Vision Development & Milestones

Pharmasaga (hereinafter referred to as "the Company") was established in January 2021 as a clinical novel drug development company. Our vision is to develop PS1, the world's first small-molecule drug with a novel mechanism, with the potential to reverse diabetes, offering diabetic patients a definitive treatment and enhancing the well-being of all humanity.

The Company's development strategy has evolved from an initial No Research, Development Only (NRDO) model to one that emphasizes both Research and Development (R&D). By controlling the most crucial patents and with a core team in novel drug development, we outsource the remaining aspects of the process to external professional vendors. This approach ensures we achieve milestones with maximum efficiency and minimal resources. The Company's profit model is to develop novel drugs through late-stage clinical trials, then license them to international pharmaceutical companies to secure upfront payments and royalties, subsequently using this cash flow to develop other high-potential drugs and indications.

In 2025, there will be an estimated 589 million people with diabetes globally, with the annual drug market approaching 100 billion USD. Yet, diabetes remains incurable. Diabetes is a multi-organ, multi-pathway disease, and pancreatic beta-cell failure is one of the main causes. The seven existing classes of anti-diabetic drugs are all unable to prevent beta-cell failure, leaving end-stage patients reliant solely on insulin injections.

Our company holds world-leading proprietary patents and technology to develop the protein disulfide isomerase (Pdia4) inhibitor, PS1, as a small-molecule novel drug for the treatment and reversal of diabetes. Pdia4 is mainly expressed in pancreatic beta-cells, and over-nutrition increases its expression, leading to elevated reactive oxygen species (ROS) within beta-cells, causing beta-cell failure and diabetes. The Pdia4 inhibitor, PS1, can reduce beta-cell ROS, effectively suppressing beta-cell failure to achieve the effect of reversing diabetes.

The two patents licensed by the Company have been approved by patent offices in multiple countries. This patent/technology originates from the extensive research of the Company's founder, Dr. Wen-Ching Yang. We have short, mid, and long-term plans for the clinical trials and regulatory approval (NDA) of PS1 for diabetes (refer to the Milestones section for details).

The product PS1 has completed preclinical trials, and Phase I clinical trials for type 2 diabetes are currently underway. Furthermore, the Company's new drug development strategy for PS1 prioritizes basic research to solve issues encountered during clinical trials. Dr. Wen-Ching Yang is an international pioneer in Pdia4 research, and this collaboration accelerates the clinical development of PS1. The success of PS1 will reduce patient suffering and mortality, vitalize the domestic new drug industry, and demonstrate international competitiveness.

◉ Milestones