DualityBio's Next-Generation HER3 ADC DB-1310 Granted FDA Fast Track Designation

SHANGHAI, July 21, 2025 /PRNewswire/ -- DualityBio (HKEX Stock Code: 9606.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310. This designation is for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

DB-1310 is a novel ADC targeting HER3 developed using DualityBio's proprietary DITAC platform. In June 2025, Dr. Aaron E. Lisberg from the University of California, Los Angeles (UCLA) presented the first-in-human Phase I/IIa clinical trial data (NCT05785741) of DB-1310 in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The results demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies.

Dr. Hua Mu, Global Chief Medical Officer of DualityBio, stated: "DB-1310 demonstrated encouraging clinical efficacy and manageable safety in patients with EGFRm nsqNSCLC and multiple solid tumors. It is noteworthy that preclinical investigations of DB-1310 in combination with EGFR TKIs and other anticancer agents have also demonstrated robust synergistic tumor suppression activity. We will spare no effort to accelerate the clinical development of DB-1310 and look forward to its potential, as a next-generation HER3 ADC, to become a novel therapeutic option for a broad population of cancer patients."

About DualityBio

Duality Biotherapeutics is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADC to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 17 countries, has enrolled over 2,000 patients for multiple clinical-stage ADC candidates.

Additionally, DualityBio have established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing bispecific ADCs, novel-payload ADCs, and autoimmune ADCs. For more information, please visit www.dualitybiologics.com.

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SOURCE Duality Biotherapeutics