AbClon announced on the 29th that AC101 (Henlius code name HLX22), a new antibody drug licensed to Henlius, is expanding its scope to breast cancer treatment, following that positive expectations on first-line treatment for gastric cancer have increased through global Phase 3 clinical trial.

Henlius, in its interim business report on the 25th, announced that HLX22 is showing superior clinical effects compared to current standard treatments. The company is currently expanding a multinational Phase 3 clinical trial (MRCT) for the treatment of first-line HER2-positive gastric cancer (G/GEJ) and has expressed great anticipation.

HLX22 is an antibody therapy that targets a specific part of the HER2 protein. By attacking a different binding site from existing treatments, it enhances cancer cell death by increasing the internalization of the HER2 protein on the surface of cancer cells by 40-80%. According to Henlius, the combination therapy of HLX22 and trastuzumab significantly improved progression-free survival (PFS) and overall survival (OS) in gastric cancer patients.

At the median follow-up period of 28.5 months, the drug showed superior results in progression-free survival, overall survival, and duration of response compared to existing standard treatments. This is a significant advancement compared to existing treatments, which only showed 6.7 months for progression-free survival, 13.8 months for overall survival, and 6.9 months for duration of response. In the Phase 2 clinical trial, the HLX22-treated group showed reduction in the risk of disease progression or death by approximately 80%, with almost no reported side effects.

Phase 3 clinical trials for HLX22 are underway in the U.S., Europe, Japan, China, and Korea. The HLX22-GC301 study is being led by top leading clinicians in the global gastric cancer field. Professor Shen Lin of Beijing Cancer Hospital, Professor Jaffer A. Ajani of MD Anderson Cancer Center, and Professor Ken Kato of the National Cancer Center of Japan are participating as principal investigators.

This year, HLX22 received Orphan Drug Designation (ODD) in the U.S. and Europe. A Phase 2 clinical trial is currently underway for breast cancer with low HER2 expression (HER2-low/HR+), which will expand the indication from gastric cancer to breast cancer. The business report states that it could be launched overseas within three years from now, signaling the start of its global commercialization.

AbClon shall secure revenue through development stage milestones and commercialization royalties for HLX22. Henlius has set a sales target of $10 billion for HLX22.

An AbClon official said, "According to the Henlius business report for the first half of this year, HLX22 has shown excellent global clinical results in gastric cancer and is very close to commercialization after receiving Orphan Drug Designation in the U.S. and Europe." They added, "Commercialization may happen faster than expected, and the expanded application to breast cancer will be a major turning point."