NANOBIOTIX Fortifies Global Position of JNJ-1900 (NBTXR3) with Regulatory Harmonization and New Patent Filing

PARIS and CAMBRIDGE, Mass., July 07, 2025 – NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX), a pioneering late-stage clinical biotechnology company focused on physics-based approaches to expand cancer treatment possibilities, today announced two significant developments poised to reinforce the global strategic positioning of its potential first-in-class radioenhancer, JNJ-1900 (NBTXR3). This innovative therapeutic is licensed to Janssen Pharmaceutica NV, a Johnson & Johnson company, underscoring a critical partnership in the oncology landscape.

Strategic Regulatory Harmonization

The first key development involves substantial progress in regulatory harmonization efforts for JNJ-1900 (NBTXR3). This initiative aims to streamline the approval process across multiple international jurisdictions, potentially accelerating patient access to this novel treatment. Regulatory harmonization is crucial for global pharmaceutical products, as it reduces redundancies in clinical trials and regulatory submissions, thereby decreasing development costs and timelines. For NANOBIOTIX and Janssen, achieving regulatory alignment signifies a concerted effort to prepare JNJ-1900 for broad market entry, reflecting confidence in its clinical profile and therapeutic potential. This strategic move is particularly impactful for a drug targeting a global disease like cancer, where consistent regulatory pathways can significantly impact commercial success and patient reach.

New Composition of Matter Patent Filed

In parallel, NANOBIOTIX has announced the filing of a new composition of matter patent for JNJ-1900 (NBTXR3). This patent filing is a critical intellectual property milestone, providing enhanced protection for the core technology behind the radioenhancer. Composition of matter patents are considered the strongest form of patent protection in the pharmaceutical industry, as they cover the chemical structure of the drug itself, rather than just its manufacturing process or use. This new patent is expected to extend the exclusivity period for JNJ-1900, safeguarding its market position and providing a long-term competitive advantage. Such intellectual property reinforcement is vital for attracting further investment and ensuring the sustained commercial viability of the product, especially given the substantial investment in its development and clinical trials.

JNJ-1900 (NBTXR3): A Novel Approach to Cancer Treatment

JNJ-1900 (NBTXR3) is a first-in-class radioenhancer designed to improve the efficacy of radiotherapy in cancer patients. Administered via intratumoral injection, the nanoparticles are activated by radiation, leading to enhanced tumor cell destruction while potentially sparing healthy tissue. This physics-based approach represents a significant advancement in oncology, offering a new modality to improve outcomes for patients who may not respond adequately to conventional radiotherapy alone. The ongoing clinical development, particularly under the stewardship of Janssen, highlights the broad applicability and potential impact of JNJ-1900 across various cancer types.

Market Context and Implications for JNJ

For Johnson & Johnson (JNJ), the progress with JNJ-1900 (NBTXR3) through its Janssen Pharmaceutica NV subsidiary reinforces its robust oncology pipeline. JNJ's diversified healthcare portfolio benefits from innovative drug candidates that address significant unmet medical needs. The potential success of JNJ-1900 could further solidify JNJ's position as a leader in cancer therapeutics, contributing to future revenue growth and market share in the highly competitive oncology sector. The strategic licensing agreement with NANOBIOTIX demonstrates JNJ's commitment to external innovation and its ability to identify and integrate promising technologies into its development programs.

Investment Insights

Investors should view these developments as positive indicators for both NANOBIOTIX and Johnson & Johnson. For NANOBIOTIX, the regulatory harmonization and new patent filing de-risk the commercialization pathway for its lead asset, potentially increasing its valuation and attractiveness to institutional investors. For JNJ, the advancements with JNJ-1900 underscore the strength of its oncology pipeline and its long-term growth prospects. The extended patent protection provides a clear runway for market exclusivity, which is a key factor in pharmaceutical investment. Investors interested in the oncology space should monitor the clinical trial progress and regulatory milestones for JNJ-1900, as successful market entry could significantly impact both companies' financial performance. The news reinforces the strategic value of the NANOBIOTIX-Janssen partnership, suggesting a strong commitment to bringing this innovative therapy to patients globally.