LEO Pharma A/S — China drug registrations and re-registration deadlines
13 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-09-10. Earliest re-registration deadline: 2027-06-12.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20220020 | Spevigo 佩索利单抗注射液 | 2027-12-12 | 2027-06-12 |
| 国药准字HJ20160204 | Calcipotriol and Betamethasone Ointment 卡泊三醇倍他米松软膏 | 2028-07-03 | 2028-01-03 |
| 国药准字HJ20130921 | Fucidin 夫西地酸乳膏 | 2028-07-31 | 2028-01-31 |
| 国药准字HJ20130928 | Fucidin 夫西地酸乳膏 | 2028-07-31 | 2028-01-31 |
| 国药准字SJ20240012 | Spesolimab Injection (Subcutaneous Injection) 佩索利单抗注射液（皮下注射） | 2029-03-04 | 2028-09-04 |
| 国药准字HJ20150372 | Xamiol 卡泊三醇倍他米松凝胶 | 2029-11-19 | 2029-05-19 |
| 国药准字HJ20150687 | Xamiol 卡泊三醇倍他米松凝胶 | 2029-11-19 | 2029-05-19 |
| 国药准字HJ20150664 | Daivonex 卡泊三醇搽剂 | 2030-07-03 | 2030-01-03 |
| 国药准字HJ20160069 | Daivonex 卡泊三醇软膏 | 2030-10-21 | 2030-04-21 |
| 国药准字HJ20160070 | Daivonex 卡泊三醇软膏 | 2030-10-21 | 2030-04-21 |
| 国药准字HJ20181015 | Protopic 他克莫司软膏 | 2031-01-14 | 2030-07-14 |
| 国药准字HJ20181016 | Protopic 他克莫司软膏 | 2031-01-14 | 2030-07-14 |
| 国药准字HJ20260033 | Calcipotriol and Betamethasone Foam 卡泊三醇倍他米松泡沫剂 | 2031-04-13 | 2030-10-13 |
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 2026-09-10, 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.