Good News | Hybio Pharmaceutical Receives U.S. FDA Approval for Glatiramer

February 11, 2026 — Hybio Pharmaceutical Co., Ltd. announced today that its self-developed Glatiramer Acetate Injection has received marketing approval from the U.S. Food and Drug Administration (FDA)for the treatment of multiple sclerosis (MS). This approval marks another successful entry of a high-complexity peptide product into the U.S. market following the company’s approval of Liraglutide Injection. It represents a further milestone in Hybio’s global expansion strategy for complex peptide therapeutics.

Glatiramer acetate is a synthetic polypeptide therapy and is widely recognized as a first-line treatment for multiple sclerosis. It is believed to exert its therapeutic effect by mimicking myelin basic protein and modulating abnormal immune responses, thereby reducing immune-mediated damage to myelin in the central nervous system. The product is indicated for patients with clinically isolated syndrome (CIS) and relapsing-remitting multiple sclerosis (RRMS), and has been shown to reduce relapse rates and slow disease progression.

According to publicly available market data, global sales of glatiramer acetate reached approximately USD 1.38 billion in 2024. As a complex generic product with significant technical and regulatory barriers, this FDA approval underscores Hybio’s capabilities in Peptide Drug development, advanced manufacturing, and robust quality systems.

Multiple sclerosis is a chronic autoimmune disease affecting the central nervous system and primarily impacts young and middle-aged adults. An estimated 2.8 million people worldwide are living with MS. The disease is characterized by symptoms such as blurred vision, sensory disturbances, and motor impairment, often leading to long-term disability and substantial healthcare burden.

This approval establishes an additional and sustainable revenue stream for the company and further strengthens its foundation for the global development and commercialization of other key peptide products, including Semaglutide and Tirzepatide.

From Liraglutide to Glatiramer Acetate, Hybio continues to demonstrate its ability to successfully develop and commercialize high-complexity peptide generics in regulated markets, reinforcing its long-term growth strategy in the global peptide therapeutics sector.