The incidence and prevalence of acute kidney injury (AKI) have been increasing worldwide. Taiwan has been ranked first in the world in terms of the incidence and prevalence of end-stage renal disease requiring dialysis. No effective treatment for AKI has been developed. In our animal study, we confirmed that administering a demethylation drug (azacitidine) to animals after AKI could reduce the subsequent occurrence of kidney fibrosis and chronic kidney disease (CKD). Although azacitidine is currently FDA-approved and widely used to treat acute myeloid leukemia and myelodysplastic syndrome. The pharmacokinetics and safety in renal function impairment patient is unknown. Therefore, firstly, we designed clinical trial for the pharmacokinetics and safety in CKD patients, and we have included several patients in the study. Subsequently, we aim to utilize these findings to tailor treatment dosages for AKI, marking a significant advancement in the management of AKI.

Our team’s primary highlight is the C/EBPA therapy targeting myeloid-derived suppressor cells for treatment, which has been initiated in collaboration with Imperial College London based on research published by both institutions. The team has commenced a US-FDA clinical trial for new drug approval (MNA-3521-011: A First-in-Human, multi-center, open-label, Phase 1 Clinical Study using RNA Oligonucleotide Drug MTL-CEBPA to Investigate Safety and Tolerability in Patients with Advanced Liver Cancer). Professor Huang Kai-Wen, the principal investigator for the Asia-Pacific region, completed the first phase of the clinical trial in 2020, with results published in Clinical Cancer Research (MTL-CEBPA, a Small Activating RNA Therapeutic Upregulating C/EBP-α, in Patients with Advanced Liver Cancer: A First-in-Human, Multicenter, Open-Label, Phase I Trial. Clinical Cancer Research. 2020). Currently, a multi-national, multi-center phase II clinical trial is underway. Additionally, another USFDA clinical trial using the same drug in combination with immunotherapy to treat all solid tumors is also being conducted in multiple countries and centers, with our team serving as the principal investigator for the Asia-Pacific region. (MNA-3521-012: An open label phase 1a/b study of MTL-CEBPA in combination with a PD-1 inhibitor).

TCTC-Liver consortium has successfully attracted and participated in 28 clinical drug trials led by major international pharmaceutical companies; 13 clinical drug/medical devices trials led by domestic pharmaceutical companies or biotechnology companies; and successfully promoted 8 clinical drug trials hosted by Clinical trials of drugs initiated by people. We conduct phase III global multi-center clinical trial “Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection” to develop new treatment strategies for combined hepatitis B and hepatitis C patients. The results of its research and development were published in the internationally renowned journal Gastroenterology and assisted manufacturers in obtaining new indications for HCV treatment (Genotype 2), assists in HCV elimination.

Facilitate the licensure of first domestically developed vaccine- A multi-national and multi-center phase 3 enterovirus 71 vaccine in young infants and children

Lung cancer is an important health issue in Taiwan, and the shift in treatment approaches from late-stage to early-stage cancer has become a global trend. The promotion and widespread adoption of low-dose computed tomography (LDCT) have led to an annual increase in the number of lung cancer cases eligible for surgery, further accelerating this transition. Therefore, early-stage lung cancer management, including surgical intervention and personalized adjuvant therapy, plays a crucial role in overall lung cancer care. Through the efforts of our clinical trial team, we have spearheaded numerous clinical trials in lung cancer. This includes a phase III, double-blind, randomized, placebo-controlled, international trial evaluating the efficacy and safety of adjuvant Osimertinib compared to a placebo in participants with completely resected tumors and positive epidermal growth factor receptor (EGFR) mutations in stage IA2-IA3 non-small cell lung cancer (ADAURA2). A total of 380 participants from approximately 200 trial centers across about 25 countries were enrolled, with 70 participants from Taiwan involved in the trial. Our institution recruited 29 participants, making it the hospital with the highest enrollment globally.

We participated in the early clinical trial design and implementation of the Medigen COVID-19 vaccine development. The Medigen protein vaccine has been authorized for emergency use in Taiwan FDA and has been available for public vaccination. The trial results were published in Lancet Respiratory Medicine and received international recognition (including a published interview in the journal Nature). It was also selected by the WHO and the Bill & Melinda Gates Foundation for sponsorship in the third phase of the trial. The technology transfer license was granted to the WHO on August 30, 2023.

Our consortium actively integrates Taiwanese researchers to engage various important studies. First, through computed tomography, it has been shown that the new bioadaptive drug-eluting stent (Dynamx) outperforms traditional drug-eleuting stents in terms of restoration of vascular motion, and this drug-eluting stent has received FDA approval. Another study, SELECT trial, focuses on evaluating the effectiveness of Semaglutide in obese patients with cardiovascular disease, showing a 20% reduction in cardiovascular events. This is a groundbreaking finding that changes general perceptions of weight loss drugs.

Additionally, our consortium, in collaboration with the Graduate Institute of Photonics and Optoelectronics at National Taiwan Normal University, has developed the " Immune magnetic reduction testing technology", which can detect Alzheimer's disease early with just 6cc of blood. This technology is world leading and received marketing authorization from the Taiwan Ministry of Health and Welfare. Our consortium has also developed the world's first instrument for diagnosing coronary artery disease using multichannel electrocardiography and has received support from the National Science and Technology Council, promoting the development of related biotechnology industries.

On the other hand, our consortium has explored the use of locally developed novel active bamboo charcoal/probiotic therapy to reduce major adverse cardiovascular events by absorbing nephrotoxins in the intestine in chronic kidney disease patients. Moreover, our consortium has conducted over 90 clinical trials, establishing a comprehensive database regarding blood lipid profile and arteriosclerosis-related diseases, providing important references for the treatment of related diseases in Taiwan. Based on these research findings, Taiwan's reimbursement criteria for lipid-lowering drugs and new lipid treatment guidelines have been updated. Our goal is to reduce cardiovascular events and lower medical expenses in the future.