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    Home > Active Ingredient News > Drugs Articles > China's innovative drug industry ushered in a golden age

    China's innovative drug industry ushered in a golden age

    • Last Update: 2021-03-23
    • Source: Internet
    • Author: User
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    The rise of the domestic innovative drug industry and the rapid introduction of innovative drugs globally have not only met the growing health needs of Chinese patients, but also promoted China's transition from a major pharmaceutical country to a powerful pharmaceutical country, and contributed more Chinese wisdom under the global innovation system.


    Reporter of Global Magazine

    After the wind and rain, China's forging ahead China's innovative medicine industry finally ushered in its own golden age.


    On the one hand, since the establishment of the National Medical Products Administration (NMPA) in March 2018, it has been seeking various measures to speed up the entry of global innovative drugs into China, and the model of introducing new drugs through participating in global simultaneous development is gradually being realized; on the other hand, Beginning in 2018, China's innovative drug industry has entered a harvest period.


    What is even more gratifying is that with the improvement of corporate R&D capabilities, China has surpassed Europe and the United States in some frontier target areas to achieve technology output.


    The rise of the domestically produced innovative drug industry and the rapid introduction of innovative drugs globally have not only met the growing health needs of Chinese patients, but also improved the availability and affordability of innovative drugs in a sustainable manner.


    Regarding issues related to the development of China's innovative drug industry, "Global" magazine recently interviewed Song Ruilin, executive chairman of China Pharmaceutical Innovation Promotion Association, and Conway, executive president of China Association of Foreign Investment Enterprises Drug Research and Development Industry Committee (RDPAC).


    Scale hits a record high

    "Global" magazine: In recent years, what are the aspects of the expansion of China's innovative drugs?

    Song Ruilin, Executive Chairman of China Pharmaceutical Innovation Promotion Association

    Song Ruilin: The scale of China's innovative drug market is expected to reach 140 billion U.


    Conway: In the past five years, the scale of China's innovative drugs has continued to expand.


    "Global" magazine: Since 2015, China's innovative drug policy environment has been continuously optimized and innovative vitality has been continuously released.


    Song Ruilin: 2015 is the first year of China's drug regulatory reform.


    For example, in the past, China's drug approvals required "three reports and three batches", and waiting in line would take a lot of time.


    Following the conditional approval of Sinopharm’s new crown inactivated vaccine for marketing, on February 5, the State Food and Drug Administration also conditionally approved Beijing Kexing Zhongwei’s new crown inactivated vaccine (Vero cell) registration application.


    Conway, Executive President, Pharmaceutical Research and Development Industry Committee (RDPAC), China Association of Enterprises with Foreign Investment

    Conway: Before 2015, the approval time of new drugs in China was 5 to 7 years later than the US Food and Drug Administration (FDA) on average.


    Into the second phalanx

    "Global" magazine: In addition to the policy environment, what other factors have promoted the innovative drug industry to enter the fast lane?

    Song Ruilin: Innovation is an ecosystem.


    Conway: There are two other factors.


    The second is clinical trial capability.


    "Global" magazine: What is the current level of China's innovative drug development in the world?

    Song Ruilin: Objectively speaking, China's innovative drugs are still in development.
    Previously, China's pharmaceutical industry was dominated by generic drugs.
    I personally think that this big picture has not undergone fundamental changes, but China's innovative drugs have already started and are moving towards first-in -class, from a follower to a parallelist, but has not yet reached the height of a leader.

    The United States has contributed the most to global innovation.
    In 2018, China contributed 7.
    8% to global new drug listings.
    It is in the second phalanx of global pharmaceutical innovation with Europe and Japan.
    However, in terms of pharmaceutical innovation capabilities and the number of innovative drugs approved It can be seen that the improvement of China's innovation capabilities has been the most significant.

    Conway: With the interaction of the three major elements of China’s pharmaceutical policy, talents, and capital, a vigorous and vigorous ecosystem is being formed.
    In terms of quantity, China has entered the second echelon of innovative drugs in 2019.
    In 2016, China’s global R&D and innovation The contribution rate of only 2%~4%, is still in the third echelon.
    In the future, how to improve the efficiency and quality of innovative R&D through policy guidelines is worthy of discussion.

    Actively participate in global simultaneous development

    "Global" magazine: How has the pattern of the innovative drug industry changed in the past two years?

    Song Ruilin: According to the types of innovative drugs, from the past, small molecules were mainly used to develop macromolecular biological drugs, especially immune-based drugs; some traditional Chinese medicine companies have also begun to turn to macromolecular biological drugs, hoping to overtake.

    The research and development model has shifted from high-throughput screening in the past to screening using big data and AI technology, paying more attention to the improvement of the entire medical research transformation ability, from the past mainly from the laboratory to the clinical half circle, and the current from the clinical to the laboratory.
    The other half of the research transformation is closed to achieve two-way transformation.
    In the future, in addition to strengthening basic research and development capabilities, we must also strengthen the research and development capabilities of clinical centers, discovering new targets and new mechanisms, especially by discovering new needs to lead drug research and development.
    As a major clinical country, we must tap the vastness of clinical medicine.
    potential.

    Conway: With the reform of drug review and approval, domestic R&D centers work closely with international research institutions and experts in various fields, participating in more and more clinical research on innovative drugs, and introducing new drugs by participating in global simultaneous development The model is gradually being realized, and the current ratio is close to 10%.

    For example, from December 2019 to December 2020, the three new indications of the anti-fibrosis treatment drug nintedanib ethanesulfonate soft capsules were submitted globally simultaneously, and these three indications were successively obtained in China.
    Approval is based on the results of phase III international multi-center clinical trials.
    Chinese patients participated in these three global studies.

    "Global" Magazine: What impact and changes will the global spread of the new crown pneumonia epidemic bring to the development of the innovative drug industry?

    Song Ruilin: The global outbreak of the epidemic has made countries around the world pay more attention to drug research and development capabilities.
    Through this epidemic, we can also see that the strength of countries in the world and the standards of powerful countries are changing: if a country does not have the ability to protect medicine and health , Then at best it can only become a rich country, it is absolutely impossible to become a powerful country.

    At present, dozens of countries have approved the purchase or emergency authorization of Chinese vaccines.
    Some European leaders have publicly called for Chinese vaccines to be declared in Europe.
    The world is gradually looking at Chinese medical products in a rational manner.
    This was unimaginable in the past.
    It will bring greater confidence and opportunities for Chinese medicine to go global.

    We provide vaccine technology to relevant countries, so this company can set up branches and local factories in this country, especially in the “Belt and Road” countries that have close cooperation with China and some member states of the Shanghai Cooperation Organization.
    There are not many countries in the world that can do pharmaceutical innovation, and most countries rely on imports for innovative drugs.
    China has a cost advantage.
    As long as it adheres to high standards and high quality, China's innovative drugs can be internationalized.
    Only through internationalization can China's pharmaceutical industry truly become a pillar industry of the country.
    We look forward to the rapid growth of local multinational pharmaceutical companies headquartered in China.

    Conway: Innovative drugs have a large R&D investment, a long cycle, and high risks.
    It usually takes more than 10 years for a drug to be on the market from the early stage of research and development.
    As the world is looking forward to the launch of vaccines and drugs related to the new crown as soon as possible, how to make vaccines be produced and used quickly, effectively, and with quality and quantity in a short period of time is the next important solution, which also highlights the medicine.
    The importance of innovation.

    Many Chinese and foreign pharmaceutical companies have invested in research and development regardless of cost, breaking the routine in the research and development of diagnostic reagents, drugs and vaccines, and have made outstanding contributions to the prevention and control of the global epidemic.
    The global spread of the new crown pneumonia epidemic has also made us realize that disease knows no borders, and innovation knows no borders.
    The epidemic cannot be dealt with alone by any country and must rely on international cooperation.

    We are delighted to see that Chinese scientists have studied the complete genetic sequence of the new coronavirus and shared it with the world as soon as possible.
    The multinational pharmaceutical company GlaxoSmithKline also provides vaccine adjuvants that can enhance the effectiveness of vaccines to Chinese vaccine research and development companies.
    For their development of a new crown vaccine candidate.

    Insufficient technology transformation capacity to become the biggest shortcoming

    "Global" magazine: Where are the shortcomings in the development of domestically produced innovative drugs?

    Song Ruilin: One is the lack of basic scientific research capabilities and technological transformation capabilities.
    As academician Shi Yigong pointed out not long ago, China’s GDP is now the second largest in the world, but our technological innovation and basic research innovation capabilities rank outside the 20th place.

    The second is that there are still problems with the talent training model.
    Let’s go back to Gong Zizhen’s famous saying: I wish God to be vigorous and to cast down talents in any style! It is necessary to break the tradition of seniority in academia and establish a new mechanism-a mechanism that can encourage researchers to study for more than a decade, and a mechanism that can give play to the potential and enthusiasm of each scientific research team.

    The third is that the supervisory capacity needs to be strengthened, and the level of scientific supervision can be improved.
    Practice tells us that a country’s drug regulatory capabilities and drug innovation capabilities are closely related, and mutual promotion and improvement are of great significance.
    On February 19, the 18th meeting of the Central Committee for Comprehensive Deepening Reform deliberated and approved the "Implementation Opinions on Comprehensively Strengthening Drug Regulatory Capacity Building", which clearly pointed out that deepening the reform of the review and approval system, promoting regulatory innovation, strengthening the construction of regulatory teams, Improve a scientific, efficient and authoritative drug regulatory system.
    This will be another important guiding document for deepening China's drug regulatory reform and enhancing drug regulatory capabilities in the future, and it is worth looking forward to.

    Conway: China's new drug research and development has just started, and there is still a big gap between China and Europe and the United States.
    International pharmaceutical companies invest large amounts of funds in pre-clinical and clinical trials and participate in translational medicine.
    For example, in the development of an innovative drug, there will be hundreds of scientists behind them who will discuss and demonstrate various clinical trial designs before clinical trials.
    There is currently a huge gap in China in this regard.

    "Global" magazine: What is the current status of the inclusion of innovative drugs in the National Medical Catalogue? What are the difficulties in the negotiation of new drugs?

    Song Ruilin: Judging from the latest medical insurance innovation drug negotiation, the market reaction has been positive.
    As a payer, medical insurance reduces costs by expanding the scale of the market, which conforms to the laws of the market and the laws of the economy.

    Speaking of difficulties, first, medical insurance negotiations are not directly quantitative, but based on market estimates.
    Medical insurance is only a payer, not a purchaser of medicines.
    This makes price negotiations relatively uncertain.

    Second, the price level.
    Innovative drugs themselves have the characteristics of high investment, high risk, and high prices.
    Therefore, it is necessary to study how to establish a multi-win medical insurance catalog adjustment mechanism.
    If the innovative drugs cannot be included in medical insurance simply because of price issues, the gains may not be worth the loss, and the patient's interests will ultimately be harmed.
    .

    Third, it is not enough to rely solely on national medical insurance to support the development of innovative drugs.
    We must develop commercial insurance and establish a multi-level health insurance system to open up a new path for the development of the pharmaceutical industry.

    In the past, China adjusted its medical insurance catalogue only once in 1978, and then once every two years.
    Currently, it has been determined that innovative drugs will be dynamically adjusted once a year.
    The current medical insurance reform is generally good for medical innovation.
    However, China should continue to expand the opening up of a class of innovative drugs, especially for those drugs that fill the clinical gap, and hope to be able to enter the medical insurance reimbursement catalog as soon as possible to benefit patients.

    Conway: The payment of innovative drugs is an important guarantee for the realization of closed-loop innovation and sustainable development of the industry.

    However, the market share of Chinese innovative drugs in the prescription drug market does not match China’s economic development level and innovative drug development goals: in the 2018 G20 national prescription drug market share analysis, the share of original research drugs during the patent period was the top three in the United States accounting for 66%.
    Australia is 59%, Germany is 57%, and China ranks 18th with only 9%.

    To narrow the gap, there are two key points: First, increase the payment funds for innovative drugs and establish a multi-level medical security system.
    Second, improve the dynamic adjustment mechanism of the medical insurance drug catalog, establish an independent review agency and an open and transparent review process; advocate value-oriented evidence-based decision-making, improve the evaluation method of innovative drug access; accelerate the implementation of negotiated drugs.

    Judging from international experience, developed countries have established professional institutions to evaluate the efficacy and economics of drugs, thereby providing a scientific basis for the entry of innovative drugs into medical insurance.
    There is still a big gap in the construction of relevant institutions in China.
    When evaluating the clinical efficacy of drugs, the choice of reference products is very important, because this determines the clinical additional benefits of innovative drugs relative to reference products.
    In the United Kingdom, France, Germany, Canada, Australia, Japan, South Korea and other countries, companies have the opportunity to communicate with the evaluation agency on the selection of reference products before the evaluation.
    Canada, Australia and France will provide companies with references during the clinical trials of drugs.
    Recommendations for product selection; in most countries, companies have the opportunity to explain and appeal to the evaluation agency during and after the evaluation.

    "Global" magazine: How to increase the availability of innovative drugs in China?

    Song Ruilin: Accessibility means that people can use it and can afford it.
    First, more innovative drugs must be developed or introduced; second, more innovative drugs can enter the medical security system; third, relevant training of hospitals and doctors must be strengthened to promote rational use of drugs.
    In the final analysis, as long as the reform of the three-drug linkage is in place, the availability of innovative drugs will definitely be improved.

    Conway: Talking about the availability of innovative drugs, a very important indicator can refer to the gap between China and the world in terms of the 5-year survival rate of cancer patients.
    In the past five years, China has launched a total of 200 innovative drugs, focusing on anti-tumor, cardiovascular system, and digestion/metabolism.
    In the field of anti-tumor, with the continuous introduction of overseas anti-tumor drugs in the Chinese market, more and more cancer patients have received effective treatment.
    The 5-year survival rate of Chinese cancer patients has increased by 10% from 2005 to 2015, reaching 40.
    5 %; However, because the availability of innovative drugs is affected by multiple links and policies, many patients are still unable to use innovative drugs in time.
    This number is significantly different from the 5-year survival rate of malignant tumors in developed countries, which is close to 70%.
    There is still a lot of room to improve the quality of life of Chinese patients through innovative drugs.

    Whether it is possible to bridge the gap between medical innovation and patient access is a major challenge facing China's medical innovation.
    New drugs are subject to drug availability and medical insurance policies.
    Many drugs can only cover a small part of potential patients after they have been approved.
    The problem of unavailability and unavailability of patients is still more prominent.
    How to continue to deepen the reform of the "three medical treatments" of medical, medical insurance, and medicine, strengthen the linkage relationship among the three parties of drug review and approval, medical insurance payment, and clinical use, improve the availability of drugs, and further enhance the sense of acquisition by the masses, is an important issue in the next stage .



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