DualityBio and BioNTech’s B7-H3 ADC DB-1311 granted China NMPA BTD for metastatic castration-resistant Prostate cancer

CAR-T Digest - August 2020

Weekly Digest - July 2026

28 July 2026: DualityBio and BioNTech’s B7-H3 ADC DB-1311 granted China NMPA BTD for metastatic castration-resistant Prostate cancer

DualityBio and BioNTech announced that China’s NMPA has granted Breakthrough Therapy Designation to the B7-H3-targeted antibody-drug conjugate Elfetabart drozuntecan (DB-1311) for the treatment of patients with advanced/unresectable or metastatic castration-resistant prostate cancer who have progressed after androgen receptor pathway inhibitors and taxane-based chemotherapy
The designation is supported by encouraging clinical data from the ongoing phase 1/2 DB-1311-O-1001 trial, where Elfetabart drozuntecan demonstrated promising antitumor activity and a manageable safety profile in metastatic castration-resistant prostate cancer.
BTD addresses a significant unmet need in mCRPC, where patients progressing after ARPI and taxane-based chemotherapy have limited effective treatment options. The designation follows the U.S. FDA FTD and further recognizes the clinical potential of Elfetabart drozuntecan in this setting
Elfetabart drozuntecan is a next-generation B7-H3-targeted ADC developed using DualityBio’s DITAC platform. It delivers a topoisomerase I inhibitor payload to B7-H3-expressing tumor cells, enabling targeted cytotoxicity while leveraging the restricted expression of B7-H3 in normal tissues. The ADC is also being evaluated in combination with the investigational PD-L1×VEGF-A bispecific immunomodulator Pumitamig across multiple solid tumors
Strategically, the first NMPA Breakthrough Therapy Designation for Elfetabart drozuntecan strengthens the global development of DualityBio and BioNTech’s B7-H3 ADC program, accelerates its regulatory pathway in China, and reinforces the partners’ strategy of expanding the asset across prostate cancer and multiple solid tumor indications while advancing next-generation ADC innovation