Selinexor, the World's First Oral Selective XPO1 Inhibitor, Receives NMPA Approval for New Indication in Combination Therapy for Relapsed/Refractory Multiple Myeloma in China

Jul 29, 2025 07:41 CST Updated 07:41

ANTENGENE CORPORATION

Innovative Oncology Drug Developer

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

On July 28, ANTENGENE CORPORATION announced,Selinexor Tablets(Product Name:Xevio®）The new indication has been officially approved by the NMPA.In combination with bortezomib and dexamethasone(XVd Regimen)，Applicable to patients with multiple myeloma who have received at least one prior line of therapy.（MM）Adult Patients。*For more information in 2025, pleaseNew Drug ApprovalIntelligence,Scan the QR code at the end of the article to add Xiaoyin and download for free.

Screenshot source: Official WeChat account of the company

This approval was based on data from a Phase III BENCH, randomized controlled, open-label, multicenter bridging study. The study compared the efficacy and safety of the XVd regimen versus the Vd regimen in 154 Chinese patients with R/R MM who had previously received 1-3 lines of therapy.

The efficacy and safety data of the BENCH study are basically consistent with those of the international multicenter Phase III clinical study, the BOSTON study, achieving the objectives of the bridging study.. Studies have confirmed that the XVd regimen has significant advantages:

XVd Regimen Shows Better Clinical Efficacy Compared to Vd Regimen in Chinese R/R MM PatientsLonger PFS and DOR, achieving higher ORR, ≥VGPR ratio, and MRD negativity rate, and showing a trend of OS extension;
Elderly Patients Benefit Significantly:Significant efficacy in the subgroup of elderly patients aged ≥65 years，SelinexorProvides a better option for this group of people.

This is the third indication for which Selinexor has been approved in China, with two previous indications already approved: 1)Monotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma（R/R DLBCL）；2）In Combination with Dexamethasone for the Treatment of R/R MM, have all beenIncluded in the National Medical Insurance Catalog.

Screenshot source: Insight Database

Selinexor is introduced by ANTENGENE CORPORATIONThe World's FirstA novel oral selective XPO1 inhibitor has been approved in 10 countries and regions within the Asia-Pacific market for the treatment of multiple indications, and is now available in 5 of these markets.(Mainland China, Taiwan Market, Australia, Singapore, and South Korea)Achieve medical insurance inclusion.

While continuously advancing the layout of the Asia-Pacific market, Antengene Corporation is also striving to expand.SelinexorThe range of indications, including the drug's use inMyelofibrosis（MF）AndEndometrial Cancer...in different disease areas.

It is worth mentioning that, in 2023In August, Antengene Corporation and Hansoh Pharma signed an agreement regardingCommercializing Selinexor and other products containing or composed of Selinexor in mainland ChinaCooperation Agreement. ANTENGENE CORPORATION will receive up to RMB200 million yuanThe down payment, and up to RMBRMB 535 millionMilestone payment.

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