Antengene ATG-010 New Drug Marketing Application Was Accepted By The State Food And Drug Administration: Treatment Of Multiple Myeloma (MM)!

- Feb 19, 2021-


Antengene recently announced that the National Medical Products Administration (NMPA) has accepted ATG-010 (selinexor, Xpovio®) for the treatment of refractory and relapsed multiple myeloma (rrMM) patients with a new drug application (NDA) .


This is the fifth new drug marketing application submitted by Antengene ATG-010 (Xpovio) in the Asia-Pacific region after Australia, South Korea, Singapore and Hong Kong, China. It is also the first new drug marketing application for SINE series compounds submitted in Mainland China, marking China Hematological cancer patients are one step closer to this new treatment option.


ATG-010 (Xpovio) is the world's first oral selective nuclear export inhibitor (SINE). It has been approved in the United States for the treatment of two major indications in the field of hematoma-multiple myeloma (MM) and diffuse Large B-cell lymphoma (DLBCL). The drug was developed by Karyopharm Therapeutics. Antengene and Karyopharm reached an exclusive cooperation and authorization, and obtained the exclusive development and commercialization rights of Xpovio in multiple Asia-Pacific markets (including Greater China, South Korea, Australia, New Zealand and ASEAN countries).


Recently, Antengene has submitted new drug marketing applications for ATG-010 for three hematoma indications (including multiple myeloma and diffuse large B-cell lymphoma) in many countries and regions in the Asia-Pacific region.


At present, ATG-010's five treatment options for multiple myeloma and diffuse large B-cell lymphoma have been included in the National Comprehensive Cancer Network (NCCN®) guidelines.


As the world's first approved SINE compound, ATG-010 can cause nuclear storage and activation of tumor suppressor proteins and other growth regulator proteins, down-regulate the levels of multiple oncoproteins in the cytoplasm, and induce a large number of entities in vitro and in vivo And the apoptosis of blood tumor cells, while normal cells are not affected. Clinical studies have proved that ATG-010 has obvious curative effect on a variety of hematomas and solid tumors and its safety is controllable.


Dr. Mei Jianming, Founder, Chairman and CEO of Antengene, said: "It is great to see that the new drug application for ATG-010 for multiple myeloma has been accepted in China. This is another important milestone for the product to enter Chinese patients. In addition to effective treatment of hematoma, ATG-010 has carried out a number of clinical trials for multiple solid tumor indications and has shown encouraging results, including a global phase 3 clinical trial (SIENDO) for the treatment of endometrial cancer. ), and the Phase 3 clinical trial (SEAL) for the treatment of liposarcoma. At the same time, we will continue to actively prepare for the commercialization of ATG-010 in China and the Asia-Pacific region, and strive to benefit patients as soon as possible."


ATG-010 (selinexor, Xpovio®) is a first-of-its-kind, oral, selective nuclear export inhibitor (SINE) compound that binds and inhibits nuclear export protein XPO1 (also known as CRM1), which results in tumor suppressor protein in the nucleus Accumulation, which will restart and amplify their tumor suppressor function, leading to selective apoptosis of cancer cells without significant impact on normal cells.


In July 2019, the US FDA approved Xpovio combined with low-dose dexamethasone for the treatment of patients with relapsed and refractory multiple myeloma (rrMM). In June 2020, the US FDA again approved Xpovio as a single-agent oral therapy for the treatment of patients with relapsed and refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, the US FDA approved the Supplemental New Drug Application (sNDA) for the extended indications of Xpovio for the treatment of multiple myeloma (MM) patients who have previously received at least first-line treatment. In the European Union, the marketing authorization application (MAA) for Xpovio for the treatment of rrMM indications has been submitted to the European Medicines Agency (EMA).


It is worth mentioning that Xpovio is the first and only approved nuclear export inhibitor (SINE), which is also the first approved drug for the new target of myeloma (XPO1) since 2015. In addition, Xpovio is also the first single-agent oral therapy for the treatment of DLBCL.


Currently, Antengene and Karyopharm are evaluating selinexor's potential in treating a series of hematological malignancies and solid tumors in multiple mid- to late-stage clinical studies, including multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL), and liposarcoma (SEAL study), endometrial cancer, recurrent glioblastoma.