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 in February 2026, targeting advanced or metastatic HR+, HER2-low breast cancer, with interim data expected to be available in 2026.

As the Company's core ADC product targeting the B7-H3 antigen, DB-1311/BNT324 has continuously released positive clinical data in multiple solid tumor indications. In June 2025, the Company presented data from 73 heavily pretreated patients with metastatic Castration-Resistant Prostate Cancer ("mCRPC") at the American Society of Clinical Oncology ("ASCO") Annual Meeting; the 6-month Radiographic Progression-Free Survival ("rPFS") rate was 67.7% (as of March 4, 2025). In February 2026, at the ASCO Genitourinary ("GU") Cancers Symposium, the Company further presented updated data from 146 heavily pretreated mCRPC patients, with a median rPFS of 11.3 months and a median Overall Survival ("mOS") of 22.5 months; in patients with no prior exposure to Lutetium-177 ("Lu-177"), the median rPFS reached 13.6 months; in patients who had previously received Lu-177 (with a median of 5 prior lines of therapy), the median rPFS remained 11.3 months, and the median OS was not yet reached. Safety findings were consistent with prior reports; nausea and hematologic events were the most common adverse events and were mainly Grade 1-2; in the 6 mg/kg dose group (n=110), the incidence of Grade ≥3 Treatment-Related Adverse Events ("TRAE") was 20.0%, the discontinuation rate due to TRAE was 5.5%, and no treatment-related deaths were reported. Meanwhile, the product also demonstrated considerable potential in gynecological tumors. Data presented at the European Society for Medical Oncology ("ESMO") Asia Congress in December 2025 showed that in previously treated cervical cancer patients (n=30), DB-1311/BNT324 achieved an Unconfirmed Objective Response Rate ("uORR") of 43.3%, a Confirmed Objective Response Rate ("cORR") of 33.3%, a Disease Control Rate ("DCR") of 86.7%, and a median Progression-Free Survival ("mPFS") of 7.0 months; in Platinum-Resistant Ovarian Cancer ("PROC") patients (n=12), the cORR was 58.3%, DCR was 75.0%, and mPFS was 8.2 months. The above data fully confirm the broad application potential of the product in various solid tumors. Based on the excellent preliminary data, the first global Phase 3 trial (NCT07365995) evaluating DB-1311/BNT324 compared to docetaxel in taxane-naïve mCRPC patients is planned to start in 2026, with primary endpoints of PFS and OS.

As an innovative ADC developed by the Company targeting the HER3 antigen, DB-1310 has achieved important clinical breakthroughs in both Non-Small Cell Lung Cancer ("NSCLC") and breast cancer("BC " ), and obtained two Fast Track Designations from the U.S. FDA. In June 2025, the Company presented clinical data from patients with Epidermal Growth Factor Receptor mutation ("EGFRm") NSCLC at the ASCO Annual Meeting. As of April 11, 2025, across the 1.5 mg/kg to 6.5 mg/kg dose range in 172 subjects, DB-1310 demonstrated a manageable safety profile, with Grade ≥3 TRAE occurring in 36% of patients and a low treatment-related discontinuation rate of 3.5%; among 46 efficacy-evaluable patients, the uORR was 43.5%, cORR was 28.3%, DCR was 91.3%, mPFS was 7.03 months, and mOS was 18.89 months; in the 5 mg/kg dose group (n=16), the cORR was 37.5%, DCR was 87.5%, mPFS was 8.28 months, and mOS was not reached. In December 2025, at the San Antonio Breast Cancer Symposium ("SABCS"), the Company presented data from pretreated HR+/HER2- breast cancer patients. In patients receiving DB-1310 at doses of 5.0-5.5 mg/kg (n=18), DB-1310 achieved a uORR of 55.6%, a cORR of 50.0%, and a confirmed DCR of 94.4%, with a manageable safety profile primarily involving Grade 1-2 hematologic and gastrointestinal events, a TRAE-related discontinuation rate of 4.5%, and no new safety signals. At the regulatory level, the R&D process of DB-1310 has been accelerated: in July 2025, it received Fast Track Designation from the FDA for the treatment of adult patients with advanced, unresectable or metastatic non-squamous NSCLC with an EGFR exon 19 deletion or L858R mutation who have progressed on or after treatment with a third-generation EGFR Tyrosine Kinase Inhibitor ("TKI") and platinum-based chemotherapy; in December 2025, it received an additional Fast Track Designation from the FDA for the treatment of adult patients with advanced/unresectable or metastatic HR-positive/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy, CDK4/6 inhibitor, with or without chemotherapy for unresectable or metastatic disease, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Deepen Global Cooperation and Unleash Strategic Synergies

DualityBio continues to advance the "Duality Flywheel Model", deepen global cooperation, and maximize the value of self-developed assets. The Company has established a robust global cooperation network, entering into multiple out-licensing and collaboration agreements with leading industry players worldwide, including core partners such as BioNTech, BeOne, Adcendo, GlaxoSmithKline ("GSK") and Avenzo, with a total transaction value exceeding US$6 billion, fully demonstrating the industry's high recognition of the Company's independent R&D technology platforms.

Exploration of IO2.0+ADC Combination Therapies

Next-generation IO+ADC combination therapy is a core development trend in the global biopharmaceutical industry. The "bispecific antibody + ADC" combination can not only improve the efficacy of indications already covered by bispecific antibody combined with chemotherapy but also expand the scope of indications that cannot be covered by existing therapies, making it an important development direction in the field of tumor treatment. The Company is collaborating with BioNTech to explore the combination potential of DB-1303/BNT323, DB-1311/BNT324 and DB-1305/BNT325 with pumitamig (PD-L1xVEGF bispecific antibody) to expand their frontline application in various solid tumors.

DB-1303/BNT323 in Combination with Pumitamig: In May 2025, the first patient was dosed in a global Phase 1/2 clinical trial evaluating the combination therapy in patients with HR+ or HR-, HER2-low, ultralow, or null advanced metastatic breast cancer or Triple-Negative Breast Cancer ("TNBC"), with trial data expected to be available in 2026.

DB-1311/BNT324 in Combination with Pumitamig: In May 2025, the first patient was dosed in a global Phase 1/2 clinical trial evaluating the combination therapy in patients with advanced lung cancers; in July 2025, the first patient was dosed in a global Phase 2 clinical trial evaluating DB-1311/BNT324 in combination with pumitamig or with DB-1305/BNT325 in patients with advanced solid tumors, with data from both trials expected to be available in 2026. For DB-1311, DualityBio holds an exclusive option to share the development and commercialization costs and profits and losses from the exploitation of the first DB-1311 product in the United States, in accordance with the terms set out in the agreement. As of the date of this announcement, the Company has not exercised this cost & profit/loss sharing option and retains the right to do so in the future.

DB-1305/BNT325 in Combination with Pumitamig Clinical Readout: In April 2025, the first clinical data evaluating the combination of pumitamig and DB-1305/BNT325 were presented at the 2025 American Association for Cancer Research ("AACR") Annual Meeting. Interim data from 67 patients showed that the combination therapy had a manageable safety profile with a low incidence of overlapping toxicities and early signs of anti-tumor activity in patients with PROC, NSCLC or TNBC; among evaluable PROC patients (n=13), seven achieved partial response and three had stable disease.

In addition, DualityBio has established cooperative partnerships with companies such as BeOne, Adcendo, GSK and Avenzo, leveraging complementary advantages in R&D and global commercialization to jointly drive value growth.

Next-Generation Innovation Progress: Continuously Expand Moat with Diversified Platforms and Product Pipelines

In addition to first-wave core assets, the Company has advanced the rapid development of a series of high-potential ADCs and Bispecific ADCs ("BsADCs"):

DB-2304 (BDCA2 ADC): A potential First-in-class ADC for the treatment of Systemic Lupus Erythematosus ("SLE") and Cutaneous Lupus Erythematosus ("CLE"), with the first patient dosed in the Phase 2a study. Data from a Phase 1 randomized controlled study (Clinical Trial Code: NCT06625671, Phase 1/2a study) was presented orally at the 53rd Autumn Immunology Conference ("AIC 2025"). The results showed that DB-2304 was generally safe and well-tolerated in healthy subjects, with linear Pharmacokinetics ("PK") characteristics, and could effectively bind to the target, verifying its pharmacologic mechanism.

DB-1418/AVZO-1418 (EGFR×HER3 BsADC): Partner Avenzo has announced the first patient dosed in the Phase 1 portion of a global Phase 1/2 trial in patients with advanced solid tumors. In November 2025, Avenzo announced that DB-1418/AVZO-1418 received Fast Track Designation from the FDA for the treatment of patients with unresectable, locally advanced, or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R mutation whose disease has progressed on or after therapy with an EGFR TKI.

DB-1419 (B7-H3×PD-L1 BsADC): Currently the only B7-H3×PD-L1 BsADC under clinical development globally, a global Phase 1/2a trial is being conducted in patients with advanced/metastatic solid tumors and is currently enrolling patients.

DB-1317 (ADAM9 ADC): A next-generation ADC targeting ADAM9, a highly expressed antigen in gastrointestinal cancers, a global Phase 1a/1b trial is being conducted in patients with selected advanced/metastatic solid tumors and is currently enrolling patients.

DB-1324 (CDH17 ADC): Licensed to GSK for development outside Greater China, received IND clearance from the FDA in December 2025, and a global Phase 1/2 clinical trial is being conducted in patients with advanced/metastatic gastrointestinal tumors and is currently enrolling patients.

2026: Build on Momentum and Forge Ahead

To fully prepare for commercialization in the Chinese market, DualityBio has established a core commercial team, with senior leaders appointed in key functional areas including strategic planning, market access and commercial partner management. In January 2025, DualityBio entered into a collaboration agreement with 3SBIO Inc. (HKEX: 1530, "3SBIO"), leveraging its professional Contract Sales Organization ("CSO") capabilities to accelerate launch preparations for Trastuzumab pamirtecan, ensuring rapid and targeted access to key markets and customer segments. In the Territory (Mainland China, Hong Kong and Macau), 3SBIO will also provide related commercialization services – including market access, medical affairs, and channel management – to support the product's commercial activities. The Company has submitted a BLA to the CDE for Trastuzumab pamirtecan (DB-1303) for the treatment of breast cancer. Globally, partner BioNTech is also actively advancing the process of submitting a BLA to the U.S. FDA for HER2-expressing endometrial cancer.

In addition to clinical execution, in line with the Company's global development and domestic commercialization layout, on October 17, 2025, the Board of Directors of the Company resolved to propose the issuance of RMB-denominated ordinary shares to be listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange.

Looking ahead, DualityBio will always implement the strategic original aspiration of "Global Team, Global Clinical Trials, Global Market", aiming to evolve into a global leading pharmaceutical enterprise and provide therapeutic options for patients worldwide.

About DualityBio

DualityBio (HKEX:09606) is a clinical-stage biotechnology company dedicated to the discovery and development of next-generation antibody-drug conjugates to treat cancer and autoimmune diseases.DualityBio has built several advanced ADC technology platforms with global intellectual property protection. Leveraging a robust pipeline, the company is conducting multiple global clinical trials across 17 countries and has enrolled more than 3,200 patients across its clinical-stage ADC candidates.

The company has established strategic collaborations with global pharmaceutical companies and biotechnology innovators to accelerate the development and commercialisation of its therapies.

For more information, please visit: www.dualitybiologics.com

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