HONG KONG, March 24, 2026 /PRNewswire/ — Duality Biotherapeutics, Inc. (Hong Kong Stock Exchange Code: 09606.HK, hereinafter referred to as “DualityBio” or the “Company”), a leading global clinical-stage innovative biopharmaceutical company, today announced its first annual results since listing on April 15, 2025 (for the year ended December 31, 2025), providing a comprehensive update on its global clinical pipeline and corporate operations.
Dr. John Zhu, Founder, founder and Chief Executive Officer of DualityBio, stated:
“Over the past decade, the innovative pharmaceutical industry has evolved from partial exploration to systematic development. Today, we stand at a brand-new starting point – an era that is more open, more uncertain yet more imaginative. Technological advancement is reshaping industry boundaries, global clinical and regulatory systems are gradually integrating, and innovation is no longer confined to a single region but occurs collaboratively worldwide, marking the ‘Great Voyage Era of Innovative Drugs’. In 2025, DualityBio anchored on innovation and forged ahead steadily in the ADC track. Leveraging the profound accumulation of our four core technology platforms, we drove the full-speed advancement of core assets: the enrollment of over 3,200 patients globally has verified our R&D strength and original aspiration for global layout; in-depth collaborations with partners such as BioNTech and Avenzo have continuously amplified innovation value, injecting strong momentum for long-term development.
In 2026, we will build on this momentum to accelerate the commercialization of core products, deepen pipeline iteration and technological breakthroughs, and steadily advance the A-share listing plan, responding to every expectation with a clearer growth path and more solid performance. The road to innovation is long and challenging. DualityBio will always be guided by unmet clinical needs, keep forging ahead in the journey of overcoming intractable diseases, and embark on a journey of value growth with all partners.”
Financial Highlights
During the reporting period, the Company achieved total revenue of RMB1.852 billion , providing a solid financial foundation for the continuous advancement of business. R&D investment remained at a high level, with annual R&D expenses reaching RMB838 million; the adjusted loss for the year was RMB389 million (calculated by deducting the fair value change of preferred shares issued prior to the Global Offering from the loss for the year. Such fair value changes arose from the preferred shares issued in connection with previous equity financings prior to the Global Offering on April 15, 2025. From this date onward, these preferred shares ceased to exist, and there will be no further profit or loss impact of this nature in subsequent financial periods). The Company maintained a healthy cash flow position, with cash and bank balances of RMB3.325 billion as of the end of the period (comprising cash and cash equivalents, restricted cash and term deposits with initial term over three months), and achieved a net cash inflow from operating activities of RMB195 million, which has been positive for three consecutive years, providing sufficient capital support for the Company’s long-term growth, subsequent pipeline advancement, clinical research and commercialization layout.
Milestone of First-Wave Assets: Pivotal Clinical and Regulatory Progress
In 2025, DualityBio drove the accelerated global clinical progress of its ADC pipeline relying on four core technology platforms. The Company currently has 10 clinical stages self-developed ADC candidates. Global clinical trials have enrolled over 3,200 patients cumulatively, with more than 1,200 new patients enrolled in 2025 alone, of which approximately 50% are located in the U.S., EU, Australia and other regions outside China, covering 17 countries and over 300 clinical centers, fully verifying the Company’s global clinical development capabilities.
The clinical development of Trastuzumab pamirtecan (DB-1303/BNT323 or “T-
Pam”) achieved a milestone breakthrough in 2025. In September 2025, the Independent Data Monitoring Committee (“IDMC”) reviewed the interim data of a Phase 3 registrational trial (DYNASTY-Breast01; NCT06265428) and confirmed that the trial had achieved the primary endpoint of Progression-Free Survival (“PFS”), as evaluated by Blinded Independent Central Review (“BICR”), relative to the control arm. This trial is conducted in China to evaluate the efficacy of DB-1303/BNT323 versus T-DM1 in patients with HER2+ unresectable and/or metastatic Breast Cancer (“BC”) previously treated with trastuzumab and taxane. Another Phase 3 trial of the product in China (NCT06265428) targets patients with HER2+ unresectable/metastatic breast cancer previously treated with trastuzumab and taxane, and the Biologics License Application (“BLA”) has been submitted to the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration (“NMPA”), which is currently in the formal acceptance and review stage. A potential registrational cohort in a global Phase 1/2 trial for HER2-expressing advanced/recurrent Endometrial Cancer (“EC”) has completed enrollment, and partner BioNTech plans to submit a BLA to the U.S. Food and Drug Administration (“FDA”) in 2026. In addition, the global Phase 3 trial of the product (DYNASTY-Breast02; NCT06018337) completed enrollment …