UCB Pharma S.A. — China registrations and re-registration filing lines
10 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2026-10-19.
| Approval number | Product | Certificate expires | Filing line (Art. 82) |
|---|---|---|---|
| 国药准字HJ20170341 | Keppra 左乙拉西坦注射用浓溶液 | 2027-04-19 | 2026-10-19 |
| 国药准字HJ20180026 | Neupro 罗替高汀贴片 | 2028-07-12 | 2028-01-12 |
| 国药准字HJ20180027 | Neupro 罗替高汀贴片 | 2028-07-12 | 2028-01-12 |
| 国药准字HJ20180028 | Neupro 罗替高汀贴片 | 2028-07-12 | 2028-01-12 |
| 国药准字HJ20180029 | Neupro 罗替高汀贴片 | 2028-07-12 | 2028-01-12 |
| 国药准字SJ20240030 | BIMZELX 比奇珠单抗注射液 | 2029-07-15 | 2029-01-15 |
| 国药准字SJ20250012 | RYSTIGGO 罗泽利昔珠单抗注射液 | 2030-03-24 | 2029-09-24 |
| 国药准字HJ20250117 | ZILBRYSQ 泽卢克布仑钠注射液 | 2030-09-29 | 2030-03-29 |
| 国药准字HJ20250118 | ZILBRYSQ 泽卢克布仑钠注射液 | 2030-09-29 | 2030-03-29 |
| 国药准字HJ20250119 | ZILBRYSQ 泽卢克布仑钠注射液 | 2030-09-29 | 2030-03-29 |
Under the Provisions for Drug Registration (药品注册管理办法) Art. 82, an application to renew an overseas-manufactured drug registration is filed with the Center for Drug Evaluation no later than 6 months before the certificate expires; the filing line column is that arithmetic applied to the expiry cell. Art. 84(1): a certificate with no application by expiry is not re-registered and is cancelled at expiry. Every figure is taken from the public NMPA database as of 2026-06-28, or computed from it. Registration data changes; the NMPA portal governs. This page states no view on whether any of these products' Domestic Responsible Person (境内责任人) arrangements meet NMPA Announcement No. 137 — that cannot be determined from a public entry.