Trial Profile

A phase 1 trial of HLX18

Status: Planning

Phase of Trial: Phase I

Latest Information Update: 09 Jan 2026

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At a glance

Drugs Nivolumab (Primary)
Indications Solid tumours
Focus Therapeutic Use

Most Recent Events

09 Jan 2026 New trial record
19 Dec 2025 According to a Henlius Biotech media release, company announced the investigational new drug (IND) application for its HLX18, a proposed nivolumab biosimilar, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain resected solid tumors.

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