Etesevimab

上海 2026年2月25日 /美通社/ -- 北京时间2026年2月25日，君实生物（1877.HK，688180.SH）宣布与德琪医药（6996.HK）达成战略合作，双方将共同探索君实生物自主研发的JS207（抗PD-1/VEGF双特异性抗体）与德琪医药的ATG-037（口服CD73小分子抑制剂）在中国大陆肿瘤患者中的联合治疗协同潜力。 JS207是君实生物自主研发的重组人源化抗PD-1和VEGF双特异性抗体，在临床前及临床研究中均显示出令人鼓舞的抗肿瘤活性及可控的安全性特征。临床前研究在多个肿瘤模型中验证了其显著的抗肿瘤疗效，并支持其差异化的作用机制。研究显示，VEGFA可增强JS207的抗原结合活性、T细胞激活效力以及对细胞表面PD-1的内吞作用。 在2025年欧洲肿瘤内科学会亚洲年会（ESMO Asia）壁报展示中，JS207单药治疗在多种实体瘤中展现出积极疗效， 其中接受一线治疗的 62例PD-L1阳性非小细胞肺癌（NSCLC）患者客观缓解率（ORR）达到58.1%，疾病控制率（DCR）达到87.1% 。此外，JS207在肝细胞癌（HCC）和肾细胞癌（RCC）等其他肿瘤类型中亦观察到临床活性，进一步支持PD-1/VEGF双靶点策略在多种肿瘤治疗场景中的潜在价值。 截至目前，JS207共有 11项Ⅱ期临床研究正在进行中 ，在非小细胞肺癌、结直肠癌、三阴乳腺癌、肝癌等瘤种中开展与化疗、单抗、抗体偶联药物（ADC）等不同药物的联合探索， 共计入组患者近 500例 。基于以上累积的数据， 美国食品药品监督管理局（ FDA）已批准JS207的新药试验（IND）申请 ，允许君实生物启动一项JS207对比纳武利尤单抗用于Ⅱ/Ⅲ期、可切除、可改变驱动基因（AGA）阴性NSCLC患者新辅助治疗的开放标签、双臂、随机、阳性对照Ⅱ/Ⅲ期研究。 ATG-037是德琪医药正在开发的一款口服CD73小分子抑制剂，相较于抗CD73单克隆抗体具有显著优势。临床前研究显示，ATG-037可更强效抑制细胞表面CD73酶活性，并克服抗体药物中常见的"弯钩效应"。此外，ATG-037相较抗体具有更高的组织穿透能力，有助于在细胞层面实现完全的CD73抑制。 根据德琪医药于2025年11月研发日公布的最新数据，ATG-037与抗PD-1疗法联合用药在免疫检查点抑制剂（CPI）耐药的黑色素瘤及NSCLC患者中显示出令人鼓舞的临床活性。在正在进行的Ⅰ/Ⅰb期STAMINA-01研究中，该联合治疗在 CPI耐药黑色素瘤患者中实现了33.3%的ORR和100%的DCR；在CPI耐药NSCLC患者中实现了21.4%的ORR和71.4%的DCR 。相关数据来自澳大利亚入组的CPI难治实体瘤患者，其中既往抗PD-1单抗治疗以帕博利珠单抗和/或纳武利尤单抗为主；在黑色素瘤患者中，超过70%为同时对抗PD-1单抗与抗CTLA-4单抗（伊匹木单抗）耐药的双重耐药人群。上述研究结果表明，ATG-037在多种肿瘤类型中具有临床意义的治疗潜力，尤其是在既往免疫治疗耐药患者中。与此同时，ATG-037 在联合治疗中整体安全性和耐受性良好，未观察到新的或非预期的安全性信号 ，长期用药患者亦未见新的安全性问题。治疗相关3级及以上不良事件发生率仅为7.9%。此外，疗效缓解亦显示出良好的持久性，其中一名患者获得完全缓解（CR）并在研究中随访超过三年，目前仍在接受ATG-037单药治疗，且单药治疗时间已超过一年；另有多名患者的缓解持续时间超过12个月。上述数据进一步支持ATG-037作为下一代免疫肿瘤联合治疗方案中潜在骨干药物的价值。 本次合作的科学依据在于 CD73抑制 与 PD-1/VEGF双靶向 机制之间的互补性及潜在协同作用。CD73被认为是肿瘤微环境中免疫抑制与血管生成的重要调控因子，其通过生成腺苷发挥作用，进而削弱抗肿瘤免疫反应。在临床和临床前研究中，CD73抑制剂已显示出与抗PD-1单克隆抗体具有显著的协同作用。此外，研究显示CD73活性可促进血管生成，包括通过上调VEGF信号通路，并可能参与抗VEGF治疗耐药的形成。鉴于免疫抑制、血管生成及腺苷信号通路在多种实体瘤中的广泛相关性，该联合策略有望适用于 多种肿瘤类型 。综合上述因素，将CD73阻断与PD-1/VEGF靶向策略联合应用，有望增强并维持治疗效果。总体而言，ATG-037与JS207的联合治疗构成一种潜在的 "三轴"策略 ，可同时调控免疫检查点信号、血管生成以及腺苷通路。 在保持良好安全性的基础上，该联合方案有望进一步增强疗效并提升临床获益的持久性，并可能转化为更优的长期结局，包括总体生存获益（ OS） 。 期待君实生物与德琪医药的紧密协作，能够充分发挥双方在靶点生物学和临床开发方面的优势，加速推进JS207与ATG-037的联合探索， 在多种肿瘤中开展信号验证 ，力争为中国大陆患者提供更具创新性的治疗选择。 —— 完 —— 1. 本材料旨在传递前沿信息，无意向您做任何产品的推广，不作为临床用药指导。 2. 若您想了解具体疾病诊疗信息，请遵从医疗卫生专业人士的意见与指导。 关于 JS207 JS207为君实生物自主研发的重组人源化抗PD-1和VEGF双特异性抗体，主要用于晚期恶性肿瘤的治疗。截至目前，JS207已获准进入Ⅱ/Ⅲ期临床研究阶段，另有11项Ⅱ期临床研究正在进行中，在非小细胞肺癌、结直肠癌、三阴乳腺癌、肝癌等瘤种中开展与化疗、单抗、抗体偶联药物（ADC）等不同药物的联合探索。JS207的临床前研究结果已在 Frontiers in Immunology 发表，早期临床结果首次在ESMO ASIA 2025以壁报形式发表。 JS207可同时以高亲和力结合于PD-1与VEGFA，有效阻断PD-1与PD-L1和PD-L2的结合，并抑制VEGF与其受体的结合。JS207具有免疫治疗药物和抗血管生成药物的疗效特性，通过中和VEGF可抑制血管内皮细胞增殖，改善肿瘤微环境，增加细胞毒性T淋巴细胞在肿瘤微环境中的浸润，从而达到更好的抗肿瘤活性。 JS207是以高亲和力、临床验证且具有差异性的抗PD-1药物特瑞普利单抗为骨架设计的，JS207的抗PD-1部分采用Fab结构，以保持与PD-1的结合亲和力，从而更好地在肿瘤微环境中富集。抗VEGF部分对人血管内皮生长因子的结合亲和力与贝伐珠单抗相当。在非临床体外细胞学试验中，比起联合使用PD-1/PD-L1单抗和VEGF单抗，同时靶向PD-1/PD-L1和VEGF的双特异性抗体可见PD-1抗原结合和内化显著增强、NFAT信号通路的协同增强作用，从而更好的活化肿瘤微环境中的免疫细胞。 关于君实生物 君实生物（688180.SH，1877.HK）成立于2012年12月，是一家以创新为驱动，致力于创新疗法的发现、开发和商业化的生物制药公司。依托全球一体化源头创新研发能力，公司已构建起涵盖超过50款创新药物的多层次产品管线，覆盖恶性肿瘤、自身免疫、慢性代谢类、神经系统、感染性疾病五大治疗领域，已有5款产品在国内或海外上市，包括我国首个自主研发、在中美欧等地40多个国家和地区获批上市的PD-1抑制剂特瑞普利单抗（拓益 ® ）。疫情期间，君实生物还参与开发了埃特司韦单抗、民得维 ® 等多款预防和治疗新冠的创新药物，积极承担本土创新药企的责任。 君实生物以"用世界一流、值得信赖的创新药普惠患者"为使命，立足中国，布局全球。目前，公司在全球拥有约2500名员工，分布在美国马里兰，中国上海、苏州、北京、广州等。 官方网站： www.junshipharma.com 官方微信：君实生物

SHANGHAI, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the company has entered into the strategic collaboration with Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK). Under the collaboration, the parties will jointly evaluate the synergistic therapeutic potential of Junshi Biosciences’ JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, in combination with Antengene’s ATG-037, an oral small-molecule CD73 inhibitor, in patients with solid tumors in Chinese Mainland, with the goal of identifying clinical signals across multiple tumor types. JS207, Junshi Biosciences’ independently developed recombinant humanized anti-PD-1/VEGF bispecific antibody, has demonstrated promising anti-tumor activity and a manageable safety pro both preclinical and clinical studies. JS207’s preclinical studies demonstrated its robust anti-tumor efficacy in multiple tumor models and supported a differentiated mechanism of action, with VEGFA shown to enhance JS207’s antigen binding activity, T-cell activation potency and internalization of cell-surface PD-1. In a poster presented at ESMO Asia 2025, JS207 monotherapy showed encouraging efficacy across solid tumors. 62 patients with PD-L1 positive non-small cell lung cancer (NSCLC) received JS207 monotherapy as first-line treatment, and achieved an objective response rate (ORR) of 58.1% and a disease control rate (DCR) of 87.1%. Clinical activity has also been observed in additional tumor types, including hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC), supporting the potential of PD-1/VEGF dual targeting across multiple tumor settings. To date, JS207 has 11 ongoing phase 2 clinical studies, exploring its use in combination with chemotherapy, monoclonal antibodies (mAb), antibody-drug conjugates (ADCs) and other drugs in NSCLC, colorectal cancer, triple-negative breast cancer, liver cancer and other tumor types, with nearly 500 patients enrolled. Based on the accumulated data from these studies, the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application, allowing Junshi Biosciences to initiate an open-label, two-arm, randomized, active-controlled, Phase 2/3 clinical study comparing JS207 to nivolumab for the neoadjuvant treatment of patients with stage 2/3, resectable, actionable genomic aberration (AGA)-negative NSCLC. ATG-037, Antengene’s orally administered small-molecule CD73 inhibitor, offers significant advantages over anti-CD73 mAbs. In preclinical studies, ATG-037 demonstrated stronger inhibition of cell-surface CD73 enzymatic activity and overcame the “hook effect” commonly observed with antibody-based approaches. In addition, ATG-037’s higher tissue penetration compared with antibodies may facilitate complete CD73 inhibition at the cellular level. ATG-037 has demonstrated encouraging clinical activity in combination with anti-PD-1 therapy in patients with checkpoint inhibitor-resistant melanoma and NSCLC, based on the latest data presented at Antengene’s R&D Day in November 2025. In the ongoing Phase 1/1b STAMINA-01 study, the combination achieved an ORR of 33.3% with a DCR of 100% in patients with CPI-resistant melanoma, and an ORR of 21.4% with a DCR of 71.4% in patients with CPI-resistant NSCLC. The dataset was generated in Australia in patients with CPI-refractory solid tumors, with pembrolizumab and/or nivolumab as the predominant prior anti-PD-1 therapies, and more than 70% of melanoma patients were refractory to both anti-PD-1 mAb and anti-CTLA-4 mAb (ipilimumab). These results support ATG-037’s clinically meaningful activity across multiple tumor types, particularly in patients with prior immunotherapy resistance. Importantly, ATG-037 has demonstrated a favorable safety and tolerability pro combination treatment, with no new or unexpected safety signals observed, including in patients receiving long-term therapy. Grade 3 or higher treatment-related adverse events only occurred in 7.9% of patients. Responses have also shown encouraging durability, including a patient who achieved a complete response and has remained on study for over three years and is currently receiving ATG-037 monotherapy for more than a year, as well as multiple patients with durations of response exceeding 12 months. These data support ATG-037’s potential role as a backbone agent for next-generation immuno-oncology combination regimens. The scientific rationale for the collaboration is based on the complementary and potentially synergistic mechanisms of CD73 inhibition and dual PD-1/VEGF targeting. CD73 is recognized as a key regulator of immune suppression and angiogenesis within the tumor microenvironment through the generation of adenosine, which can dampen anti-tumor immune responses. In both clinical and preclinical settings, CD73 inhibitors have demonstrated meaningful synergy with anti-PD-1 mAbs. In addition, CD73 activity has been shown to promote angiogenesis, including through upregulation of VEGF signaling, and may contribute to the development of resistance to anti-VEGF therapies. Given the broad relevance of immune suppression, angiogenesis and adenosine signaling across solid tumors, this combination strategy has the potential to be applicable across multiple tumor types. Taken together, these observations suggest that combining CD73 blockade with PD-1/VEGF-directed approaches has the potential to enhance and sustain therapeutic effects. Together, the combination of ATG-037 with JS207 represents a potential “triple-axis” approach that simultaneously modulates immune checkpoint signaling, angiogenesis, and the adenosine pathway. With the potential to deepen responses while maintaining a favorable safety profile, the combination of ATG-037 with JS207 may further improve the durability of benefit and may translate into improved overall survival. We look forward to the close collaboration between Junshi Biosciences and Antengene, leveraging their respective expertise in target biology and clinical development to accelerate the evaluation of JS207 in combination with ATG-037 across multiple solid tumor types, with the goal of identifying clinical signals and delivering more innovative treatment options for patients in Chinese Mainland. About JS207 JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, was independently developed by Junshi Biosciences for the treatment of advanced malignant tumors. To date, JS207 has been approved for conducting phase 2/3 clinical study, and it has 11 ongoing phase 2 clinical studies, exploring its use in combination with chemotherapy, mAbs, ADCs and other drugs in NSCLC, colorectal cancer, triple-negative breast cancer, liver cancer and other tumor types. Preclinical results of JS207 have been published in Frontiers in Immunology , while early-stage clinical data were first presented in a poster session at ESMO ASIA 2025. JS207 can simultaneously bind to PD-1 and VEGFA with high affinity, effectively blocking the binding of PD-1 to PD-L1 and PD-L2 while also inhibiting the binding of VEGF to its receptor. JS207 has the efficacy of both immunotherapeutic drugs and anti-angiogenic drugs. Through the neutralization of VEGF, JS207 inhibits the proliferation of vascular endothelial cells, improves the tumor microenvironment, and increases the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, thereby achieving better anti-neoplasm activity. JS207’s design is based on the high-affinity, clinically proven and differentiated anti-PD-1 drug, toripalimab as the backbone. The anti-PD-1 moiety of JS207 adopts a Fab structure to maintain binding affinity to PD-1, thereby attaining better enrichment in the tumor microenvironment. The anti-VEGF moiety has a binding affinity for human vascular endothelial growth factor that is comparable to that of bevacizumab. In non-clinical in vitro cytological tests, compared with the combination of an anti-PD-1/PD-L1 monoclonal antibody and a VEGF monoclonal antibody, a bispecific antibody simultaneously targeting PD-1/PD-L1 and VEGF demonstrated significantly enhanced PD-1 antigen binding and internalization, as well as synergistic enhancement of the NFAT signaling pathway, thereby better activating immune cells in the tumor microenvironment. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: Junshi Biosciences Contact Information IR Team: Junshi Biosciences info@junshipharma.com + 86 021-6105 8800 PR Team: Junshi Biosciences Zhi Li zhi_li@junshipharma.com + 86 021-6105 8800