SHANGHAI, China, April 9, 2026
DualityBio has announced that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for its investigational antibody-drug conjugate (ADC) trastuzumab pamirtecan (T-Pam), marking a critical regulatory milestone toward potential approval for treating unresectable or metastatic HER2-positive breast cancer. The application is supported by positive interim Phase III clinical trial results, positioning the therapy as a promising new option in the rapidly evolving oncology landscape.
Phase III Data Demonstrates Strong Clinical Benefit
The BLA submission is based on results from the pivotal Phase III clinical trial (DB-1303-O-3001), a randomized, controlled, multicenter study conducted in China comparing trastuzumab pamirtecan with trastuzumab emtansine (T-DM1) in patients who had previously received standard therapies. The study successfully met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) as assessed by blinded independent central review.
This achievement highlights the clinical superiority of the investigational ADC, reinforcing its potential to address a major unmet need in oncology. Breast cancer remains one of the most prevalent cancers globally, with over 350,000 new cases reported annually in China alone, emphasizing the urgency for more effective and targeted treatment options. The ability of trastuzumab pamirtecan to deliver enhanced anti-tumor activity with a manageable safety profile further strengthens its positioning as a next-generation therapy.
Advanced ADC Technology Targets HER2 Tumors
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Trastuzumab pamirtecan represents a third-generation ADC, built using DualityBio’s proprietary DITAC (Duality Immune Toxin Antibody Conjugates) platform, which combines targeted monoclonal antibodies with potent cytotoxic payloads. The therapy specifically targets the HER2 receptor, a protein associated with aggressive tumor growth and poor prognosis in several cancers.
What sets this ADC apart is its ability to target tumors with varying levels of HER2 expression, including HER2-low and HER2-ultra-low tumors, significantly expanding its potential patient population. Preclinical and early clinical data have demonstrated robust anti-tumor activity across multiple solid tumor types, including breast and endometrial cancers, as well as other advanced malignancies. This broader targeting capability reflects a major advancement in precision oncology, enabling more patients to benefit from targeted biologic therapies.
Global Development and Regulatory Momentum
The acceptance of the BLA by the NMPA marks a key step in DualityBio’s strategy to accelerate global commercialization and regulatory approvals. The company is actively collaborating with 3SBio for commercialization in China and maintaining a strategic global partnership with BioNTech to drive international development of the therapy.
In addition to its progress in China, the ADC program has received Fast Track and Breakthrough Therapy designations from the U.S. FDA, reflecting its potential to deliver clinically meaningful improvements over existing therapies. DualityBio is currently conducting multiple global clinical trials across 17 countries, with over 3,200 patients enrolled, demonstrating a strong commitment to advancing innovative cancer treatments worldwide.
From a cGxP perspective, this milestone underscores the importance of GCP-compliant clinical trials, GMP-controlled biologics manufacturing, and rigorous regulatory review processes. The transition from late-stage clinical development to regulatory submission highlights the complexity of biologics development and quality assurance, particularly for advanced modalities like ADCs that require precise conjugation, stability control, and safety validation.
The acceptance of the BLA for trastuzumab pamirtecan by China’s regulatory authority represents a significant advancement in the field of oncology therapeutics, reinforcing DualityBio’s position as a leader in next-generation ADC development. By demonstrating superior clinical efficacy, expanded targeting capabilities, and strong regulatory momentum, this therapy has the potential to transform treatment options for patients with HER2-positive and HER2-low breast cancer. As the global demand for precision medicine and targeted biologics continues to grow, innovations like trastuzumab pamirtecan are expected to play a pivotal role in shaping the future of cancer care and improving patient outcomes worldwide.
Source: DualityBio press release
