Innovation and Pipeline
Our proprietary technology platforms optimize a series of innovative drug candidates for oncology and inflammatory disorders. Our pipeline covers a full range of assets from those in preclinical research all the way to our dimeric G-CSF fusion protein program that has successfully completed pivotal Phase III studies in the US, Europe and China.
Evive’s mission is to develop novel biologic therapies to provide patients with life-saving treatments and accelerate existing medical science towards therapies for patients with limited treatment options and who are suffering from serious diseases
Evive benefits greatly and gains peer recognition from our expertise in target identification, sophisticated cell engineering, high standard and large-scale manufacturing, efficient clinical development programs and well-defined regulatory pathways. Key members of our team have leadership experience in R&D, manufacturing, clinical studies, and commercial launch, and extensive experience interacting with regulators in multiple markets, making Evive one of the few biopharmaceutical companies in Asia that spans the end to end value chain from R&D to commercial launch.
This also enables us to make the best use of special programs for efficient regulatory pathways such as orphan drug designation and special protocol assessments.
Fundamental Science and Discovery
Conduct fundamental research and leverage peer reviewed literature, collaborations with leading research organizations and internal technology platforms to produce novel assets for further development and validate new clinical applications for existing assets.
Apply a myriad of preclinical research activities including pharmacokinetic, pharmacodynamic, ADME (absorption, distribution, metabolism, and excretion), and toxicology through in vitro and in vivo models in our small rodent facility and with partner research providers to make our assets ready for IND filing (innovative new drug) and to create supplementary data for clinical stage assets.
Internally managed and leveraging both established contract research organizations and collaborations with leading research institutions, we conduct clinical studies at each phase of the development cycle in accordance with regulatory authorities’ guidance and industry best practices to ensure patient safety above all.
Drug Substance Manufacturing
Post-candidate selection, our manufacturing team moves our assets from establishing a master cell bank and working cell banks through optimization to scale up manufacturing for GMP clinical batches and full commercial scale, supported by a robust Quality Assurance system and leveraging internal analytical and testing capabilities.
Manage interactions with regulatory agencies in multiple territories through internal capabilities and support from advisors to navigate the complexities of drug development and approval for product commercialization.
Manage clinical studies around the world with our strong medical affairs and clinical operations team based in New Jersey. We keep daily active communication with our KOLs, statistician and CRO to ensure well-designed and rigorously conducted trials