Antengene Corp. Ltd.

氨基观察-创新药组原创出品 作者 | 黄恺 政府工作报告再提“创新药”，并明确下一步支持方向。 今年的政府工作报告提出，健全药品价格形成机制，制定创新药目录，支持创新药发展。这是政府工作报告首次提出“创新药目录”。 AI制药企业，开始布局机器人了。 3月5日 ，英矽智能宣布已在其AI驱动的全自动机器人药物发现实验室部署首个双足人形机器人，取名为“监督者”。 “监督者”将通过数据采集和生成开展具身人工智能的系统训练，系统性学习人类实验室科学家的技能，进而支持协助实验室参观、远程呈现、跟踪记录和实验室监督等日常工作。 在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）政府工作报告再提“创新药” 2025年政府工作报告再提“创新药”，并进一步明确下一步支持方向。今年的政府工作报告提出，健全药品价格形成机制，制定创新药目录，支持创新药发展。这是政府工作报告首次提出“创新药目录”。 2）礼来中国呼吁将靶向病因创新药纳入医保 3月5日，礼来中国总裁兼总经理德赫兰表示，尽快将用于阿尔茨海默病疾病早期、靶向病因、可显著减缓疾病进程的创新药物纳入医保，提升患者的可及性和可负担性。  / 02 / 医药动态 1）荣灿生物HPV治疗性mRNA疫苗获得FDA临床许可 日前，荣灿生物医药人乳头瘤病毒（HPV）治疗性mRNA疫苗，获得美国食品药品监督管理局（的临床试验许可。 2）德琪医药希维奥在印度尼西亚正式获批上市 3月5日，德琪医药宣布，印度尼西亚食品药品监督管理局（BPOM）已批准希维奥®的新药上市申请。 / 03 / 器械跟踪 1）赛诺医疗冠脉产品在越南获得注册证 3月5日，赛诺医疗公告表示，HT Supreme™药物洗脱支架系统获得越南MoH的批准。 / 04 / 数字医疗日报 1）英矽智能部署首个人形机器人 3月5日 ，英矽智能宣布已在其AI驱动的全自动机器人药物发现实验室部署首个双足人形机器人，取名为“监督者”。“监督者”将通过数据采集和生成开展具身人工智能的系统训练，系统性学习人类实验室科学家的技能，进而支持协助实验室参观、远程呈现、跟踪记录和实验室监督等日常工作。 / 05 / 海外药闻 1）DS8201显著延长晚期胃癌患者生命 日前，阿斯利康和第一三共宣布，3期临床试验DESTINY-Gastric04显示，在HER2阳性不可切除和/或转移性胃癌或胃食管交界腺癌患者中，Enhertu作为二线疗法，与活性对照相比，在总生存期这一主要终点达到了统计学显著和具有临床意义的改善。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

- XPOVIO® is the first and only approved XPO1 inhibitor in Indonesia. - From the second half of 2024 to now, XPOVIO® was successively approved in Thailand, Malaysia and Indonesia, significantly expanding Antengene's commercial presence in APAC. To date, XPOVIO® has been approved for multiple indications in ten markets across the APAC region. - XPOVIO® has been approved for health insurance coverage in the mainland of China, Taiwan market, Australia, Singapore and South Korea. SHANGHAI and HONG KONG, March 5, 2025 /PRNewswire/ -- 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 cancer, today announced that the Indonesia National Agency of Drug and Food Control (BPOM) has approved a New Drug Application (NDA) for XPOVIO® (selinexor) for three indications: (1) In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy;(2) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and an anti‐CD38 monoclonal antibody; and (3) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy who are not eligible for haematopoietic cell transplant. 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). The ASEAN region, with its steady economic growth and a population exceeding 600 million, has become a market of significant potential for global biomedical development. The accelerating aging population in ASEAN has increased the overall disease burden on patients and local communities, leading to a growing demand for novel therapeutics. Currently, Antengene is actively expanding its presence into APAC markets in efforts to introduce more innovative medicines to the ASEAN region in the future, improving the level of healthcare in these regions and benefiting more patients in need. 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, 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, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Several clinical studies of the therapy are underway in mainland China. Credit: Chay_Tee/Shutterstock. Antengene’s new drug application (NDA) for Xpovio (selinexor) has gained approval from the Indonesia National Agency of Drug and Food Control for three indications. The approval paves the way for Xpovio to be used in conjunction with other therapies and as a monotherapy in specific cancer treatments. The approval for the indications is in conjunction with bortezomib and dexamethasone for treating adults with multiple myeloma (MM) who have undergone a minimum of one previous treatment. Xpovio can also be used as a single agent to treat adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), including DLBCL which arises from follicular lymphoma, after a minimum of two systematic therapy lines. Xpovio with dexamethasone is approved for treating adults with R/R MM who have undergone at least four previous therapies and whose disease is refractory to a minimum of two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs) and an anti‐cluster of differentiation 38 (CD38) monoclonal antibody. With this new approval, the therapy extends its reach in the Asia Pacific (APAC) region, in which it has already been approved in 10 nations and included in national insurance schemes in five markets. Antengene is currently working on broadening the therapy’s presence, aiming to introduce more medicines to the Association of Southeast Asian Nations (ASEAN) region. The company is focused both on widening the market reach of Xpovio and on expanding its indications. It is exploring several combo regimens of the therapy for conditions including myelofibrosis and endometrial cancer. Several clinical studies are underway in mainland China to evaluate Xpovio in treating relapsed/refractory haematologic malignancies and solid tumours. Three of these are being conducted jointly by Antengene and Karyopharm Therapeutics. In July 2024, China’s National Medical Products Administration approved Xpovio as a monotherapy for treating adults with R/R DLBCL.