Company
TaiMed Biologics was formed on September 4, 2007 to realize the vision of creating a world-class, innovation-based biotechnology company that will satisfy the unmet medical needs of patients around the world. The company will capitalize on its tremendous intellectual, extensive expertise, and management resources to develop a strong health-care product pipeline that benefits patients, rewards investors, and propels ourselves to prominence in the biotechnology industry. The company signed an agreement with Genentech for the licensing of Ibalizumab shortly after its formation. This drug candidate, also known as TMB-355, is a proprietary humanized anti-CD4 monoclonal antibody for the treatment of HIV/AIDS.
TaiMed Biologics is committed to conducting business with integrity and passion. We remain to be forward-thinking and utilize our resources wisely and efficiently in order to meet our long-term objectives.
Founders
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
President of Republic of China (Taiwan), Former chairperson of TaiMed Biologics.
Company History
2022
- Apr
- 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.
2021
- Dec
- 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.
- Sep
- The results of phase 3 study of Trogarzo IV Push successfully met the target.
- Mar
- The company adjust the COVID-19 antibody implementation project that suspended internal development and made an equity investment in RenBio Inc.
2020
- Sep
- The new anti-HIV drug Trogarzo was officially launched for sales in Europe and Germany.
- Aug
- 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.
- Mar
- 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.
2019
- Oct
- 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.
- Sep
- The company's new anti-HIV drug Trogarzo IV-push officially obtained the drug marketing license from European Commission (EC).
- Aug
- The company's new anti-HIV drug TMB-365 has been approved by the U.S. FDA for the Phase I human clinical trials
- Apr
- Bispecific Antibody, a new anti-HIV drug under development by the company, began its Phase I clinical trial in US.
- Mar
- 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.
2018
- Aug
- TMB-355 Phase III pivotal trial results were published in The New England Journal of Medicine.
- May
- The company purchased the real estate on Ruigang Road as the company's operating office.
- Apr
- 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.
- Mar
- The U.S. FDA approved the biologics license application (BLA) for the new anti-HIV drug TMB-355 (in the trade name of Trogarzo).
2017
- May
- TaiMed Submits Biologics License Application to US FDA for Ibalizumab (TMB-355)
- Mar
- 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
2016
- Dec
- Initiated TMB-607 Phase I clinical study for HIV teatment in US
- Nov
- 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
- Sep
- US$ 500 thousand R&D subsidies from US FDA for the TMB-355 phase III clinical trial
- Aug
- Board of directors Approved to build production facility in Hsinchu Biomedical Science Park.
- Jul
- TMB-355 BLA (CMC section) filed to US FDA for reviewing
- Mar
- TaiMed and Theratechnologies signed an exclusive Marketing and Distribution Agreement for Ibalizumab in US and Canada territory
2015
- Nov
- Publicly listed on Taipei Exchange Market in Taiwan on 23 November, 2015
- Aug
- Initiated TMB-355 IV injection Phase IIII clinical study for HIV in US and Taiwan
- Apr
- Initiated the development for TMB-365, improved from TMB-360 by ADARC
- Feb
- Breakthrough therapy designated by FDA for TMB-355 IV injection
2014
- Dec
- Licensing of TMB-360(LM 52), the second generation of ibalizumab from TMB USA
- Otc
- Organ Drug status designated by US FDA for TMB-355 HIV treatment in multi-drug resistant patients
- Aug
- NT$ 1,497 thousand R&D subsidies from MOEA for the HIV long-acting injection development of TMB-607
- Jul
- Terminated the project of integrase Inhibitor (INI), licensing from Ambrilia Biopharma Inc
- Apr
- US FDA Approved Ibalizumab Manufactured by WuXi PharmaTech for Treatment of Patients on Expanded Access
- Mar
- Terminated the project of Tamiphosphor, licensing from Academia Sinica
- Jan
- TaiMed office and Lab relocated to Ruigang Road, Neihu Science Park
2013
- Otc
- The technology HIV antibody TMB-360(LM 52), the second generation of ibalizumab, published in “Nature Biotechnology” magazine
- Sep
- NT$ 9 million R&D subsidies from MOEA for the clinical trial of phase I/II of TMB-355 IM & SC injection
2012
- Otc
- Completed TMB-355 SC injection phase I clinical study for HIV in U
- Jul
- TaiMed and WuXiApptec signed the CMO contract for TMB-355
2011
- Aug
- Technology Transfer silver medal for TMB-355 project received at the 2013 Taipei Biotech Award
- Jun
- Completed the end of phase II meeting with US FDA for the Ibalizumab (TMB-355) IV injection clinical trial
- Apr
- TMB USA, 100% of TaiMed subsidiary, exclusively Licensed the Fusion Proteins technology from Rockefeller University
- Mar
- Exclusively licensed two HIV treatment projects from Ambrilia Biopharma Inc. one is Protease Inhibitor (PI)，the other is Integrase Inhibitor (INI)
2010
- Jun
- Listed on Emerging Market in Taipei Exchange Market (ticker number:4147)
- May
- Approval for TaiMed shares retroactive handling of public issuance procedure from Securities and Futures Bureau
2009
- Nov
- TMB-355 prevention research subsidies from Bill & Melinda Gates Foundation
- Apr
- TaiMed Chinese name changed as “中裕新藥股份有限公司”
2008
- Dec
- Exclusively licensed Tamiphosphor project from Academia Sinica
- Sep
- Qualified as new drug company under the “Act for the development of Biotech and new pharmaceuticals industry” from MOEA
- Jul
- Established preclinical lab in the Biotech Incubation Center of Academia Sinica
- May
- Initiated TMB-355 IV injection phase IIb clinical trial
- Mar
- Appointed James Chang as CEO of Taimed
2007
- Otc
- Established TaiMed Biologics USA in Irvine, California
- Sep
- 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