DualityBio Advances Global ADC Pipeline and Commercialisation Strategy in First Post-Listing Results

HONG KONG, March 24, 2026: Duality Biotherapeutics, Inc. (9606.HK) reported its first full-year results since listing in April 2025, highlighting strong progress across its global clinical pipeline, strategic collaborations and early commercialisation preparations in the fast-evolving antibody-drug conjugate (ADC) space.

The clinical-stage biopharmaceutical company recorded total revenue of RMB1.852 billion for the year ended December 31, 2025, supported by sustained investment in research and development, which stood at RMB838 million. The company reported an adjusted loss of RMB389 million, reflecting its continued focus on advancing pipeline assets.

DualityBio maintained a solid liquidity position, with cash and bank balances of RMB3.325 billion and positive operating cash flow for the third consecutive year, providing a strong financial base for ongoing clinical development and future commercialisation.

Flagship Asset Drives Regulatory Momentum

A key highlight for the year was the clinical and regulatory advancement of DualityBio’s lead asset, Trastuzumab pamirtecan (DB-1303/BNT323), developed in partnership with BioNTech.

In 2025, a Phase 3 trial in HER2-positive metastatic breast cancer met its primary endpoint of progression-free survival, marking a significant milestone. The company has since submitted a Biologics License Application to China’s National Medical Products Administration, with the application currently under review.

In parallel, global development continues to progress, including ongoing trials in endometrial cancer and HER2-low breast cancer, with additional data expected in 2026.

Expanding ADC Pipeline Shows Broad Clinical Potential

DualityBio continued to advance a diversified pipeline of 10 clinical-stage ADC candidates, supported by four proprietary technology platforms.

The company has enrolled more than 3,200 patients globally across 17 countries and over 300 clinical centres, reinforcing its international clinical development capabilities. Approximately half of new patient enrolments in 2025 were outside China, including the United States, Europe and Australia.

Among its pipeline assets, DB-1311/BNT324, targeting the B7-H3 antigen, demonstrated encouraging efficacy across multiple solid tumour indications, including prostate, cervical and ovarian cancers. Updated clinical data showed improved progression-free survival and overall survival outcomes in heavily pretreated patient populations.

Another candidate, DB-1310, targeting HER3, achieved key clinical milestones in lung and breast cancers and received two Fast Track Designations from the U.S. Food and Drug Administration, accelerating its regulatory pathway.

Strategic Collaborations Strengthen Global Positioning

Partnerships remain central to DualityBio’s growth strategy. The company has established collaborations with leading global pharmaceutical and biotechnology players, including BioNTech, GlaxoSmithKline, Avenzo, Adcendo and BeOne.

These partnerships, with a combined transaction value exceeding US$6 billion, reflect strong external validation of the company’s technology platforms and pipeline potential.

In addition, DualityBio is actively exploring next-generation combination therapies, particularly integrating ADCs with immuno-oncology approaches, including bispecific antibodies. Early-stage trials combining its ADC candidates with PD-L1-based therapies are underway, with data expected in 2026.

Pipeline Expansion and Next-Generation Innovation

Beyond its core assets, DualityBio continues to expand its pipeline with next-generation ADCs and bispecific ADCs targeting both oncology and autoimmune diseases.

New candidates such as DB-2304 for lupus, DB-1418 for advanced solid tumours, and DB-1324, licensed to GSK for development outside Greater China, highlight the company’s strategy to diversify across therapeutic areas while leveraging its core ADC technology platforms.

Several of these assets have already entered early-stage global clinical trials, reinforcing the company’s long-term innovation pipeline.

Commercialisation Preparations Gain Momentum

As its lead assets approach potential approval, DualityBio has begun building its commercial infrastructure, particularly in China.

The company has established a core commercial team and entered into a collaboration with 3SBIO to support market access, medical affairs and channel management for DB-1303 in Mainland China, Hong Kong and Macau.

This marks an important step in transitioning from a research-focused organisation to a fully integrated biopharmaceutical company with commercial capabilities.

Outlook: Scaling Innovation and Global Growth

Looking ahead, DualityBio is expected to focus on accelerating commercialisation of its core products, advancing pipeline development and strengthening its global footprint.

The company is also progressing plans for a potential A-share listing in Shanghai, signalling its ambition to deepen access to capital markets and support long-term growth.

With a robust pipeline, strong global partnerships and increasing regulatory momentum, DualityBio is positioning itself as a key emerging player in the global ADC landscape, targeting unmet clinical needs in oncology and beyond.