Our Mission and Innovation
At TaiMed Biologics, our mission transcends the traditional boundaries of medicine. We are redefining the landscape of HIV treatment through the development and commercialization of groundbreaking therapies. Established in Taiwan, our company embodies innovation and leadership in the biopharmaceutical industry, focusing on fulfilling the unmet medical needs of patients across the globe.
A Historic Milestone: Trogarzo®
Our journey marked a historic milestone in March 2018 with the U.S. Food and Drug Administration (FDA) approval and market launch of Trogarzo®, the world's first and only monoclonal antibody-based drug for HIV treatment. This landmark achievement not only positioned TaiMed as the first Taiwanese company to receive FDA approval for a Biologics License Application (BLA) but also underscored our commitment to pioneering HIV therapeutics.
Pioneering Future Therapies
Building on the success of Trogarzo®, TaiMed is persistently pioneering the evolution and development of a revolutionary long-acting monoclonal antibody (mAb)-based combination therapy using emerging novel technology platforms. Our goal is to establish this therapy as the leading choice for first-line maintenance therapy in HIV. Our vision is to become a globally recognized, highly specialized company in HIV drug development, addressing the critical and unmet medical needs of patients worldwide.
Expanding Horizons with CDMO Services
In addition to our internal research and development endeavors, TaiMed has expanded its horizons by leveraging its expertise as a Contract Development and Manufacturing Organization (CDMO) for biologics. Our CDMO division offers a comprehensive suite of services to clients within the pharmaceutical industry, ranging from product development, analytical method development and qualification, process development and scale-up, and GMP production of biologics. This strategic integration of our development capabilities with CDMO services positions TaiMed as a versatile and valuable partner in the pharmaceutical landscape, ensuring the highest quality standards and regulatory compliance from development to market.
Our Commitment to Excellence
At TaiMed Biologics, we are more than just a company; we are a beacon of hope and innovation in the fight against HIV. Our unwavering commitment to excellence, combined with our relentless pursuit of groundbreaking, breakthrough therapies, is reshaping the HIV treatment paradigm. As we continue to advance our mission, we remain dedicated to improving the lives of patients and contributing significantly to the field of biopharmaceutical innovation.
David Ho, M.D., Chief of TaiMed Scientific Advisor
Director and CEO, Aaron Diamond AIDS Research Center, and Irene Diamond Professor, Rockefeller University.
Dr. Ho has been a world leading authority in AIDS research for 25 years while publishing over 350 papers. He championed combination antiretroviral therapy that has resulted in unprecedented control of HIV in patients. Among Dr. Ho’s many honors include his election to the membership of the American Academy of Arts and Sciences; Institute of Medicine, National Academy of Science in the United States; Academia Sinica (Republic of China); and Chinese Academy of Engineering. Dr. Ho also holds the rare honor of simultaneously serving on Board of Trustees of the California Institute of Technology and the Board of the Massachusetts Institute of Technology Corporation.
LanBo Chen, Ph.D., Chairman of TMB USA Inc.
Academicians of the Academia Sinica, Professor of Pathology, Emeritus, at Harvard Medical School,
Ing-Wen Tsai, Ph.D. in law from the London School of Economics and Political Science
Former President of Republic of China (Taiwan), Former chairperson of TaiMed Biologics.
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2019-10-01Feb
The long-acting AIDS treatment combination of TMB-365/380 has passed the review by the U.S. FDA and has been granted 'Fast Track Designation' as a new drug.
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2019-10-01Nov
The pioneer group of the clinical trial for the long-acting combination therapy of TMB-365 and TMB-380 has completed data analysis. The results met expectations and confirmed the dosages for future implementation -
2019-10-01Feb
Our company and WEP Clinical have officially started promoting the Named Patient Program (NPP) for the new AIDS drug Trogarzo.
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2019-10-01Oct
Our company's new AIDS drug, Trogarzo Intravenous Push (IV Push), has been approved for marketing authorization (sBLA) by the U.S. FDA as a biologic new drug. -
2019-10-01Apr
Announcement of Change of the Company's CEO (President /General Manager)
The US FDA Approves IND Applicaion for Bi-monthly and Quarterly dosing of TMB-365/TMB-380 Combination for Treatment of HIV Infection.
The European Medicines Agency(EMA) Approves Supplemental BLA Filing for The Addition of Samsung Biologics in Korea for Commercial Manufacturing of Trogarzo. -
Mar
TaiMed Expands Its Business Model from Biologic Drug Innovator to CDMO. -
Feb
The US FDA Approves Supplemental BLA Filing for The Addition of Samsung Biologics in Korea for Commercial Manufacturing of Trogarzo.
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2019-10-01Dec
The submission of sBLA to the U.S. FDA for the Trogarzo intravenous (IV) push form of administration. -
Oct
TMB-365 was successfully completed the phase I study, and the data results far exceeded the original set standards. -
2019-10-01Sep
The results of phase 3 study of Trogarzo IV Push successfully met the target. -
2019-10-01Mar
The company adjust the COVID-19 antibody implementation project that suspended internal development and made an equity investment in RenBio Inc.
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Sep
The new anti-HIV drug Trogarzo was officially launched for sales in Europe and Germany. -
2019-10-01Aug
The company and Columbia University in the City of New York signed a global exclusive license for the latest monoclonal antibody for the prevention and treatment of COVID-19. -
2019-10-01Mar
The company has reached a full agreement with American companies Genentech and Biogen on the issue of royalties related to the new anti-HIV drug Trogarzo.
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2019-10-01Oct
The company’s subsidiary TMB USA and the National Institutes of Health have agreed to transfer the latest patented antibody technology VRC07-523LS for a new anti-HIV drug.
Considering the company's overall business strategy, the TMB-607 new drug R&D project was terminated. -
2019-10-01Sep
The company's new anti-HIV drug Trogarzo IV-push officially obtained the drug marketing license from European Commission (EC). -
2019-10-01Aug
The company's new anti-HIV drug TMB-365 has been approved by the U.S. FDA for the Phase I human clinical trials -
2019-10-01Apr
Bispecific Antibody, a new anti-HIV drug under development by the company, began its Phase I clinical trial in US. -
2019-10-01Mar
The company's new anti-HIV drug Trogarzo IV-push dosage form has been approved by the U.S. FDA to conduct Phase III clinical trials.
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2019-10-01Aug
TMB-355 Phase III pivotal trial results were published in The New England Journal of Medicine. -
2019-10-01May
The company purchased the real estate on Ruigang Road as the company's operating office. -
2019-10-01Apr
The board of directors elected James Chang as chairman of the company.
The new anti-HIV drug Trogarzo was officially launched for sales in the United States. -
2019-10-01Mar
The U.S. FDA approved the biologics license application (BLA) for the new anti-HIV drug TMB-355 (in the trade name of Trogarzo).
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2019-10-01May
TaiMed Submits Biologics License Application to US FDA for Ibalizumab (TMB-355) -
2019-10-01Mar
License agreement with ADARC for Bispecific Antibodies technology
TaiMed and Theratechnologies agreed to extend the exclusive Marketing and Distribution Agreement for Ibalizumab to Europe territory
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2019-10-01Dec
Initiated TMB-607 Phase I clinical study for HIV teatment in US -
2019-10-01Nov
TMB-355 maintains significant reduction of viral load in patients with multi-drug resistant HIV-1 over 24 Weeks based on the results of the Phase III study-301 trial -
2019-10-01Sep
US$ 500 thousand R&D subsidies from US FDA for the TMB-355 phase III clinical trial -
2019-10-01Aug
Board of directors Approved to build production facility in Hsinchu Biomedical Science Park. -
2019-10-01Jul
TMB-355 BLA (CMC section) filed to US FDA for reviewing -
2019-10-01Mar
TaiMed and Theratechnologies signed an exclusive Marketing and Distribution Agreement for Ibalizumab in US and Canada territory
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2019-10-01Nov
Publicly listed on Taipei Exchange Market in Taiwan on 23 November, 2015 -
2019-10-01Aug
Initiated TMB-355 IV injection Phase IIII clinical study for HIV in US and Taiwan -
2019-10-01Apr
Initiated the development for TMB-365, improved from TMB-360 by ADARC -
2019-10-01Feb
Breakthrough therapy designated by FDA for TMB-355 IV injection
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2019-10-01Dec
Licensing of TMB-360(LM 52), the second generation of ibalizumab from TMB USA -
2019-10-01Oct
Organ Drug status designated by US FDA for TMB-355 HIV treatment in multi-drug resistant patients -
2019-10-01Aug
NT$ 1,497 thousand R&D subsidies from MOEA for the HIV long-acting injection development of TMB-607 -
2019-10-01Jul
Terminated the project of integrase Inhibitor (INI), licensing from Ambrilia Biopharma Inc -
2019-10-01Apr
US FDA Approved Ibalizumab Manufactured by WuXi PharmaTech for Treatment of Patients on Expanded Access -
2019-10-01Mar
Terminated the project of Tamiphosphor, licensing from Academia Sinica -
2019-10-01Jun
TaiMed office and Lab relocated to Ruigang Road, Neihu Science Park
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2019-10-01Oct
The technology HIV antibody TMB-360(LM 52), the second generation of ibalizumab, published in “Nature Biotechnology” magazine -
2019-10-01Sep
NT$ 9 million R&D subsidies from MOEA for the clinical trial of phase I/II of TMB-355 IM & SC injection
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2019-10-01Oct
Completed TMB-355 SC injection phase I clinical study for HIV in U -
2019-10-01Jul
TaiMed and WuXiApptec signed the CMO contract for TMB-355
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2019-10-01Aug
Technology Transfer silver medal for TMB-355 project received at the 2013 Taipei Biotech Award -
2019-10-01Jun
Completed the end of phase II meeting with US FDA for the Ibalizumab (TMB-355) IV injection clinical trial -
2019-10-01Apr
TMB USA, 100% of TaiMed subsidiary, exclusively Licensed the Fusion Proteins technology from Rockefeller University -
2019-10-01Mar
Exclusively licensed two HIV treatment projects from Ambrilia Biopharma Inc. one is Protease Inhibitor (PI)，the other is Integrase Inhibitor (INI)
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2019-10-01Jun
Listed on Emerging Market in Taipei Exchange Market (ticker number:4147) -
2019-10-01May
Approval for TaiMed shares retroactive handling of public issuance procedure from Securities and Futures Bureau
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2019-10-01Nov
TMB-355 prevention research subsidies from Bill & Melinda Gates Foundation -
2019-10-01Apr
TaiMed Chinese name changed as “中裕新藥股份有限公司”
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2019-10-01Dec
Exclusively licensed Tamiphosphor project from Academia Sinica -
2019-10-01Sep
Qualified as new drug company under the “Act for the development of Biotech and new pharmaceuticals industry” from MOEA -
2019-10-01Jul
Established preclinical lab in the Biotech Incubation Center of Academia Sinica -
2019-10-01May
Initiated TMB-355 IV injection phase IIb clinical trial
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2019-10-01Oct
Established TaiMed Biologics USA in Irvine, California -
2019-10-01Sep
TaiMed Biologics Inc. established as a new drug development company
TaiMed and Genentech signed an exclusive license agreement for anti-cd4 antibody known as Ibalizumab (TMB-355)
Board of directors elected Ing-Wen Tsai, Ph.D as the first chairperson of TaiMed
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