Selinexor

新闻纲要 2025年12月2日，专注于肿瘤治疗领域的创新药企德琪医药（6996.HK）宣布重大研发进展：中国国家药品监督管理局（NMPA）已正式批准其核心管线产品ATG-022的两项1b/2期临床试验申请（IND），分别为ATG-022联合默沙东（MSD）PD-1抑制剂帕博利珠单抗（KEYTRUDA®）的二联疗法，以及ATG-022联合帕博利珠单抗与化疗的三联疗法，相关研究被命名为CLINCH-2。作为一款靶向CLDN18.2的抗体偶联药物（ADC），ATG-022此次联合疗法IND的获批，不仅标志着其临床开发进入多线联合治疗的关键阶段，更为胃癌等消化道肿瘤患者带来了精准治疗的新希望，同时彰显了德琪医药在ADC领域的研发实力与全球合作视野。 01 关于德琪医药 德琪医药成立以来便以“研发-first”为战略核心，聚焦肿瘤治疗领域未被满足的临床需求，是一家兼具全球研发视野与本土商业化能力的创新生物制药公司，总部位于中国上海和香港，业务覆盖全球主要医药市场。自登陆港交所以来，公司始终保持稳健的研发投入，构建了以ADC、小分子抑制剂、T细胞衔接器（TCE）等前沿技术为核心的多元化管线，涵盖胃癌、肺癌、黑色素瘤等多个高发瘤种，形成了“临床前-临床-商业化”的完整产业布局。 在研发实力方面，德琪医药搭建了自主创新的AnTenGager™ TCE平台，凭借空间位阻遮蔽等核心技术，在降低药物毒性、提升靶向精度方面形成独特优势，目前该平台已面向全球开放合作，推动行业技术进步。商业化领域，其首款获批产品希维奥®（塞利尼索片）2025年上半年实现收入5.32千万元，环比大幅增长70.6%，同时销售与行政费用显著下降，展现出“创新驱动+精益运营”的双轨发展成效。 02 ATG-022——打破表达限制的CLDN18.2 ADC新势力 靶点价值：CLDN18.2成消化道肿瘤靶向治疗“黄金靶点” CLDN18.2（紧密连接蛋白18.2）是消化道肿瘤领域的明星靶点，作为细胞紧密连接的关键组成部分，其在胃癌、胃食管结合部腺癌中特异性高表达，阳性率可达87%，在胰腺癌等实体瘤中也有较高表达，而在正常组织中几乎不表达，这使其成为靶向治疗的理想靶点。《2022全球癌症统计报告》显示，中国胃癌新发病例数占全球37.0%，死亡病例数占39.4%，但传统化疗与PD-1抑制剂治疗效果有限，三线治疗中位生存期仅约半年，临床需求迫切，这为CLDN18.2靶向药物提供了广阔的研发空间。 药物优势：高亲和力突破表达限制，疗效安全性双优 ATG-022作为德琪医药自主研发的CLDN18.2 ADC，采用“高亲和力抗体+MMAE细胞毒性载荷”的经典结构，却在临床数据中展现出差异化优势。其核心亮点在于对CLDN18.2的亲和力达到pmol级别，这种超高亲和力使其突破了同类药物对靶点表达水平的依赖——不仅在中高表达患者中疗效显著，在低表达及超低表达（IHC 2+ ≤ 20%）人群中同样展现出抗肿瘤活性。 已完成的CLINCH I/II期研究数据印证了其临床价值：在CLDN18.2中高表达患者（IHC 2+ > 20%）中，2.4mg/kg剂量组客观缓解率（ORR）达40%，包含1例完全缓解（CR），疾病控制率（DCR）高达90%，12个月总体生存率（OS）为66.2%；即便在低表达人群中，其ORR仍达33.3%，同样出现CR病例。这种“全表达范围覆盖”的特性，使其相比仅针对高表达人群的同类药物，能惠及更广泛的患者群体。 03 结语 ATG-022联合疗法IND的获批，是德琪医药研发管线推进的重要里程碑，更是中国ADC药物从“跟跑”向“领跑”跨越的缩影。当前全球CLDN18.2 ADC领域竞争激烈，国内药企凭借临床需求驱动、资本赋能与政策支持，已在研发进度上占据优势，多款药物进入III期临床阶段。ATG-022凭借全表达范围疗效、良好安全性及清晰的联合治疗布局，有望在竞争中脱颖而出。 对于患者而言，这款药物的推进意味着胃癌治疗将告别“一刀切”的传统模式，进入“精准化+个体化”的新时代；对于行业而言，德琪医药的研发实践为ADC药物的联合治疗提供了可借鉴的思路；对于企业自身，随着CLINCH-2研究的开展，ATG-022有望加速商业化进程，进一步巩固其在肿瘤治疗领域的地位。 未来，随着临床数据的不断积累，以及在胰腺癌、妇科肿瘤等其他CLDN18.2阳性瘤种中的探索，ATG-022有望成为德琪医药的核心增长引擎，更有望为中国创新药企在全球ADC赛道的竞争中，赢得更多话语权。 END 往期精选 点击获取 触界生物，自2017年成立以来，一直致力于为医疗健康与生命科学领域的企业提供创新的聚合平台服务，包括专业的线下活动和线上媒体服务。我们专注于一系列前沿的细分领域，涵盖：抗体药物、细胞与基因治疗、重组蛋白、mRNA&小核酸、创新疫苗、肿瘤精准医疗、类器官、多肽药物、小分子药物、合成生物学、再生医学与医美等领域。详情了解请点击官方网站：https://www.chujietech.com/。 触界生物2026年会议计划如下：

//   ▶XPOVIO® (selinexor) has received approvals for three indications in Hong Kong. These include its previous approval as the treatment for multiple myeloma (MM) when used together with dexamethasone (Xd), and its recent approvals as a monotherapy for relapsed or refractory diffuse large B-cell lymphoma (R/RDLBCL) and as a combination therapy when used together with bortezomib and dexamethasone (XVd) for MM patients who received at least one prior therapy. ▶ XPOVIO® is the first approved XPO1 inhibitor in Hong Kong. With expanding indications in MM and DLBCL, XPOVIO® is set to benefit more patients in Hong Kong. ▶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, December 3, 2025 — Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, today announced that the Department of Health, the Government of the Hong Kong Special Administrative Region (HKSAR) has approved two supplemental New Drug Applications (sNDA) for 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; and XPOVIO® 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. To date, XPOVIO® has been approved in Hong Kong for three indications. Previously, the XPOVIO® Xd regimen was approved in Hong Kong for the treatment of relapsed/refractory multiple myeloma (R/R MM) in adult patients. The approval of the two additional indications will further expand its coverage of a broader patient population and provide survival benefits to more patients in need. 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). Moving forward, XPOVIO® is expected to receive public insurance coverage in more APAC markets. About Antengene Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages and includes several in-house discovered programs, including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 × 4-1BB bispecific antibody), ATG-031 (CD24-targeting macrophage activator), and ATG-042 (oral PRMT5-MTA inhibitor). Antengene has also developed AnTenGager™, a proprietary T cell engager 2.0 platform featuring “2+1” bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune disease, solid tumors and hematological malignancies indications. To date, Antengene has obtained 32 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets. Its lead commercial asset, XPOVIO® (selinexor), is approved in the 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.