Deqi Pharmaceuticals " first-in-class" anti-cancer drugs have been approved in China phase 3 clinical trials

On December 18, Deqi Pharmaceuticals announced that China's State Drug Administration (NMPA) had approved a Phase 3 clinical trial application for oral selective nuclear output inhibitors ATG-010 (selinexor) in a joint treatment of patients with recurring refractic multiple myeloma (MM) in China.
it's worth noting that the drug has today been approved by the FDA for New Adaptation Listing Application (SNDA), a combined treatment with boronicazome and low-dose dexamisunds in adult MM patients who have received at least one line of treatment in the past.
public information, selinexor is an oral selective nuclear output inhibitor (SINE) of "first-in-class", developed by Dechi Pharmaceuticals in collaboration with Karyopharm Therapeutics.
the drug has been approved in the United States to treat patients with relapsed recurring incurable MM and patients with recurring recurring incurable large B-cell lymphoma (DLBCL).
press release, the ATG-010 is currently the first and only oral SINE compound approved by the FDA.
December 2020, the National Comprehensive Cancer Network (NCCN) incorporated three combinations of ATG-010 treatments for recurring recurring multiple myeloma into clinical practice guidelines.
currently, Deqi Pharmaceuticals is conducting a Phase 2 registered clinical study of ATG-010 for recurring multiple myeloma in China, and a Phase 2 registered clinical study on recurring resuscable large B-cell lymphoma.
same time, Deki Pharmaceuticals initiated a clinical study of ATG-010 for the treatment of exocytocyte lymphoma, NK/T cell lymphoma, and non-small cell lung cancer with KRAS mutations.
recently, Deqi Pharmaceuticals has submitted applications for the listing of new ATG-010 drugs in several markets in Asia Pacific.
According to the press release, this NMPA-approved, randomized, open multi-center Phase 3 study aims to compare the effectiveness and safety of ATG-010, boroniczomi, and dexomethon (SVd) treatments with boroniczomi and dexamison (Vd) treatments in adult patients with recurring recurring multiple myeloma in China who have previously received 1-3 treatment options.
trial is expected to include 150 patients who will be treated with SVd or Vd at random on a 2:1 scale.
。