Recently, Hengrui Pharmaceuticals's self-developed CD79b antibody-drug-conjugate (ADC) innovation SHR-A1912 for injection has been granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphomas (R/R DLLC) that have received at least 2 lines of therapy in the past. SHR-A1912 was granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) that has previously received at least 2 lines of therapy.

This is also the 2nd product of the Company to be granted Fast Track status by the FDA. In January this year, the Company announced that its self-developed HER3 ADC innovative drug SHR-A2009 for injection was granted Fast Track status by the FDA for the treatment of metastatic non-small-cell lung cancer ("NSCLC") with EGFR mutation that has progressed after third-generation EGFR tyrosine kinase inhibitor and platinum-containing chemotherapy. NSCLC).

Previously, the clinical trial application for SHR-A1912 for the treatment of B-cell non-Hodgkin's lymphoma was granted implied approval by the U.S. FDA, and the clinical trial application for SHR-A1912 as a single agent and in combination with immunochemotherapy for the treatment of B-cell non-Hodgkin's lymphoma was successively granted approval by the China National Drug Administration (NMPA), and is now in the Phase II clinical trial stage.

Non-Hodgkin's lymphoma (NHL) is one of the most common hematologic malignancies, and diffuse large B-cell lymphoma (DLBCL) is the most common subtype of NHL, accounting for 30-40% of newly diagnosed cases worldwide [1,2].DLBCL is highly aggressive and malignant, and the current first-line standard treatment regimen for DLBCL cures about 60% of patients, but about 40% of patients will still relapsed or refractory. Patients with relapsed/refractory DLBCL have a poor prognosis [3], and there is a huge unmet clinical need in this population for more effective treatment modalities.

CD79b is a signaling component of the B-cell antigen receptor complex with a high degree of B-cell lineage specificity, is highly expressed on a variety of B-cell lymphomas (including >95% of DLBCL), and has a mechanism of action that broadly kills B-cell tumors [4,5]; therefore, drug development targeting CD79b will provide a new therapeutic Options.

SHR-A1912 for injection is a CD79b-targeted ADC independently developed by Hengrui Pharmaceuticals, which can specifically bind to CD79b-expressing tumor cells, and hydrolyze and release small-molecule toxins in the lysosome after endocytosis by tumor cells, thus inducing apoptosis of tumor cells.

At present, based on Hengrui Pharmaceuticals Modular ADC Innovation Platform (HRMAP), after 10 years of ADC R&D accumulation, Hengrui has become a domestic enterprise with advanced progress in the layout of popular targets and many differentiated ADC products, and nine new and differentiated ADC molecules including SHR-A1912 have been successfully approved for clinical use, and five products have achieved international synchronous development. There are also a number of innovative drug products in various solid tumor therapeutic areas, with a view to bringing more therapeutic choices to patients. In the future, Hengrui will continue to adhere to the concept of "patient-centeredness", focus on unmet clinical needs, and strive to develop more new drugs and good drugs to benefit patients around the world.

https://mp.weixin.qq.com/s/PJCC1uGxJgOttUvg4AxNmQ