What We Do

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Capability

R&D (Preclinical)
To fully take advantage of the versatility of the DiKine™ and the long-acting multi-specific antibodies platform, Evive is actively exploring next generation therapeutics to address unmet medical needs in the field of inflammation, metabolism, and oncology. Cytokines, hormones, and their agonists or antagonists are among the primary targets for therapeutics developed based on the DiKine™ platform. Multiple tumor targets have been selected to develop therapeutics based on the long-acting multi-specific antibodies platform.
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Clinical Research
The Global Clinical Research Center (GCR) is an important component of Evive’s Research and Development organization. It aims to connect frontline global innovation with clinical practice and accelerate translation of scientific discoveries into medicines to fulfill our mission of developing high-quality innovative medicines for the treatment of cancer and other major diseases. GCR has attracted members with the capabilities, expertise, and talents for medical research, clinical operations, biometrics, pharmacovigilance, and clinical quality. We work dedicatedly with clinical trials and collaborations in the clinical community to generate evidence to determine whether our investigational therapies have potential to benefit patients and to save and improve lives.
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CMC
Evive utilizes cutting-edge technologies to discover, develop, and produce biopharmaceutical therapeutics. Our integrated CMC drug development expertise focuses on stable mammalian cell line, robust cell growth and product expression, streamlined downstream purification/viral clearance and formulation platform, comprehensive analytics and phase appropriate quality system that complies to the clinical drug requirement by major world health authorities. Our CMC Development team is experienced with biopharmaceutical lifecycle management from pre-clinical to IND/NDA/BLA filings, especially in product/process/method development, optimization, characterization and validation.
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Manufacturing
Evive Beijing is a mammalian cell (CHO) based biologics manufacturing facility, including the drug substance and drug product manufacturing sites located in the Beijing Economic Development Area (BDA). Evive Beijing is a wholly-owned subsidiary of Evive Biotechnology Ltd. The facilities produce investigative products for late phase clinical trials as well as commercial products that meet compliance requirement by FDA/EMA/NMPA. Evive Beijing’s core team is comprised of experts with substantial global pharmaceutical experience in cGMP manufacturing, quality, supply chain and global regulatory filing.
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Quality
Evive has implemented world-class Quality Management System (QMS) based on PIC/S GMP guidelines. It satisfies cGMP requirements of US, Europe, China and other relevant countries/regions. The goal is to ensure product quality, patient safety, and continuous improvement. The Quality department comprises of commercial QA/QC groups at Evive Beijing, clinical stage QA/QC groups at Evive Shanghai, and Corporate Quality group in US. Quality partner with Manufacturing, Supply Chain, Facility and Engineering, and other relevant departments to ensure compliance, and commercial and clinical supplies.
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Regulatory Affairs
The Regulatory Affairs team participates and manages strategic product development plans for Evive Products. We advise phase-appropriate development goals that meet FDA/EMA/CDE requirements to ensure smooth filing and development during IND/IMPD stage. We specialize in directing and managing marketing applications for biologics to CDE/FDA/EMA. The team is highly experienced in: 1. Directing and managing market authorization BLA to FDA, MAA to EMA, and NDA to CDE; 2. Coordinating Regulatory filing for ROW; 3. Managing and responding to inquiries from health authorities; 4. Managing and preparing meeting packages with health authorities; 5. Filing and strategic planning for CMC and clinical development during IND/IMPD
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