#China #Shanghai #Cancer Treatment #DualityBio #Trastuzumab Pamirtecan

DualityBio Achieves Milestone: NMPA Acceptance for Trastuzumab Pamirtecan

In a significant development for cancer treatment, DualityBio has announced that its application for Trastuzumab pamirtecan has been accepted for review by the National Medical Products Administration (NMPA) of China. Known by its code names T-Pam, DB-1303, or BNT323, this experimental antibody-drug conjugate (ADC) is proposed as a second-line treatment for patients suffering from unresectable or metastatic HER2-positive breast cancer. The approval request is based on promising interim results from a pivotal Phase III clinical trial, identified as study DB-1303-O-3001.

Clinical Trial Insights

The clinical trial, DB-1303-O-3001, is a randomized, open-label, multicenter study conducted across China. It is designed to assess the efficacy and safety of Trastuzumab pamirtecan compared to the currently used drug Trastuzumab emtansine (T-DM1) in patients who have already undergone chemotherapy based on trastuzumab and taxanes. The trial has achieved its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) for those treated with Trastuzumab pamirtecan as evidenced by assessments from an independent data monitoring committee (IDMC).

Dr. Hua Mu, Global Chief Medical Officer at DualityBio, stressed the urgency of effective cancer treatments in China where breast cancer incidence is alarmingly high, citing over 350,000 new cases annually, making it the second most common cancer among Chinese women. He expressed excitement over this milestone for T-Pam, highlighting its potential to provide a crucial new therapeutic option for breast cancer patients.

Strategic Collaborations

In navigating the commercial path for Trastuzumab pamirtecan, DualityBio has established a partnership with 3SBio to advance its market presence in mainland China, Hong Kong, and Macau. Moreover, the company aims to strengthen its global strategic alliance with BioNTech, continually seeking to enhance the development and availability of T-Pam on an international scale. This global effort underscores DualityBio's commitment to maximizing the clinical value of the drug, ultimately aiming to expand treatment options for patients worldwide.

About Trastuzumab Pamirtecan

Trastuzumab pamirtecan stands out as a third-generation ADC targeting HER2, developed collaboratively by BioNTech and DualityBio. Utilizing DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform, it focuses on tumors that express the HER2 protein, often associated with aggressive cancer paths. Preclinical and initial clinical results indicate that Trastuzumab pamirtecan effectively targets HER2 receptors in tumors, regardless of expression level, while maintaining a manageable safety profile and widening the therapeutic window.

Additionally, Trastuzumab pamirtecan is currently under evaluation for various solid tumors in multiple clinical trials. It holds Fast Track and Breakthrough Therapy designations from the FDA for those diagnosed with endometrial cancer in the United States, reflecting its potential as a valuable treatment candidate.

About DualityBio

Headquartered in China, Duality Biotherapeutics (HKEX09606) is at the forefront of clinical biotech, focused on discovering and developing novel ADCs for cancer and autoimmune diseases. With an extensive technological portfolio, DualityBio leads several global clinical trials across 17 countries and has engaged over 3,200 patients. The company has formed strategic partnerships with leading global biopharmaceutical enterprises, furthering its capabilities in innovative cancer treatments. For more information, visit DualityBio's website.