Process Optimization for Malaria Therapy

Shin Poong Pharmaceutical is reducing manufacturing costs and improving access to Pyramax® (pyronaridine-artesunate), a WHO-recommended artemisinin-based combination therapy for uncomplicated malaria. Pyramax® plays a critical role in WHO’s Antimalarial Drug Resistance Strategy as an alternative to artemether-lumefantrine, which faces increasing resistance. The WHO strategy advocates for multiple first-line therapies to support treatment diversification and combat drug resistance. This project optimizes pyronaridine API manufacturing through process modification, supplier qualification, and GMP validation to reduce cost of goods. Activities include securing MFDS Drug Master File approval and EMA variation approval, conducting equivalence testing and stability studies, and performing preliminary technology transfer preparation for future African manufacturing partnerships, including partner screening, site audits, and technical feasibility assessments.