Amgen Inc. — 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: 2027-06-27.
| Approval number | Product | Certificate expires | Filing line (Art. 82) |
|---|---|---|---|
| 国药准字SJ20180021 | REPATHA 依洛尤单抗注射液 | 2027-12-27 | 2027-06-27 |
| 国药准字SJ20180022 | REPATHA 依洛尤单抗注射液 | 2027-12-27 | 2027-06-27 |
| 国药准字SJ20260027 | IMDELLTRA 注射用塔拉妥单抗 | 2028-04-06 | 2027-10-06 |
| 国药准字SJ20260028 | IMDELLTRA 注射用塔拉妥单抗 | 2028-04-06 | 2027-10-06 |
| 国药准字SJ20190025 | XGEVA 地舒单抗注射液 | 2029-05-08 | 2028-11-08 |
| 国药准字SJ20200026 | BLINCYTO 注射用贝林妥欧单抗 | 2030-05-05 | 2029-11-05 |
| 国药准字SJ20250027 | Evenity 罗莫索珠单抗注射液 | 2030-12-15 | 2030-06-15 |
| 国药准字HJ20210065 | OTEZLA 阿普米司特片 | 2031-04-27 | 2030-10-27 |
| 国药准字HJ20210066 | OTEZLA 阿普米司特片 | 2031-04-27 | 2030-10-27 |
| 国药准字HJ20210067 | OTEZLA 阿普米司特片 | 2031-04-27 | 2030-10-27 |
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.