Astellas Pharma Europe B.V. — China drug registrations and re-registration deadlines
13 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-09-14.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20171298 | BETMIGA 米拉贝隆缓释片 | 2027-03-14 | 2026-09-14 |
| 国药准字HJ20171299 | BETMIGA 米拉贝隆缓释片 | 2027-03-14 | 2026-09-14 |
| 国药准字HJ20171305 | BETMIGA 米拉贝隆缓释片 | 2027-03-14 | 2026-09-14 |
| 国药准字HJ20171306 | BETMIGA 米拉贝隆缓释片 | 2027-03-14 | 2026-09-14 |
| 国药准字HJ20140209 | Vesicare 琥珀酸索利那新片 | 2028-05-28 | 2027-11-28 |
| 国药准字HJ20200043 | XTANDI 恩扎卢胺软胶囊 | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20150029 | Tacrolimus Sustained-release Capsules 他克莫司缓释胶囊 | 2029-07-09 | 2029-01-09 |
| 国药准字HJ20150031 | Tacrolimus Sustained-release Capsules 他克莫司缓释胶囊 | 2029-07-09 | 2029-01-09 |
| 国药准字SJ20240034 | PADCEV 注射用维恩妥尤单抗 | 2029-08-12 | 2029-02-12 |
| 国药准字SJ20240035 | PADCEV 注射用维恩妥尤单抗 | 2029-08-12 | 2029-02-12 |
| 国药准字SJ20240050 | VYLOY 注射用佐妥昔单抗 | 2029-12-24 | 2029-06-24 |
| 国药准字HJ20200033 | Tacrolimus Granules 他克莫司颗粒 | 2030-02-06 | 2029-08-06 |
| 国药准字HJ20200034 | Tacrolimus Granules 他克莫司颗粒 | 2030-02-06 | 2029-08-06 |
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.