- JNJ-1900 (NBTXR3) has been reclassified from a medical device to a medicinal product by European health authorities, aligning with US classification.
- Nanobiotix (NASDAQ: NBTX) has filed a new composition of matter patent for JNJ-1900 (NBTXR3), enhancing intellectual property protection.
- JNJ-1900 (NBTXR3) is undergoing a global Phase 3 trial for head and neck cancer, among other tumor types and therapeutic combinations.
PARIS and CAMBRIDGE, Mass., July 7, 2025 — Nanobiotix (NASDAQ: NBTX), a late-stage clinical biotechnology company, has announced two crucial advancements that aim to strengthen the global standing of its radioenhancer, JNJ-1900 (NBTXR3). The product, which is licensed by Janssen Pharmaceutica NV, a Johnson & Johnson company, has been reclassified by major European health authorities as a medicinal product, a move that aligns its regulatory status with that of the United States and other key markets.
This reclassification marks a significant regulatory milestone, reflecting updated insights into the mechanism of action of JNJ-1900 (NBTXR3). The change is anticipated to streamline future development and regulatory approval processes for this novel oncology product, which utilizes functionalized hafnium oxide nanoparticles activated by radiotherapy.
In tandem with the reclassification, Nanobiotix has also filed a new composition of matter patent for JNJ-1900, fortifying its intellectual property portfolio. This patent filing underscores the company's commitment to securing robust protection for its product, potentially extending market exclusivity and increasing commercial viability.
JNJ-1900 (NBTXR3) is currently advancing through a global clinical development program, which includes a pivotal Phase 3 trial in head and neck cancer. The product's versatility is under investigation across various solid tumor types and therapeutic combinations, showcasing its potential as a first-in-class radioenhancer technology in radiation oncology.
