Hengrui’s CD79b ADC innovative drug SHR-A1912 received FDA fast track qualification

February 26, 2024  Source: drugdu 98

"/Recently, SHR-A1912, an innovative CD79b antibody-drug-conjugate (ADC) drug for injection independently developed by Hengrui, 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 received at least two lines of therapy in the past. This will help accelerate the advancement of clinical trials and marketing registration.

This is also the company's second product to obtain fast tracks designation from the US FDA. In January this year, the company announced that its independently developed HER3 ADC innovative drug SHR-A2009 for injection has been granted fast track designation by the FDA for the treatment of third-generation EGFR-positive tumors, EGFR-mutated metastatic non-small cell lung cancer (NSCLC) with disease progression after amino acid kinase inhibitors and platinum-containing chemotherapy.

Previously, the clinical trial application of SHR-A1912 for the treatment of B-cell non-Hodgkin lymphoma has been implicitly approved by the U.S. FDA. The trial applications have also been successively approved by the National Medical Products Administration (NMPA) of China and have now entered the Phase II clinical trial stage.

Non-Hodgkin lymphoma (NHL) is one of the most common hematological 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 highly malignant. The current first-line standard treatment regimen for DLBCL can cure about 60% of patients, but about 40% of patients will still relapse or be refractory to treatment. The prognosis of patients with relapsed/refractory DLBCL is poor [3]. This population has huge unmet clinical needs and there is an urgent need to find more effective treatments.

CD79b is a signaling component of the B cell antigen receptor complex. It is highly specific for the B cell lineage. It is highly expressed on a variety of B cell lymphomas (including >95% of DLBCL) and has broad-spectrum killing of B cells. The mechanism of action of cell tumors [4,5], therefore, the development of drugs targeting CD79b will provide new options for the treatment of B-cell NHL, especially DLBCL.

SHR-A1912 for injection is a CD79b-targeted ADC independently developed by Hengrui. It can specifically bind to tumor cells expressing CD79b. After endocytosis by tumor cells, it is hydrolyzed in lysosomes to release small molecule toxins, thus induces tumor cell apoptosis.

At present, based on the Hengrui Pharmaceutical Modular ADC Innovation Platform (HRMAP), after 10 years of ADC R&D accumulation, Hengrui has become a domestic enterprise that has made advanced progress in the layout of popular targets and has many differentiated ADC products. Currently, it has Nine new and differentiated ADC molecules, including SHR-A1912, have been successfully approved for clinical trials. Five products have achieved simultaneous international development. There are also multiple innovative drug products deployed in various solid tumor treatment fields, with the aim of bringing better results to patients with multiple treatment options. In the future, Hengrui will continue to adhere to the "patient-centered" concept, focus on unmet clinical needs, and strive to develop more new and good drugs to benefit patients around the world.

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