Henlius Begins First Patient Dosing in Global Phase 3 Trial
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
