On the 26th, AbClon announced that the first patient has been dosed in the phase 3 international multi-center clinical trial (HLX22-GC-301) for AC101 (Henlius’ codename HLX22). The HLX22-GC-301 trial, which evaluates the combination of trastuzumab and chemotherapy, has received Phase 3 clinical trial approvals in China, the United States, and Japan.

HLX22 is a candidate for global first-line treatment for HER2 (human epidermal growth factor receptor 2)-positive advanced gastric and gastroesophageal junction (GEJ) cancer, based on AC101, which was licensed to Henlius Biotech (Henlius) in 2016. To date, no dual HER2 blockade therapy for HER2-positive gastric cancer has received global commercialization approval.

A company representative stated, "HER2-positive gastric and gastroesophageal junction cancer is a major global health issue, with approximately one million new cases reported annually." They further noted, "This disease is often diagnosed at an advanced stage, leading to poor prognosis, with a five-year survival rate of only 6%."

Patients with HER2-positive gastric cancer generally have worse prognoses than those with HER2-negative disease. Although trastuzumab in combination with chemotherapy is the current standard treatment, its efficacy and outcomes require further improvement.

HLX22 is an antibody designed to bind to HER2 proteins alongside trastuzumab, promoting HER2 internalization and degradation, thereby enhancing anti-tumor activity. Preclinical and Phase 1 trial results have demonstrated that the combination of HLX22 and trastuzumab produces a synergistic effect, leading to tumor suppression, cancer cell apoptosis, and a favorable safety profile. The ongoing clinical trial is evaluating progression-free survival (PFS) and overall survival (OS) as its primary efficacy endpoints, comparing HLX22 to existing treatment regimens.

Meanwhile, on the 17th, AbClon was recognized as a "Global Outstanding Partner" at the 30th anniversary ceremony of China’s Fosun Pharma Group, held in Shanghai, highlighting