Recently, SHR-A1912, an innovative drug for injection of CD79B antibody-drug conjugate (ADC) independently developed by Hengrui Pharmaceutical, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA).For refractory diffuse large B-cell lymphoma (R r DLBCL) with at least 2 prior linesObtaining this qualification will help accelerate the progress of clinical trials and marketing registration.
This is tooThe company's second product has been recognized by the US FDA Fast Track QualificationIn 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 mutations that have progressed after third-generation EGFR tyrosine kinase inhibitors and platinum-containing chemotherapy.
Previously, the IND application of SHR-A1912 for B-cell non-Hodgkin lymphoma** has been approved by the US FDA, and the clinical trial application of SHR-A1912 as a single agent and in combination with immunochemotherapy for B-cell non-Hodgkin lymphoma** has also been approved by the National Medical Products Administration (NMPA) of China, and has now entered the phase II clinical trial stage.
Non-Hodgkin 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 to 40 percent of newly diagnosed cases worldwide [1,2]. DLBCL is highly aggressive and highly malignant, and the current first-line standard regimen for DLBCL can be used in about 60% of patients, but about 40% of patients will still be or refractory. ** The prognosis of patients with refractory DLBCL is poor [3], and there is a huge unmet clinical need in this population, and there is an urgent need to find more effective methods.
CD79B is a signaling component of the B-cell antigen receptor complex, which is highly specific for the B-cell lineage, has high expression on a variety of B-cell lymphomas (including 95% DLBCL), and has a broad mechanism of action that kills B-cell tumors [4,5].
SHR-A1912 for injection isAn ADC independently developed by Hengrui Pharmaceutical targeting CD79B, which can bind specifically to CD79B-expressing tumor cells, and release small molecule toxins in lysosomes after endocytosis by tumor cells, thereby inducing apoptosis of tumor cells.
At present, based on Hengrui Pharmaceutical's modular ADC innovation platform (HRMAP), after 10 years of ADC R&D accumulation, Hengrui has become a domestic enterprise with advanced layout on popular targets and many differentiated ADC products, including SHR-A1912Nine novel and differentiated ADC molecules have been successfully approved for clinical trials, and five products have achieved international simultaneous developmentThere are also a number of innovative drug products in various solid tumor fields, in order to bring more choices to patients. In the future, Hengrui Pharmaceutical will continue to adhere to the concept of "patient-centered", focus on unmet clinical needs, and strive to develop more new and good drugs to benefit patients around the world.
About FTD:
Fast Track Designation (FTD) is a designation granted by the U.S. FDA to a drug under development to promote the development of new drugs for the most serious disease and to address unmet clinical needs.
After the drug obtains FTD, the new drug development company will have more opportunities to communicate with the FDA in the subsequent drug development and review process. Discussing the R&D plan and data of the drug under development with the FDA in the early stage of drug development can identify and solve the current problems in the R&D in a timely manner, which will help accelerate the subsequent R&D and approval of drugs. In addition, new drug development companies can submit new drug research materials to the FDA on a rolling basis when submitting a marketing application (NDA BLA). These preferential policies provide a favorable guarantee for accelerating the research and development of new drugs.
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