On the 31st, Voronoi announced through a correction disclosure on major management matters related to investment decisions that it has additionally reflected the Hong Kong Department of Health (DOH) in the approval for changes to the global Phase 1/2 clinical trial plan for 'VRN110755,' a candidate substance for the treatment of non-small cell lung cancer (NSCLC).

In the previous disclosure prior to correction, the approving authorities were the Taiwan Food and Drug Administration (TFDA) and the Australian Human Research Ethics Committee (HREC). With this correction, the Hong Kong Department of Health has been added, expanding the scope of approval to a total of three authorities. Voronoi explained that it received notification from its CRO partner on July 30, 2026, regarding the Hong Kong Department of Health's approval for the clinical trial plan amendment (Phase 1/2) and reflected this in the disclosure.

This global Phase 1/2 multi-center clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of VRN110755 in patients with advanced non-small cell lung cancer harboring EGFR mutations. A maximum of 391 patients will be recruited, with the trial to be conducted across North America, Asia, Oceania, and Europe.

According to the clinical design, the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) will first be determined in the Phase 1a dose-escalation study. Subsequently, the optimal dose, efficacy, and safety will be further evaluated through the Phase 1b dose-expansion study and Phase 2. Voronoi had been pursuing the amendment approval to expand into Phase 1b/2 in order to evaluate the optimal dose and efficacy in the target patient population, following the confirmation of the drug's safety, tolerability, and preliminary efficacy signals in Phase 1a.