2024年7月，继首次被批准用于治疗复发或难治性多发性骨髓瘤（R/R MM）之后，希维奥^®在中国获批第二项适应症，用于治疗R/R DLBCL。截至目前，希维奥^®在中国累积获批的两项适应症均已被纳入国家医保目录，医保覆盖人群进一步扩大。

值得一提的是，希维奥^®在半年之内，实现了新适应症从获批、上市到纳入医保的“三级跳”，以高效的“德琪速度”快速、切实地为我国DLBCL患者带来了更有效、便捷、可负担的创新解决方案，也充分体现出国家医保局对这款创新药物的认可。在提高患者生存获益的同时，大幅减轻患者及其家庭的治疗负担，这无疑表明了德琪医药“改善肿瘤患者生活质量”的愿景与目标正在逐步实现。

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9个国家和地区获批用于治疗多项适应症，并在其中4个市场（中国大陆、澳大利亚、新加坡和韩国）实现医保收录。未来，公司预计其将在更多亚太市场获得医保收录。

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、泰国和澳大利亚的新药上市批准。

Antengene Announces XPOVIO^®’s New Indication Included in 2024 China National Reimbursement Drug List, Making the Drug More Accessible to DLBCL Patients in the Country

Shanghai and Hong Kong, PRC, November 28, 2024 — 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 hematologic malignancies and solid tumors, today announced that the new indication of XPOVIO^® (selinexor) in adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have received at least two lines of systematic therapy, has been included into the 2024 China National Reimbursement Drug List (NRDL) which will officially take effect on January 1, 2025.

Following its initial approval for the treatment of relapsed/refractory multiple myeloma (R/R MM), XPOVIO^® received approval for its second indication in China in July 2024, for the treatment of patients with R/R DLBCL. To date, the two approved indications of XPOVIO^® in China have both been adopted by the NRDL, allowing a growing population of patients to benefit from the drug.

In just half a year, XPOVIO^® reached three key milestones with the new indication, from the regulatory approval, to commercial launch and inclusion into the NRDL. Such swift execution by Antengene, coupled by the strong support from China’s National Healthcare Security Administration, have brought an effective, convenient and affordable innovative treatment strategy to Chinese patients with DLBCL. By bringing survival benefit to patients at ever lower financial burden on patients and their families, Antengene is making firm steps in improving the lives of cancer patients around the world.

“DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL) in adults. With an incidence rising year over year, patients with R/R DLBCL are subjected to enormous disease and financial burdens,” said Prof. Jun Zhu, from Peking University affiliated Beijing Cancer Hospital. “As a novel inhibitor of the nuclear export protein, XPOVIO^® has provided Chinese patients a new treatment option that offers a unique mechanism of action (MOA), clear efficacy, and convenience of use allowing patients to receive oral treatment at home and thereby significantly reduced the cost associated with inpatient treatment. The adoption of XPOVIO^®’s indication in DLBCL by the NRDL is a great news for patients with R/R DLBCL as it will significantly improve the accessibility of this innovative drug.”

With a novel mechanism of action, XPOVIO^® is the world’s first approved orally-available, selective XPO1 inhibitor, which has already been approved in nine countries and regions in APAC, and included in the national insurance schemes in four of these markets (the mainland of China, Australia, Singapore and South Korea). Moving forward, XPOVIO^® is expected to receive public insurance coverage in more APAC markets.

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 and Australia.