AbClon announced on the 28th that its Chinese partner, Henlius successfully held ‘2025 Global R&D Day’ event under the slogan of "Collaborate to Create."

The event was attended by Henlius key executives, academic experts, and multinational investors, who shared the latest research achievements, strategic visions, and the current status of advanced technology and therapeutic development. At the event, Henlius presented AC101 (Henlius code name HLX22) as a core innovative pipeline and emphasized its differentiated mechanism of action and clinical data.

During the presentation by Jason Zhu, CEO of Henlius, he stated that HLX22 has high potential to expand as a pan-tumor therapy covering a broad range of solid tumors, including HER2-positive gastric and breast cancers. He expressed confidence in developing it into a blockbuster drug, setting a future global market size of over $10 billion (approximately 14 trillion KRW) annually. Henlius is accelerating its global growth strategy centered on HLX22 by strengthening its development and commercialization capabilities in major markets such as the United States, China, and Japan.

HLX22 is a novel monoclonal antibody being clinically developed as a first-line treatment for HER2-positive metastatic gastric cancer, characterized by its binding to a different epitope compared to trastuzumab. Notably, gastric and gastroesophageal junction (G∙GEJ) cancer occurs in approximately 1 million cases annually, ranking as the fifth most common cancer worldwide. Among these, HER2-positive patients, accounting for about 12-23%, have a relatively poor prognosis.

Currently, HLX22 has entered into a global Phase 3 clinical trial (HLX22-GC301) as a first-line treatment in combination with trastuzumab and XELOX chemotherapy. The randomized, double-blind study is being conducted up to 550 patients across Asia, Europe, and North America. Earlier Phase 2 clinical trial (HLX22-GC201) results showed that the progression-free survival (PFS) in the combination therapy group was significantly longer compared to the control group, with a tumor response rate reaching 87.1% and demonstrating favorable safety.

Particularly encouraging is the more significant response observed in the Asian patient population, where the efficacy of pembrolizumab is limited, raising high expectations for HLX22. The market impact is also expected to be substantial, given the potential for indication expansion to HER2-expressing solid tumors beyond gastric cancer, such as breast, lung, and pancreatic cancers. The interim results of the global Phase 3 trial of HLX22 are scheduled to be presented at the American Society of Clinical Oncology (ASCO) in 2025.

A representative from AbClon stated, "As the company holding the original technology for HLX22, we anticipate securing both high technical value and revenue potential along with the global clinical progress of this product. We will continue to strengthen global partnerships and expand our position in the antibody therapeutics market."

End.