DualityBio Achieves Phase 3 Success with Lead ADC Candidate, Advances Global Pipeline Across Multiple Cancer Types
核心洞察
DualityBio (搜索)'s lead ADC candidate Trastuzumab pamirtecan (DB-1303/BNT323) achieved its primary endpoint of progression-free survival in a Phase 3 trial for HER2 (搜索)+ metastatic breast cancer, with a BLA submitted to China's NMPA.
The company's B7-H3 (搜索)-targeting ADC DB-1311/BNT324 demonstrated promising efficacy in heavily pretreated metastatic castration-resistant prostate cancer patients, with median radiographic progression-free survival of 11.3 months and overall survival of 22.5 months.
DualityBio (搜索) has enrolled over 3,200 patients across its 10 clinical-stage ADC candidates globally, with strategic partnerships totaling over $6 billion in transaction value with companies including BioNTech, GSK, and Avenzo (搜索).
DualityBio (搜索) has achieved a significant milestone with its lead antibody-drug conjugate (ADC) candidate reaching Phase 3 success, while advancing a robust pipeline of next-generation cancer therapeutics across multiple tumor types. The clinical-stage biotechnology company reported substantial progress across its ADC portfolio in 2025, with over 1,200 new patients enrolled in global trials.
Lead ADC Achieves Phase 3 Milestone
Trastuzumab pamirtecan (DB-1303/BNT323), DualityBio (搜索)'s HER2 (搜索)-targeting ADC, achieved a critical regulatory milestone in September 2025 when the Independent Data Monitoring Committee confirmed the Phase 3 DYNASTY-Breast01 trial had met its primary endpoint of progression-free survival. The trial evaluated DB-1303/BNT323 versus T-DM1 in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab and taxane.
The company has submitted a Biologics License Application to China's National Medical Products Administration for the treatment of breast cancer, which is currently under formal review. Partner BioNTech plans to submit a BLA to the U.S. FDA in 2026 for HER2 (搜索)-expressing endometrial cancer based on a completed registrational cohort from a global Phase 1/2 trial.
B7-H3-Targeting ADC Shows Broad Tumor Activity
DB-1311/BNT324, targeting the B7-H3 (搜索) antigen, has demonstrated significant clinical activity across multiple solid tumor types. In heavily pretreated metastatic castration-resistant prostate cancer patients, updated data from 146 patients presented at the ASCO Genitourinary Cancers Symposium in February 2026 showed a median radiographic progression-free survival of 11.3 months and median overall survival of 22.5 months.
The safety profile remained manageable, with Grade ≥3 treatment-related adverse events occurring in 20.0% of patients in the 6 mg/kg dose group, and a treatment-related discontinuation rate of 5.5%. No treatment-related deaths were reported.
The ADC also showed promise in gynecological cancers. In previously treated cervical cancer patients, DB-1311/BNT324 achieved a confirmed objective response rate of 33.3% and disease control rate of 86.7%, with median progression-free survival of 7.0 months. In platinum-resistant ovarian cancer patients, the confirmed objective response rate reached 58.3%.
Based on these results, the first global Phase 3 trial comparing DB-1311/BNT324 to docetaxel in taxane-naïve metastatic castration-resistant prostate cancer patients is planned to start in 2026.
HER3-Targeting ADC Earns FDA Fast Track Designations
DB-1310, targeting the HER3 (搜索) antigen, has received two Fast Track Designations from the FDA and shown clinical activity in both non-small cell lung cancer and breast cancer. In EGFR (搜索)-mutated NSCLC patients, the ADC demonstrated a confirmed objective response rate of 28.3% and median progression-free survival of 7.03 months across dose levels of 1.5-6.5 mg/kg in 172 subjects.
In pretreated HR+/HER2 (搜索)- breast cancer patients receiving 5.0-5.5 mg/kg doses, DB-1310 achieved a confirmed objective response rate of 50.0% and disease control rate of 94.4%, with a manageable safety profile primarily involving Grade 1-2 events.
Expanding Pipeline and Strategic Partnerships
DualityBio (搜索) has established a comprehensive global partnership network with transaction values exceeding $6 billion. Key collaborations include partnerships with BioNTech for combination therapies exploring next-generation immunooncology approaches, combining ADCs with bispecific antibodies.
The company is advancing several next-generation candidates, including DB-2304, a potential first-in-class ADC for systemic lupus erythematosus that has entered Phase 2a development, and multiple bispecific ADCs targeting various solid tumor indications.
Commercial Preparation and Global Expansion
To prepare for commercialization, DualityBio (搜索) has established a core commercial team and entered into a collaboration agreement with 3SBIO (搜索) Inc. to leverage contract sales organization capabilities for Trastuzumab pamirtecan launch preparations in China. The company has also proposed listing RMB-denominated shares on the Shanghai Stock Exchange's Science and Technology Innovation Board.
With global clinical trials spanning 17 countries and over 300 clinical centers, DualityBio (搜索) has enrolled more than 3,200 patients cumulatively across its clinical-stage ADC candidates, with approximately 50% of new enrollments in 2025 occurring outside China in the U.S., EU, and Australia.