There may be dozens of types of gastric cancer, and this drug is used for some types, but it may not be useful for other types."

"Current drug development has progressed from target drugs to a drug model for molecular typing of diseases, from the original blockbuster drug development model to a precision-guided drug development model," Li Jia said.

Huacheng Import and Export Data Observation Report, to accelerate the research and development of new drugs in China, it is necessary to transform from imitation innovation to original innovation

Under the promotion of my country's "Major New Drug Creation" major scientific and technological projects, from 2008 to 2018, 41 Class I new drugs were born in my country, of which 10 were newly added in 2018. In 2019, China added 12 new Class I drugs and 15 new drugs in 2020.

Li Jia said that China has produced more than 20 new drugs every year, which is rare in the world. At the same time, some emerging therapies, such as biotechnology drugs, cell therapy, gene therapy, gene editing, etc., have also made great breakthroughs recently.

According to a McKinsey survey, my country was still in the third echelon of new drug R&D in 2016, contributing 1%-5% to global pharmaceutical R&D. In 2018, China's contribution to global pharmaceutical research and development rose to 4%-8%, and it has entered the second echelon in the world.

"my country has produced a lot of new drugs in recent years, but the sales have not come up, and there is a big gap compared with the sales of other new drugs in the world." Li Jia said.

According to Huacheng Import and Export Data Observation report, the sales of adalimumab, the world's No. 1 drug king, exceeded US$19.17 billion in 2019, and will approach US$20 billion in 2020. The sales of PD-1/PD-L1 of multinational pharmaceutical companies have already exceeded 20 billion US dollars.

Li Jia said that my country has become the second largest drug market in the world, second only to the United States, but none of the top 50 global sales of drugs made in China is on the list.

At the same time, my country's biomedical innovation capability is still relatively weak. Li Jia mentioned that in my country, the number of generic drugs reaches 95%, the me-too drugs are the most among the new drugs on the market, and there are very few original drugs. The new drug market is monopolized by the products of major international companies.

"We have moved from tracking imitation to imitative innovation, but we must pay attention to original innovation from today." Li Jia emphasized.

Whether new drug research and development should pursue speed (First-in-Class) or quality (Best-in-class) has always been a hot topic in the industry.

Li Jia believes that in order to achieve real pharmaceutical innovation and break the barriers of international monopoly, it is necessary to be First-in-Class (the first of its kind).

"First-in-Class represents the most profitable part of the pharmaceutical field and can best solve unmet clinical needs." Li Jia said, taking PD-1 as an example, my country's PD-1 antibody is 4 years slower than other countries. , the first and second accounts for 85% of the market, while the third, fourth, and fifth listings account for about 10%, and the final sum will not exceed 5%. It looks like we have five PD-1s on the market, but the real world market share is less than 5%, so from that perspective, time trumps everything.

So, is it possible for China to overtake the curve in terms of innovative drugs?

Li Jia believes that the next five to ten years will usher in a period of restructuring, transformation and upgrading of the global pharmaceutical industry, and China is facing a rare opportunity period.

"The great revolution in the research and development of original innovative drugs, which is centered on five technologies, namely, new target discovery, new biomarker discovery, new molecular entity discovery, combination drug research and rapid drugability research, is in deep development, and we can achieve overtaking in some areas." Li Jia said that biomedicine is not only about the creation of new drugs, but also includes all-round changes in the fields of translational medicine, regenerative medicine, intelligent medicine, new material industry, and high-end pharmaceuticals. The entire biopharmaceutical industry may be different.

"Biomedicine has reached a golden age! I think within 20 to 30 years, China will have its own big pharmaceutical companies. We have 6,000 local pharmaceutical companies, and many returnees have established biotech. It's possible." Li Jia said.