德琪医药ATG-010联合R-GDP治疗复发难治性弥漫性大B细胞淋巴瘤的全球多中心2/3期临床试验获批准

中国上海和香港，2021年1月25日--致力于研发和商业化同类首款及/或同类最优血液及肿瘤学疗法的领先创新生物制药公司--德琪医药有限公司（简称“德琪医药”，香港联交所股票代码：6996.HK）今日宣布，国家药品监督管理局（NMPA）已批准ATG-010（selinexor）联合R-GDP（SR-GDP）用于治疗复发难治性弥漫性大B细胞淋巴瘤（rrDLBCL）的临床试验申请。

该试验是一项全球性多中心2/3期研究，旨在评价ATG-010联合R-GDP在复发难治性弥漫性大B细胞淋巴瘤患者中的疗效及安全性（XPORT-DLBCL-030）。试验将在中国，北美、澳洲和欧洲多个国家和地区设立的临床研究中心开展。

作为首个口服型选择性核输出抑制剂（SINE）产品，ATG-010可以引起肿瘤抑制蛋白和其他生长调节蛋白的核内储留和活化，以及下调胞浆内多种致癌蛋白水平，并在体外和体内诱导大量实体和血液肿瘤细胞的凋亡，而正常细胞不受影响。2020年6月，美国食品药品监督管理局（FDA）批准ATG-010作为单药口服疗法用于治疗rrDLBCL患者。这是ATG-010获批治疗的第二个血液瘤适应症，该治疗方案已被纳入美国国家综合癌症网络（NCCN®）指南。此前，德琪医药已在中国开展ATG-010治疗既往接受过至少2种且不超过5种系统性治疗方案的rrDLBCL患者的2期临床研究。

“NMPA批准德琪开展这项临床试验，具有非常重要的意义，弥漫性大B细胞淋巴瘤患者的治疗手段有限，这将是一个全新的、优化的口服疗法，”德琪医药创始人、董事长兼首席执行官梅建明博士表示。“作为2021年我们参加的首个国际多中心临床试验，也是德琪全球化发展的优势体现。我们将同海外合作伙伴无缝对接，推进试验在中国的开展。”

关于ATG-010（selinexor，XPOVIO®）

ATG-010（selinexor，XPOVIO®）是同类首款且唯一一款口服型选择性核输出抑制剂（SINE），由Karyopharm Therapeutics Inc.（纳斯达克股票代码: KPTI）开发。德琪医药与Karyopharm达成独家合作和授权，获得了ATG-010在多个亚太市场包括大中华区、韩国、澳大利亚、新西兰和东盟国家的独家开发和商业化权益。
2019年7月，美国食品药品监督管理局（FDA）批准selinexor (XPOVIO®)联合低剂量地塞米松用于治疗复发难治性多发性骨髓瘤（rrMM）患者。2020年6月，美国FDA再次批准selinexor (XPOVIO®)作为单药口服疗法用于治疗复发难治性弥漫性大B细胞淋巴瘤（rrDLBCL）患者。2020年12月，美国FDA批准了selinexor (XPOVIO®)用于治疗既往接受过至少一次治疗的多发性骨髓瘤患者。Selinexor (XPOVIO®) 的一项上市许可申请（MAA）已经递交欧洲药品管理局（EMA），要求有条件地批准selinexor (XPOVIO®) 用于rrMM。Selinexor (XPOVIO®)是目前首款且唯一一款被美国FDA批准的口服SINE化合物，可用于治疗多发性骨髓瘤和弥漫性大B细胞淋巴瘤。此外，selinexor (XPOVIO®)针对多个实体肿瘤适应症开展了多项中期和后期临床试验，包括脂肪肉瘤和子宫内膜癌。2020年11月，德琪医药合作伙伴Karyopharm在2020年结缔组织肿瘤学年会（CTOS 2020）上报告了3期SEAL试验的积极数据。SEAL是一项随机、双盲、安慰剂对照交叉试验，旨在比较口服单药selinexor (XPOVIO®)与安慰剂在脂肪肉瘤患者中的疗效。另外，Karyopharm近期公布了selinexor (XPOVIO®)用于治疗子宫内膜癌患者的3期SIENDO试验已完成计划的中期无效性分析，数据安全监查委员会（DSMB）推荐SIENDO试验无需作任何修改按计划继续进行。SIENDO试验的首要数据结果预计在2021年下半年公布。

关于德琪医药

德琪医药有限公司（简称“德琪医药”，香港联交所股票代码：6996.HK）是一家专注于创新抗肿瘤药物的亚太地区临床阶段生物制药公司，旨在为中国、亚太地区及全球各地的患者提供最前沿的抗肿瘤创新疗法。自成立以来，德琪医药已建立起拥有12款临床及临床前创新药物的丰富产品管线，并在亚太地区取得12个临床试验批件。德琪人以“医者无疆，创新永续”为愿景，力争通过对同类首款/同类最优疗法的专研与市场化，解决亚太乃至全球患者未满足的临床需求。

前瞻性声明

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章刊发日期作出。任何该等意向均可能因未来发展而出现变动。

* XPORT-DLBCL-030研究由Karyopharm Therapeutics Inc.发起；XPOVIO®为Karyopharm Therapeutics Inc.注册商标；R-GDP：利妥昔单抗、吉西他滨、地塞米松和顺铂。

Antengene Announces Approval of IND Application in China for ATG-010 in Combination with R-GDP (SR-GDP) for the Treatment of rrDLBCL in a Global Phase 2/3 Study

Shanghai and Hong Kong, PRC, January 25, 2021-- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, announced today that the National Medical Products Administration (NMPA) has granted approval for the Investigational New Drug (IND) application for ATG-010 (selinexor) combined with R-GDP (SR-GDP) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). The trial is a global Phase 2/3, multicenter study aiming to evaluate the safety and efficacy of ATG-010 in combination with R-GDP in patients with rrDLBCL (XPORT-DLBCL-030). It will be conducted at multiple international centers located in China, U.S., Australia, Europe and other regions. ATG-010 (selinexor) is the first oral selective inhibitor of nuclear export (SINE) product in the world. It induces the apoptosis of cancer cells in vitro and in vivo by causing the nuclear storage and activation of tumor suppressor proteins and other growth-regulating proteins, and by down-regulating the intracytoplasmic levels of various oncogenic proteins while normal cells are not affected. In June 2020, the US Food and Drug Administration (FDA) approved ATG-010 as a single-agent for the treatment of rrDLBCL. This is the second indication for ATG-010 in hematological malignancies and the treatment regimen has been added to the National Comprehensive Cancer Network (NCCN®) Guidelines. In China, Antengene is conducting a Phase 2 clinical trial of ATG-010 in the treatment of patients with rrDLBCL who have received at least two but no more than five previous systemic regimens. “Being granted the trial approval by the NMPA bears great significance as it brings us a step closer to offering an optimized new oral therapy to patients with DLBCL who now have very limited treatment options,” said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. “As the first global multicenter trial we are taking part in this year, the study once again signifies the advantages of our globalized development strategies. We will collaborate seamlessly with our global partners to ensure the successful initiation of the trial in China.”

About ATG-010 (selinexor, XPOVIO®)

ATG-010 (selinexor, XPOVIO®), a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor (XPOVIO®) in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor (XPOVIO®) as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor (XPOVIO®) also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same rrMM indication. Selinexor (XPOVIO®) is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor (XPOVIO®) is also being evaluated in several other mid-and later-Phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor (XPOVIO®) versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO trial of selinexor (XPOVIO®) in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since its establishment, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets and obtained 12 investigational new drug approvals in Asia Pacific. The vision of Antengene is to “Treat Patients Beyond Borders”. Antengene aims to address significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.

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.

*XPORT-DLBCL-030 was initiated by Karyopharm Therapeutics Inc.; XPOVIO® is a registered trademark of Karyopharm Therapeutics Inc.; R-GDP: Rituximab, Gemcitabine, Dexamethasone and Cisplatin.
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