德琪医药ATG-022临床研究获积极成果：高龄胃癌患者达到完全缓解（CR）

ATG-022是德琪医药自主研发的Claudin 18.2抗体偶联药物。此前，公司在ASCO GI 2025大会上公布了ATG-022的最新临床数据：在CLDN18.2中高表达（IHC 2+ ≥ 20%）患者中，客观缓解率（ORR）为42.9%，疾病控制率（DCR）为95.2%；在CLDN18.2低表达（IHC 2+ < 20%）患者中，ORR为30.0%，DCR为50.0%。现有临床数据显示，ATG-022对Claudin 18.2高表达、低表达及超低表达患者均展现出有意义的疗效及良好的安全性。这一广谱抗肿瘤活性使ATG-022相比其他CLDN18.2靶向疗法，有望为更广泛的患者群体带来治疗新选择。目前，公司正在中国大陆及澳大利亚进行ATG-022的II期剂量扩展阶段研究，现已进入临床价值中后期验证的关键阶段。

这位高龄患者达到CR的临床结果令人鼓舞，充分展现了ATG-022作为创新ADC药物的治疗潜力。值得一提的是，这并非研究中唯一的CR病例。在整个研究过程中，我们还观察到另外2例CR患者，分别来自中国大陆和澳大利亚。迄今为止，已有3例患者在治疗中达到CR。我们期待在2025年10月的ESMO年会上公布ATG-022的最新研究数据。德琪医药将全力推进CLINCH研究的临床开发，加速这一突破性治疗方案的研发进程。这正是我们始终坚守的使命——医者无疆，创新永续。我们将继续以责任为墨，以创新为笔，为更多肿瘤患者书写新的生命希望。

Antengene’s ATG-022 Clinical Study Achieves Positive Results: CR Achieved in Elderly Gastric Cancer Patient

Recent reports from official channels indicate that in Antengene’s Phase I/II CLINCH study of ATG-022 (CLDN18.2 antibody-drug conjugate), an elderly patient with advanced gastric cancer who has progressed on multiple lines of chemotherapy, immunotherapy and targeted therapy despite extensive metastases achieved a complete response (CR) following ATG-022 monotherapy. The patient’s tumor-free status was confirmed by PET/CT in May 2025.

ATG-022 is a CLDN18.2 ADC discovered and developed in-house by Antengene. At the ASCO GI 2025 conference earlier this year, Antengene presented updated clinical data for ATG-022. In patients with moderate-to-high CLDN18.2 expression (IHC 2+ ≥ 20%), the objective response rate (ORR) was 42.9%, and the disease control rate (DCR) was 95.2%.  Among patients with low CLDN18.2 expression (IHC 2+ < 20%), the ORR was 30.0%, and the DCR was 50.0%. These data demonstrate that ATG-022 delivers clinically meaningful efficacy and favorable safety profile across a spectrum of CLDN18.2 expression levels, including high, low, and even ultra-low expression. Its broad-spectrum antitumor activity suggests that ATG-022 may offer therapeutic benefits to a wider patient population compared to other CLDN18.2-targeted therapies. Currently, the Phase II dose-expansion study of ATG-022 is ongoing in the mainland of China and Australia.

This achievement of a CR in this elderly gastric cancer patient is extremely encouraging, highlighting the therapeutic potential of ATG-022 as a novel ADC therapy. Importantly, this is not the only CR observed in the ongoing study. To date, three CR cases have been observed, including patients from both the mainland of China and Australia. Antengene looks forward to presenting updated data from the ATG-022 study at the upcoming ESMO Congress in October 2025. The company remains fully committed to advancing the CLINCH study and accelerating the development of ATG-022 as a potential first-in-class and best-in-class therapeutic option for patients with CLDN18.2-positive cancers. This progress reflects Antengene’s unwavering commitment to its vision: "Treating Patients Beyond Borders." With responsibility as our foundation and innovation as our guide, we continue to pursue meaningful breakthroughs that bring a brighter outlook to cancer patients worldwide.