Sanofi B.V. — China drug registrations and re-registration deadlines
12 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-02-04.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20181037 | Renvela 碳酸司维拉姆片 | 2027-08-04 | 2027-02-04 |
| 国药准字HJ20181038 | Renvela 碳酸司维拉姆片 | 2027-08-04 | 2027-02-04 |
| 国药准字HJ20200037 | Mozobil 普乐沙福注射液 | 2028-05-15 | 2027-11-15 |
| 国药准字HJ20140464 | Fludara 注射用磷酸氟达拉滨 | 2028-07-12 | 2028-01-12 |
| 国药准字HJ20140465 | Fludara 注射用磷酸氟达拉滨 | 2028-07-12 | 2028-01-12 |
| 国药准字SJ20140067 | Cerezyme 注射用伊米苷酶 | 2028-10-25 | 2028-04-25 |
| 国药准字SJ20190040 | Fabrazyme 注射用阿加糖酶β | 2029-04-24 | 2028-10-24 |
| 国药准字SJ20190041 | Fabrazyme 注射用阿加糖酶β | 2029-04-24 | 2028-10-24 |
| 国药准字SJ20150035 | Thymoglobuline 兔抗人胸腺细胞免疫球蛋白 | 2029-10-07 | 2029-04-07 |
| 国药准字SJ20150036 | Thymoglobuline 兔抗人胸腺细胞免疫球蛋白 | 2029-10-07 | 2029-04-07 |
| 国药准字SJ20200010 | Aldurazyme 注射用拉罗尼酶浓溶液 | 2029-11-14 | 2029-05-14 |
| 国药准字SJ20150049 | Myozyme 注射用阿糖苷酶α | 2030-05-13 | 2029-11-13 |
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 2026-06-28, 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.