Supermodel-powered platform translates tumor biology across patient populations, addressing a structural gap in East-to-West asset licensing
SAN DIEGO–(BUSINESS WIRE)–#ISO27001–Genialis, the therapeutic intelligence company, today announced Genialis™ BioBridge to help pharmaceutical sponsors translate clinical results generated in Chinese patient populations into biomarker-ready assets for Western trials and regulatory submissions.
The global drug development landscape has shifted with many innovative oncology therapies now being discovered and clinically validated first in China before being licensed for development in North America and Europe. Chinese biopharma out-licensing reached $137.7 billion in 2025, driven by 157 deals — nearly three times the transaction volume of 2024. While these transactions provide Western sponsors with access to promising therapies, they also pose biological and regulatory challenges. Clinical efficacy signals, biomarker strategies, and patient response patterns observed in Chinese trials may not translate directly to Western patient populations.
Regulatory agencies, including the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA), typically require evidence that therapeutic activity and biomarker performance remain robust across geographically diverse populations. BioBridge was built to help sponsors answer that question before launching costly global development programs.
BioBridge is powered by the Genialis™ Supermodel, a large molecular model of cancer biology pre-trained on more than one billion RNA-sequencing data points from globally diverse patients. BioBridge uses clinical and molecular data to estimate responder populations in diverse global regions. This allows pharma sponsors to anticipate differences in efficacy signals from Chinese trial results. Biobridge yields actionable biomarkers for Western development programs through four steps:
- Harmonizing molecular data across clinical sites, platforms, and vendors to reduce technical variability
- Mapping patient samples into the Genialis Supermodel’s shared biological framework, trained on globally diverse cancer datasets from partners including Tempus, Cancer Research UK, Academica Sinica (Taipei), Sidra Medicine (Qatar), and 4basecare (India), among others
- Identifying and validating molecular predictors of response and resistance across patient populations
- Deploying biomarker-driven patient stratification strategies to support clinical development, trial enrichment, and regulatory submissions
“Clinical trial results don’t always translate seamlessly across populations. The biological factors that influence response to a therapy can vary based on genetics, disease characteristics, and treatment context,” said Rafael Rosengarten, Ph.D., Chief Executive Officer and Co-Founder, Genialis. “Rather than relying on broad demographic assumptions, BioBridge evaluates the underlying molecular programs associated with response and resistance, helping sponsors understand whether a therapeutic signal is likely to remain robust as development expands globally.”
The Supermodel’s cross-histological and cross-geographic capabilities are validated in published research. Uhlik et al. (Frontiers in Oncology, 2023) demonstrated that the Xerna™ TME Panel, an RNA-based biomarker built on Supermodel technology, classified tumor microenvironment biology robustly across a dozen cancer types in the context of numerous investigational and approved therapies, spanning immune checkpoint inhibitors to next-generation anti-angiogenic bispecifics. BioBridge applies the same biology-first prediction capabilities to the population-level question every East-to-West licensing deal eventually confronts.
“East-to-West licensing has become one of the defining trends in biopharma. Yet every transaction ultimately faces the same question: will the efficacy and biomarker signals observed in one population hold up in another? BioBridge was built to help sponsors answer that question using biology rather than assumptions,” said Krista McKerracher, MBA, Chair of the Board, Genialis; former Vice President, Global Franchise Head, Oncology Global Development, Novartis.
Genialis will be at BIO 2026 in San Diego, June 22–25, 2026, to meet with sponsors evaluating cross-population development challenges. To arrange a meeting or learn more, visit genialis.com/supermodel or contact [email protected].
About Genialis
Genialis is creating a world where healthcare delivers the best possible outcomes for patients, families, and communities. Genialis provides therapeutic intelligence with its Supermodel of cancer biology, developing clinically actionable biomarkers informed by the world’s most diverse cancer data to guide precision medicine. Partnering with leading pharmaceutical and diagnostic companies, Genialis is transforming medicine through data.
Contacts
Media Contact:
Andrea Vuturo
Vuturo Group for Genialis
[email protected]
+1 (415) 689-8414
