DualityBio files China application for breast cancer therapy

SHANGHAI, April 9, 2026 /PRNewswire/ -- DualityBio ("DualityBio" or the "Company", Stock Code: 9606.HK) today announced that the Biologics License Application (BLA) for the investigational antibody-drug conjugate ("ADC") trastuzumab pamirtecan ("T-Pam", also known as DB-1303 or BNT323), has been accepted for review by the China National Medical Products Administration (NMPA). With the BLA filing, DualityBio is seeking approval for trastuzumab pamirtecan as second-line treatment for patients with unresectable or metastatic HER2-positive breast cancer. The application is based on positive interim results from the pivotal Phase III clinical trial (Study DB-1303-O-3001).

The DB-1303-O-3001 trial is a randomized, controlled, open-label, multicenter Phase III clinical trial conducted in China. It aims to evaluate the efficacy and safety of trastuzumab pamirtecan compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane chemotherapy. As assessed by the Independent Data Monitoring Committee (IDMC), the trial has met its primary endpoint of statistically significant improvement of progression-free survival (PFS, assessed by Blinded Independent Central Review, BICR) for trastuzumab pamirtecan compared to T-DM1 at a pre-specified interim analysis.

Dr. Hua Mu, Global Chief Medical Officer of DualityBio, stated: "China has over 350,000 new breast cancer cases annually [1], representing a high incidence rate and ranking as the second most common cancer among Chinese women. We are delighted to see that DB-1303/T-Pam has achieved a milestone in its commercialization progress, demonstrating its potential to provide an effective new treatment option for breast cancer patients. In the China market, we have entered into a collaboration with 3SBio to jointly advance the commercialization of multiple indications of DB-1303/T-Pam in Chinese mainland, Hong Kong and Macao. Globally, we will continue to deepen our global strategic partnership with BioNTech to further drive the global development of this product. DB-1303/T-Pam is a globally co-developed new drug with strong strategic partners in both China and global markets. We will work closely together to accelerate the product's marketing approval process, maximize its global clinical value, present more treatment options to patients worldwide."

For more information, please visit www.dualitybiologics.com