By Fineline Cube 
UCB S.A. (EBR: UCB), a global biopharmaceutical company, announced today that the National Medical Products Administration (NMPA) has approved the marketing authorization for Zilucoplan (brand name: Zilbrysq) in combination with standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti‑acetylcholine receptor (AChR) antibody positive.
Key Highlights
| Item | Detail |
|---|---|
| Company | UCB S.A. |
| Product | Zilucoplan (Zilbrysq) |
| Regulatory Body | China NMPA |
| Indication | Adult gMG, AChR‑positive |
| Administration | Once‑daily, subcutaneous, self‑administered |
| Unique Feature | First home‑administered C5 inhibitor for gMG |
What Is Zilucoplan?
Zilucoplan is a once‑daily, self‑administered, subcutaneous peptide inhibitor that targets complement component 5 (C5). It is the only self‑administered targeted C5 inhibitor therapy for gMG, preventing complement‑mediated damage at the neuromuscular junction. Patients can complete the injection at home in just 5‑8 seconds, offering a convenient and effective addition to standard gMG treatment regimens.
Market Impact in China
- Expanded Access – The NMPA approval provides Chinese patients with a novel, at‑home therapy that can improve disease control and quality of life.
- Competitive Edge – Zilucoplan’s unique administration route differentiates it from existing intravenous C5 inhibitors.
- Strategic Growth – The approval supports UCB’s broader strategy to strengthen its presence in the rapidly growing Chinese biopharma market.
About UCB S.A.
UCB is a global biopharmaceutical company focused on developing innovative therapies for central nervous system, rare diseases, and immunology. The company’s portfolio includes a range of monoclonal antibodies, peptides, and small molecules designed to address unmet medical needs worldwide.
Forward‑Looking Statements
This release contains forward‑looking statements regarding regulatory approvals, commercialization plans, and market potential. These statements are based on current expectations and are subject to risks, uncertainties, and changes in market conditions.-Fineline Info & Tech