Denovo Biopharma LLC Enters into an Exclusive Out-License Agreement with Chuang Yi Global Asset Management Co., Ltd. for Biomarker-Guided DB104 (liafensine) in Patients with Treatment-Resistant Depression (TRD) in Taiwan

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SAN DIEGO, June 23, 2025 (GLOBE NEWSWIRE) -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative drugs, today announced that it has out-licensed its biomarker-guided DB104 (liafensine) program to one of Taiwan's leading pharmaceutical companies, Chuang Yi Global Asset Management Co., Ltd. (CYMD).This agreement gives CYMD exclusive rights to develop and commercialize DB104 in Taiwan, with Denovo maintaining worldwide rights outside of Taiwan.

"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. "Currently, there are no approved antidepressants to treat TRD in Taiwan, representing a significant unmet need. 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. It also brings a tremendous market potential for our partner. We are also in discussion with multiple pharma partners in other regions and believe a transaction like this underscores the potential benefits of a biomarker-guided approach for TRD patients around the globe.”

About DB104 (biomarker-guided liafensine)

Liafensine is a first-in-class triple reuptake inhibitor targeting transporters for serotonin, norepinephrine, and dopamine. It was licensed from Albany Molecular Research, Inc. (now Curia) and was previously developed by Bristol-Myers Squibb (BMS), who had conducted 14 clinical trials which proved the superior safety of the liafensine but failed to show efficacy. Using the archived clinical samples from those studies, Denovo's unique artificial intelligence (AI) and whole genome scan-based DGM biomarker platform allowed discovery of a novel pharmacogenomic biomarker within the ANK3 gene, which can predict liafensine's efficacy. Denovo's ENLIGHTEN Phase 2b study results prospectively demonstrated robust efficacy of liafensine in TRD patients, a major breakthrough in applying precision medicine in psychiatry.

About Denovo Biopharma

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Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to execute efficient clinical trials in targeted patient subpopulations to increase the probability of success. Denovo has seven late-stage drugs in its pipeline addressing major unmet medical needs in central nervous system diseases and oncology, most of which are first in class drugs with global rights. Visit www.denovobiopharma.com for additional information.

Investor Contact:

Stephen Jasper

Gilmartin Group

[email protected]

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