The NMPA has granted BTD for B7-H3-targeted ADC HS-20093 for castration-resistant prostate cancer

CAR-T Digest - August 2020

29 April 2026: The NMPA has granted BTD for B7-H3-targeted ADC HS-20093 for castration-resistant prostate cancer

Hansoh Pharmaceutical announced that China’s National Medical Products Administration has granted Breakthrough Therapy designation to its self-developed B7-H3–targeted antibody–drug conjugate HS-20093 for the treatment of metastatic castration-resistant prostate cancer
The designation applies to patients who have previously been treated with novel endocrine therapies and taxane-based chemotherapy, a setting where treatment options remain limited, and disease progression is common
This regulatory recognition is intended to accelerate the clinical development and review of HS-20093, reflecting its potential to address a significant unmet need in advanced prostate cancer
The milestone further strengthens Hansoh’s oncology pipeline, highlighting its continued investment in next-generation ADC technologies targeting novel cancer antigens such as B7-H3
With Breakthrough Therapy designation in place, HS-20093 is positioned for expedited development as the company advances its clinical program in metastatic castration-resistant prostate cancer