On Jul. 24, 2020, Sumgen announced that the IND application for anti-CD38 human monoclonal antibody (SG301) was formally accepted by the Center for Drug Evaluation (CDE) of NMPA. This is the second clinical trial application submitted by Sumgen since its formal operation in 2017 and also the first IND application for anti-CD38 monoclonal antibody drug independently developed by China.
Multiple myeloma (MM) is the second most common hematologic malignancy after non-Hodgkin's lymphoma (NHL). This disease is characterized by the deterioration and abnormal hyperplasia of clonal plasma cells in the bone marrow, which replace normal blood cells in the body and result in anemia and uncontrollable bleeding. MM also leads to reduced bone mineral density and strength and increases the risk of infections by weakening immune responses. In China, the incidence of MM has exceeded that of acute leukemia.
Although great progress has been made in the clinical treatment of MM in terms of chemotherapy, proteasome inhibitors and immunomodulators, recurrence is still observed in almost all patients. Thus, there is an urgent demand for new treatment regimens. With greater understanding of the disease biology and therapeutic targets of MM, some targeted treatments have made breakthrough progress, especially CD38. At the end of 2015, the FDA approved the marketing of the first anti-CD38 antibody drug Darzalex (Daratumumab) for the clinical treatment of MM. Besides MM, Darzalex can also be a potential treatment for other tumors with high CD38 expression, including diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), plasma cell leukemia (PCL), acute myeloid leukemia (AML), follicular lymphoma (FL), and mantle cell lymphoma (MCL). Since its entrance into the market, the sales volume of Darzalex has increased annually from 2016 to 2019. According to the latest financial statement released by Johnson & Johnson, the global sales of Darzalex in 2019 reached $2.9 billion USD. Market research conducted by Evaluate Pharma predicted that the global sales of Darzalex is expected to reach $6 billion USD in 2024, and analysts estimated that the sales of Darzalex may exceed $10 billion USD. In Mar. 2020, FDA approved the marketing of Sanofi’s Isatuximab, which is the world’s second anti-CD38 antibody drug approved by the US FDA.
SG301 is a proprietary anti-CD38 human monoclonal antibody developed by Sumgen and a class I therapeutic biological product. SG301 recognizes a new epitope and has a unique mechanism of action. In vitro and in vivo bioactivity studies showed that SG301 was significantly superior to Darzalex. Sumgen owns the rights for the global development of SG301.
Dr. Lv, founder and CEO of Sumgen, stated that, “We are very glad that the clinical trial application for the SG301 project has been accepted. The rapid progression of this project again proves the innovative and execution capabilities of Sumgen. Three innovative drugs of Sumgen will enter the phase of IND application (in both China and the US) this year. SG301 is one of them, and it is also the first tumor-targeted therapeutic antibody following the first tumor immunotherapy antibody SG001 of Sumgen. The pre-IND application for this project has been submitted to the US FDA, and the IND application is estimated to be formally submitted in early September. This year we will also complete the clinical trial applications for Sumgen’s first antibody fusion protein drug and first bispecific antibody drug. We will accelerate the development of multiple innovative antibody products (including SG301) in order to provide high-quality Chinese antibodies for patients worldwide.”
Copyright Rm. 301, F3, Building C, Block 2, No. 688, Bin'an Road, Changhe Zhejiang ICP Filing No. 18039044
