ST Pharm Signs Agreement with International Nonprofit Orphan Disease Drug Development Foundation for Process Technology Development

Optimization Development of Process for Visceral Leishmaniasis (VL) Candidate Substance

[Asia Economy Reporter Lee Gwan-joo] ST Pharm announced on the 27th that it has signed an agreement with the Switzerland-based international non-profit neglected disease drug development foundation (DNDi) to optimize the pre-commercialization process of a visceral leishmaniasis (VL) candidate substance.

Established in 2003, DNDi is a non-profit organization jointly founded by five major international research institutions including M?decins Sans Fronti?res (MSF) and the World Health Organization (WHO). It develops treatments for neglected diseases that global pharmaceutical companies are reluctant to develop due to low commercial viability. However, the current manufacturing process results in high production costs, making it difficult for low- and middle-income neglected patients to afford treatment costs, thus requiring cost reduction through process technology optimization before commercialization.

DNDi was selected as a research funding recipient by the Global Health Technology Research Fund (Light Fund), a Korean foundation supporting international health research, and is promoting process optimization research with ST Pharm. ST Pharm is responsible for optimizing the process of the drug currently undergoing global Phase 1 clinical trials, developing process technologies that reduce the number of steps and apply alternative processes to enable more cost-effective production. Additionally, ST Pharm plans to apply its innovative environmentally friendly CFT (Continuous Flow Technology) to improve yield, enhance purity, and minimize production waste. If the process optimization succeeds, both companies plan to develop additional process technologies and proceed with sample production for Phase 3 clinical trials.

Visceral leishmaniasis, transmitted by sandfly bites, attacks internal organs such as the liver and spleen, causing acute anemia and leukemia, and is a fatal parasitic infection disease that can lead to death if not treated early. Approximately 600 million people in East Africa, India, and Latin America are exposed to the risk of visceral leishmaniasis infection, with 50,000 to 90,000 infections annually, but existing drugs have drawbacks in terms of safety and cost.

Choi Jun-young, head of ST Pharm’s synthesis research center, said, “We are very pleased with this agreement with DNDi as ST Pharm’s innovative technology can provide hope to impoverished patients, especially children, in low- and middle-income countries who cannot access treatments.” Dr. Stephen Robinson, Director of Pharmaceutical Development at DNDi, said, “We will optimize the manufacturing process by applying ST Pharm’s advanced technology and chemical process expertise to create future treatments that can be supplied affordably to millions of people at risk worldwide. We are very pleased to start this partnership in Korea.”

This content was produced with the assistance of AI translation services.