Denovo Biopharma LLC announced on June 23, 2025, that it has entered into an exclusive out-licensing agreement with Chuang Yi Global Asset Management Co., Ltd. (CYMD) for its biomarker-guided DB104 (liafensine) program in Taiwan. The agreement grants CYMD exclusive rights to develop and commercialize the treatment-resistant depression therapy in Taiwan, while Denovo retains worldwide rights outside of Taiwan.
Strategic Partnership Addresses Unmet Medical Need
"Our out-license agreement with CYMD allow us to focus our resources to develop DB104 in major markets while ensuring that patients will gain timely access to this innovative therapy in other regions of the world," said Wen Luo, Ph.D., Denovo's Chief Executive Officer. The partnership addresses a critical gap in Taiwan's treatment landscape, as there are currently no approved antidepressants to treat treatment-resistant depression (TRD) in the region.
Luo emphasized the clinical significance of the drug, noting that "DB104, backed by robust efficacy and an excellent safety profile demonstrated in the recent Phase 2b study, presents an ideal novel treatment option for patients suffering from TRD." The CEO also indicated that the company is in discussions with multiple pharmaceutical partners in other regions, suggesting broader global expansion plans for the biomarker-guided approach.
Novel Mechanism and Precision Medicine Approach
DB104 represents a first-in-class triple reuptake inhibitor that targets transporters for serotonin, norepinephrine, and dopamine. The drug was originally licensed from Albany Molecular Research, Inc. (now Curia) and was previously developed by Bristol-Myers Squibb (BMS), which conducted 14 clinical trials that demonstrated superior safety but failed to show efficacy.
The breakthrough came through Denovo's innovative approach to drug development. Using archived clinical samples from the original Bristol-Myers Squibb studies, Denovo's artificial intelligence (AI) and whole genome scan-based DGM biomarker platform enabled the discovery of a novel pharmacogenomic biomarker within the ANK3 gene. This biomarker can predict liafensine's efficacy, transforming a previously unsuccessful drug into a targeted therapy.
Clinical Validation Through ENLIGHTEN Study
The company's ENLIGHTEN Phase 2b study results prospectively demonstrated robust efficacy of liafensine in TRD patients, representing what Denovo describes as "a major breakthrough in applying precision medicine in psychiatry." This biomarker-guided approach allowed the company to identify the patient population most likely to benefit from the treatment, addressing the efficacy challenges that had previously limited the drug's development.
Company Pipeline and Future Prospects
Denovo Biopharma LLC positions itself as a clinical-stage biopharmaceutical company that uses novel biomarker approaches to execute efficient clinical trials in targeted patient subpopulations, aiming to increase the probability of success. The company maintains a pipeline of seven late-stage drugs addressing major unmet medical needs in central nervous system diseases and oncology, with most being first-in-class drugs with global rights.
The Taiwan licensing agreement underscores the potential commercial value of Denovo's precision medicine approach, with Luo noting that the deal "brings a tremendous market potential for our partner" and "underscores the potential benefits of a biomarker-guided approach for TRD patients around the globe."
