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ACCELERATING CARDIOVASCULAR INNOVATION — BEYOND THE CO-CRYSTAL MODEL
We are excited to announce the successful completion of our pivotal EMA bioequivalence study for Sacubitril and Valsartan tablets, confirming Cmax and AUC within the accepted bioequivalence range a critical regulatory milestone.
This result paves the way for first-wave submission in Europe and signals our readiness to compete in one of the most demanding cardiovascular segments.
Market Entry Advantage
In a strategic move, our formulation is built using a non-co-crystal design-around approach, avoiding the originator’s technology while delivering equivalent performance. This intelligent differentiation positions us for earlier market entry and freedom to operate in key geographies. This success is the result of tight execution, regulatory foresight, and cross-functional excellence. Deep appreciation to our CRO partners and internal R&D teams who delivered this milestone on time and with high quality.
With a DCP slot already reserved and dossier readiness targeted for March 2026, we are well-positioned to move swiftly into the next regulatory phase.
Congratulations to our internal and CRO teams for their precise execution and timely delivery of this critical study — a testament to true scientific and operational excellence.
Out-Licensing Now Open
We are actively exploring partnerships with companies looking to expand their cardiovascular portfolios through high-value, de-risked assets ready for regulatory filing.
To connect, please contact: Maxim Vlasenko, Lead Business & Strategy, GlobalLux RX | Your Gateway to Scalable Innovation.
Contact maxim.vlasenko@globalluxrx.comWe are excited to announce the successful completion of our pivotal EMA bioequivalence study for Sacubitril and Valsartan tablets, confirming Cmax and AUC within the accepted bioequivalence range a critical regulatory milestone.
This result paves the way for first-wave submission in Europe and signals our readiness to compete in one of the most demanding cardiovascular segments.
Market Entry Advantage
In a strategic move, our formulation is built using a non-co-crystal design-around approach, avoiding the originator’s technology while delivering equivalent performance. This intelligent differentiation positions us for earlier market entry and freedom to operate in key geographies. This success is the result of tight execution, regulatory foresight, and cross-functional excellence. Deep appreciation to our CRO partners and internal R&D teams who delivered this milestone on time and with high quality.
With a DCP slot already reserved and dossier readiness targeted for March 2026, we are well-positioned to move swiftly into the next regulatory phase.
Congratulations to our internal and CRO teams for their precise execution and timely delivery of this critical study — a testament to true scientific and operational excellence.
Out-Licensing Now Open
We are actively exploring partnerships with companies looking to expand their cardiovascular portfolios through high-value, de-risked assets ready for regulatory filing.
To connect, please contact: Maxim Vlasenko, Lead Business & Strategy, GlobalLux RX | Your Gateway to Scalable Innovation.
