Sanofi Winthrop Industrie — China drug registrations and re-registration deadlines
52 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-09-20.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20171182 | APROVEL 厄贝沙坦片 | 2027-03-20 | 2026-09-20 |
| 国药准字HJ20171184 | APROVEL 厄贝沙坦片 | 2027-03-20 | 2026-09-20 |
| 国药准字HJ20171185 | APROVEL 厄贝沙坦片 | 2027-03-20 | 2026-09-20 |
| 国药准字HJ20171186 | APROVEL 厄贝沙坦片 | 2027-03-20 | 2026-09-20 |
| 国药准字HJ20171187 | APROVEL 厄贝沙坦片 | 2027-03-20 | 2026-09-20 |
| 国药准字HJ20171237 | Plavix 硫酸氢氯吡格雷片 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20171238 | Plavix 硫酸氢氯吡格雷片 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20181237 | Stilnox 酒石酸唑吡坦片 | 2027-08-30 | 2027-02-28 |
| 国药准字HJ20181238 | Stilnox 酒石酸唑吡坦片 | 2027-08-30 | 2027-02-28 |
| 国药准字HJ20225004 | Cordarone 盐酸胺碘酮注射液 | 2027-11-14 | 2027-05-14 |
| 国药准字HJ20225005 | Cordarone 盐酸胺碘酮注射液 | 2027-11-14 | 2027-05-14 |
| 国药准字SJ20230002 | Insulin Glargine and Lixisenatide Injection(Ⅱ) 甘精胰岛素利司那肽注射液(Ⅱ) | 2028-01-09 | 2027-07-09 |
| 国药准字HJ20140194 | COAPROVEL 厄贝沙坦氢氯噻嗪片 | 2028-01-11 | 2027-07-11 |
| 国药准字HJ20140195 | COAPROVEL 厄贝沙坦氢氯噻嗪片 | 2028-01-11 | 2027-07-11 |
| 国药准字HJ20140196 | COAPROVEL 厄贝沙坦氢氯噻嗪片 | 2028-01-11 | 2027-07-11 |
| 国药准字HJ20140197 | COAPROVEL 厄贝沙坦氢氯噻嗪片 | 2028-01-11 | 2027-07-11 |
| 国药准字HJ20171121 | Solian 氨磺必利片 | 2028-01-27 | 2027-07-27 |
| 国药准字HJ20171122 | Solian 氨磺必利片 | 2028-01-27 | 2027-07-27 |
| 国药准字HJ20140085 | TAXOTERE 多西他赛注射液 | 2028-03-28 | 2027-09-28 |
| 国药准字HJ20140086 | TAXOTERE 多西他赛注射液 | 2028-03-28 | 2027-09-28 |
| 国药准字HJ20170035 | Xatral XL 盐酸阿夫唑嗪缓释片 | 2028-04-10 | 2027-10-10 |
| 国药准字HJ20170036 | Xatral XL 盐酸阿夫唑嗪缓释片 | 2028-04-10 | 2027-10-10 |
| 国药准字SJ20180024 | Fasturtec 注射用拉布立海 | 2028-04-12 | 2027-10-12 |
| 国药准字SJ20181018 | Fasturtec 注射用拉布立海 | 2028-04-12 | 2027-10-12 |
| 国药准字HJ20140172 | Rilutek 利鲁唑片 | 2028-08-28 | 2028-02-28 |
| 国药准字HJ20140173 | Rilutek 利鲁唑片 | 2028-08-28 | 2028-02-28 |
| 国药准字HJ20170183 | Imovane 佐匹克隆片 | 2028-12-10 | 2028-06-10 |
| 国药准字HJ20171064 | Eloxatin 注射用奥沙利铂 | 2028-12-10 | 2028-06-10 |
| 国药准字HJ20171065 | Eloxatin 注射用奥沙利铂 | 2028-12-10 | 2028-06-10 |
| 国药准字SJ20230021 | Beyfortus 尼塞韦单抗注射液 | 2028-12-25 | 2028-06-25 |
| 国药准字SJ20230022 | Beyfortus 尼塞韦单抗注射液 | 2028-12-25 | 2028-06-25 |
| 国药准字SJ20190042 | Praluent 阿利西尤单抗注射液 | 2029-05-28 | 2028-11-28 |
| 国药准字SJ20190043 | Praluent 阿利西尤单抗注射液 | 2029-05-28 | 2028-11-28 |
| 国药准字HJ20170268 | Clexane 依诺肝素钠注射液 | 2029-05-29 | 2028-11-29 |
| 国药准字HJ20170269 | Clexane 依诺肝素钠注射液 | 2029-05-29 | 2028-11-29 |
| 国药准字HJ20170270 | Clexane 依诺肝素钠注射液 | 2029-05-29 | 2028-11-29 |
| 国药准字HJ20170271 | Clexane 依诺肝素钠注射液 | 2029-05-29 | 2028-11-29 |
| 国药准字HJ20170272 | Clexane 依诺肝素钠注射液 | 2029-05-29 | 2028-11-29 |
| 国药准字HJ20170273 | Clexane 依诺肝素钠注射液 | 2029-05-29 | 2028-11-29 |
| 国药准字HJ20170274 | Clexane 依诺肝素钠注射液 | 2029-05-29 | 2028-11-29 |
| 国药准字HJ20150256 | Plavix 硫酸氢氯吡格雷片 | 2029-12-12 | 2029-06-12 |
| 国药准字HJ20150257 | Plavix 硫酸氢氯吡格雷片 | 2029-12-12 | 2029-06-12 |
| 国药准字HJ20150258 | Plavix 硫酸氢氯吡格雷片 | 2029-12-12 | 2029-06-12 |
| 国药准字SJ20250001 | SARCLISA 艾沙妥昔单抗注射液 | 2030-01-07 | 2029-07-07 |
| 国药准字SJ20250002 | SARCLISA 艾沙妥昔单抗注射液 | 2030-01-07 | 2029-07-07 |
| 国药准字SJ20150033 | PENTAXIM 吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗 | 2030-01-08 | 2029-07-08 |
| 国药准字SJ20150034 | PENTAXIM 吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗 | 2030-01-08 | 2029-07-08 |
| 国药准字SJ20200017 | Dupixent 度普利尤单抗注射液 | 2030-01-23 | 2029-07-23 |
| 国药准字SJ20235004 | Dupixent 度普利尤单抗注射液 | 2030-01-23 | 2029-07-23 |
| 国药准字HJ20181050 | Cordarone 盐酸胺碘酮片 | 2030-02-25 | 2029-08-25 |
| 国药准字HJ20181243 | Cordarone 盐酸胺碘酮片 | 2030-02-25 | 2029-08-25 |
| 国药准字SJ20210024 | Dupixent 度普利尤单抗注射液 | 2031-01-29 | 2030-07-29 |
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.