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On August 4, 2025, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, Abogen's self-developed novel mRNA cancer vaccine ABO2102, which simultaneously covers multiple KRAS mutations, submitted an Investigational New Drug (IND) application (Acceptance No.:CXSL2500388) has obtained clinical tacit approval.As the first therapeutic tumor vaccine in China targeting multiple KRAS mutations, ABO2102 is applicable to patients with solid tumors carrying any of the five common KRAS mutations. It represents a significant advancement in the highly challenging field of difficult-to-drug targets.ABO2102 received clinical trial approval from the U.S. Food and Drug Administration (FDA) in May this year. This recent approval in China marks an important milestone for ABO2102, achieving dual filings and approvals in both China and the United States, fully demonstrating Abogen's globally leading innovation capabilities and international layout in the field of cancer immunotherapy.ABO2102, a therapeutic cancer vaccine developed by Abogen based on its self-innovated mRNA technology platform, has demonstrated excellent anti-tumor activity in preclinical studies through multi-dimensional technological breakthroughs and achieved broad coverage of HLA (Human Leukocyte Antigen) subtypes. This vaccine provides a novel solution for the treatment of KRAS-mutant solid tumors, showcasing strong clinical transformation potential.ABO2102 has the potential to shift the paradigm of KRAS-targeted therapy from "passive inhibition" to "active immune clearance," demonstrating breakthrough clinical value. This vaccine, based on a multi-epitope antigen design, precisely covers high-incidence cancer types such as pancreatic cancer, non-small cell lung cancer, and colorectal cancer. Its modular technology platform further supports rapid expansion to other mutation-related indications. With the advantage of being an off-the-shelf product, ABO2102 can be used for salvage treatment in advanced patients and as an adjuvant therapy post-surgery in early-stage cases. Additionally, due to its excellent safety profile, the vaccine can be combined with chemotherapy, radiotherapy, or immune checkpoint inhibitors, establishing a multidimensional synergistic tumor treatment system.The successful dual filing and approval of ABO2102 in both China and the United States marks a significant recognition by global regulatory systems, further highlighting Abogen's innovative strength and international competitiveness in the field of mRNA drug development. In the future, as clinical research progresses, ABO2102 is expected to bring breakthrough treatments for patients with KRAS mutation-related tumors, reshaping the landscape of tumor immunotherapy.
