Frontage Laboratories Inc, a US-based global Contract Research, Development and Manufacturing Organisation (CRDMO) and a subsidiary of Frontage Holdings Corporation (HKEX:1521), said on Friday that it has expanded its early phase clinical research capabilities across the United States and China.
The company said that this strategic growth enhances its ability to support pharmaceutical and biotech partners with accelerated, high-quality clinical development solutions.
Frontage's US operations are anchored by a 160-bed, 36,000-sq-ft Phase I clinical unit in Secaucus, New Jersey, designed to conduct large-scale Phase I and Bioequivalence (BE) studies, as well as radiolabelled human AME research. The company has further strengthened its C14-hAME capabilities through a dedicated unit staffed by licensed radiation experts and supported by an on-site nuclear pharmacy for sterile and non-sterile radiolabelled compounding. Frontage has executed combined hAME and Absolute Bioavailability studies aligned with the FDA's 2024 guidance.
In response to growing industry demand, Frontage is also expanding into Oncology Phase I trials through partnerships with regional hospitals and clinical networks, enabling patient-based research across key cancer indications.
As the industry approaches a significant wave of patent expirations, Frontage's multiple US clinical units are positioned to manage complex, high-volume BE programmes, and collaboration with Frontage China enables flexible Multi-Regional Clinical Trial (MRCT) execution.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval