德琪医药希维奥第三项合适症在韩国获批上市，为韩国MM患者带来新采选

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这是希维奥在韩国斩获的第三项合适症，用于调养多发性骨髓瘤（MM）患者。

希维奥已在韩国、中国大陆、澳大利亚和新加坡已毕医保收录，公司展望其将在亚太地区的更多市集取得医保收录。

希维奥已在亚太市集的9个国度和地区获批用于调养多种合适症，公司还在印度尼西亚提交了居品的新药上市苦求（NDA），展望于本年下半年获批。

中国上海和香港，2024年10月18日–用功于研发，坐蓐和销售同类首款及/或同类最优血液及实体肿瘤疗法的交易化阶段提高立异生物制药公司–德琪医药有限公司（简称“德琪医药”，香港交往所股票代码：6996.HK）当天告示，韩国食物医药品安一皆（MFDS）已批准希维奥（塞利尼索片）的补充新药上市苦求（sNDA），同一硼替佐米和地塞米松用于调养至少给与过一种先前调养的多发性骨髓瘤（MM）成东说念主患者。

此前，希维奥已在韩国获批同一地塞米松用于调养复发/难治性多发性骨髓瘤（R/R MM）和单药调养复发/难治性弥散性大B细胞淋巴瘤（R/R DLBCL）两项合适症。本年7月，希维奥获纳入韩国医保报销药品目次，成为首款纳入韩国医保的XPO1禁止剂。

希维奥是大众首个全新机制的口服采选性XPO1禁止剂，已在亚太市集的9个国度和地区获批用于调养多种合适症，并在其中4个市集（韩国、中国大陆、澳大利亚和新加坡）已毕医保收录。这次希维奥又一新合适症在韩国获批上市，将为韩国的MM患者带来更为丰富的立异调养采选，惠及更多患者荒谬家庭。

在抓续激动亚太市集布局的同期，公司也正努力扩展希维奥的合适症边界。基于其特有的作用机制，公司正在诱骗希维奥在骨髓纤维化（MF）和子宫内膜癌等不同疾病限制的多种同一疗法。

对于希维奥（塞利尼索）

希维奥是大众首个全新机制的口服采选性核输出卵白（XPO1）禁止剂，具有“全新机制、协同增效、快速起效、抓久缓解”四大特色。

通过禁止核输出卵白XPO1，希维奥可促使肿瘤禁止卵白和其他滋长调度卵白的核内储留和活化，并下调细胞浆内多种致癌卵白水平。希维奥施展抗肿瘤作用机制的三条通路为：1）使抑癌卵白在细胞核中彰着团结，再激活施展抗肿瘤作用；2）使致癌基因mRNA淹留在细胞核，裁减胞浆内致癌卵白水平；3）激活糖皮质激素受体（GR）通路，收复激素明锐性。基于其特有的作用机制，希维奥在不同疾病限制的多种同一疗法正在进行诱骗。现在，德琪医药正在中国大陆地区开展多项（其中三项大众临床西宾由德琪医药与Karyopharm Therapeutics Inc.[纳斯达克交往所股票代码：KPTI] 共同开展）针对复发/难治性血液及实体肿瘤的临床接洽。

对于德琪医药

德琪医药有限公司（简称“德琪医药”，香港交往所股票代码：6996.HK）是一家以研发为脱手，并已投入交易化阶段的生物制药提高企业，以“医者无疆，立异永续”为愿景，德琪医药专注于血液及实体肿瘤限制的同类首款和同类最优疗法的早期研发、临床接洽、药物坐蓐及交易化，用功于通过提供打破性疗法，改善大众患者生计质地。

自2017年以来，德琪医药现已诞生起一条领有9款从临床延展至交易化阶段的肿瘤药物质产研发管线，其中，6款居品具有大众权力，3款居品具有亚太权力。公司已在好意思国及多个亚太市集取得29个临床批件（IND），并递交了10个新药上市苦求（NDA）。现在，希维奥（塞利尼索片）已取得中国大陆、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。

前瞻性述说

本文所作出的前瞻性述说仅与本文作出该述说当日的事件或贵府关系。除法律规定外，于作出前瞻性述说当日之后，不管是否出现新贵府、往日事件或其他情况，咱们并无包袱更新或公开修改任何前瞻性述说及料思以外的事件。请细阅本文，并清爽咱们的履行往日功绩或施展可能与预期有弱点各异。本文内关系任何董事或本公司意向的述说或提述乃于本文刊发日历作出。任何该等意向均可能因往日发展而出现变动。关系这些成分和其他可能导致往日功绩与任何前瞻性声明存在弱点各异的成分的进一步计划，请参阅咱们遗弃2023年12月31日的公司年报中形貌的其他风险和不细目性，以及之后向香港证券交往所提交的文献。

Antengene Announces XPOVIO (selinexor) Approved for Its Third Indication in South Korea, Bringing Fresh Hope to Patients with MM in the Country

- This approval for XPOVIO for the treatment of patients with multiple myeloma (MM) marks the third approved indication of the drug in South Korea.

- To date, XPOVIO has already been included in national health insurance or reimbursement schemes in South Korea, the mainland of China, Australia and Singapore, and is expected to achieve national reimbursement coverage in more APAC markets.

- XPOVIO has been approved for multiple indications in nine markets across the APAC region. Antengene has submitted a new drug application (NDA) for XPOVIO in Indonesia with approval expected in the second half of 2024.

Shanghai and Hong Kong, PRC, October 18, 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 South Korean Ministry of Food and Drug Safety (MFDS) has approved a supplemental New Drug Application (sNDA) for XPOVIO (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.

Prior to the recent approval, XPOVIO has been approved for two indications in South Korea that are: in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM (R/R MM); and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). In July 2024, XPOVIO was included into the reimbursement drug list in South Korea, thus became the first XPO1 inhibitor approved for public insurance coverage in the country.

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 South Korea, the mainland of China, Australia and Singapore. This recent approval for XPOVIO in South Korea will bring another innovative therapy to the clinical management of MM patients in South Korea, benefiting countless patients and families.

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 29 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.

(德琪医药-B)

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