摘要：中国上海和香港，2024年11月28日–致力于研发，生产和销售同类首款及/或同类最优血液及实体肿瘤疗法的商业化阶段领先创新生物制药公司–德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）今日宣布，希维奥（塞利尼索片）新增一项适应症纳入《国
中国上海和香港，2024年11月28日–致力于研发，生产和销售同类首款及/或同类最优血液及实体肿瘤疗法的商业化阶段领先创新生物制药公司–德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）今日宣布，希维奥（塞利尼索片）新增一项适应症纳入《国家基本医疗保险、工伤保险和生育保险药品目录（2024年）》（以下简称“国家医保目录”），医保支付范围为：既往接受过至少两线系统性治疗的复发或难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）成人患者。新版国家医保目录将于2025年1月1日起正式生效。
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。
朱军
北京大学肿瘤医院教授
“DLBCL是成人非霍奇金淋巴瘤（NHL）最常见类型，且发病率正逐年递增，复发或难治性患者更是承受着极大的疾病和经济负担。希维奥作为全新机制的核输出蛋白抑制剂，以独特的机制（MOA），疗效明确，用药便利，可自行在家口服，减轻住院负担和费用，为中国患者提供了一种新的治疗选择。此次希维奥DLBCL适应症被纳入医保目录，将大幅提高患者对这款创新药物的用药可及性，对复发或难治性DLBCL患者意义重大。”
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。
关于希维奥（塞利尼索）
希维奥是全球首个全新机制的口服选择性核输出蛋白（XPO1）抑制剂，具有“全新机制、协同增效、快速起效、持久缓解”四大特点。
通过抑制核输出蛋白XPO1，希维奥可促使肿瘤抑制蛋白和其他生长调节蛋白的核内储留和活化，并下调细胞浆内多种致癌蛋白水平。希维奥发挥抗肿瘤作用机制的三条通路为：1）使抑癌蛋白在细胞核中明显聚集，再激活发挥抗肿瘤作用；2）使致癌基因mRNA滞留在细胞核，降低胞浆内致癌蛋白水平；3）激活糖皮质激素受体（GR）通路，恢复激素敏感性。基于其独特的作用机制，希维奥在不同疾病领域的多种联合疗法正在进行开发。目前，德琪医药正在中国大陆地区开展多项（其中三项全球临床试验由德琪医药与Karyopharm Therapeutics Inc.[纳斯达克交易所股票代码：KPTI] 共同开展）针对复发/难治性血液及实体肿瘤的临床研究。
关于德琪医药
德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：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。
前瞻性陈述
本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内有关任何董事或本公司意向的陈述或提述乃于本文刊发日期作出。任何该等意向均可能因未来发展而出现变动。有关这些因素和其他可能导致未来业绩与任何前瞻性声明存在重大差异的因素的进一步讨论，请参阅我们截至2023年12月31日的公司年报中描述的其他风险和不确定性，以及之后向香港证券交易所提交的文件。
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.
About XPOVIO (selinexor)
XPOVIO is the world’s first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.
By blocking the nuclear export protein XPO1, XPOVIO can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]).
About Antengene
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.
Forward-looking statements
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company’s Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange.
来源：动态宝
