TAIPEI (TVBS News) — ScinoPharm Taiwan (台灣神隆, TWSE: 1789), a Taiwan-based pharmaceutical company, announced on Monday (Jan. 5) that it secured U.S. FDA approval for Glatiramer Acetate Injection, becoming the first company in Taiwan to reach this milestone. The drug treats Multiple Sclerosis (MS), a central nervous system autoimmune disease affecting approximately 2.9 million people worldwide, with nearly 1 million affected in the U.S., according to the U.S. National MS Society. The company plans to begin sales in the second quarter of 2026 in collaboration with its U.S. sales partner.
Market reports indicate that Glatiramer Acetate's global market value reached US$1.5 billion (around NT$47 billion) in 2024 and is projected to grow to US$2.8 billion (around NT$87.6 billion) by 2033. ScinoPharm Taiwan has invested in process development and manufacturing capabilities for MS treatment, achieving breakthroughs in high-threshold processes to enter the U.S. market. Since its approval in 1996, Glatiramer Acetate has been considered one of the most challenging generic drugs globally, with the FDA establishing a review pathway for such non-biological complex drugs.
Multiple Sclerosis can cause disability, walking difficulties, and vision impairment, with relapsing-remitting MS being the most common form affecting approximately 85% of newly diagnosed patients. Glatiramer Acetate helps reduce abnormal immune attacks on the brain and spinal cord nerves, significantly lowering relapse frequency, slowing disease progression, and improving brain MRI lesions. ScinoPharm Taiwan highlighted its integrated advantages in research, manufacturing, and analysis that enabled the successful acquisition of the U.S. drug license for this complex medication.
ScinoPharm Taiwan emphasized that this achievement validates its capability to compete with internationally renowned pharmaceutical companies in the billion-dollar drug market. The approval injects momentum for future global expansion and growth for the Taiwan-based company in the competitive pharmaceutical industry. The company plans to continue advancing strategic collaborations in Europe, Asia, and emerging markets to expand its international market footprint beyond the U.S. approval. ◼ (At time of reporting, US$1 equals approximately NT$31.3)