Antengene Corporation, a global biotechnology company focused on developing innovative therapies for diseases with significant unmet medical needs, has received endorsement from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate the pivotal Phase 3 CLINCH-3 study of ATG-022. The investigational therapy is being developed for patients with Claudin 18.2 (CLDN18.2)-positive advanced gastric or gastroesophageal junction adenocarcinoma.

The CLINCH-3 trial is expected to begin in China and will subsequently expand into a multi-regional clinical trial (MRCT). The study represents a major milestone in Antengene’s oncology development programme and is intended to support future regulatory submissions for marketing approval of ATG-022 as a monotherapy treatment.

Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene, described the regulatory endorsement as a significant achievement for the company. He noted that the approval highlights Antengene’s end-to-end research and development capabilities, spanning novel molecule discovery, clinical development and registrational studies. He added that the Breakthrough Therapy Designation previously granted to ATG-022 facilitated productive discussions with regulators and accelerated the pathway towards this pivotal study.

The CLINCH-3 trial will be led by Professor Lin Shen of Peking University Cancer Hospital as the principal investigator. Designed as a randomised, controlled, open-label, multicentre Phase 3 study, the trial will compare ATG-022 against investigator-selected standard treatments in patients with CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

The primary endpoints of the study include progression-free survival assessed by an independent review committee and overall survival. Secondary endpoints will evaluate objective response rate, duration of response, disease control rate, safety and other efficacy measures.

The initiation of the Phase 3 programme is supported by encouraging findings from the ongoing Phase 1/2 CLINCH study. Clinical data demonstrated that ATG-022, when administered as a monotherapy, delivered promising anti-tumour activity alongside a favourable safety profile in patients with advanced gastric and gastroesophageal cancers.

Professor Lin Shen highlighted the urgent need for more effective treatment options in advanced gastric cancer, particularly for patients in third-line and later treatment settings, where existing therapies often provide limited clinical benefits. He stated that ATG-022 has shown meaningful survival outcomes, strong anti-tumour efficacy and manageable safety results, positioning it as a potentially transformative therapy for patients with CLDN18.2-positive disease.

Beyond the pivotal monotherapy study, Antengene is pursuing a broader clinical development strategy for ATG-022. Ongoing research includes combination studies with anti-PD-1 therapies and chemotherapy in first-line gastric cancer, as well as investigations in other CLDN18.2-positive solid tumours. Early clinical signals have indicated potential activity beyond gastrointestinal cancers, supporting further expansion into additional tumour types.

ATG-022 is part of Antengene’s growing oncology pipeline, which includes several innovative immuno-oncology and targeted therapy programmes. The company has secured 32 investigational new drug approvals across the United States and Asia and has achieved multiple regulatory approvals in Asia-Pacific markets for its lead commercial product, Xpovio (selinexor).

With the launch of the CLINCH-3 trial, Antengene aims to accelerate the development of ATG-022 and expand treatment options for patients facing advanced gastric and gastroesophageal cancers, while strengthening its position in the global oncology landscape.