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22 Feb 2024: Hengrui Medicine’s SHR-A1912 ADC gets Fast Track status from FDA
- Hengrui Medicine’s innovative CD79b antibody-drug-conjugate (ADC) drug, SHR-A1912, receives fast-track designation from the FDA for treating relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in 2L+ setting
- Hengrui Pharmaceuticals’ SHR-A1912 is an ADC targeting CD79b, binding to tumor cells, and inducing apoptosis by releasing toxins post-lysosomal hydrolysis, promising for cancer treatment
- SHR-A1912’s clinical trial application for B-cell non-Hodgkin lymphoma received implicit FDA approval and successive approval from China’s NMPA, advancing to Phase II trials
- The company’s second product, HER3 ADC SHR-A2009, received fast-track status in January for treating third-generation EGFR-positive tumors, marking another milestone for the company
