During the past decade, the biopharmaceutical industry in China has been transformed by government policies designed to support innovation and modernize drug discovery, development and review processes. Biopharmaceutical companies in China have used this support to create platforms for the development of highly sophisticated drugs such as antibody-drug conjugates (ADCs) and bispecific and multispecific antibodies.
Here, we examine trends in the development of such ‘enhanced’ antibody therapeutics in China compared with the USA and Europe, particularly in the past decade (2015-2024). We focus on trends in first clinical studies, first global approvals, clinical success rates and the characteristics of the molecules developed in these two regions (see Supplementary information for details). Data for our analyses were collected from public sources and cross-checked against data from the Beacon ADC and Bispecific modules.
Trends in the initiation of clinical studies and global first approvals. ADCs and multispecific antibodies are highly innovative drugs with enhanced functions compared with those of conventional, monoclonal antibodies (mAbs). ADCs are designed to deliver small-molecule toxins to tumours, while multispecific antibodies bind to two or more different antigenic sites in the targeted protein or proteins. Owing to their enhanced functionality, both antibody formats hold substantial promise as next-generation therapeutics for complex diseases, particularly cancer, but the molecules are far more complicated to create and manufacture than conventional mAbs.
China’s recent focus on policy-driven innovation, which has included increased R&D investment, improvements in manufacturing and advances in clinical trial efficiency, has resulted in a substantial increase in the number of enhanced antibodies from Chinese companies that entered clinical study since 2020 (Fig. 1a). Indeed, the number of clinical-stage enhanced antibodies created by Chinese companies now exceeds that of US and European companies combined.
As the clinical trial and regulatory review process is rarely shorter than 5 years, only 16 of the enhanced antibody therapeutics (12 bispecific antibodies and 4 ADCs) in our dataset have been granted marketing approval as of August 2025, with the majority (11, 69%) of these originating at US or European companies. Considering all approvals of enhanced antibodies (that is, disregarding the year that clinical trials were started), 28 enhanced antibody therapeutics (16 bispecific antibodies and 12 ADCs) originating in China, the USA or Europe were approved between 1 January 2015 and 31 August 2025 (Fig. 1b).
Comparison of clinical success rates. We calculated clinical phase transition and approval success rates for enhanced antibody therapeutics, focusing on those for cancer as nearly 90% of the molecules in our dataset are for cancer and success rates are known to vary with therapeutic area. Our results are preliminary, as most of the China-originated molecules entered clinical study during 2020-2024 and thus the final fates (approval or termination) of most are not yet known.
As of August 2025, only one molecule from this cohort, trastuzumab rezetecan, has been approved. Nevertheless, our data show that enhanced antibody therapeutics created by Chinese companies are less likely to be terminated at every stage of the clinical development process compared to those originating at companies based in the USA or Europe, resulting in overall approval success rates of 57% compared with 15%, respectively (Fig. 2a). When data for these cohorts are stratified by format, our results show that both China-originated ADCs and multispecific molecules substantially outperform those created by companies in the USA or Europe (Fig. 2b). These success rates will need to be confirmed in the future, after additional clinical evaluation enables companies to determine the fates of more of the molecules.
Trends in formats and mechanisms of action. Our data show that China-based companies are increasingly focused on innovative formats for their enhanced antibody therapeutics for cancer. For example, the number of China-originated bispecific ADCs entering the clinic increased compared to those originated in companies based in the USA or Europe (China, 12%; USA or Europe, 5%) in 2024.
In addition, the distribution of ADC payloads shows the absence of well-established DNA-binding payloads and a higher percentage of the newer topoisomerase I inhibitor payloads in Chinese ADCs compared to those originating at companies based in the USA or Europe (Fig. 2c). Moreover, the distribution of the general mechanism of action of bispecific and multispecific antibodies shows differences between the proportion of well-established cell engagers without immunomodulatory properties — which comprise 59% of the molecules created at companies based in the USA or Europe, compared with 30% of those from China-based companies — and the more innovative bispecific and multispecific antibodies that have both immunomodulatory properties and target a tumour-associated antigen and/or the tumour microenvironment (China, 25%; USA or Europe, 6%) (Fig. 2d). These differences in payloads, formats and mechanisms of action may help explain the higher clinical phase transition rates of the China-originated enhanced antibody therapeutics compared to those originating at companies based in the USA or Europe.
Our analysis provides evidence that China’s recent focus on policy-driven innovation has enabled companies based there to surpass those in the USA and Europe in the development of sophisticated antibody therapeutics. The USA and Europe are thus at a competitive disadvantage in this area, and the USA, in particular, is not well positioned to respond, given the recent reductions in the workforce at key government agencies, such as the Food and Drug Administration and the National Institutes of Health, and the defunding of scientific programmes.
The biopharmaceutical industry is increasingly focused on developing ADCs and multispecific antibody therapeutics because of their enhanced functionality relative to mAbs. In total, 29 enhanced antibody therapeutics (17 bispecific antibodies and 12 ADCs) created globally were approved during 2015-2024 (Supplementary Table 1). The total approved in the next decade (2025-2034), however, is expected to be substantially higher, as three have been approved so far in 2025, marketing applications for four more are undergoing evaluation, and nearly 70 are in late-stage clinical studies (Supplementary Table 1). The global clinical pipeline currently includes nearly 500 enhanced antibody therapeutics, more than half of which were created by Chinese companies. If current conditions continue, Chinese companies may come to dominate the antibody therapeutics sector of the biopharmaceutical industry within the next 5 years.
