Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) SHR-A1912, targeting CD79b, in the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL) in patients who have received at least second-line treatment. This designation underscores the potential significance of SHR-A1912 in addressing an area of high unmet medical need.
SHR-A1912, which has previously been granted approval for study in B-cell non-Hodgkin’s lymphoma in the US, is currently undergoing a Phase I/II study in China. The study is exploring the use of SHR-A1912 either alone or in combination with immunochemotherapy for the treatment of the specified condition.
In the commercial landscape, Roche’s Polivy (polatuzumab vedotin) is considered the most comparable drug currently available. Polivy received accelerated approval in the US in 2019 and in China in 2023, setting a benchmark for ADC therapies in this space.
The Fast-Track Designation for SHR-A1912 highlights Jiangsu Hengrui Medicine’s commitment to advancing innovative oncology treatments and its efforts to meet global standards in drug development.- Flcube.com
