Voronoi announced on the 8th that it has completed the submission of an Investigational New Drug (IND) amendment application to the Hong Kong Department of Health (DOH) for a global Phase 1/2 clinical trial of 'VRN110755,' a candidate treatment for EGFR (Epidermal Growth Factor Receptor) mutant non-small cell lung cancer (NSCLC).

This announcement is a correction of the disclosure dated June 25 of this year, reflecting the addition of Hong Kong to the list of countries where the global clinical trial approval application has been filed. According to the company, on July 8, 2026, it received notification from the CRO (Contract Research Organization) that the Phase 1/2 clinical trial amendment application had been submitted to the Hong Kong Department of Health.

The key details of the clinical trial plan remain the same as those in the previous disclosure. Once the Hong Kong Department of Health's approval status is confirmed, the company plans to immediately disclose the relevant information.

Accordingly, the institutions where the IND application for VRN110755 has been filed have been expanded to include the Hong Kong Department of Health (DOH), in addition to the existing: △Taiwan Food and Drug Administration (TFDA), △Australia Human Research Ethics Committee (HREC), △Singapore Health Sciences Authority (HSA), △European Medicines Agency (EMA), △Malaysia National Pharmaceutical Regulatory Agency (NPRA), and △Thailand Food and Drug Administration (FDA Thailand).

VRN110755 is a global Phase 1/2 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy in patients with EGFR-mutant advanced non-small cell lung cancer. The trial will be conducted as a multi-center study across North America, Asia, Oceania, and Europe, involving a total of 391 subjects. The clinical trial period, including long-term follow-up, is planned for up to 6 years.

Having previously confirmed safety, tolerability, and early efficacy signals in Phase 1a, the company is now pursuing approval to amend the trial to Phase 1b/2 in order to evaluate the optimal dosage and efficacy in the target patient population. This disclosure additionally reflects the completion of the Hong Kong Department of Health approval application for the aforementioned amendment plan.