Microbix Advances Manufacturing Modernization for Kinlytic Urokinase Clot-Dissolving Drug
Key Insights
Microbix Biosystems (search) and partner Sequel Pharma (search) have successfully modernized drug substance manufacturing methods for Kinlytic urokinase (search), eliminating animal-derived components from cell culture media.
The biologic thrombolytic drug, already approved in the U.S., is being prepared for market re-entry through a supplemental biologics license application targeting catheter clearance applications.
Manufacturing improvements have cleared pivotal technical hurdles, with the project progressing into formulation and drug product development phases ahead of a targeted 2028 market return.
Microbix Biosystems (search) Inc. has achieved a significant manufacturing milestone in its effort to return the blood clot-dissolving drug Kinlytic urokinase (search) to global markets, with its commercialization partner Sequel Pharma (search) successfully modernizing production methods for the biologic's active ingredient.
The contract development and manufacturing organization (CDMO) engaged by Sequel Pharma (search) has completed modernization of drug substance manufacturing for Kinlytic, specifically reducing or eliminating the use of animal-derived products in cell culturing media. This advancement represents a critical step toward filing a supplemental biologics license application (sBLA) with the FDA to re-enter the U.S. market.
Manufacturing Modernization Advances Safety Standards
The manufacturing improvements align with modern best practices and provide additional safety precautions beyond existing cell-source screening, medium ingredient screening, and product purification processes. Work toward the sBLA filing began in March 2024 and is progressing as expected in accordance with FDA guidance, now advancing into the formulation, fill, and finish drug product phases of development.
Kinlytic's active ingredient is an enzyme derived from cell culture that safely dissolves blood clots. The drug is already approved for clinical use in the United States, and the current development work focuses on validating new manufacturing processes rather than establishing clinical efficacy.
Market Re-entry Strategy Targets Catheter Applications
Sequel Pharma (search), a U.S.-based specialty pharmaceutical company with expertise in developing and commercializing niche drugs, has committed to provide all funding needed to return Kinlytic to global markets. The initial focus targets the U.S. market for dissolving clots in indwelling venous catheters, known as catheter clearance applications.
Cameron Groome, CEO and President of Microbix, stated, "We're pleased to report this important progress toward the reapproval and reintroduction of Kinlytic, initially for Catheter Clearance in the United States. Microbix appreciates the work and support from Sequel and our CDMO partners and we are excited about the prospect of returning this medically-important drug to widespread clinical use, with a targeted timeline of calendar 2028."
Technical Hurdles Cleared in Development Process
Dr. Ken Hughes, COO of Microbix, emphasized the significance of the manufacturing achievements, commenting, "It remains a pleasure to be working alongside Sequel, with Microbix's scientists able to support the modernization of Drug Substance manufacturing. While there are further steps to complete in the course of preparing for our sBLA file submission, we believe that the recently-completed Drug Substance work has cleared pivotal and technically challenging hurdles."
The collaboration leverages Microbix's biological expertise and infrastructure, with the company maintaining over 120 skilled employees and generating C$18.6 million in revenues during its latest fiscal year (2025). Microbix operates with multiple regulatory accreditations, including ISO 9001 & 13485 accreditation, U.S. FDA registration, Australian TGA registration, and Health Canada establishment licensing.
Regulatory Pathway and Timeline
The development team is working toward sBLA submission, which represents the regulatory pathway for biologics that are already approved but require manufacturing changes or new indications. The process follows established FDA guidance for biologic drug development and manufacturing validation.
Microbix indicated it will continue updating shareholders on Kinlytic-related achievements as they become meaningful, with anticipated future disclosures potentially including manufacturing, clinical, regulatory, or commercial milestones leading up to the targeted 2028 market return.