From Breakthrough Cancer Therapy to the Regulatory Frontier: Introducing My New Chlorine Dioxide Injection Patent
In 2013, I began my journey exploring the medical potential of chlorine dioxide (ClO₂), a compound long known for its disinfection abilities but overlooked in the realm of targeted therapies. Over the last decade, I have secured multiple patents to protect my discoveries and lay a foundation for clinical applications. Now, in 2025, I am proud to announce a new milestone: the filing of a novel patent specifically for a pharmaceutical-grade injectable chlorine dioxide solution and its production and storage system — a crucial step toward full regulatory approval and global use in cancer care.
Revisiting Two Landmark Patents
1. Targeting Solid Tumors (WO2016074203A1 – November 2014)
In this pivotal patent, I demonstrated for the first time the feasibility of injecting chlorine dioxide directly into solid tumors. The patent outlines mechanisms through which ClO₂ can selectively kill tumor cells by oxidative stress, offering a non-toxic alternative to chemotherapy or radiation.
🔗 WO2016074203A1 – Intratumoral Treatment of Solid Tumors
2. Chlorine Dioxide Injections for Therapeutic Use (US20190015445A1 – 2016)
Filed two years later, this patent extended the therapeutic applications of ClO₂ to include immune stimulation and multi-disease indications. It marked a major step in formulating ClO₂ for injection with sufficient pharmacological activity and safety.
🔗 US20190015445A1 – Injectable Chlorine Dioxide for Medical Use
Why a New Patent Was Needed
Although the two earlier patents established the mechanism and effectiveness of ClO₂ injection therapy, they lacked a precise and scalable pharmaceutical preparation system that could meet international regulatory standards — particularly those of the FDA, EMA, and NMPA. Without this, it would be impossible to:
Submit an Investigational New Drug (IND) application to the FDA
Conduct formal multicenter clinical trials
Pass GMP-level quality control testing
Achieve standardized international distribution
The new 2025 patent solves this bottleneck.
The New Patent: "Preparation and Storage Method of Pure Chlorine Dioxide Liquid" (2025 Filing)
This invention introduces a fully enclosed system that enables the production, liquefaction, and storage of highly pure chlorine dioxide at ultra-high concentration (20,000 ppm or more), in a stable and transportable form. It emphasizes:
High-yield generation of ClO₂ gas using pharmaceutical-grade raw materials
Gas-liquid separation and controlled liquefaction via temperature and vacuum regulation
Long-term storage in specialized low-temperature vials
Ensured sterility and dosing precision, critical for human or veterinary injections
📌 Application Number: 202510595755.9
📌 Filing Date: May 9, 2025
Why This Patent Enables FDA Submission
To apply for FDA IND approval, one must submit a complete CMC (Chemistry, Manufacturing, and Controls)section, which includes:
Detailed process flow of drug manufacturing
Batch reproducibility and quality assurance systems
Shelf-life stability data
Impurity profile and microbiological testing
Sterile production environment description
Only this new patent supports such rigorous requirements. The prior patents focused on the therapeutic logic and clinical mechanism. This one focuses on the drug product itself.
Without a regulated and consistent production process, no injectable drug can be approved — no matter how effective it is.
Meeting Real-World Clinical Demands
Clinics in Germany, Mexico, Spain, and now China are already using my therapy under special access or physician-guided compassionate use. However, the injection formulations currently in use are based on the 2016 patent — functional but not suitable for formal new drug applications.
The new system solves this by enabling mass production with GMP compliance. This makes:
Clinical trials in the U.S., EU, or Asia possible
Licensing and contract manufacturing scalable
Regulatory dialogue with authorities transparent and evidence-based
What Comes Next
Now that the patent is officially filed, I will be initiating the following roadmap:
Pilot-scale production using the patented method
Phase I human trial design with institutional partners
FDA Pre-IND consultation (target: early 2026)
This is the gateway to turning a visionary therapy into a globally recognized new drug.
🔬 If you're a clinician, researcher, regulatory expert, or potential investor interested in the path forward, please contact me directly. Together, we are bringing a paradigm-shifting therapy from theory into reality.
📩 Contact: xuewu.liu@cdsxcancer.com
📱WhatsApp: +8613522136898
🌐 www.cdsxcancer.com