AbClon "Innovative Antibody Therapeutic AC101 Designated as Orphan Drug for Gastric Cancer Treatment in Europe Following the US"

[Financial News] AbClon announced on the 27th that the antibody therapeutic 'AC101 (Henlius code name HLX22)', which was licensed to Henlius Biotech in China, received Orphan Drug Designation (ODD) for gastric cancer treatment from the European Commission (EC).
With this designation, HLX22 has become an anti-HER2 targeted therapy that received ODD designation from both the US FDA in March and the European EC in May. It is evaluated as an innovative therapy with significantly superior efficacy compared to existing treatments in the field of gastric cancer treatment, completing a major framework for commercialization faster than expected.
The ODD designation was based on the positive evaluation of the Committee for Orphan Medicinal Products (COMP) under the European Medicines Agency (EMA). The EC determined that HLX22 meets the criteria for orphan drugs aimed at treating life-threatening or serious diseases. HLX22 will receive various incentives during the research and development and approval process, including support for clinical trial design, centralized marketing authorization procedures, 10 years of market exclusivity after approval, and regulatory fee reductions.
Globally, gastric cancer remains a serious public health challenge. According to the International Agency for Research on Cancer's 'GLOBOCAN', approximately 1 million new gastric cancer diagnoses and over 660,000 deaths occurred in 2022, with most patients diagnosed at an advanced stage, resulting in poor prognosis. Particularly, HER2-positive gastric cancer accounts for 12-23% of all gastric cancer patients and is reported to have a worse prognosis than HER2-negative patients.
Currently, the standard first-line treatment for HER2-positive metastatic gastric cancer patients is a combination therapy of trastuzumab and chemotherapy, and in some cases, immunotherapy is also combined. However, treatment outcomes still have room for significant improvement. AbClon explained that HLX22 is gaining attention as a new treatment alternative.
HLX22 is being developed as a first-line treatment for patients with HER2-positive metastatic gastric and gastroesophageal junction (GC/GEJC) cancer. Currently, a phase 3 clinical trial (HLX22-GC-301) is underway using trastuzumab and chemotherapy together, and global development is actively progressing. The phase 3 clinical trial has received IND approval in major countries such as China, the United States, Japan, Australia, South Korea, and Germany. To date, the first patient administration has been completed in China, Japan, and Australia.
According to the phase 2 clinical data announced by Henlius, the combination of HLX22 and the trastuzumab biosimilar Hanquyou (HERCESSI™/Zercepac®) showed a significant improvement in survival rate and anticancer effect compared to existing treatments, while maintaining good safety.
HLX22 is also attempting to expand its indications to other cancer types with a much larger patient population than gastric cancer. Currently, HLX22 is being tested in a phase 2 clinical trial in China, in combination with trastuzumab deruxtecan (T-DXd), targeting HER2-low expression and hormone receptor (HR) positive locally advanced or metastatic breast cancer patients. The first patient administration has already been completed.
An AbClon representative stated, “With the European ODD designation, we will further accelerate the global clinical and commercialization of HLX22,” adding, “Henlius sees the maximum business revenue target for HLX22 as $10 billion annually, which would generate royalties of over 700 billion won for AbClon.”
dschoi@fnnews.com Choi Doo-sun Reporter