Golden Biotechnology Corporation
Golden Biotechnology Corporation (GBC) is an advanced drug development company focused on the clinical development of new therapeutic agents to meet high unmet medical needs. With a proven track record in clinical research, regulatory affairs, and commercialization, GBC is dedicated to transforming patients' lives through innovative therapies, particularly Antroquinonol, which has demonstrated efficacy and safety in various clinical trials. The company actively collaborates with partners worldwide and is committed to research and development of new therapies for diseases such as cancer, infectious diseases, and neurodegenerative disorders.
Industries
Nr. of Employees
medium (51-250)
Golden Biotechnology Corporation
15F, No.27-6, Sec.2, Zhongzheng E. Rd., Tamsui Dist., New Taipei City 251, Taiwan
Products
Lead clinical-stage small-molecule oral therapeutic (NCE)
A clinical-stage small-molecule NCE developed as an oral therapeutic candidate with completed preclinical work and multiple Phase I/II studies across oncology, infectious disease and neurodegenerative indications.
Lead clinical-stage small-molecule oral therapeutic (NCE)
A clinical-stage small-molecule NCE developed as an oral therapeutic candidate with completed preclinical work and multiple Phase I/II studies across oncology, infectious disease and neurodegenerative indications.
Services
Design and operational management of early- to mid-stage clinical trials including protocol development, site coordination, data monitoring and interaction with independent DMCs.
Preparation and execution of regulatory interactions and filings (IND, Pre-EUA, End-of-Phase-2 requests) and planning toward marketing authorization.
Structuring and executing regional licensing agreements and commercial partnerships including milestone and royalty arrangements.
Management of clinical API and formulation production, packaging, outsourcing and equipment validation to supply clinical trials.
Design and operational management of early- to mid-stage clinical trials including protocol development, site coordination, data monitoring and interaction with independent DMCs.
Preparation and execution of regulatory interactions and filings (IND, Pre-EUA, End-of-Phase-2 requests) and planning toward marketing authorization.
Structuring and executing regional licensing agreements and commercial partnerships including milestone and royalty arrangements.
Management of clinical API and formulation production, packaging, outsourcing and equipment validation to supply clinical trials.
Expertise Areas
- Clinical trial management (Phase I–III)
- Small-molecule drug discovery and preclinical development
- Regulatory affairs and submissions (IND, Pre-EUA, EOP2, orphan designations)
- GMP manufacturing and quality systems for clinical supplies
Key Technologies
- Small-molecule NCE development
- Oral dosage formulation
- Randomized double-blind placebo-controlled trial design
- Multi-center international clinical trials