Antengene Corp., Ltd (HKG: 6996) has announced market filings for its Xpovio (selinexor) in Macau, Malaysia, and Thailand, with indications for relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The China-based biopharma also plans to make another market filing in Indonesia during the first half of this year.
Drug Profile and Development
Discovered by US-based Karyopharm Therapeutics Inc. (Nasdaq: KPTI), Xpovio is the world’s first and only FDA-approved oral XPO1 inhibitor, used to treat hematological malignancies. Karyopharm licensed the rights for the drug to Antengene in Greater China, South Korea, and ASEAN countries in May 2018. The drug was first approved in the US to treat R/R MM and R/R DLBCL in 2019 and was conditionally approved in China in November 2021. It subsequently gained market approvals in Singapore and Australia in March of this year and was approved in South Korea and Taiwan. Xpovio was introduced in Boao Lecheng in January 2021 as a clinically urgent drug.
Future Prospects and Strategic Implications
The market filings in Macau, Malaysia, and Thailand, along with the planned filing in Indonesia, position Antengene to further expand its presence in the Asia-Pacific region. By leveraging its partnership with Karyopharm and the drug’s established efficacy and safety profile, Antengene aims to address significant unmet medical needs in the treatment of hematological malignancies, improving patient outcomes and quality of life.-Fineline Info & Tech