TaiMed Biologics Inc.
Taiwan-based biopharmaceutical company and biologics CDMO focused on monoclonal antibody therapeutics for HIV. Operates a qualified cGMP protein facility using single-use bioprocessing and offers integrated CDMO services including upstream/downstream process development and scale-up, analytical method development and QC testing, formulation and stability programs, technology transfer and regulatory submission support, and clinical development from Phase I–III. The company has commercialized a monoclonal antibody for multidrug‑resistant HIV-1 and has conducted clinical development and label-extension work for alternative parenteral administration routes.
Industries
Nr. of Employees
medium (51-250)
TaiMed Biologics Inc.
3F, No.607, Ruiguang Rd., Neihu Dist., Taipei City 11492, Taiwan (R.O.C.)
Products
Commercialized monoclonal antibody for multidrug‑resistant HIV-1
A humanized monoclonal antibody indicated for treatment of adults with multidrug‑resistant HIV-1 infection; supported by Phase I–III clinical data and regulatory approvals in multiple jurisdictions.
Second-generation long-acting monoclonal antibody candidates
Long-acting monoclonal antibody candidates engineered for improved resistance profiles and extended dosing intervals; progressed through Phase I and into combination Phase II studies.
Combination long-acting antibody regimens (clinical development)
Investigational combination therapy of two long-acting monoclonal antibodies for maintenance therapy; clinical studies evaluate extended dosing intervals (e.g., every 8–12 weeks).
Antibody–drug conjugate (ADC) research programs
R&D programs developing ADCs that conjugate monoclonal antibodies with small‑molecule payloads for targeted intracellular delivery to CD4+ cells, intended to increase antiviral payload delivery to infected cells.
Commercialized monoclonal antibody for multidrug‑resistant HIV-1
A humanized monoclonal antibody indicated for treatment of adults with multidrug‑resistant HIV-1 infection; supported by Phase I–III clinical data and regulatory approvals in multiple jurisdictions.
Second-generation long-acting monoclonal antibody candidates
Long-acting monoclonal antibody candidates engineered for improved resistance profiles and extended dosing intervals; progressed through Phase I and into combination Phase II studies.
Combination long-acting antibody regimens (clinical development)
Investigational combination therapy of two long-acting monoclonal antibodies for maintenance therapy; clinical studies evaluate extended dosing intervals (e.g., every 8–12 weeks).
Antibody–drug conjugate (ADC) research programs
R&D programs developing ADCs that conjugate monoclonal antibodies with small‑molecule payloads for targeted intracellular delivery to CD4+ cells, intended to increase antiviral payload delivery to infected cells.
Services
Integrated contract development and manufacturing services for monoclonal antibodies covering process development, analytical method development and validation, formulation development, cGMP manufacturing at pilot and commercial scale, stability testing and regulatory support.
Analytical method development, validation and routine QC testing for protein therapeutics including potency, purity, impurity, biophysical and stability analyses to support product release and regulatory filings.
Regulatory strategy, dossier preparation and submission support for INDs, BLAs/MAAs and supplemental filings, and assistance with regulatory meetings and interactions.
Integrated contract development and manufacturing services for monoclonal antibodies covering process development, analytical method development and validation, formulation development, cGMP manufacturing at pilot and commercial scale, stability testing and regulatory support.
Analytical method development, validation and routine QC testing for protein therapeutics including potency, purity, impurity, biophysical and stability analyses to support product release and regulatory filings.
Regulatory strategy, dossier preparation and submission support for INDs, BLAs/MAAs and supplemental filings, and assistance with regulatory meetings and interactions.
Expertise Areas
- Clinical trial management and adaptive trial design
- Bioprocessing and single-use scale-up (CHO cell systems)
- Analytical characterization and method development/validation for biologics
- Regulatory strategy and submission preparation (IND/BLA/MAA and supplements)
Key Technologies
- Single-use bioreactor systems (pilot to 2,000 L)
- CHO cell culture and scale-up
- Automated chromatography and multi-step purification
- Ultrafiltration/diafiltration systems
News & Updates
Presentation of results on a CD4+ targeted antibody–drug conjugate for HIV treatment at ID Week 2025.
Company participation announced for BioHK 2025.
Company invited to share antibody therapeutics R&D and manufacturing strategies at Biologics CDMO Asia 2025.
Company exhibiting at BIO 2025 in Boston.
Initiation of Phase IIb clinical study protocol preparation for a long-acting antibody combination regimen and engagement with the U.S. FDA.
Saudi Food and Drug Authority granted orphan drug designation for the company's HIV monoclonal antibody for multidrug‑resistant HIV-1 infection.
Presentation of results on a CD4+ targeted antibody–drug conjugate for HIV treatment at ID Week 2025.
Company participation announced for BioHK 2025.
Company invited to share antibody therapeutics R&D and manufacturing strategies at Biologics CDMO Asia 2025.
Company exhibiting at BIO 2025 in Boston.
Initiation of Phase IIb clinical study protocol preparation for a long-acting antibody combination regimen and engagement with the U.S. FDA.
Saudi Food and Drug Authority granted orphan drug designation for the company's HIV monoclonal antibody for multidrug‑resistant HIV-1 infection.