Chinese drugs are increasingly receiving FDA and EMA approval: in the past ten years, the country has shifted from exporting generics to innovative drugs and biotechnology.

The Chinese pharmaceutical industry has significantly changed its position in the global market over the past decade. While the international presence of Chinese-developed drugs was previously primarily tied to generics and manufacturing capabilities, since 2015, more and more Chinese developments have begun to undergo full regulatory approval in the United States, Europe, and other major pharmaceutical markets. This was demonstrated by a new study published in August 2026 in the journal eClinicalMedicine.

The authors tracked international approvals of Chinese-origin drugs over 35 years, from 1990 to 2025. The United States served as the primary reference point, as the U.S. Food and Drug Administration uses well-structured and publicly monitored regulatory pathways. Europe and other countries were used for comparison and to assess the extent to which Chinese drugs are truly becoming global, rather than simply entering a single large foreign market.

The authors discovered a turning point around 2015. In the US, the number of approvals of Chinese generics through the abbreviated procedure reached 570 between 2016 and 2020, and another 567 between 2021 and 2025. But a more significant change was the change in the portfolio structure: approvals of original small molecules, biologics, biosimilars, and other technologically more complex products simultaneously began to increase. Between 2021 and 2025, the researchers registered 37 approvals through the New Drug Application procedure, used for new drugs.

This doesn't mean China has already displaced the US or Europe in global pharmaceutical innovation. The study shows otherwise: the country has undergone a significant evolution from a predominantly manufacturing and generics model to a system in which individual companies are able to conduct international development, build an evidence base, and obtain approvals from several major regulators simultaneously. This transformation has been particularly advanced in oncology and immunology.

Key figures of the study

Indicator	Result
Analysis period	1990-2025
Main market analysis	USA
Additional markets	Europe, UK, Japan, Australia, Canada and others
ANDA in the United States, 2016-2020	570 approvals
ANDA in the US, 2021-2025	567 approvals
NDA in the US, 2021-2025	37 approvals
The first BLAs of Chinese developments in analysis	2022
BLA surge	After 2023
The most notable directions	Oncology and immunology
Other growing areas	Cardiovascular diseases, diseases of the nervous system
DOI	10.1016/j.eclinm.2026.104121

[1]

How scientists measured the global success of Chinese drugs

The study was a retrospective, longitudinal, descriptive analysis, not a clinical trial. The authors did not test the efficacy of any specific drug in patients, but rather reconstructed the history of which Chinese developments had successfully received approval on international markets. The primary source was the MENET database, which the researchers supplemented with publicly available information from national and international regulators. This design allows for a clear understanding of structural changes in the entire industry over decades.

For the United States, the authors separately examined three fundamentally different regulatory pathways. The Abbreviated New Drug Application (ANDA) is used primarily for generics; the New Drug Application (NDA) is used for new drugs, typically small molecules; and the Biologics License Application (BLA) is used for biological drugs. Therefore, the shift from almost exclusively abbreviated applications to the increasing number of full-fledged applications for new drugs and biological products provides a rough indication of the technological sophistication of the export portfolio.

However, the figures must be interpreted carefully. In the American portion of the study, the unit of analysis was the regulatory approval event, not necessarily a unique molecule. A single drug can potentially receive multiple regulatory approvals, for example, for different formulations or indications. Therefore, 570 approvals under the abbreviated procedure cannot automatically translate into "570 completely different Chinese drugs." This nuance is especially important when comparing different time periods.

The authors analyzed the European system somewhat differently, focusing on products approved by the European Medicines Agency. Due to the differences in the structure of the American and European regulatory systems, approval rates between the FDA and EMA should not be directly compared as equal. In this study, Europe serves more as an independent test of whether the American trend is being replicated in another highly regulated market. This approach demonstrated that the transformation is not limited to the United States.

What do the basic American procedures mean?

Procedure	What is it used for?	What does it say about the development of the industry?
ANDA	Generic versions of already known drugs	Ability to ensure quality, manufacturing and bioequivalence
NDA	New drugs	Requires its own evidence base for safety and effectiveness
BLA	Biological products	Reflects the development of a complex biotech platform
FDA approval	Specific product/use approval	High regulatory threshold
EMA approval	Entering the European market	Independent verification of quality, effectiveness and safety

Since 2015, generics have gone from being an exception to a mainstream product.

In the first decades of the period under review, Chinese drugs appeared on the American market relatively rarely. When international approvals did occur, they were more often for generic versions—drugs that replicate existing medications after the relevant patents expired. This model requires high manufacturing standards but is fundamentally different from independently discovering a new molecule and conducting an entire clinical development program.

After 2015, the situation changed dramatically. From 2016 to 2020 alone, researchers counted 570 US ANDA approvals associated with Chinese developers or manufacturers. In the next five years, 2021 to 2025, this high level remained virtually unchanged—567 approvals. Thus, a transition occurred from an occasional presence to a sustained, massive entry of Chinese generic products into the world's largest pharmaceutical market.

This is a significant milestone for the pharmaceutical industry. Obtaining FDA approval for a generic drug means more than simply producing a chemically similar substance. The manufacturer must demonstrate compliance with quality, stability, and manufacturing requirements, and, where applicable, bioequivalence to the reference drug. Therefore, the continued success of hundreds of such approvals over the years indirectly demonstrates that some Chinese industry has learned to consistently comply with US regulatory requirements.

Moreover, the generics phase likely served as a kind of infrastructural school for the subsequent transition to innovation. International production requires quality control systems, documentation, inspections, and interaction with international regulators. These capabilities can then be used in the development of indigenous innovative products. The authors of the new study consider the transition from the "manufacturing-led" international model to an innovative one as one of the central trends of the period studied.

How the international presence has changed

Period	Main characteristics
1990s	Single international approvals
2000s	Gradual increase in producer participation
Until 2015	Predominance of generic routes
2016-2020	ANDA approvals soar to 570
2021-2025	ANDA volume remains high at 567
2021-2025	At the same time, the release of original drugs is accelerating
After 2023	The presence of biological products is growing particularly noticeably.

[2]

Now, original drugs are on the rise: 37 NDA approvals in just five years

More important in terms of innovation potential is the growth of New Drug Applications. This approach differs significantly from the generic route: the developer must provide regulators with a comprehensive evidence base on the efficacy, safety, pharmacology, and manufacturing of the new drug. Therefore, the increasing number of NDAs reflects not so much the expansion of production capacity as the ability to create and internationally develop proprietary drugs.

It is here that the most significant shift occurred in the last five years of the study. Between 2021 and 2025, the authors registered 37 US NDA approvals for Chinese developments. For an industry that was virtually absent from FDA innovation applications several decades ago, such a concentration of decisions in a relatively short time signifies a significant shift in the pharmaceutical development model.

Another indicator is the emergence of Biologics License Applications. Biologics are much more complex than standard small molecules: they include, for example, monoclonal antibodies and a number of other products created using living systems. In the sample under consideration, the first such approvals appeared only in 2022, and after 2023, they began to become significantly more frequent. This is a very late but rapidly growing part of the international portfolio.

Taken together, the authors see a shift from the model of "a Chinese factory producing an affordable generic version of a well-known drug" to a significantly more diverse system. It now includes innovative small molecules, original biologics, biosimilars, and some more complex therapeutic technologies. It is this shift, rather than the absolute number of approvals, that is the study's main finding.

Three levels of international drug development

Level	Product type	What is required
1	Generic	Prove quality and equivalence
2	New small molecule	Full-fledged preclinical and clinical development
3	Biological drug	Complex development, production and control of a biological product
China's trend	From level 1 to a combination of all three	Particularly noticeable after 2015

Oncology and immunology have become the main drivers of Chinese expansion.

International growth is distributed extremely unevenly across therapeutic areas. Since 2015, the category of anticancer and immunomodulatory drugs has seen the most significant growth. This is where Chinese companies have most rapidly transitioned from the domestic market to international development programs. King's College London notes that targeted anticancer drugs and immunotherapy are becoming increasingly prominent among Chinese developments.

This concentration is no coincidence. There is a huge need for new drugs in oncology, and the molecular subdivision of tumors into multiple genetic subtypes creates a large number of potential targets for new drugs. Furthermore, for some anticancer developments, early evidence of significant activity can relatively quickly generate international interest and lead to partnerships with global pharmaceutical companies.

This trend aligns well with another study by the same researchers, published in April 2026 in JCO Global Oncology. In it, the authors described the transformation of the Chinese oncology pharmaceutical industry following the 2015 regulatory reform – from a predominantly imitative model to a much more competitive innovation ecosystem. The new study adds important confirmation to this picture: changes can already be seen not only within the Chinese pipeline but also in the actual decisions of international regulators.

At the same time, the heavy reliance on oncology is also a weakness. The authors believe that further development will require expanding therapeutic diversity. Since 2015, signs of growth have emerged in cardiovascular medicine and the treatment of nervous system diseases, but their international portfolio remains significantly smaller. A sustainable position for a global developer requires success not in one or two high-investment areas, but across a broad range of medical needs.

Which areas are most strongly represented?

Therapeutic direction	International dynamics
Oncology	The most pronounced expansion
Immunology	Rapid growth, including biologics
Targeted therapy	More and more noticeable among innovative products
Immunotherapy	One of the important areas of international development
Cardiovascular diseases	Growth after 2015, but on a smaller scale
Nervous system	More international products are appearing
Other directions	So far, the representation is relatively limited

[3]

Europe confirms the trend, although there are fewer Chinese approvals there

The US market was the primary analytical focus of the study, but the authors specifically examined Europe to determine whether the increase in approvals was an FDA peculiarity or reflective of a broader process. The European Medicines Agency did approve fewer Chinese developments, but the nature of these drugs was particularly telling: they included a disproportionate number of oncology, immunology, and biotech products.

According to researchers, Chinese developers are increasingly gaining recognition in Europe not only for their original drugs but also for their biosimilars. A biosimilar is not a typical chemical generic. A biological molecule is too complex to create an absolutely identical copy, so the developer must demonstrate a high degree of similarity to the reference drug in terms of structure, biological activity, pharmacokinetics, efficacy, and safety.

This makes European approvals of biosimilars an important indicator of manufacturing maturity. For such products, synthesizing the active ingredient using a known chemical formula is not enough; a high-precision biotechnological manufacturing system is required. The emergence of Chinese companies in this category demonstrates that international competition is gradually expanding to complex biological drugs.

However, absolute figures for the US and Europe cannot be simply tabulated as a result of competition between the FDA and EMA. The US portion of the study considered regulatory events, while the European portion focused primarily on products. Furthermore, registration rules, the use of centralized and national procedures, and market structures differ. Therefore, the European data in the study are primarily of qualitative significance: they confirm that the growth of Chinese developments is visible across several independent regulatory systems.

What the comparison between the US and Europe showed

Characteristic	USA	Europe
Role in research	Main analytical market	Comparative market
Regulator	FDA	EMA
Generics	A very large number of approvals	Presented, but the analysis is different
New small molecules	Rapid growth	The number is less
Biological drugs	Started growing rapidly after 2022	It's becoming more and more noticeable
Biosimilars	Significant direction	A particularly noticeable direction
Oncology and immunology	Dominate among innovations	Also dominant
Is it possible to directly compare approval numbers?	No	No

[4]

Some Chinese drugs are now receiving approval in several major countries at once.

Another stage of pharmaceutical internationalization is the transition from a single approval abroad to a global development program. The authors identified drugs that were launched sequentially or roughly simultaneously in the US, EU, UK, Japan, Australia, Canada, and other countries. This pattern was particularly common among oncology and immunology developments.

This is a significantly more complex task than registration in a single country. Parallel entry requires designing clinical trials so that their results satisfy multiple regulatory authorities, agreeing on study endpoints and patient populations in advance, ensuring a uniform international manufacturing standard, and preparing vast amounts of documentation to meet various requirements.

This is why the authors believe this development is a sign of increasing regulatory maturity and global development capabilities among some Chinese pharmaceutical companies. Chinese molecules are increasingly being developed not according to the old pattern of "first many years in the domestic market, then an attempt to expand internationally," but with an eye toward multinational clinical trials and registration in multiple jurisdictions simultaneously.

This does not guarantee commercial success. FDA or EMA approval does not automatically mean a drug will be included in insurance coverage, national reimbursement systems, or clinical guidelines. After regulatory approval, separate processes begin to assess comparative effectiveness, price, economic feasibility, and competition with existing treatments. However, the ability to pass multiple independent regulatory approvals is a necessary prerequisite for a global pharmaceutical market.

What does the transition to global development look like?

Old model	New model
Developed primarily for China	Planning an international program
Chinese clinical data	Multinational studies
Late attempt to register abroad	Early interaction with foreign regulators
One foreign market	Multiple jurisdictions
Generics	Generics + original molecules + biological products
National product	A potentially global drug

China has become one of the world's largest drug development centers.

The scale of the changes is evident not only in the number of approved drugs but also across the entire research pipeline. According to Pharmaprojects data, cited by King's College London, at the beginning of 2025, approximately 7,032 drug projects were in active development in China. This corresponded to approximately 29.5% of the global pipeline and was second only to the United States. For the United States, the comparable figure was 11,455 drugs, or approximately 48% of the global pipeline.

However, it's also important to interpret this figure correctly. 7,032 does not represent the 7,032 Chinese drugs already developed, nor does it represent the number of drugs that will definitely reach patients. Pharmaprojects' methodology considers the geographic location of development: the same international drug may be simultaneously being studied in the US, China, Europe, and other countries, and therefore be counted in multiple countries.

Nevertheless, the growth of China's share is impressive. According to the same review, the share of drugs in active development in China increased from 26.7% to 29.5% in just one year. This reflects several processes: the expansion of domestic Chinese biotech companies, the increase in clinical trials, and, simultaneously, the interest of Western developers in including China in global programs.

Thus, the growth of international approvals is not an isolated phenomenon. It occurs against the backdrop of a massive expansion of research infrastructure. However, there is a huge gap between "a drug is in development" and "a drug has demonstrated clinical benefit and received approval": a significant portion of experimental molecules inevitably cease development. Therefore, the dynamics of actual FDA and EMA approvals, studied by Xu and colleagues, provides a more accurate indicator of international progress.

Where pharmaceutical development took place in early 2025

Country	Drugs under active development	Share of global pipeline*
USA	11,455	48.0%
China	7,032	29.5%
South Korea	3,386	14.2%
United Kingdom	3 214	13.5%
Australia	2,615	11.0%
Germany	2,545	10.7%
France	2,485	10.4%
Canada	2,446	10.2%
Spain	2,381	10.0%

*One drug may be under development in several countries at the same time, so percentages do not add up to 100%. Source: Pharmaprojects, January 2025. [5]

Why did the turning point happen around 2015?

The year 2015 in the study is more than just a convenient statistical cutoff point. This period coincides with the beginning of profound reforms to China's drug development and registration system. Previous work by Xu, Sullivan, and colleagues describes the 2015 reform as one of the factors driving the transition from accumulated regulatory delays and a focus on reproducible drugs to a much more innovative system.

One of the results of the reforms has been the gradual convergence of evidence requirements with international standards. For a company planning exclusively for the Chinese market, the clinical program can be built around the requirements of the national regulator. For simultaneous expansion into the US, Europe, and Japan, the study design must take into account the requirements of all these systems much earlier. The authors believe it is precisely this international orientation that is a prerequisite for further growth.

The nature of the Chinese pharmaceutical industry itself has also changed. The large number of biotech startups, the development of contract research and manufacturing organizations, increased funding for development, and the rapid growth of clinical trials have made it possible to create much more complex drugs. This has been most evident in oncology, where China boasts both a huge patient base and a significant domestic market.

However, the study does not prove that a specific reform directly caused every recorded approval. Its design is descriptive, not causal. The authors see a temporal coincidence between structural reform and a sharp increase in international activity, but the economy, investment, scientific development, global partnerships, and strategic shifts at individual companies all acted simultaneously. Therefore, 2015 is best understood as the beginning of a new phase, rather than as the sole cause of what happened.

Approval of a drug does not mean it is necessarily better than existing drugs.

This is one of the main limitations of interpreting the study. The researchers measured regulatory approvals, not the relative clinical value of the drugs. The FDA or EMA may deem a drug sufficiently effective and safe to market, but that doesn't necessarily mean it treats patients better than all competitors, is less expensive, or offers significant benefits in terms of life expectancy and quality of life.

Approvals of generic and innovative drugs also reflect very different achievements. A large number of ANDAs indicates manufacturing and regulatory capacity to supply high-quality generic equivalents, but does not indicate the number of new scientific discoveries. Therefore, the authors specifically analyzed ANDAs, NDAs, and BLAs separately. It is the rapid growth of the latter two categories that makes the current trend fundamentally different from the initial generic expansion.

There are also methodological limitations. The study relies on the MENET database and publicly available regulatory data, and the completeness of historical data over a 35-year period may vary across countries and periods. Different regulatory systems also count products and registration events differently. Therefore, absolute figures are particularly useful for analyzing trends within a single system, but caution is required when directly comparing the FDA, EMA, and regulators in other countries.

Finally, international success is distributed very unevenly across companies and therapeutic areas. The authors point directly to a concentration in oncology and immunology and believe expansion into other medical fields is necessary. Therefore, the study does not imply that the entire Chinese pharmaceutical industry has already achieved an equally high level of global success; rather, it points to significant progress primarily by a select group of companies and products that have successfully overcome international regulatory barriers.

What the study shows and what it doesn't prove

It can be concluded	It is impossible to conclude
International approvals for Chinese drugs have soared.	All Chinese drugs have become innovative
China has successfully expanded beyond the generic segment.	Each approved drug is better than its Western counterpart.
NDAs and BLAs have become much more common	37 NDA = 37 completely unique molecules
Oncology and immunology are leading the way	China is equally strong in all therapeutic areas
The EMA also approves innovative and biosimilar products.	FDA and EMA numbers can be compared directly
Some drugs receive approval in multiple countries	Regulatory approval ensures commercial success
The progress of international development is obvious	The study proved the reason for this progress.

What the changes mean for patients and the global drug market

For patients, the main potential effect is increased competition. If more independent developers enter the market with new molecules or biosimilars, healthcare systems have more treatment options. In some cases, competition can lower prices, especially after the introduction of several biosimilars or generics. However, the new study did not examine the extent to which this will occur for specific Chinese drugs.

For global pharmaceutical companies, China is increasingly becoming not only a sales market and manufacturing site, but also a source of molecules. This is changing the licensing system: large international companies can acquire the rights to Chinese developments or jointly conduct further clinical trials. Thus, the line between "Chinese" and "Western" drugs is becoming less clear-cut – a molecule can be discovered by a Chinese biotech company, licensed to an international concern, and then simultaneously studied on several continents.

For regulators, the growing number of global applications poses another challenge: the need to further harmonize requirements and monitor the quality of evidence. The authors believe that continued international expansion will depend on globally focused clinical development, greater regulatory alignment, and expanded multinational collaboration.

This is why researchers don't describe what's happening as China's transition to global leadership complete. Rather, the data reveals the beginning of a new phase. The country has already proven its ability to mass-market generics and, increasingly, complex original drugs to the largest regulated markets. The next question is whether this trend can spread beyond oncology and immunology, and whether the growing number of international registrations will translate into measurable clinical benefits and improved treatment access for patients worldwide. As one of the authors, Zhihao Xu, put it, the main challenge now is to maintain this momentum, expand it to other therapeutic areas, and ensure that innovations translate into real benefits for patients.

How China's Role in Global Pharmaceuticals Has Changed

Earlier	Now
Production site	Production + in-house development
Mostly generics	Generics + innovative drugs
A small number of foreign registrations	Hundreds of annual regulatory events
Small chemical molecules	Small molecules + biologics + biosimilars
Developed primarily for the domestic market	More and more global programs
Sequential release by country	Almost parallel registrations are possible
The main competitive factor is cost	Scientific and clinical innovation is added
China as a market	China increasingly as a source of new drug developments

Key findings of the study

Indicator	What was discovered?
Period	1990-2025
The main trend	A sharp acceleration in international approvals after 2015
ANDA 2016-2020	570
ANDA 2021-2025	567
NDA 2021-2025	37
First BLAs in analysis	2022
Growing bioapprovals	Especially after 2023
Leading area	Oncology and immunology
Europe	Fewer approvals, but growing number of innovative products and biosimilars
Other markets	There are drugs approved in the US, Europe, UK, Japan, Australia, Canada and other countries.
The scale of development in China in 2025	about 7032 active projects, 29.5% of the world pipeline by development location
Major structural shift	From generics to original small molecules, biologics and other complex technologies
The main limitation	The study evaluates regulatory expansion, not comparative clinical value.

[6]

News source

Xu Z, Jenei K, Sullivan R. International approval of Chinese pharmaceuticals: a USA-anchored analysis with comparative insights from Europe and other markets. eClinicalMedicine. 2026;98:104121. The study presents a retrospective longitudinal analysis of international approvals of Chinese-developed drugs over the period 1990–2025, with the United States as the primary analytical system and Europe and other markets as comparison jurisdictions. DOI: 10.1016/j.eclinm.2026.104121.