Recently, Deqi Pharmaceutical Co., Ltd. announced that the world's first oral XPO1 inhibitor Seliniso (ATG-010, trade name: XPOVIO, generic name: selinexor) combined with dexamethasone's new drug application (NDA) has passed South Korea The Ministry of Food and Drug Safety (MFDS) priority review procedure is approved.

Seliniso is used to treat relapsed or refractory multiple myeloma (rrMM) that has received at least four previous treatments (four-line therapy including two proteasome inhibitors, two immunomodulators, and CD38 monoclonal antibody) Adult patients and adult patients with single-agent treatment of relapsed and refractory diffuse large B-cell lymphoma (rrDLBCL) who have previously received at least 2 lines of therapy.

Celiniso's approval not only means that Deqi Pharmaceuticals has accelerated the pace of international innovation, but also brings long-awaited hope for treatment of patients in the Asia-Pacific blood field.

Nuclear export protein 1 (XPO1) is the main nuclear export protein. The transport includes: tumor suppressor proteins (TSPs, such as: p53, IκB, FOXO), and oncoprotein mRNA that binds to elF4E (such as: c-Myc, Bcl-xL, cyclins) and glucocorticoid receptor (GR).

Celinisol is an oral selective XPO1 inhibitor (SINE) that inhibits nuclear export protein XPO1, promotes the nuclear storage and activation of tumor suppressor proteins and other growth regulatory proteins, and down-regulates the levels of multiple oncogenic proteins in the cytoplasm. Induce tumor cell apoptosis, but normal cells are not affected. Based on its unique mechanism of action, Celinisol can be combined with many other drugs to improve efficacy.

At the European Hematology Association (EHA) conference in 2021, the latest research results of the Phase II MARCH trial of Celiniso combined with dexamethasone (Sd regimen) for the treatment of Chinese patients with relapsed and refractory multiple myeloma were announced.

A planned analysis of the first 60 patients who received treatment, the median follow-up time was 9.5 months, and the results showed that the objective response rate (ORR) was 26.7%. In addition, the test results showed that the Sd regimen had an ORR of 33.3% in patients exposed to three types of drugs (immunomodulators, proteasome inhibitors, and CD38 monoclonal antibodies), and an ORR of 44.4 in patients who had previously received CAR-T therapy. %.

Celiniso is the first drug to enter the market in the Deqi pharmaceutical product pipeline, and it is also the company's core asset. Dece Pharma has submitted Celiniso's NDA in 5 Asia-Pacific markets, and it is expected to be approved in the fourth quarter of 2021 and the first quarter of 2022.