CB-708

Antengene Corporation Limited has announced that Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has approved a supplemental New Drug Application (sNDA) for XPOVIO (selinexor), extending the medicine’s use to adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior systemic therapies and are ineligible for autologous stem cell transplant.[1] This new hematology oncology indication significantly broadens the clinical and commercial footprint of XPOVIO in the Malaysian market, where the product had previously been approved only for specific multiple myeloma settings. 安腾基因公司宣布，马来西亚国家药品监管机构（NPRA）已批准XPOVIO（selinexor）的补充新药申请（sNDA），将该药物的使用范围扩展至接受过至少两种先前系统治疗且不符合自体干细胞移植条件的复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）成年患者。这一新的血液肿瘤适应症显著扩大了XPOVIO在马来西亚市场的临床和商业覆盖范围，此前该产品仅在特定多发性骨髓瘤治疗中获得批准。For B2B pharma stakeholders across Asia, this expansion highlights both the accelerating pace of advanced oncology approvals in Southeast Asia and the growing strategic importance of Malaysia within regional market access plans.. 对于亚洲各地的B2B制药行业利益相关者而言，此次扩展不仅突显了东南亚地区先进肿瘤药物审批步伐的加快，也彰显了马来西亚在区域市场准入计划中日益增长的战略重要性。Before this decision, XPOVIO was already approved in Malaysia in two multiple myeloma (MM) indications: in combination with bortezomib and dexamethasone for adult patients who had received at least one prior therapy, and in combination with dexamethasone for heavily pretreated adults whose disease is refractory to multiple proteasome inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody.[1] With the DLBCL expansion, Malaysian hematologists now have an orally administered, first-in-class selective inhibitor of nuclear export (XPO1) to manage a highly challenging, late-line lymphoma population. 在此次获批之前，XPOVIO已在马来西亚获得两项多发性骨髓瘤（MM）适应症的批准：与硼替佐米和地塞米松联合用于已接受过至少一种先前治疗的成年患者，以及与地塞米松联合用于对多种蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体耐药的重度预处理成年患者。[1] 随着DLBCL适应症的扩展，马来西亚的血液科医生现在拥有了一种口服的、首创的选择性核输出（XPO1）抑制剂，可用于管理极具挑战性的晚期淋巴瘤患者群体。From a business and market access standpoint, Antengene now commands three approved indications for XPOVIO in Malaysia across two major hematology segments, improving the asset’s utilization potential and strengthening physician familiarity with the brand.. 从商业和市场准入的角度来看，安腾医药现在在马来西亚的两大血液学领域拥有XPOVIO的三个获批适应症，提高了该药物的使用潜力，并增强了医生对品牌的熟悉度。XPOVIO is described as the world’s first approved, orally available, selective XPO1 inhibitor, and it has already secured regulatory approvals in ten countries and regions across the Asia Pacific, including mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, Malaysia, Thailand, Indonesia, and Australia.[1] In five of these markets—mainland China, Taiwan, Australia, South Korea, and Singapore—the product has been integrated into national insurance or reimbursement schemes, establishing an important precedent for eventual payer negotiations in additional Asian jurisdictions. XPOVIO被描述为全球首款获批的口服选择性XPO1抑制剂，已在亚太地区的十个国家和地区获得监管批准，包括中国大陆、台湾、香港、澳门、韩国、新加坡、马来西亚、泰国、印尼和澳大利亚。[1] 在其中五个市场——中国大陆、台湾、澳大利亚、韩国和新加坡——该产品已被纳入国家保险或报销体系，为未来在其他亚洲司法管辖区的支付方谈判树立了重要先例。The Malaysian DLBCL approval therefore not only has direct local impact but also reinforces the broader APAC narrative that regionally developed or co-developed oncology innovations can achieve wide geographic penetration accompanied by structured reimbursement pathways.. 因此，马来西亚对DLBCL的批准不仅具有直接的本地影响，还加强了更广泛的亚太地区叙事，即区域内开发或共同开发的肿瘤创新可以实现广泛的地理覆盖，并伴随有结构化的报销途径。For regulators, payers, and hospital decision makers in Asia, this development illustrates how targeted therapies with well-differentiated mechanisms of action can be rapidly life-cycle managed through indication expansions that leverage existing safety, efficacy, and pharmacoeconomic data. DLBCL remains one of the most common non-Hodgkin lymphomas worldwide, and outcomes in heavily pretreated, transplant-ineligible patients are generally poor, driving demand for additional therapeutic options. 对于亚洲的监管机构、支付方和医院决策者来说，这一进展展示了如何通过利用现有的安全性、有效性和药物经济学数据，快速实现针对适应症扩展的生命周期管理，从而管理具有明确差异化作用机制的靶向疗法。弥漫性大B细胞淋巴瘤（DLBCL）仍然是全球最常见的非霍奇金淋巴瘤之一，而对于经过多线治疗且无法接受移植的患者，其预后通常较差，这推动了对更多治疗选择的需求。The Malaysian NPRA’s willingness to greenlight a supplemental filing in this population signals increasing regulatory comfort with novel mechanisms in hematologic malignancies, provided that sponsors can deliver robust clinical evidence and clear benefit–risk profiles. This, in turn, influences investment planning for other regional and global biotech companies evaluating where to prioritize Phase 2 or Phase 3 trials and subsequent submissions.. 马来西亚NPRA愿意在这一人群中批准补充申请，这表明只要申办方能够提供强有力的临床证据和明确的效益-风险概况，监管机构对血液恶性肿瘤中的新机制越来越有信心。这反过来又影响了其他地区和全球生物技术公司在评估优先进行二期或三期试验及后续提交的地点时的投资规划。From an R&D pipeline perspective, Antengene has positioned itself as an Asia-rooted, R&D-driven biotech with a mix of in-licensed and internally discovered assets.[1] The company reports having obtained 32 Investigational New Drug (IND) approvals across the United States and Asia, and it has submitted New Drug Applications (NDAs) in 11 Asia Pacific markets. 从研发管线的角度来看，德琪医药将自己定位为一家扎根亚洲、以研发为驱动的生物技术公司，拥有授权引入和内部发现的资产组合。[1] 该公司报告称已在美国和亚洲获得32项研究性新药（IND）批准，并已在11个亚太市场提交了新药申请（NDAs）。Its pipeline includes programs such as ATG-022 (a CLDN18.2 antibody–drug conjugate), ATG-037 (an oral CD73 inhibitor), ATG-101 (a PD-L1 × 4-1BB bispecific antibody), ATG-031 (a CD24-targeting macrophage activator), and ATG-042 (an oral PRMT5-MTA inhibitor).[1] The successful expansion of XPOVIO’s label in Malaysia can be viewed as a proof point that Antengene can navigate multi-jurisdictional regulatory frameworks and leverage its commercial infrastructure to optimize the value of its lead oncology asset while laying the groundwork for future launches.. 其研发管线包括ATG-022（CLDN18.2抗体药物偶联物）、ATG-037（口服CD73抑制剂）、ATG-101（PD-L1 × 4-1BB双特异性抗体）、ATG-031（靶向CD24的巨噬细胞激活剂）和ATG-042（口服PRMT5-MTA抑制剂）等项目。[1] XPOVIO在马来西亚成功扩展适应症可以被视为一个证明点，表明Antengene能够驾驭多辖区的监管框架，并利用其商业基础设施优化其领先肿瘤资产的价值，同时为未来的上市奠定基础。For executives and strategists in the regional pharma ecosystem, the Malaysian DLBCL approval underscores the significance of a multi-country, multi-indication strategy when advancing oncology therapies in Asia. The ability to align regulatory submissions across markets like China, ASEAN members, South Korea, and Australia not only maximizes the return on clinical development investment but also supports cross-border evidence generation and real-world data collection. 对于区域制药生态系统中的高管和战略家来说，马来西亚对DLBCL的批准强调了在亚洲推进肿瘤治疗时多国、多适应症策略的重要性。在诸如中国、东盟成员国、韩国和澳大利亚等市场协调监管提交，不仅能够最大化临床开发投资的回报，还能支持跨境证据生成和真实世界数据收集。Payers and health technology assessment (HTA) bodies in emerging Asian markets increasingly look to peer markets for benchmarking, and an oncology drug that has already demonstrated acceptance in several advanced healthcare systems often faces lower barriers to formulary inclusion. This dynamic may accelerate subsequent pricing and reimbursement discussions for XPOVIO in Malaysia, particularly if local health economic models show value in high-need lymphoma populations.. 新兴亚洲市场的支付方和卫生技术评估 (HTA) 机构越来越多地将同类市场作为基准参考，一种已在多个先进医疗体系中显示出被接受度的肿瘤药物通常在纳入处方集时面临的障碍较低。如果当地的卫生经济学模型显示出在高需求淋巴瘤人群中的价值，这种动态可能会加速XPOVIO在马来西亚的后续定价和报销讨论。Operationally, the expansion of indications in a country such as Malaysia can drive incremental demand for supporting diagnostic, pharmacy, and distribution infrastructure. Hospital pharmacies and oncology centers will need to adapt their treatment protocols, stock management, and patient monitoring frameworks to incorporate XPOVIO for DLBCL patients who qualify under the new criteria. 在实际操作层面，像马来西亚这样的国家扩大适应症可以推动对支持诊断、药房和分销基础设施的增量需求。医院药房和肿瘤中心将需要调整其治疗方案、库存管理以及患者监测框架，以将XPOVIO纳入适用于符合新标准的DLBCL患者的治疗中。Meanwhile, Antengene’s field teams across medical affairs, market access, and commercial functions will likely intensify engagement with key opinion leaders, professional societies, and payers to communicate the clinical profile of selinexor and clarify its positioning relative to existing regimens and emerging competitors. 同时，安腾睿的医学事务、市场准入和商业职能领域的团队可能会加强与关键意见领袖、专业协会和支付方的沟通，以传达塞利尼索的临床特性，并阐明其相对于现有治疗方案和新兴竞争对手的定位。These activities contribute to a more robust innovation ecosystem in Southeast Asia and may influence other biotech and pharmaceutical firms considering similar launch sequences.. 这些活动有助于东南亚地区打造更强大的创新生态系统，并可能影响其他考虑类似上市顺序的生物技术和制药公司。At the strategic portfolio level, the DLBCL label extension in Malaysia enhances XPOVIO’s differentiation as a hematology franchise product rather than a single-indication multiple myeloma therapy. This shift is critical from a lifecycle management and valuation standpoint: multi-indication oncology brands typically command stronger long-term revenue trajectories, particularly when supported by ongoing clinical trials exploring combination regimens and earlier lines of therapy. 在战略投资组合层面，XPOVIO在马来西亚的DLBCL标签扩展增强了其作为血液学特许经营产品的差异化，而不仅是单一适应症的多发性骨髓瘤疗法。从生命周期管理和估值的角度来看，这一转变至关重要：多适应症的肿瘤品牌通常具有更强的长期收入增长潜力，特别是当有持续的临床试验探索联合治疗方案和更早的治疗线时。For board members, investors, and licensing partners, the Malaysian approval could therefore be interpreted as incremental de-risking of the asset in Asia Pacific, with positive implications for partnering discussions, co-commercialization negotiations, and potential out-licensing deals targeting specific territories.. 因此，对于董事会成员、投资者和授权合作伙伴来说，马来西亚的批准可被解读为在亚太地区对该资产的逐步去风险化，这对合作讨论、共同商业化谈判以及针对特定地区的潜在对外授权交易具有积极意义。In the wider context of Asia’s biopharmaceutical development, Antengene’s progress with XPOVIO reflects a broader transition in the region from generics-dominated portfolios toward innovation-led pipelines focused on first-in-class and best-in-class products. Countries such as Malaysia, with evolving regulatory capacity and growing oncology burden, are becoming test beds for agile access models and collaborative engagement between regulators, payers, and innovative biotechs. 在亚洲生物制药发展的更广泛背景下，Antengene在XPOVIO方面取得的进展反映了一个更为广泛的转变，即该地区从以仿制药为主的产品组合向以创新为主导的研发管线过渡，聚焦于首创新药和同类最佳产品。像马来西亚这样监管能力不断演进且肿瘤负担日益加重的国家，正成为灵活准入模式以及监管机构、支付方和创新型生物技术公司之间协作互动的试验场。The XPOVIO DLBCL approval will likely be monitored by other ASEAN regulators, as well as multinational companies planning to position novel targeted therapies in comparable patient segments. For Asia-focused B2B pharma stakeholders—from CDMOs and CROs to digital health providers and data analytics firms—this development signals continued demand for sophisticated support services that can help innovative therapies navigate the complex intersection of clinical evidence, regulatory expectations, and payer requirements across multiple Asian jurisdictions.. XPOVIO DLBCL的批准可能会受到其他东盟监管机构以及计划在相似患者群体中定位新型靶向疗法的跨国公司的关注。对于专注于亚洲的B2B制药行业利益相关者——从CDMO、CRO到数字健康服务提供商和数据分析公司而言，这一进展表明，对能够帮助创新疗法应对多个亚洲司法管辖区临床证据、监管期望和支付方要求复杂交集的高端支持服务的需求将持续存在。Looking ahead, Antengene has indicated that it expects XPOVIO to receive public insurance coverage in additional Asia Pacific markets beyond the five where it is already reimbursed.[1] While specific timelines and payer negotiations remain confidential, each new indication and jurisdiction strengthens the data and market access dossier that the company can present to health authorities. 展望未来，Antengene 表示预计 XPOVIO 将在已经获得报销的五个亚太市场之外，进一步获得其他市场的公共保险覆盖。[1] 虽然具体的时间表和支付方谈判仍属保密，但每一个新的适应症和管辖区域都加强了该公司可以向卫生当局提交的数据和市场准入档案。For Malaysian healthcare regulators and hospital administrators, the key operational questions will center on how to best integrate selinexor into treatment algorithms for DLBCL, evaluate patient selection criteria, manage side-effect profiles in real-world practice, and assess the budget impact within constrained oncology funding envelopes. 对于马来西亚的医疗保健监管者和医院管理人员来说，关键的操作问题将集中在如何最好地将塞利尼索整合到DLBCL的治疗方案中、评估患者选择标准、在实际操作中管理副作用情况，以及在有限的肿瘤资金范围内评估预算影响。Answers to these questions will shape not only the commercial performance of XPOVIO in Malaysia but also the evolving standards of care for relapsed or refractory DLBCL across the broader Asia Pacific region.. 这些问题的答案不仅将影响XPOVIO在马来西亚的商业表现，还将塑造整个亚太地区复发或难治性DLBCL的护理标准演变。