Research&Development
Technology
Platform

With our experienced R&D team, profound insights into ADC design, and strong execution capabilities, we have created four leading ADC technology platforms: DITAC, DIBAC, DIMAC, and DUPAC, to break through the boundaries of ADC therapy. Our technology platform serves as the foundation for continuous innovation and value creation, and its value and diversity have been validated in our pipeline assets and recognized by multinational pharmaceutical partners.

Researching Pipelines
DITAC - Leading TOP1i ADC Platform
Program
Target
Indications
(lines of treatment)
Mono/
Combo
Preclinical/
IND-Enabling
Phase 1
Phase 1/2a
Phase 2
Phase 3
Commercial Rights
Partners
More

DB-1303
/BNT323

HER2

  • HER2-expressing EC (2L+)
    Mono
    Global (Single-arm, Potential Registrational Study)

  • HER2-expressing EC (2L+)
    Mono
    Global (Single-arm, Potential Registrational Study)

  • HR+/HER2-low BC (chemo naïve)
    Mono
    Global

  • HER2+ BC (2L+)
    Mono
    China

  • HER2+ BC (1L)
    +Pertuzumab
    Global

  • Solid Tumors (OC, CRC, esophageal cancer, etc.)
    Mono
    Global

Mainland China, Hong Kong, Macau

More

DB-1311/BNT324

B7-H3

  • SCLC (2L+)
    Mono
    Global

  • CRPC (late line)
    Mono
    Global

  • ESCC (2L+)
    Mono
    Global

  • NSCLC (2L+)
    Mono
    Global

  • Solid Tumors
    Mono
    Global

Mainland China, Hong Kong, Macau (U.S.: Option to Co-develop and Co-commercialize)

More

DB-1310

HER3

  • EGFRm NSCLC (TKI-resistant)
    + Osimertinib
    Global

  • KRASm NSCLC (2L+)
    Mono
    Global

  • HER2+ BC (Post-Enhertu)
    + Trastuzumab
    Global

  • Solid Tumors (CRPC, HNSCC, ESCC, BTC, etc.)
    Mono
    Global

Global

More

DB-1305 /BNT325

TROP2

  • OC (2L+)
    Mono
    Global

  • NSCLC (2L+)
    Mono
    Global

  • NSCLC, OC, CC, TNBC (multiple lines)
    +PD-L1/VEGF bsAb
    Global

  • Solid Tumors (CC, TNBC, etc.)
    Mono
    Global

Mainland China, Hong Kong, Macau

Coming soon

DB-1312 /BG-C9074

B7-H4

  • Solid Tumors
    Mono / + Tislelizumab
    Global

/

Coming soon

DB-1314

Undisclosed

  • Solid Tumors
    Mono

Global

Coming soon

DB-1317

Undisclosed

  • Solid Tumors
    Mono

Global

Coming soon

DB-1324

Undisclosed

  • Solid Tumors
    Mono

Mainland China, Hong Kong, Macau

DIBAC - Leading Bispecific ADC Platform
Program
Target
Indications
(lines of treatment)
Mono/
Combo
Preclinical/
IND-Enabling
Phase 1
Phase 1/2a
Phase 2
Phase 3
Commercial Rights
Partners
Coming soon

DB-1419

B7-H3 x PD-L1

  • Solid Tumors
    Mono
    Global

Global

Coming soon

DB-1418

HER3 x EGFR

  • Solid Tumors
    Mono

China

Coming soon

DB-1421

Undisclosed

  • Solid Tumors
    Mono

Global

DUPAC - Unique Novel MOA Payload ADC Platform
Program
Target
Indications
(lines of treatment)
Mono/
Combo
Preclinical/
IND-Enabling
Phase 1
Phase 1/2a
Phase 2
Phase 3
Commercial Rights
Partners
Coming soon

DB-1316

Solid Tumors

  • Undisclosed
    Mono

Global

DIMAC - Leading Immune-modulating ADC Platform
Program
Target
Indications
(lines of treatment)
Mono/
Combo
Preclinical/
IND-Enabling
Phase 1
Phase 1/2a
Phase 2
Phase 3
Commercial Rights
Partners
Coming soon

DB-2304

BDCA2

  • SLE、CLE
    Mono
    Global

Global

Core Products Key Products FDA Breakthrough Therapy Designation NMPA Breakthrough Therapy Designation FDA Fast Track Designation FDA Orphan Drug Designation

Note: 1. Expected trial completion date on ClinicalTrials.gov
Mono = Monotherapy, Combo = Combination Therapy, IND= Investigational New Drug, NCT = National Clinical Trial, ADC = Antibody-drug Conjugate, HER2 = Human Epidermal Growth Factor Receptor 2, HER2-expressing = HER2 Status of Tumor Cells Identified with a Test Score of IHC 1+ or Above, EC = Endometrial Cancer, HR+ = Hormone Receptor Positive, HER2-low=HER2 Status of Tumor Cells Identified with a Test Score of IHC 1+ or IHC 2+/ISH-, BC = Breast Cancer, Chemo = Chemotherapy, HER2+ = HER2 Status of Tumor Cells Identified with a Test Score of Either IHC 3+ or IHC 2+/ISH+, OC = Ovarian Cancer, CRC = Colorectal Cancer, SCLC = Small Cell Lung Cancer, NSCLC = Non-small Cell Lung Cancer, HER3 = Human Epidermal Growth Factor Receptor 3, EGFRm = EGFR Mutant, TKI = Tyrosine Kinase Inhibitor, KRASm = Kirsten Rat Sarcoma Virus Mutant, CRPC = Castration-resistant Prostate Cancer, HNSCC = Head and Neck Squamous Cell Carcinoma, BTC = Biliary Tract Cancer, TROP2= Human Trophoblast Cell-surface Antigen 2, CC = Cervical Cancer, TNBC = Triple-negative Breast Cancer, PD-L1 = PD-1 Ligand 1, VEGF = Vascular Endothelial Growth Factor, bsAb = Bispecific Antibody, EGFR = Epidermal Growth Factor Receptor, BDCA2 = Blood Dendritic Cell Antigen 2, MOA = Mechanism of Action, SLE = Systemic Lupus Erythematosus, CLE = Cutaneous Lupus Erythematosus, FDA = U.S. Food and Drug Administration, NMPA = National Medical Products Administration of the PRC

Commercialization

DualityBio's commercialization strategy will integrate a variety of business models, including licensing, co-promotion, and direct sales, to flexibly adapt to different market environments and maximize product value and market coverage.

 

Currently, the company is fully committed to building a professional and highly efficient core commercialization team, covering key functional areas such as market access, marketing, post-launch medical support, channel operation management, and partnership management. This team will be responsible for formulating and implementing commercialization strategies in the Greater China region. The team is dedicated to establishing and strengthening core commercialization capabilities in market access, distribution network development, and brand strategy planning in the Greater China region, laying a solid foundation for the successful launch and market promotion of products. Meanwhile, we have established close cooperation with outstanding domestic partners, leveraging their professional contract sales organization (CSO) capabilities to fully advance the launch preparations for our first commercialized product, ensuring that the product can quickly and accurately reach the target market and customer base.

 

In markets outside the Greater China region, we have licensed the rights to our first commercialized product to excellent overseas partners. By leveraging their extensive resources and expertise in the international market, we aim to accelerate the global commercialization of the product, further expand our market footprint, and enhance our brand's international influence.