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The pharmaceutical industry is an important part of China's national economy, and it is also a strategic emerging industry
related to the national economy and people's livelihood and economic development.
China's modern pharmaceutical industry began at the end of the 20th century, started relatively late, and its early innovation and research and development capabilities were relatively weak, and it was urgent to promote industrial innovation and upgrading
through accelerated transformation.
The quality and level of clinical trials are crucial to the innovation and development of the pharmaceutical industry, and the number of IND or clinical trial applications is also one of the important indicators to measure the level of
research and development.
Looking back at the acceptance of domestic innovative drug registration applications, the number of IND applications has grown rapidly in recent years, among which 2019, 2020 and 2021 have reached a new level for three consecutive years; In 2021, the number of IND applications for innovative drugs reached 1,821, which is also more than 1,000 for two consecutive years
.
Source: 2021 Drug Evaluation Report
Thanks to the drug review reform that began in 2015 and a series of regulatory innovation measures have been introduced one after another, China's clinical trial and research level has changed from "following the run" in the third echelon in the past to "running alongside" in the second echelon now, facing the future and ranking among the first echelon "leading", crossing the threshold
of standardization, standardization and internationalization.
of standardization, standardization and internationalization.
1 Standardization, standardization and internationalization lay the foundation for the development of clinical trials
1 Standardization, standardization and internationalization lay the foundation for the development of clinical trialsOn July 22, 2015, the Announcement of the State Food and Drug Administration on Carrying out Self-inspection and Verification of Drug Clinical Trial Data (No.
117 of 2015) was officially released
.
In accordance with the requirements of the Announcement, strictly following the "four strictest" regulatory principles of the strictest standards, the strictest supervision, the most severe penalties and the most serious accountability, the national drug regulatory department organizes the self-inspection and verification of clinical trial data for drugs that have been declared for production or imported for review
.
In the end, 1,622 clinical trial projects with new drug applications were self-examined, of which nearly 80% were voluntarily withdrawn
before August 25, 2015.
Yao Chen, Director of the Medical Statistics Office of Peking University First Hospital
Professor Yao Chen, director of the Medical Statistics Office of Peking University First Hospital, said in an interview that China promulgated the first version of the Good Clinical Trial Practice (GCP) in 1997, then updated the GCP in 2003, and released the latest version of GCP in 2020.
However, due to the long-term dominance of generic drugs in the early Chinese pharmaceutical market, problems such as more duplication of data, long waiting time for individual declarations, and backlog of reviews gradually emerged, and "722 data verification" precisely grasped the key points of past clinical trial problems and reversed the "handover" R&D mentality
of clinical trials in the past.
of clinical trials in the past.
In December 2016, the BMJ press release wrote that "the survey found that 80% of clinical trial data in China is false", which is actually a misinterpretation
of 80% of clinical trial projects 。 In June 2018, Yao Chen, Yan Xiaoyan and Dong Chongya of the Clinical Research Institute of Peking University wrote an opinion article "Protecting" in response to the news report published by BMJ in 2016
the accuracy of clinical trial data in
China ("Ensuring the Accuracy of Clinical Trial Data in China") proposed for the first time "Solutions to Improve the Accuracy of Clinical Trial Data in China" and published it on the BMJ website
.
Professor Yao Chen pointed out that the quality of clinical trial data in China has undergone fundamental changes since 2016, and routine inspection of drug marketing registration research based on risk has become the norm, and the attributibility, legibility, simultaneity, originality, accuracy, completeness, consistency and durability of data have become the top priorities of researchers, sponsors and regulatory agencies for research data quality.
"722 data verification" has laid a normal and lasting development foundation for the improvement of clinical trial quality in China; With strict regulation and high costs of breaking the law, the possibility of deliberate falsification of clinical trial data is now slim
.
.
"722 data verification" can be said to be the "watershed" of China's clinical research supervision, China's drug regulatory authorities take the "four strictest" as the fundamental compliance and action guidelines for regulatory work, issue a series of laws and regulations, strengthen the on-site inspection of registration applications, and make every effort to ensure the quality of
clinical trials carried out in China.
On August 18, 2015, the State Council officially issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices", which has since been affectionately known as "Document No.
44" by the industry, which has fundamentally changed the regulatory and market pattern of China's pharmaceutical industry, which puts forward five major goals, including improving the quality of review and approval, solving the backlog of registration applications, improving the quality of generic drugs, encouraging research and creating new drugs, and improving the transparency of review and approval, which has profoundly affected the trajectory of industrial development
.
44" by the industry, which fundamentally changed the regulatory and market pattern of China's pharmaceutical industry.
Subsequently, in February 2016, the General Office of the State Council issued the "Opinions on Carrying out the Consistency Evaluation of the Quality and Efficacy of Generic Drugs"; In February 2017, the State Council issued the "13th Five-Year Plan for National Drug Safety"; In October 2017, the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices; The new version of GCP in 2020 has higher and higher requirements for the quality of clinical trials, such as statistical full intervention in clinical trials (trial protocol design, randomization and blinding, data management and statistical analysis, etc.
).
.
.
A series of top-level designs have further created a good environment
for the transformation of China's pharmaceutical industry.
According to the 2019 Annual Drug Evaluation Report released on July 30, 2020, from 2015 to 2016, the backlog of drug approvals decreased from nearly 22,000 to 4,423
.
In 2016, the Center for Drug Review completed 12,068 applications for review and registration; In 2017, 9,680 applications for examination and approval were completed; In 2018, 9,796 applications for examination and approval were completed
.
Guo Changmao, Deputy Director of the Southern Institute of Medicine Economics, State Food and Drug Administration
Guo Changmao, deputy director of the Southern Institute of Medicine of the State Medical Products Administration, believes that the overall plan for the reform of the drug review and approval system is summarized in four aspects: improving quality, improving efficiency, encouraging innovation and transparency; Taking the reform of the drug review and approval system as an opportunity to solve the review backlog as a breakthrough, a series of measures such as the drug marketing authorization holder system, the consistency evaluation of generic drugs, the reform of chemical drug registration classification, and the priority review and approval of drugs have been implemented successively to comprehensively improve the quality of drugs, encourage drug research and development and innovation, and promote industrial restructuring, transformation and upgrading
.
Quality is the foundation of survival, and innovation is the soul
of development.
In recent years, new drugs independently developed in China or developed in cooperation with multinational pharmaceutical companies have begun to go abroad; At the same time, China has become an important clinical research center, and many multinational pharmaceutical companies have also included more and more Chinese clinical trial institutions and principal investigators in international multi-center clinical trials, and the quality of clinical research data has been significantly improved for all to see
.
Guo Changmao further said that drug regulatory standards have been continuously improved, the efficiency of review and approval has continued to improve, many Chinese innovative drugs with high clinical value have been approved for marketing faster, and many imported drugs with high clinical value have also shortened the gap with foreign market time, and the international competitiveness of drugs made in China has been greatly enhanced
.
.
2 Fully integrated with the world, "global synchronous development" has gradually become a reality
2 Fully integrated with the world, "global synchronous development" has gradually become a realityTimes and individuals have always confirmed and stirred each other, and examining the historical changes of an industry must have a macro picture as well as micro details
.
Nowadays, China's pharmaceutical industry has leapt to improve the quality of development, and a large number of innovative drugs have stood on the global stage, which is by no means a one-day achievement
.
Since joining the International Technical Coordination Committee for Registration of Drugs for Human Use (ICH) in June 2017 and becoming a member of the ICH Management Committee in June 2018, the national drug regulatory authorities have fully accepted the ICH concept and technical requirements representing a higher level in the field of global drug registration, which not only promotes the rapid entry of domestic innovative drugs into the international market, but also makes it possible
to synchronize global R&D and registration.
Taking BeiGene, an innovative pharmaceutical company, as an example, the "international" layout of the innovative drug zebratinib has witnessed and experienced the high-quality development process
of clinical trials in China.
The reform of drug review has been further advanced, the efficiency of review and approval has been greatly improved, and the establishment of accelerated review procedures, communication and exchange mechanisms for innovative drugs, and acceptance of overseas research data have become a key opportunity
to realize the simultaneous development of zebratinib in China and the United States.
of clinical trials in China.
The reform of drug review has been further advanced, the efficiency of review and approval has been greatly improved, and the establishment of accelerated review procedures, communication and exchange mechanisms for innovative drugs, and acceptance of overseas research data have become a key opportunity
to realize the simultaneous development of zebratinib in China and the United States.
BeiGene seized the opportunity to rapidly complete bridging trials in China using early clinical data obtained from foreign Phase I studies, followed by the launch of a pivotal Phase II clinical study (BGB-3111-206) for relapsed or refractory mantle cell lymphoma (MCL) in December 2016.
In fact, the marketing application of zebratinib for MCL indications in China and the United States is based on BGB-3111-206 data and data from a number of global simultaneous clinical studies of
zebratinib.
Finally, the MCL indication of zebratinib was approved
in China and the United States in November 2019 and June 2020, respectively.
Dr.
Wang Lai, Senior Vice President and Head of Global R&D, BeiGene
Dr.
Wang Lai, senior vice president and global head of research and development at BeiGene, told reporters that in the development process of zebratinib, Chinese clinical trial institutions and researchers have played a key role, especially the key phase II clinical study BGB-3111-206 that supports MCL indications, which was all completed in China, led by Professor Zhu Jun of Peking University Cancer Hospital; Since then, Chinese researchers have played a key role
in study design, patient recruitment and management, data collection and analysis, and research data reporting in many phase II pivotal clinical studies and global phase III clinical studies.
"The policy reform of China's regulatory authorities has greatly improved the development efficiency of innovative drugs, and during the development of zebratinib, the regulatory authorities have been providing a lot of specific guidance to enterprises to help them better balance scientific and registration needs, accelerate drug development, and benefit patients
as soon as possible.
"
as soon as possible.
"
It is based on the global R&D layout in line with international standards, at present, the commercial territory of zebratinib has expanded to more than 55 markets around the world; A number of zebratinib research data released by top academic conferences such as the annual meeting of the American Society of Clinical Oncology (ASCO) and the annual meeting of the European Association of Hematology (EHA) have also been highly recognized
by the global academic community.
It can be said that zebratinib is only a microcosm
of China's drug review reform and high-quality development of clinical trials.
From 2019 to 2021, 143, 217 and 219 drug registration applications were approved through priority review and approval
, respectively.
A batch of urgently needed clinical drugs pass through these channels to benefit patients
faster.
Remazolam tosylate for injection in 2019, emitavir phosphate capsules, cyclopofol injection, sulfatinib capsules, benzenequinium bromide nasal spray in 2020, emittenofovir tablets, donafenib tosylate tablets, proline hengliflozin tablets in 2021, utidelon injection, Hypermeibe tablets, orebatinib tablets.
.
.
Once global synchronous development was synonymous with high difficulty, the current domestic regulatory regulations have basically eliminated the obstacles to the synchronous development of innovative drugs at home and abroad, and will surely become the norm for high-level innovation of many pharmaceutical companies in the future
.
3 Global innovation speaks out of China
3 Global innovation speaks out of ChinaFrom "catching the tide" to "leading the tide"
All the way through the wind and rain, sail the future
.
On June 1, 2022, the State Medical Products Administration released the "2021 Annual Drug Evaluation Report" data showing that 1,886 applications for the registration of innovative drugs (998 varieties) were accepted in 2021, a year-on-year increase of 76.
10%; In terms of the acceptance of innovative drugs, according to the statistics of drug types, there were 54 innovative traditional Chinese medicines (51 varieties), a year-on-year increase of 134.
78%; 1166 innovative chemical drugs (508 varieties), a year-on-year increase of 55.
05%; There were 666 innovative biological products (439 varieties), a year-on-year increase of 125.
00%.
Nowadays, standing at the key node of a new round of high-quality development of China's pharmaceutical industry, some hot fields have followed the world's frontier and achieved breakthroughs in individual fields, from "Me-too" to "Best-in-class" and then to "First-in-class", which is a significant change
in pharmaceutical innovation ideas and strength in recent years.
in pharmaceutical innovation ideas and strength in recent years.
In October this year, in the final analysis of the global phase III "head-to-head" ALPINE trial, zebratinib achieved a favorable result of progression-free survival (PFS) compared with ibrutinib, becoming the world's first and only BTK inhibitor in the field of chronic lymphocytic leukemia (CLL), compared with ibrutinib, in terms of PFS and overall response rate (ORR), once again verifying its therapeutic potential as the world's "best-in-class" BTK.
It is also an important breakthrough
for innovative drugs to achieve global leadership.
In 2021, 47 innovative drugs were reviewed and approved, including 11 traditional Chinese medicines, 24 chemical drugs, and 12 biological products, including 2 innovative drugs approved for marketing at home and abroad (rispram oral solution powder and pratinib capsules), including 5 first innovative drugs (i.
e.
First-in-Class) approved for marketing; Approval of two CAR-T models for the first time
Drugs (Aquilencel injection, ruchicel injection) went on the market, achieving a breakthrough of "zero" in the field of cell therapy; In 2021, the US FDA approved 50 new drugs, and the number of innovative drugs in China is close to the US FDA data
.
It is not difficult to feel that with the construction of top-level systems and the implementation of a series of policies, China's pharmaceutical innovation has rapidly entered a period
of vigorous development from the exploration stage.
In terms of clinical trial research, more and more international multi-center clinical trials are led by Chinese scholars, and many clinical trial results have been published in top international journals, which further confirms that China's clinical trial research level has been internationally recognized
.
Lu Shun, Director of the Department of Oncology, Shanghai Jiao Tong University Chest Hospital
Professor Lu Shun, director of the oncology department of Shanghai Jiao Tong University Chest Hospital, was deeply impressed by these changes, and told reporters in an interview that the level of clinical trial research in China has now been significantly improved
.
"Before 2010, Chinese clinical researchers mainly implemented, learning how to standardize clinical trials under the guidance of GCP principles, this period was 'catching up with the tide'; after years of exploration and practice, China's economy and national strength continued to grow, China's pharmaceutical industry has also developed rapidly, more and more Chinese drugs began to go international, and Chinese clinical researchers have also begun to move from 'trend' to 'leading the tide'
.
"
.
"
Diseases know no borders, and patients know no borders
.
The results of the phase III clinical study of roxadustat in the treatment of anemia in patients with long-term dialysis and non-dialysis chronic kidney disease (CKD) were published in the New England Journal of Medicine (NEJM); The results of the first-line treatment of EGFR-sensitive mutation-positive locally advanced or metastatic non-small cell lung cancer stage III.
AENEAS were published in the Journal of Clinical Oncology (JCO).
The full text of the interim analysis data of the zebratinib phase III SEQUOIA head-to-head study was published in the top international journal The Lancet Oncology
Lancet Oncology) magazine.
.
.
One solid clinical data after another conveys the voice
of China in the process of global drug development and clinical transformation.
Professor Lu Shun believes that more and more high-quality clinical data results are displayed on international platforms, which is conducive to enhancing the importance and attention of Chinese clinical research at home and abroad.
In addition, it is important to have a clear understanding of the differences
between academic and regulatory requirements for clinical research.
"Whether a clinical study data can be academically recognized and whether it can pass regulatory approval are two different situations; Some high-level clinical research results are published in well-known journals around the world, but the research data does not support the regulatory approval of the product, because each country has its own regulatory 'rules', some are differences in clinical needs, and some are differences in population race
.
To gain regulatory acceptance, these 'rules'
must be clear.
”
The most critical point for enterprises to "go overseas" is to practice hard, strictly follow global standards, and comply with the regulatory requirements
of various countries.
Song Ruilin, executive president of China Association for the Promotion of Pharmaceutical Innovation, pointed out that China's pharmaceutical innovation has entered a new era, that is, the stage of high-quality development, and to strengthen ourselves is to cultivate our soil more mature, industrial policies are clearer and more reasonable, and the company's R&D strategy is more long-term, so that it is possible to have a place
in the global wave of pharmaceutical innovation.
Song Ruilin, Executive President of China Association for the Promotion of Pharmaceutical Innovation
"For innovative pharmaceutical companies, a global architecture should be established, which requires innovative pharmaceutical companies to measure their value
to global medical institutions and clinical services from the drug screening stage.
" Song Ruilin believes that to build the world's best and most powerful industrial cluster, it is necessary to establish a full-chain high-quality development system
covering drug discovery, development, clinical trials, approval, hospital use and medical insurance payment.
covering the whole chain of drug discovery, development, clinical trials, approval, hospital use and medical insurance payment.
Looking back at the industrial transformation in the new era, behind the grand narrative, there are vivid and real stories
in the wave of transformation and upgrading.
Following the concept of "quality comes from design", the confidence in the quality of clinical research data comes from the clinical trial itself, how do China's excellent pharmaceutical innovation enterprises think about the global layout of early R&D and how to practice clinical translational research design from the source? The New Media Center of "Medical Economic News" will unlock the code
of excellent global pharmaceutical innovation enterprises successfully "going overseas" in the next issue.
