October 9, 2026, Shanghai – The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has recently announced that the Investigational New Drug (IND) application for ATH-097, the first innovative drug candidate developed by Atheron, has been officially accepted (Acceptance Numbers: CXHL2601236, CXHL2601237).

This marks the first pipeline of Atheron to enter the IND stage since its inception, signifying the company's official transition from early-stage research to clinical development. Notably, it took only 17 months from project initiation to IND acceptance, demonstrating exceptional R&D efficiency and execution, setting a new "Atheron Speed" in innovative drug development.

About ATH-097

ATH-097 is an inhibitor targeting MRGPRX2, a Class A GPCR (G protein-coupled receptor) primarily expressed on mast cells. Mast cells, as granular cells in tissues, play crucial roles in host defense, allergic reactions, and vascular homeostasis. Currently, IgE receptor (FcεRI)-mediated mast cell activation is the most extensively studied and well-recognized mechanism in allergies and hypersensitivity. However, MRGPRX2 has been confirmed as a key receptor mediating IgE-independent mast cell activation, exhibiting varying affinities for multiple ligands (such as antimicrobial host defense peptides, neuropeptides, and even certain FDA-approved drugs). This discovery reveals a novel pathological pathway for mast cell activation. Therefore, the development of MRGPRX2 inhibitors holds promise to fill the therapeutic gap in non-IgE mediated allergic and inflammatory diseases, offering highly promising novel treatment options for mast cell-related diseases. Preclinical studies indicate that ATH-097 demonstrates superior efficacy and safety compared to similar molecules, possessing Best-in-Class potential.

About Atheron

Atheron is a biotechnology company focusing on oncology and autoimmune diseases. The company possesses end-to-end in-house R&D capabilities spanning from molecular discovery, preclinical evaluation, process development, and manufacturing to clinical research. It currently has 11 pipelines (small and large molecules) and five cutting-edge technology platforms, including antibody engineering, T-cell engagers (TCEs), AthTAC, AthRiTAC, and oral peptides, committed to delivering more innovative therapies to patients worldwide.