希维奥^®是全球首个全新机制的口服选择性XPO1抑制剂，已在亚太市场的10个国家和地区获批用于治疗多项适应症，并在其中5个市场（中国大陆、台湾市场、澳大利亚、新加坡和韩国）实现医保收录。

东盟拥有超过6亿人口，随着经济的稳步增长，已成为全球生物医药发展的重要潜力市场。人口老龄化的加速使东盟市场的整体疾病负担不断加重，社会对新型治疗药物的需求持续增加。公司正积极推进亚太市场布局，未来将继续把更多创新药物带到东盟市场，以提升当地的医疗健康水平，造福更多患者。

在持续推进亚太市场布局的同时，公司也正努力扩充希维奥^®的适应症范围。基于其独特的作用机制，公司正在开发希维奥^®在骨髓纤维化（MF）和子宫内膜癌等不同疾病领域的多种联合疗法。

德琪医药有限公司（简称“德琪医药”，香港交易所代码：6996.HK）是一家以研发为驱动，并已进入商业化阶段的生物制药领先企业，以“医者无疆，创新永续”为愿景，德琪医药专注于血液及实体肿瘤领域的同类首款和同类最优疗法的早期研发、临床研究、药物生产及商业化，致力于通过提供突破性疗法，改善全球患者生活质量。

自2017年以来，德琪医药现已建立起一条拥有9款从临床延展至商业化阶段的肿瘤药物资产研发管线，其中，6款产品具有全球权益，3款产品具有亚太权益。公司已在美国及多个亚太市场获得31个临床批件（IND），并递交了10个新药上市申请（NDA）。目前，希维奥^®（塞利尼索片）已获得中国大陆、中国台湾、中国香港、中国澳门、韩国、新加坡、马来西亚、泰国、印度尼西亚和澳大利亚的新药上市批准。

XPOVIO^® (selinexor) Approved for Commercialization in Indonesia, Further Expanding Antengene’s Commercial Presence in APAC

- XPOVIO^® is the first and only approved XPO1 inhibitor in Indonesia.

- From the second half of 2024 to now, XPOVIO^® was successively approved in Thailand, Malaysia and Indonesia, significantly expanding Antengene’s commercial presence in APAC. To date, XPOVIO^® has been approved for multiple indications in ten markets across the APAC region.

- XPOVIO^® has been approved for health insurance coverage in the mainland of China, Taiwan market, Australia, Singapore and South Korea.

Shanghai and Hong Kong, PRC, March 5, 2025 — Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced that the Indonesia National Agency of Drug and Food Control (BPOM) has approved a New Drug Application (NDA) for XPOVIO^® (selinexor) for three indications: (1) In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy;(2) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and an anti‐CD38 monoclonal antibody; and (3) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy who are not eligible for haematopoietic cell transplant.

With a novel mechanism of action, XPOVIO^® is the world’s first approved orally-available, selective XPO1 inhibitor, which has already been approved in ten countries and regions in APAC, and has been included in the national insurance schemes in five of these markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea).

The ASEAN region, with its steady economic growth and a population exceeding 600 million, has become a market of significant potential for global biomedical development. The accelerating aging population in ASEAN has increased the overall disease burden on patients and local communities, leading to a growing demand for novel therapeutics. Currently, Antengene is actively expanding its presence into APAC markets in efforts to introduce more innovative medicines to the ASEAN region in the future, improving the level of healthcare in these regions and benefiting more patients in need.

While bringing XPOVIO^® to more APAC markets, Antengene is also striving to expand the indications of XPOVIO^®. Leveraging the drug’s novel mechanism of action, Antengene is currently developing multiple combination regimens of XPOVIO^® for the treatment of various indications including myelofibrosis (MF), and endometrial cancer.

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of “Treating Patients Beyond Borders”.

Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO^® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia.