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Committed to Biomedical Therapy Clinical Development and Promotion

Currently focused on the development of new drugs for HIV treatment and prevention,
and the introduction of early-stage research drugs from research institutions.

A monoclonal antibody for the treatment of HIV multi-drug-resistant patients, and is a last-line therapy for HIV/AIDS.

Trogarzo® (ibalizumab, TMB-355, TNX-355, Hu5A8) is a biologic that can block the entry of HIV into host cells.
Trogarzo®is an attachment inhibitor and specifically binds to the second extracellular domain of the CD4 receptor.
Trogarzo®can prevent the transmission of HIV via cell-cell fusion while preserving the body's immune function.

Product Discovery Pre-clinical Studies Phase I Studies Phase II Studies Phase III Studies BLA / MAA Market
ProductTrogarzo® IV Infusion Discovery
 
Pre-clinical Studies
 
Phase I Studies
 
Phase II Studies
 
Phase III Studies
 
BLA / MAA
 
Market
 
A monoclonal antibody protein drug for the treatment of HIV multi-drug-resistant patients, and is a last-line therapy for HIV/AIDS.
Product Function Description

 

TROGARZO® (ibalizumab, TMB-355, TNX-355, Hu5A8)is the first humanized monoclonal antibody used for HIV infection, blocking the virus from entering cells while preserving immune function. The IV Push is a rapid administration option of Trogarzo® and is one of the FDA-approved administration methods.

Product Discovery Pre-clinical Studies Phase I Studies Phase II Studies Phase III Studies BLA / MAA Market
ProductTROGARZO® IV Push Discovery
 
Pre-clinical Studies
 
Phase I Studies
 
Phase II Studies
 
Phase III Studies
 
BLA / MAA
 
Market
 
A monoclonal antibody for the treatment of HIV multi-drug-resistant patients, and is a last-line therapy for HIV/AIDS.
Product Function Description

 

TROGARZO® (ibalizumab, TMB-355;, TNX-355, Hu5A8)is the first humanized monoclonal antibody used for HIV infection. It specifically binds to the CD4 receptor, preventing the virus from entering host cells while preserving normal immune function. It has been approved for market release via IV injection and has undergone the phase 1 clinical trial for subcutaneous injection, demonstrating its safety and effectiveness. In the phase 1/2 clinical trial completed in Taiwan for subcutaneous/intramuscular (i.m.) injection, Trogarzo® showed tremendous antiviral activity regardless of the administration route. The phase 3 clinical trial, which was initiated in 2021, assesses the effectiveness of intramuscular injection of Trogarzo®, providing more administration options.

Product Discovery Pre-clinical Studies Phase I Studies Phase II Studies Phase III Studies BLA / MAA Market
ProductTROGARZO®IM Injection Discovery
 
Pre-clinical Studies
 
Phase I Studies
 
Phase II Studies
 
Phase III Studies
 
BLA / MAA
 
Market
 
TMB-365 is the second-generation Trogarzo® monoclonal antibody used for HIV treatment and prevention. It exhibits better drug resistance and efficacy compared to Trogarzo®. Developed by a team led by Dr. David Ho, TaiMed holds exclusive global rights for its development and marketing.
Product Function Description

 

  • The V5-glycan on HIV-1 gp120 is crucial for Trogarzo® in inhibiting HIV-1 infection.
  • After binding to the CD4 receptor, Trogarzo® creates a steric hindrance that prevents conformational changes in the V5-glycan, thereby blocking HIV-1 from infecting T cells.
  • Some HIV-1 strains without V5-glycan, leading to reduced sensitivity to Trogarzo® and the development of drug resistance.
  • TMB-365 is an improved version of Trogarzo®, with the addition of glycan on the light chain, enhancing its effectiveness against HIV-1.
  • TMB-365 exhibits similar binding capability to the CD4 receptor as Trogarzo®, creating steric hindrance regardless of the presence of glycan in the V5-glycan, thus preventing HIV-1 from infecting T cells.

 

Product Discovery Pre-clinical Studies Phase I Studies Phase II Studies Phase III Studies BLA / MAA Market
ProductTMB-365 Discovery
 
Pre-clinical Studies
 
Phase I Studies
 
Phase II Studies
 
Phase III Studies
 
BLA / MAA
 
Market
 
TMB-380 is a broadly neutralizing monoclonal antibody drug with high potent, broad spectrum, and long-lasting effects against HIV-1. When used in combination with TMB-365, it becomes part of a dual therapy against HIV.
Product Function Description

 

  • TMB-365 and TMB-380 superior antiviral activities, with pharmacokinetic profile indicating the potential of dosing bi-monthly or quarterly.
  • TaiMed has developed a phase 1b/2 clinical trial of TMB-365 /TMB-380 combination, and submitted an IND application to the US FDA in 2022.
  • A phase 1b/2a clinical trial with adaptive design was proposed for viral-suppressed HIV-1 patients. The study will investigate the safety and efficacy of the TMB-365 /TMB-380 combination at different dose levels every 8 or 12 weeks.

 

Product Discovery Pre-clinical Studies Phase I Studies Phase II Studies Phase III Studies BLA / MAA Market
ProductTMB-365/TMB-380 combination Discovery
 
Pre-clinical Studies
 
Phase I Studies
 
Phase II Studies
 
Phase III Studies
 
BLA / MAA
 
Market
 
ABOUT

Qualified cGMP Protein Facility with a Professional CDMO Service Team

Taiwan possesses a highly educated talent pool, a stable business environment, and well-established regulations, making it an ideal choice for global CDMO services.Our qualified cGMP facility and CDMO service team strive to provide comprehensive services, including cGMP manufacturing, process development, analysis & analytical method development, formulation development, regulatory affairs, and more. We are committed to delivering reliable and high-quality services, offering competitive pricing, and flexible collaboration models. TaiMed is undoubtedly your best CDMO partner of choice.

Our services

We are doing a couple of things you might be interested in

High-Quality and
Cost-Competitive

Flexible
Manufacturing Solutions

Comprehensive Services
from Laboratory to Commercialization

TaiMed’s cGMP facility

Our cGMP facility utilizes single-use technology, offering cost-effective and versatile manufacturing that complies with global regulations. Our services span from pilot scale to full commercialization for monoclonal antibody development. TaiMed is your one-stop integrated solution for all your needs.

CDMO Services

Our services encompass cGMP manufacturing, process development, analytical method development and validation, formulation development, and monoclonal antibody stability testing. With our experienced in the successful development of proprietary monoclonal antibody products, we offer a range of solutions and are committed to driving your product development forward.

CDMO Service Process

We are doing a couple of things you might be interested in

Process Development

Process Development

Formulation Development

Formulation Development

cGMP Manufacturing

cGMP Manufacturing

Analysis and Analytical Method Development

Analysis and Analytical Method Development

Regulatory Affairs

Regulatory Affairs

Partnerships

TaiMed collaborates with relevant biotech and medical institutions to continuously research and
develop technologies that promote the well-being of the human population.

合作夥伴
中裕新藥與相關生技醫療機構合作,持續研發促進人民福祉之技術

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