Antengene Corp., Ltd (HKG: 6996) has announced a market approval filing in Indonesia for its drug Xpovio (selinexor). The company is seeking approval for the treatment of relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
Background on Xpovio and Its Approvals
Discovered by US-based Karyopharm Therapeutics Inc. (NASDAQ: KPTI), Xpovio is the world’s first and only FDA-approved oral XPO1 inhibitor, utilized for the treatment of hematological malignancies. Karyopharm licensed the rights for the drug to Antengene in Greater China, South Korea, and ASEAN countries in May 2018. The drug received its initial approval in the US to treat R/R MM and R/R DLBCL in 2019 and was conditionally approved in China in November 2021. Since then, it has gained market approval in Singapore and Australia, and has also won approvals in South Korea and Taiwan. Xpovio was introduced in China’s Boao Lecheng pilot zone in January 2021 as a clinically urgently needed drug.
Antengene’s Expansion Plans for Xpovio
Antengene has also made approval filings for the molecule in Malaysia and Thailand, demonstrating the company’s commitment to expanding access to Xpovio across the region. The drug’s potential approval in Indonesia would further extend its reach, providing more patients with a treatment option for these serious hematological conditions.-Fineline Info & Tech
