By Fineline Cube 
Antengene Corporation Limited (HKG: 6996) announced that the Malaysian National Pharmaceutical Regulatory Agency has approved a supplemental New Drug Application (sNDA) for Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two lines of systemic therapy, who are ineligible for autologous stem cell transplant.
Regulatory Milestone & Product Profile
| Attribute | Details |
|---|---|
| Company | Antengene Corporation Limited (HKG: 6996) |
| Product | Xpovio (selinexor) |
| Regulatory Authority | Malaysian National Pharmaceutical Regulatory Agency |
| Approval Type | Supplemental New Drug Application (sNDA) |
| Indication | Relapsed/refractory DLBCL (after ≥2 prior systemic therapies, ineligible for ASCT) |
| **Mechanism | First and only oral XPO1 inhibitor (Selective Inhibitor of Nuclear Export) |
Licensing Partnership Structure
| Element | Details |
|---|---|
| Original Developer | Karyopharm Therapeutics Inc. (NASDAQ: KPTI) |
| Licensee | Antengene Corporation Limited |
| Deal Date | May 2018 |
| Territory | Greater China, South Korea, and ASEAN countries |
| Rights | Development and commercialization rights for Xpovio |
Market Context & Strategic Significance
- ASEAN Expansion: Marks Xpovio’s second indication approval in Malaysia following multiple myeloma (MM) approval
- DLBCL Burden: Malaysia sees ~1,200 new DLBCL cases annually; limited options for transplant‑ineligible patients
- Oral Advantage: Xpovio offers oral administration vs. IV chemotherapy, improving patient convenience
- Reimbursement Path: Previous MM approval established reimbursement framework; DLBCL indication may secure premium pricing
- Pipeline Synergy: Strengthens Antengene’s hematology‑oncology franchise across ASEAN markets
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Xpovio’s commercialization timelines, market penetration, and partnership execution in Malaysia. Actual results may differ due to regulatory, competitive, and reimbursement uncertainties.-Fineline Info & Tech