Cellectar Biosciences Strengthens Intellectual Property Position Ahead of Key Regulatory Milestones

Cellectar secures key patents in Europe and China for its lead drug iopofosine I 131, strengthening IP as it prepares for a 2026 EMA submission targeting Waldenström's macroglobulinemia.

Cellectar Biosciences has significantly bolstered the global protection for its key therapeutic assets through a series of new patent grants. This strategic expansion of its intellectual property (IP) portfolio comes at a pivotal moment as the company advances its lead drug candidate toward potential regulatory approval.

Broadened Patent Coverage Across Major Markets

The company has recently secured patents in several critical international jurisdictions, including Europe and China. These newly granted rights cover essential compounds at the core of its technology platform: ether- and alkyl-phospholipid conjugates. The scope of protection is comprehensive, extending to both cancer treatment applications and the imaging of cancer stem cells.

Specifically, the patents provide protection for iopofosine I 131, the firm's lead candidate, as well as for another pipeline asset, CLR 125. In a parallel development, Cellectar has obtained patents for specialized "Fractionated Dosing" regimens in countries such as Mexico, Canada, and Turkey. This move fortifies the legal framework around its treatment protocols ahead of any future commercial launch.

A Clear Path Toward European Regulatory Submission

The reinforcement of its IP estate is timed with a clear regulatory strategy. Cellectar is currently preparing to file for conditional marketing authorization with the European Medicines Agency (EMA). The initial application will focus on using iopofosine I 131 for the treatment of Waldenström's macroglobulinemia.

Management has outlined a timeline targeting a submission in the third quarter of 2026. Should the EMA review proceed favorably, a commercial launch in Europe could follow in early 2027. In the United States, the drug has already been designated as a "Breakthrough Therapy" by the Food and Drug Administration (FDA), a status that can facilitate a more expedited review pathway.

Pipeline Progress and Upcoming Financial Disclosure

Beyond its lead program, Cellectar continues to advance other candidates in its pipeline. CLR 125 is currently in a Phase 1b clinical trial targeting breast cancer. A separate program, CLR 225, is being developed for various solid tumors.

Investors will gain further insight into the company's financial readiness for these upcoming milestones with the release of its fourth-quarter 2025 earnings report, scheduled for mid-March 2026. This disclosure is expected to provide details on the company's resource allocation for the planned regulatory filing and subsequent commercialization efforts.