Three times in five years, 18% of early R&D comes from China?

"From patent application to approval to go public, in 2020, this time has been shortened to 9 years
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In 2020, despite the new coronary pneumonia pandemic, cancer treatment is still the most popular field of clinical research and development, and it is also the field that has the greatest impact on the industry.
Innovative therapies and new technologies are put into practice in this field
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01 New drugs on the market: The development time of new anti-cancer drugs has dropped to 9 years on average

In terms of innovative drugs, the number of new anti-tumor drugs approved in 2020 is still increasing sharply
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Looking at the year of 2020 alone, a total of 17 new cancer drugs in the United States have been approved, of which 10 were approved based on the results of clinical phase II trials, and 2 were approved based on phase I/II clinical trials
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The time taken for new oncology drugs to be approved reflects the attention of regulatory agencies to unmet clinical needs.
"Improved efficacy compared with existing standard therapies" or "lack of treatment options" are the key to the approval of innovative drugs
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Among them, mechanisms such as FIC, breakthrough therapy identification, and orphan drugs have become a means of accelerating approval.
It is worth noting that the development of genomics is also being applied in accelerating approval
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In terms of First-in-class, 5 new anti-tumor drugs will be approved in 2020, including lymphoma new drug Monjuvi, epithelioid sarcoma new drug Tazverik, multiple myeloma new drug Blenrep, neurofibroma new drug Koselugo, and prostate-specific membrane antigen positive Positron emission tomography drug gallium 68 PSMA-11 for lesions
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IQVIA counts the drugs that have been approved for marketing through various mechanisms such as breakthrough therapy certification and orphan drug certification in the five years from 2015 to 2020
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In 2020, 12 new oncology drugs were approved for breakthrough therapy before they were approved for marketing.
Between 2015 and 2020, 38 were approved for breakthrough therapy.
Obtaining this certification is one of the means to accelerate the review and approval of drugs
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For rare cancers, 16 new drugs have obtained orphan drug certification in 2020, and between 2015 and 2020, 49 have obtained orphan drug certification;

In addition, there are various mechanisms for accelerated review and approval.
Between 2015 and 2020, 57 drugs were approved through accelerated review and approval
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The application of genetic testing is also one of the means to accelerate review and approval.
The wide application of pharmacogenomics allows many drugs to be approved based on relatively limited trial data, a small number of research subjects, a single clinical trial, or early clinical trial data.
Of
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In general, entering the 21st century, there are 161 kinds of new anti-tumor active substances in the world, and there are 64 kinds in 2015-2020
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In terms of the approval of new anti-tumor drugs for the market, in the past five years, 62 models have been launched in the United States, 43 models in the European Union (including the United Kingdom), 40 models in Japan and 37 models in China
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It is worth noting that the number of new anti-tumor active substances approved in China reflects the obvious effect of China's drug review reform.
As can be seen from the figure, the growth on behalf of China is significantly higher than that of other countries or regions, as well as the global level
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In 2020, the average time from the first patent application of a new anti-tumor drug to its approval for marketing has also hit a record low.
This time has been shortened to 9 years.
Both the review and approval policies and the patent protection policies and regulations have shown that Protection of the life span of innovative drugs
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02 R&D: Reaching a new high in clinical trials.
Chinese companies are embarking on the world stage

From the overall research and development situation, in 2020, the number of drug candidates in the oncology R&D pipeline is close to 3,500, an increase of 75% compared to 2015, which indicates that the unmet clinical needs in the oncology field are still large
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Approximately 1,600 tumor-related clinical trials will be launched in 2020, a record high
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The comprehensive success rate of oncology drugs from phase I clinical trials to regulatory submission has increased from less than 10% in 2010 to 15.
8% in 2020; the comprehensive success rate of rare oncology drugs is 32.
9%, which is 5-5% of common oncology drugs.
6 times
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In 2020, due to the sharp increase in clinical development productivity of phase II clinical studies for rare cancers, oncology clinical development productivity (combined indicators of success rate, clinical trial complexity, and trial duration) has improved, but the overall development productivity level is still significant Lower than other diseases
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The number of drugs in the early stage of research and development is about 1,000, an increase of 43% compared to 2016, mainly for a new generation of biological therapies including gene editing, CAR-T and RNA therapy
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Approximately 80% of the pre-oncology R&D pipeline and two-thirds of the late-stage R&D pipeline come from emerging biopharmaceutical companies-these companies spend less than US$200 million in R&D annually
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Among the more than 740 companies developing anti-cancer drugs, more than 500 are completely dedicated to the field of oncology
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It is worth noting that emerging biopharmaceutical companies (companies with annual sales of less than US$500 million and R&D expenditures of less than US$200 million) control nearly 80% of the early pipelines, but large pharmaceutical companies have a considerable share of ADC and BiTE development.
Big share
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Small molecule targeted products include dozens of mechanisms and are the largest field in the pipeline, mainly dominated by smaller emerging biopharmaceutical companies
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In most cases, the research share of large companies will increase in the later stages of the clinical trial.
The reason is that large companies will enter through mergers, acquisitions, and partnerships
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Large companies have a larger share of the early development of early bispecific T cell receptors (BITEs), which may be an area that will receive continued attention in the next few years
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In addition, antibody-drug conjugates (ADC) also have a larger early stage share of large companies.
This may be because combination drugs often involve antibody drugs that have been marketed by major pharmaceutical companies
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Another characteristic of emerging biopharmaceutical companies is that although their share has declined in 2020, they still account for two-thirds of late-stage oncology research and development projects
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In the past 15 years, the contribution of emerging biopharmaceutical companies has been stable at 65%-67%
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In the same period, the share of large pharmaceutical companies was between 24% and 27%, although the absolute number of drugs increased from 98 in 2005 to 243 in 2020
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There are more than 600 emerging biopharmaceutical companies in the world that are actively carrying out oncology research projects, and there are 15 large pharmaceutical companies, that is, companies with annual global sales of more than 10 billion US dollars
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Compared with 2015, the share of late-stage pipelines owned by emerging biopharmaceutical companies has fallen by 2 percentage points in 2020.
This is mainly due to the fact that some companies are facing the impact of the COVID-19 interruption, causing their research projects to no longer be active
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At the same time, there are a considerable number of small companies whose oncology pipeline usually has only one molecule in development
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IQVIA research shows that in terms of molecular R&D (and revenue), leading oncology companies usually spend more than one-third of their overall R&D on oncology
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There are currently 605 emerging biopharmaceutical companies with advanced oncology pipeline activities, of which 450 are 100% focused on oncology
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In addition to these 450 emerging biopharmaceutical companies that are 100% focused on oncology, another 51 small companies are also 100% focused on oncology
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Of all 501 companies, 389 companies have only one drug in development
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For these companies, the risks inherent in drug development may mean that although some companies will succeed, there is only one drug under development, which increases the risk of R&D failure to the company
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Another trend is that companies headquartered in China, the proportion of drugs produced in the early development stage has increased from 3% 10 years ago to 18%
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From 2005 to 2015, the United States’ share of global early-stage tumor R&D remained relatively stable, but in the past five years, the United States’ share in this field has fallen to 45%
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At the same time, the share of the European region has dropped from 40% to 26%, but the absolute number of active projects has risen from 583 to 639
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Contrary to the situation in Europe and the United States, companies headquartered in China accounted for 18% of products in the early R&D pipeline, up from 6% in 2015 and 2% in 2005
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At the same time, research shows that 13% of the world's new generation of biotherapeutics are developed by companies headquartered in China
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By 2017, the US’s share in the global early development of next-generation biotherapeutics has been rising to 69%, but has since fallen by 11%, while China’s share has risen sharply by 10% to 13% during the same period
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In the past five years, the share of European projects has fallen from 30% to 23%, while the absolute number of active projects has risen from 26 to 92
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The products of Chinese companies currently account for 13% of the early production lines of new-generation biotherapy, up from 5% 5 years ago and 2% in 2005
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Note: This article is edited from the IQVIA report "Global Oncology Trends 2021: Outlook to 2025"