What Denovo Biopharma does

Denovo Biopharma (索元生物医药) is a clinical-stage biopharmaceutical company headquartered in Hangzhou, China with a wholly-owned US subsidiary in San Diego, California and a clinical center in Beijing. Founded in 2011, the company employs 11-50 people and operates as a private, venture-backed entity. Its core technology is the Denovo Genomic Marker (DGM™) platform — described as the industry's first platform and algorithm to perform de novo genomic biomarker discovery retrospectively using archived clinical plasma samples. The platform scans the entire human genome to identify single nucleotide polymorphisms (SNPs) correlated to drug responsiveness in specific patient subpopulations, enabling the company to resurrect late-stage drug candidates that failed in broad populations but showed efficacy signals in subsets.

The company's business model is asset-light and drug-repurposing oriented: it in-licenses late-stage clinical compounds from international pharmaceutical companies (Eli Lilly, Lundbeck, Sunesis, Tocagen, Orion/J&J, Jiangsu Wuzhong) after their Phase 2/3 trials demonstrated safety but insufficient broad-population efficacy, then applies its DGM™ platform to discover predictive genetic biomarkers (DGM1, DGM4, DGM7 and others), redesigns trials in biomarker-positive subpopulations, and advances drugs toward regulatory approval. Its pipeline consists of eight candidates — six first-in-class and two Class 1 new drugs — focused on oncology (glioblastoma, AML, NSCLC) and central nervous system diseases (treatment-resistant depression, schizophrenia, Alzheimer's, psychosis). The company generates revenue (none currently realized) through future product sales, milestone payments, and royalties from licensing arrangements. Its commercial channels consist of international multi-center clinical trials across China, the US, Canada, and Australia, with go-to-market executed via business development outreach, scientific publications, and conference presentations.

The company is pre-revenue with no approved products. It completed a roughly RMB 300 million (~$45.8M) Series D financing in December 2020, has secured FDA Fast Track designation for DB102 and FDA IND approvals for DB103 and DB107, and received a $12M CIRM grant for DB107's Phase I/II trial in 2024. Its DB104 (liafensine) Phase 2b ENLIGHTEN trial in treatment-resistant depression hit all primary and secondary endpoints in 2024, representing the first successful genomic biomarker-guided CNS trial.

Name

Denovo Biopharma

Legal name

杭州索元生物医药股份有限公司 (Hangzhou Suoyuan Biomedical/Pharmaceutical Co., Ltd.)

Website

https://denovobiopharma.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Denovo Biopharma is a clinical-stage biopharmaceutical company that in-licenses failed late-stage drug candidates from global pharma and uses its proprietary DGM™ biomarker discovery platform to identify responsive patient subpopulations, advancing precision medicines in oncology and CNS diseases.

Ownership category

akta.pro rank

Product category

Clinical-stage precision medicine biopharmaceuticals (oncology and CNS)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Predictive Biomarkers for Therapy Selection (response/non-response stratification) (HLAAAMAE), Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE), Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk) (HLAAAMAF)

Keywords

• Precision medicine biopharmaceuticals
• Biomarker-guided drug development
• Oncology drug pipeline
• CNS therapeutics development
• Genomic biomarker discovery

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Drug Development and Commercialization: Denovo acquires or in-licenses late-stage clinical drug candidates from international pharmaceutical companies (after Phase 2/3 trials have demonstrated safety but insufficient efficacy in broad populations). Using its proprietary biomarker discovery platform, the company identifies responsive patient subpopulations, redesigns clinical trials, and advances drugs through regulatory approval to global markets. Revenue is generated through product sales upon approval and potential milestone/royalty payments from licensing arrangements.
2. Biomarker-Driven Drug Licensing: The company licenses global or regional rights to failed-but-salvageable drugs, applies its biomarker platform to find predictive genetic markers, and re-develops them for targeted patient populations. Revenue model includes upfront payments, development milestones, and commercial royalties from pharmaceutical partnerships.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Denovo Biopharma in-licenses late-stage clinical drug candidates from international pharmaceutical companies that have demonstrated safety but failed to show efficacy in broad patient populations. Using its proprietary Denovo Genomic Marker (DGM™) biomarker discovery platform, the company retrospectively identifies genetic biomarkers from archived clinical samples that predict drug responsiveness, then re-develops these drugs in biomarker-selected patient subpopulations through clinical trials. Its pipeline spans oncology and CNS indications including glioblastoma, treatment-resistant depression, AML, NSCLC, Alzheimer's, and schizophrenia.

Product overview

Denovo Biopharma is a clinical-stage biopharmaceutical company developing a pipeline of eight first-in-class drug candidates focused on oncology and central nervous system (CNS) diseases. The company's model involves acquiring late-stage clinical compounds from global pharmaceutical companies that demonstrated safety but failed in broad patient populations, then using their proprietary Denovo Genomic Marker (DGM) biomarker discovery platform to identify genetic biomarkers that predict drug efficacy in specific patient subpopulations. The pipeline includes DB104 (liafensine for treatment-resistant depression with DGM4 biomarker), DB107 (gene therapy for glioblastoma with DGM7 biomarker), DB103 (pomaglumetad methionil for psychosis), DB105 (for Alzheimer's disease), DB106 (vosaroxin for AML), DB108 (recombinant endostatin for NSCLC), DB109 (idalopirdine for Alzheimer's disease), and DB102 (enzastaurin for GBM with DGM1 biomarker).

Differentiator

Problem solved

Functional benefit

Products and services

• DB102 (enzastaurin) A first-in-class drug candidate for first-line treatment of glioblastoma multiforme (GBM), guided by the DGM1 companion diagnostic biomarker for patient selection. DB102 received FDA Fast Track designation and is in the international Phase 3 ENGAGE study planning to enroll over 300 newly diagnosed glioblastoma patients across China, US, and Canada. Licensed to Aytu BioPharma in April 2021 for development in rare genetic diseases.
• DB104 (liafensine) A first-in-class triple reuptake inhibitor targeting serotonin, norepinephrine, and dopamine transporters for the treatment of treatment-resistant depression (TRD). Guided by the DGM4 biomarker discovered by Denovo, DB104's biomarker-guided Phase 2b ENLIGHTEN study hit all endpoints, representing the first successful use of genomic biomarkers in CNS disease treatment.
• DB107 (Toca 511 + 5-FC) A first-in-class gene therapy comprising the Toca 511 retroviral replicating vector (delivering cytosine deaminase gene to tumor cells) combined with oral 5-fluorocytosine (5-FC) prodrug, which converts to 5-FU at tumor sites. Indicated for recurrent glioblastoma (GBM) with the DGM7 biomarker used as companion diagnostic for patient selection. Received FDA IND approval enabling investigator-initiated clinical studies.
• DB103 (pomaglumetad methionil) A first-in-class mGlu2/3 receptor agonist (LY404039 prodrug with methionine for improved oral bioavailability via hPepT1 transport) developed for schizophrenia and psychosis. Licensed from Eli Lilly after 37 prior clinical trials involving over 3,800 subjects. Targets the glutamate system without cross-reaction to CNS dopamine D2 receptors.
• DB105 (ORM-12741) A first-in-class selective alpha-2C adrenoceptor (AR) antagonist licensed from Orion Corporation and Johnson & Johnson for Alzheimer's disease, schizophrenia, and depression. Distinct mechanism from amyloid and tau-targeting approaches. Exposed to 540 subjects across 13 studies with good safety and tolerability profile observed.
• DB106 (Vosaroxin) A first-in-class non-anthracycline quinolone-derived topoisomerase II inhibitor in-licensed from Sunesis Pharmaceuticals for acute myeloid leukemia (AML) and solid tumors. Over 1,200 patients dosed across 16 clinical studies with encouraging safety profile; showed significant survival improvements in poor-prognosis subpopulations in the Phase 3 VALOR trial.
• DB108 (recombinant human endostatin) A Class 1 recombinant protein drug (20KDa, 184 amino acids, two disulfide bonds, no glycosylation sites, identical amino acid sequence to human endostatin) expressed in E. coli. In-licensed from Jiangsu Wuzhong Pharmaceutical Group for non-small cell lung cancer (NSCLC). Demonstrated good safety, tolerability, and significant efficacy benefit in median progression-free survival in Phase 3 trial.
• DB109 (idalopirdine) An oral selective 5-HT6 receptor antagonist in-licensed from Lundbeck in July 2021 for Alzheimer's disease, schizophrenia, and cognitive improvement. Distinct novel mechanism of action. Evaluated in clinical studies with over 2,500 subjects.
• DGM™ Biomarker Discovery Platform The industry's first proprietary biomarker discovery platform and algorithm to perform de novo genomic biomarker discovery retrospectively using archived clinical plasma samples. Scans the entire human genome to identify single nucleotide polymorphisms (SNPs) correlated to drug responsiveness, enabling patient selection for clinical trials and clinical use of previously failed drug candidates.

Quantifiable outcome

• DB104 (liafensine) with DGM4 biomarker achieved all primary and secondary endpoints in Phase 2b ENLIGHTEN study for treatment-resistant depression in April 2024 — the first successful genomic biomarker-guided treatment in CNS.
• +3 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Nine partnerships are on record, tiered core.

• OrygencoreStrategic or Co-development Partner · 11 February 2026Denovo Biopharma partnered with Orygen to initiate a Phase 2 investigator-initiated trial studying DB103 (pomaglumetad methionil) for first-episode psychosis and clinical high risk of psychosis. The open-label, 12-week feasibility trial led by Professor Patrick McGorry at Orygen's Parkville, Australia facility evaluates safety, tolerability, and efficacy of twice-daily 40 mg doses in patients aged 18-25 who have shown insufficient response to first-line antipsychotics.
• Aytu BioPharmacoreOEM/ Whitelabel/ Licensing PartnerIn April 2021, Denovo Biopharma licensed Aytu BioPharma to develop DB102 (enzastaurin) for the treatment of rare genetic diseases. Denovo granted development, manufacturing, and commercial rights to Aytu BioPharma for this indication.
• Eli LillycoreOEM/ Whitelabel/ Licensing PartnerDenovo licensed global development, manufacturing, and commercial rights to DB103 (pomaglumetad methionil) from Eli Lilly. Eli Lilly had previously completed 37 clinical trials with over 3,800 subjects on the drug. Denovo is applying its biomarker discovery platform to identify responsive patient subpopulations.
• Orion Corporation / Johnson & JohnsoncoreOEM/ Whitelabel/ Licensing PartnerDenovo in-licensed DB105 (ORM-12741) from Orion Corporation and Johnson & Johnson. DB105 is a selective alpha-2C adrenoceptor antagonist being developed for Alzheimer's disease with a mechanism distinct from beta amyloid and tau-targeting approaches.
• TocagencoreOEM/ Whitelabel/ Licensing PartnerDenovo acquired DB107 from Tocagen, a two-part cancer-selective immunotherapy comprising the Toca 511 retroviral replicating vector gene therapy and 5-fluorocytosine (5-FC) prodrug. Denovo discovered the DGM7 biomarker enabling targeted clinical development for recurrent GBM.
• Sunesis PharmaceuticalscoreOEM/ Whitelabel/ Licensing PartnerDenovo in-licensed DB106 (Vosaroxin), a first-in-class non-anthracycline topoisomerase II inhibitor from Sunesis Pharmaceuticals. The drug has been dosed in over 1,200 patients across 16 clinical studies and showed significant survival improvements in poor-prognosis subpopulations in the Phase 3 VALOR trial.
• Jiangsu Wuzhong Pharmaceutical Group (江苏吴中医药集团有限公司)coreOEM/ Whitelabel/ Licensing PartnerDenovo in-licensed DB108 (recombinant human endostatin) from Jiangsu Wuzhong Pharmaceutical Group for the treatment of non-small cell lung cancer (NSCLC). The drug demonstrated good safety, tolerability, and significant efficacy benefit in median progression-free survival in a Phase 3 trial.
• LundbeckcoreOEM/ Whitelabel/ Licensing PartnerIn July 2021, Denovo in-licensed DB109 (idalopirdine) from Lundbeck, a novel selective 5-HT6 receptor antagonist for Alzheimer's disease and schizophrenia. The drug was evaluated in over 2,500 subjects across multiple clinical studies.
• University of MiamicoreStrategic or Co-development PartnerThe University of Miami received FDA IND approval and initiated an investigator-initiated clinical study on DGM7-positive recurrent GBM patients using DB107. This academic partnership advances the biomarker-guided clinical development of DB107.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Myriad Genetics: Myriad Genetics is a molecular diagnostics and companion diagnostics company that develops biomarker tests to guide treatment selection, similar to how Denovo's DGM biomarkers guide drug selection. Both companies monetize companion diagnostic IP tied to therapeutic regimens.
• Sage Therapeutics: Sage Therapeutics is a CNS-focused biopharmaceutical company developing first-in-class treatments for depression and neurological disorders, including treatment-resistant depression — a direct therapeutic overlap with Denovo's lead DB104 (liafensine) program.
• Axsome Therapeutics: Axsome Therapeutics is a CNS-focused biopharmaceutical company developing novel therapies for difficult-to-treat neurological conditions including treatment-resistant depression, sharing Denovo's CNS therapeutic focus and biomarker-guided precision approach.
• Karuna Therapeutics: Karuna Therapeutics developed xanomeline-trospium (Cobenfy) for schizophrenia, addressing similar CNS indications to Denovo's DB103 (pomaglumetad methionil) for psychosis. Recently acquired by Bristol-Myers Squibb, illustrating the partnership/acquisition exit opportunity for CNS-focused biotechs.
• Personalis: Personalis is a genomic biomarker discovery company providing whole-genome sequencing and analytics for clinical trial patient selection, mirroring Denovo's DGM platform approach of using comprehensive genomic data to identify drug-responsive patient subgroups.
• Medicinova: Medicinova is a clinical-stage biopharmaceutical company focused on repositioning compounds with established safety profiles for CNS and inflammatory indications, sharing Denovo's strategy of in-licensing late-stage drugs and developing them for underserved therapeutic areas.

Broad incumbents

• Foundation Medicine (Roche): Foundation Medicine, owned by Roche, is the largest genomic profiling company for oncology, performing comprehensive genomic profiling to identify biomarkers that guide therapy selection. It operates at greater scale but addresses the same fundamental precision medicine thesis as Denovo's DGM platform.
• Tempus AI: Tempus AI is a technology company advancing precision medicine through AI-powered genomic profiling and clinical trial matching, applying genomic biomarker data to therapy selection at scale and representing a broader incumbent version of Denovo's precision medicine thesis.

Emerging players

• Black Diamond Therapeutics: Black Diamond Therapeutics is a precision oncology company developing biomarker-guided therapies for genetically defined cancer populations, applying a similar patient stratification thesis to Denovo's oncology pipeline (DB102, DB107).
• Cogent Biosciences: Cogent Biosciences is a precision oncology company developing biomarker-targeted therapies for defined patient populations, reflecting the broader precision medicine industry approach that Denovo's biomarker-guided pipeline embodies.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/denovo-biopharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 record

Funding overview

Funding rounds5 records

Investors15 records

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M&A

Investments

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Frequently asked questions about Denovo Biopharma