Daiichi Sankyo Europe GmbH — China drug registrations and re-registration deadlines
7 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-08-20.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20230005 | Enhertu 注射用德曲妥珠单抗 | 2028-02-20 | 2027-08-20 |
| 国药准字HJ20180097 | LIXIANA 甲苯磺酸艾多沙班片 | 2028-09-05 | 2028-03-05 |
| 国药准字HJ20180098 | LIXIANA 甲苯磺酸艾多沙班片 | 2028-09-05 | 2028-03-05 |
| 国药准字HJ20180099 | LIXIANA 甲苯磺酸艾多沙班片 | 2028-09-05 | 2028-03-05 |
| 国药准字SJ20250021 | Datroway 注射用德达博妥单抗 | 2030-08-18 | 2030-02-18 |
| 国药准字HJ20260056 | VANFLYTA 盐酸奎扎替尼片 | 2031-06-09 | 2030-12-09 |
| 国药准字HJ20260057 | VANFLYTA 盐酸奎扎替尼片 | 2031-06-09 | 2030-12-09 |
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.