Bortezomib

药械追踪 No.1 / 诺和诺德CB1激动剂monlunabant减重IIa期数据差强人意 丹麦诺和诺德（NYSE：NVO）近日公布了在研小分子口服大麻素受体1（CB1）反向激动剂monlunabant用于治疗肥胖症的IIa期临床试验数据。投资者对这些数据反应消极，导致诺和诺德股价单日下跌超过4%。 此次试验评估了monlunabant每日一次 10 mg、20 mg 和 50 mg 剂量与安慰剂相比的疗效和安全性。治疗16周后，所有剂量的monlunabant都实现了具有统计学意义的显著体重减轻，其中，10mg剂量组的患者体重减轻了7.1kg，而安慰剂的体重减少了0.7kg，相当于减轻了约6.5%体重，但在投资者看来，这与减肥神药Wegovy（司美格鲁肽）在16周内减重8%、在12个月内减重15%的能力相比，可能稍显逊色。Monlunabant治疗产生的不良事件为轻度至中度，包括胃肠道和神经精神性事件。 诺和诺德指出，需要进一步试验来确定monlunabant的适当剂量，并预计2025年将进行更大规模的IIb期试验。 ->点击阅读原文，解锁完整双语新闻 No.2 / 赛诺菲赛可益获FDA批准一线治疗多发性骨髓瘤 赛诺菲（EURONEXT:SAN；NASDAQ:SNY）近日宣布，旗下抗CD38抗体赛可益（艾沙妥昔单抗）获得美国FDA批准上市，用于联合标准治疗（硼替佐米、来那度胺和地塞米松[VRd]）一线治疗新诊断的不适合接受移植的多发性骨髓瘤（MM）成年患者。这是该药物在美国获批的第三个MM适应证。 此前，艾沙妥昔单抗于2020年在美国首次获批上市，用于既往已接受过至少2种疗法（包括来那度胺和一种蛋白酶体抑制剂）的复发难治性多发性骨髓瘤（RRMM）成人患者；该药又于2021年获FDA批准扩展新适应证，联合卡非佐米和地塞米松用于既往接受过1-3线治疗的复发性或难治性多发性骨髓瘤成人患者。该药物上市申请日前已获得中国国家药品监督管理局（NMPA）受理。 ->点击阅读原文，解锁完整双语新闻 企业动态 No.1 / 华东医药与惠升生物达成降糖药惠优静商业化合作 2024年9月20日，华东医药（000963.SZ）全资子公司华东医药（杭州）有限公司宣布，与四环医药（0460.HK）旗下非全资附属公司惠升生物就其已上市创新产品惠优静（脯氨酸加格列净片）在中国大陆的商业化权益达成独家战略合作。根据协议条款，华东医药将负责惠优静在中国大陆的商业化市场推广，惠升生物作为MAH持有人将负责惠优静的注册、临床开发、生产和供应。 惠优静已经获得中国、美国、欧洲、日本、韩国、香港等多个国家和地区专利权。2024年1月19日，惠优静获得国家药品监督管理局（NMPA）正式批准上市，用于单药治疗或与盐酸二甲双胍联合使用，改善成人2型糖尿病患者的血糖控制。 ->点击阅读原文，解锁完整双语新闻 行业政策 No.1 / 中国领导的14国科学家联合倡议开展人类基因组计划二期 近日，由中国科学家领导的国际研究团队在《细胞》杂志上发表文章《献给人类1%的礼物：人类基因组计划二期》（The 1% gift to humanity: The Human Genome Project II），倡议启动人类基因组计划二期（HGP2），以面对精准医学发展面临的全球挑战，其中发出倡议的科学家包括来自华大集团的员工。该计划的初步目标是完成全球1%人口的基因组测序。 HGP2计划背后的全球协调对于从不同人群中收集多组学数据至关重要，这能够促使遗传和多组学变异的临床相关性被编目并纳入临床实践和公共卫生指南。 文章指出，要实现这些目标，就需要在全球范围内进行跨国合作，以克服各种挑战，包括经济、组织、基础设施、科学以及伦理、法律和社会影响等。这些科学家表示：“在一个企业竞争加剧和地缘政治威胁全球合作的时代，我们必须更加努力，使精准医疗成为全人类普遍的礼物——对后代来说，是可用和可及的”。 1990年，“人类基因组计划”（HGP）启动，并于2003年结束。该计划生成了人类基因组的第一个序列，还包括对五种模式生物基因组的研究。这项壮举由来自美国、英国、日本、德国、法国和中国超过20所大学和研究中心的科学家共同完成。 ->点击阅读原文，解锁完整双语新闻 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻

//   ▶ 希维奥®是在泰国获批上市的首款且唯一一款XPO1抑制剂。 ▶ 希维奥®已在亚太市场的9个国家和地区获得多项新药上市批准，公司还在印度尼西亚提交了产品的新药上市申请（NDA），预计于今年下半年获批。 ▶ 希维奥®已在中国大陆、澳大利亚、新加坡和韩国实现医保收录。 中国上海和香港，2024年9月23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，泰国食品药品监督管理局已批准希维奥®（中文通用名：塞利尼索，英文商品名：XPOVIO®）的新药上市申请（NDA）。用于两个适应症的治疗：（1）联合硼替佐米和地塞米松用于治疗至少接受过一种先前治疗的多发性骨髓瘤（MM）成人患者；（2）联合地塞米松用于治疗接受过至少四种既往治疗且对至少两种蛋白酶体抑制剂、两种免疫调节剂和一种抗CD38单克隆抗体药物难治，并在接受最后一种治疗时出现疾病进展的MM成人患者。 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个国家和地区获得多项新药上市批准。此次希维奥®成功在泰国获批上市，将为泰国的MM患者带来全新的创新治疗选择，惠及更多患者及其家庭。截至目前，希维奥®已在中国大陆、澳大利亚、新加坡和韩国实现医保收录。 东盟拥有超过6亿人口，随着经济的稳步增长，已成为全球生物医药发展的重要潜力市场。人口老龄化的加速使东盟市场的整体疾病负担不断加重，社会对新型治疗药物的需求持续增加。德琪医药致力于改善东盟人民的健康福祉，继 8 月在马来西亚获得批准上市，本次在泰国正式获批以外，我们还预计于2024 年下半年取得印度尼西亚的正式获批。未来，公司将继续把更多创新药物带到东盟市场，以提升当地的医疗健康水平，造福更多患者。 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29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® (selinexor) Approved for Commercialization in Thailand - XPOVIO® is the first and only approved XPO1 inhibitor in Thailand. - 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. - XPOVIO® has been approved for health insurance coverage in the mainland of China, Australia, Singapore and South Korea. Shanghai and Hong Kong, PRC, September 23, 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 cancer, today announced that the Thailand Food and Drug Administration has approved a New Drug Application (NDA) for XPOVIO® (selinexor) for two 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; and (2) in combination with dexamethasone for the treatment of adult patients with MM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. 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 markets in APAC. This successful approval for XPOVIO® in Thailand will introduce novel therapies to the clinical management of patients with MM in Thailand, benefiting many patients and their families in the country. To date, XPOVIO® has also been included in national health insurance or reimbursement schemes in the mainland of China, Australia, Singapore and South Korea. The ASEAN region, with its steady economic growth and a population exceeding 600 million, has become a significant potential market 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. Fulfilling its commitment to enhancing the health and well-being of the ASEAN population, Antengene has successfully obtained NDA approvals for XPOVIO® in Malaysia in August and very recently in Thailand, and expects XPOVIO® to be approved in Indonesia in the second half of 2024. Looking ahead, the company aims to introduce more innovative medicines to the ASEAN market, bringing improved healthcare to more patients in the region. 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.