Selinexor

//  ▶ 这是希维奥®在中国获批的第3项适应症，与硼替佐米和地塞米松联用（XVd方案），适用于既往接受过至少一线治疗的多发性骨髓瘤（MM）成人患者。▶ 在希维奥®已获批的3项适应症中，2项已纳入国家医保目录，包括单药治疗复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）以及联合地塞米松治疗R/R MM。▶ BENCH研究的试验数据显示，XVd方案对比Vd方案（硼替佐米和地塞米松），在既往至少接受过一线治疗的中国R/R MM患者中具有更好的临床疗效，观察到更长的无进展生存期（PFS）和缓解持续时间（DOR），达到更高的客观缓解率（ORR），并显示出总生存期（OS）延长的趋势。▶ 希维奥®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。中国上海和香港，2025年7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）的新适应症正式获得国家药品监督管理局（NMPA）批准，与硼替佐米和地塞米松联用（XVd方案），适用于既往接受过至少一线治疗的多发性骨髓瘤（MM）成人患者。此次获批是基于一项名为BENCH的III期随机对照、开放性、多中心桥接研究数据。该研究在154例既往接受过1-3线治疗的R/R MM中国患者中，对比了XVd方案与Vd方案的有效性及安全性。BENCH研究的疗效和安全性数据与国际多中心III期临床研究BOSTON研究基本一致，达到桥接研究的目标。研究证实：XVd方案优势显著：XVd方案对比Vd方案，在中国R/R MM患者中具有更好的临床疗效，观察到更长的PFS和DOR，达到更高的ORR、≥VGPR比例和MRD阴性率，并显示出OS延长的趋势；老年患者获益突出：≥65岁的老年患者亚组疗效显著，希维奥®为这一人群提供了更优选择。路瑾 教授BENCH研究的主要研究者北京大学人民医院“MM是血液系统第二大常见恶性肿瘤, 随着自体造血干细胞移植（autologous hematopoietic stem cell transplantation，ASCT）和新药在一线治疗中的应用，患者的总生存期已显著延长，但仍是一种不可治愈的疾病，患者终将面临复发。塞利尼索作为全新机制的核输出蛋白抑制剂，通过BENCH研究证实在中国MM患者中具有明确的疗效，新适应症的获批对R/R MM患者，尤其是首次复发的患者意义重大。”侯健 教授BENCH研究的主要研究者上海交通大学医学院附属仁济医院“MM的发病率呈逐年上升趋势，Globocan 2022统计数据显示，中国MM 新发病例为30300例,死亡人数达18662例，存在迫切的未被满足的临床需求。塞利尼索联合硼替佐米及地塞米松的方案，具有独特的机制，疗效明显，无需静脉用药，可减轻医疗负担，为临床治疗提供了全新的策略。”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。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。 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），并在11个亚太市场递交了新药上市申请（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。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2024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® Approved in China for the Second-Line Treatment of Multiple Myeloma, Marking the Third Approved Indication of the Drug- This approval for XPOVIO® in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy marks the third approved indication of the drug in China.- XPOVIO® as a monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and in combination with dexamethasone in patients with R/R MM, two of the three approved indications of XPOVIO® in China, have already been included into China’s National Reimbursement Drug List.- Results from the BENCH study show that, compared to the Vd regimen (bortezomib in combination dexamethasone), the XVd regimen offers greater efficacy, a longer progression-free survival (PFS), a longer duration of response (DOR), a higher objective response rate (ORR), and a trend of prolonged overall survival (OS) in Chinese patients with R/R MM who have received at least one prior therapy.- XPOVIO® 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).Shanghai and Hong Kong, PRC, July 28, 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 hematologic malignancies and solid tumors, today announced that the China National Medical Products Administration (NMPA) has approved XPOVIO® (selinexor) in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy, a new indication of XPOVIO®.This approval for XPOVIO® is based on the data of the BENCH trial, a randomized, controlled, open-label, multicenter Phase III bridging study which compared the safety and efficacy of XVd and Vd regimens in 154 Chinese patients with R/R MM who have received one to three prior lines of therapy. The efficacy and safety data of the BENCH study are generally consistent with those from the global, multicenter, Phase III BOSTON study and met the objectives of the bridging study which showed:Clear superiority of the XVd regimen: compared to the Vd regimen, the XVd regimen demonstrated better clinical efficacy, longer PFS and DOR, a higher ORR, a higher rate of very good partial response (VGPR) or deeper responses and minimal residual disease (MRD) negativity, as well as a trend of prolonged OS.Notable clinical benefits for elderly patients: the study observed particularly notable efficacy in the cohort of elderly patients aged ≥65, validating XPOVIO® as a better treatment option for this patient population.Prof. Jin Lu, principal investigator of the BENCH study from Peking University People’s Hospital, said, “MM is the second most common hematologic malignancy. The clinical application of autologous hematopoietic stem cell transplantation (ASCT) and novel agents in the first-line setting have resulted in longer overall survival for patients. However, the condition remains incurable with most patients end up relapsing. As a novel inhibitor of the nuclear export protein that adopts a novel mechanism of action, selinexor was proven by the BENCH study to be significantly efficacious in Chinese patients with MM. This approval for XPOVIO® is a great news for patients with R/R MM, especially those relapsing for the first time.”Prof. Jian Hou, principal investigator of the BENCH study from Shanghai Jiaotong University School of Medicine Affiliated Renji Hospital, commented, “The incidence of MM has been steadily rising year after year. According to the Globocan statistics for 2022, there were 30,300 new cases of MM and 18,662 MM related deaths in China, a figure that highlights an urgent unmet clinical need. Selinexor in combination with bortezomib and dexamethasone incorporates a unique mechanism of action and demonstrated significant efficacy. Moreover, XPOVIO® does not require intravenous administration, therefore provides clinicians a new treatment strategy that can effectively reduce burden on patients.”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).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 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”. 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 new drug applications (NDAs) in 11 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.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, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange.