Building focused capabilities around complex biologics.
FG BioTherapeutics USA is being developed as a U.S.-centered biopharmaceutical company with plasma therapeutics as a specialized foundation and selected opportunities across specialty biopharma, biosimilars, and U.S. licensing.
A focused first portfolio, supported by U.S. operating capability.
The company is being built around product selection discipline, regulatory strategy, CMC and supply planning, quality governance, market access, and an operating model that can support later commercialization.
Plasma Therapeutics
Portfolio strategy, U.S. development, CMC oversight, supply strategy, quality, manufacturing model, Medical Affairs, access, and commercialization planning.
Specialty Biopharma
Selected assets where clinical value, U.S. evidence requirements, manufacturing feasibility, and reimbursement support a strong product case.
Biosimilars
Selective opportunities where analytical burden, patent timing, manufacturing economics, and U.S. access dynamics justify the investment.
U.S. Licensing
License-in, co-development, and co-commercialization opportunities that fit the platform without creating unnecessary operating complexity.
Development, supply, quality, and access have to work together.
Complex biologics do not become viable U.S. products through science alone. Regulatory pathway, clinical evidence, CMC, supply reliability, reimbursement, channel access, and product accountability need to be evaluated together from the beginning.
- Regulatory strategy is part of asset selection, not an afterthought.
- Supply and manufacturing feasibility are tested alongside clinical value.
- Quality authority is intended to remain independent of schedule pressure.
- Commercial capability is added in step with product maturity.
Build only what the portfolio can justify.
FG is developing a phased Houston-area manufacturing program. Site scope, engineering, permitting, and technical approvals remain in progress. The final configuration is intended to follow approved product needs rather than assumptions made too early.
Manufacturing & Supply
From formation to a durable U.S. operating company.
Formation & Operating Launch
Build the core organization, governance, portfolio process, quality system, vendors, budgets, and initial development plans.
Product Development & Transfer
Advance FDA strategy, evidence plans, CMC, technology transfer, external supply, and facility engineering.
Launch Preparation
Reach product-specific milestones and add market-access and medical capability when timelines justify it.
Integrated U.S. Platform
Manage approved products, development assets, selected manufacturing capabilities, and strategic transactions through a repeatable model.
Build a durable U.S. biopharmaceutical company that can repeatedly advance complex biologic opportunities from disciplined selection through development, reliable supply, and patient access.
That long-term direction depends on a focused portfolio, independent regulatory and quality capability, practical manufacturing and supply choices, strong market-access capability, and experienced U.S. management with clear accountability.
Focused Portfolio
Concentrate resources on a small number of well-understood programs with clear medical, regulatory, manufacturing, and commercial logic.
Integrated U.S. Capability
Connect regulatory, clinical, CMC, quality, supply, manufacturing, market access, and commercialization through one accountable operating model.
Repeatable Execution
Build a management system that can evaluate opportunities, allocate resources against milestones, and stop or restructure weak programs when the facts change.
Build functions rather than inherit finished ones.
FG is in a genuine 0-to-1 stage. Senior leaders are expected to shape role boundaries, decision rights, teams, operating cadence, product choices, and standards before habits become fixed.
Explore CareersGeneral inquiries
For recruiting and employment matters, please use the dedicated Human Resources contact on our Careers page.