By Fineline Cube 
Antengene Corporation Limited (HKG: 6996) announced that Hong Kong’s Department of Health approved two supplementary New Drug Applications (sNDAs) for XPOVIO (selinexor), expanding its indications to multiple myeloma (MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL).
sNDA Approvals & New Indications
| Indication | Regimen | Patient Population |
|---|---|---|
| Multiple Myeloma | XPOVIO + bortezomib + dexamethasone (XVd) | Adult patients with ≥1 prior therapy |
| R/R DLBCL | XPOVIO monotherapy | Adults with ≥2 prior systemic therapies, ineligible for stem cell transplantation; includes transformed follicular lymphoma |
XPOVIO Drug Profile & Market Position
| Attribute | Details |
|---|---|
| Drug Class | First oral Selective Inhibitor of Nuclear Export (SINE) compound |
| **Mechanism | Novel mechanism blocking nuclear export of tumor suppressor proteins |
| Asia-Pacific Approvals | Approved in 10 countries/regions |
| Reimbursement Coverage | National drug lists in 5 markets: Mainland China, Taiwan, Australia, Singapore, South Korea |
| Strategic Value | Expands Antengene’s hematology-oncology franchise in Greater China |
Market Context & Strategic Outlook
- Multiple Myeloma Market: Hong Kong sees ~200 new MM cases annually; oral regimens preferred for elderly patients
- DLBCL Unmet Need: R/R DLBCL represents 30% of all lymphoma cases; limited options for transplant-ineligible patients
- Commercial Synergy: XVd regimen positions XPOVIO against established triplet therapies; monotherapy fills gap in heavily pre-treated DLBCL
- Reimbursement Pathway: Hong Kong approval expected to support Macau and Taiwan filings; strengthens regional pricing strategy
Forward‑Looking Statements
This brief contains forward‑looking statements regarding XPOVIO commercialization timelines and market penetration. Actual results may differ due to regulatory, competitive, and reimbursement uncertainties.-Fineline Info & Tech