The world’s first ‘anti-HER2 therapy’ was grated ODD in both the U.S. and Europe; US 바카라사이트 제작 granted in March
[by Yu, Suin] AbClon announced on May 27 that its antibody treatment candidate, ‘AC101 (development code HLX22 under Henlius),’ which was licensed to China’s Henlius Biotech, has received ‘Orphan Drug Designation (ODD)’ from the European Commission (EC) for the treatment of gastric cancer.
With this designation, HLX22 has become the world’s first ‘anti-HER2 targeted therapy’ to receive ODD designation from both the U.S. Food and Drug Administration (FDA) in March and the European Commission (EC) in May. It is regarded as having established a commercialization framework ahead of schedule, positioning itself as an innovative treatment with markedly superior efficacy compared to existing treatments in the field of gastric 바카라사이트 제작.
The ODD designation was granted following a favorable assessment by the Committee for Orphan Medicines (COMP) of the European Medicines Agency (EMA). The EC concluded that HLX22 satisfies the criteria for designation as an orphan drug intended for the 바카라사이트 제작 of life-threatening or serious conditions.
HLX22 is eligible to receive a range of regulatory and R&D incentives, including assistance with clinical trial design, access to centralized marketing approval procedures, ten years of market exclusivity following marketing approval, and reductions in associated regulatory fees.
Gastric 바카라사이트 제작 continues to pose a serious global public health challenge. According to GLOBOCAN 2022 data from the International Agency for Research on 바카라사이트 제작 (IARC), approximately one million new cases of gastric 바카라사이트 제작 were diagnosed in 2022, with over 660,000 related deaths. The majority of patients are diagnosed at an advanced stage with a poor prognosis. Notably, HER2-positive gastric 바카라사이트 제작 accounts for approximately 12-23% of all gastric 바카라사이트 제작 cases and is associated with a worse prognosis compared to HER2-negative cases.
Currently, the ‘standard first-line treatment’ for patients with HER2-positive metastatic gastric 바카라사이트 제작 consists of ‘trastuzumab and chemotherapy’ combination therapy, with immunotherapy added in some cases. However, treatment outcomes remain limited, indicating there is much room for improvement. Accordingly, AbClon noted that HLX22 is garnering attention as a promising new treatment alternative.
HLX22 is under development as a first-line treatment for patients with HER2-positive metastatic gastric 바카라사이트 제작 and gastroesophageal junction 바카라사이트 제작 (GC/GEJC). According to the company, a phase 3 clinical trial (HLX22-GC-301) combining trastuzumab and chemotherapy is currently underway, and global development efforts are actively progressing.
The phase 3 clinical trial has received Investigational New 바카라사이트 제작 (IND) approval in several major countries, including China, the United States, Japan, Australia, Korea, and Germany. To date, the first patient administration has been completed in China, Japan, and Australia.
According to phase 2 clinical trial data presented by Henlius, the HLX22 and trastuzumab biosimilar ‘HANQUYOU (marketed as HERCESSI/Zercepac)’ combination therapy demonstrated significantly improved survival rates and anti바카라사이트 제작 efficacy compared to existing treatments while maintaining a favorable safety profile. The design of the ongoing Phase 3 clinical trial, along with related updates, is scheduled to be presented at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) this week.
HLX22 is also being investigated for potential indication expansion beyond gastric 바카라사이트 제작, targeting 바카라사이트 제작 types with a significantly larger patient population. Currently, a phase 2 clinical trial is underway in China to evaluate HLX22 in combination with ‘trastuzumab deruxtecan (T-DXd)’ for patients with HER2 low-expression and hormone receptor (HR)-positive locally advanced or metastatic breast 바카라사이트 제작. The first patient in this study has already been dosed.
“With the European Orphan 바카라사이트 제작 Designation, we will further accelerate the global clinical development and commercialization of HLX22,” an AbClon official said. “Henlius projects the maximum annual sales target potential of HLX22 as USD 10 billion (approximately KRW 14 trillion), a figure expected to generate over KRW 700 billion in royalties (current technology fees) for AbClon.”