Roche Pharma (Schweiz) AG — China drug registrations and re-registration deadlines
33 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-01-06.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20171024 | Actemra 托珠单抗注射液 | 2027-07-06 | 2027-01-06 |
| 国药准字SJ20171025 | Actemra 托珠单抗注射液 | 2027-07-06 | 2027-01-06 |
| 国药准字SJ20171026 | Actemra 托珠单抗注射液 | 2027-07-06 | 2027-01-06 |
| 国药准字HJ20220068 | Rozlytrek 恩曲替尼胶囊 | 2027-07-25 | 2027-01-25 |
| 国药准字HJ20220069 | Rozlytrek 恩曲替尼胶囊 | 2027-07-25 | 2027-01-25 |
| 国药准字SJ20220017 | Trastuzumab Injection (Subcutaneous Injection) 曲妥珠单抗注射液（皮下注射） | 2027-09-29 | 2027-03-29 |
| 国药准字SJ20180003 | MIRCERA 甲氧聚二醇重组人促红素注射液 | 2028-01-09 | 2027-07-09 |
| 国药准字SJ20180005 | MIRCERA 甲氧聚二醇重组人促红素注射液 | 2028-01-09 | 2027-07-09 |
| 国药准字SJ20180006 | MIRCERA 甲氧聚二醇重组人促红素注射液 | 2028-01-09 | 2027-07-09 |
| 国药准字SJ20180007 | MIRCERA 甲氧聚二醇重组人促红素注射液 | 2028-01-09 | 2027-07-09 |
| 国药准字SJ20181016 | Herceptin 注射用曲妥珠单抗 | 2028-05-15 | 2027-11-15 |
| 国药准字SJ20181017 | Herceptin 注射用曲妥珠单抗 | 2028-05-15 | 2027-11-15 |
| 国药准字SJ20215003 | Herceptin 注射用曲妥珠单抗 | 2028-05-15 | 2027-11-15 |
| 国药准字SJ20180025 | HEMLIBRA 艾美赛珠单抗注射液 | 2028-08-23 | 2028-02-23 |
| 国药准字SJ20180027 | HEMLIBRA 艾美赛珠单抗注射液 | 2028-08-23 | 2028-02-23 |
| 国药准字SJ20180028 | HEMLIBRA 艾美赛珠单抗注射液 | 2028-08-23 | 2028-02-23 |
| 国药准字SJ20230017 | Columvi 格菲妥单抗注射液 | 2028-11-06 | 2028-05-06 |
| 国药准字SJ20255005 | Columvi 格菲妥单抗注射液 | 2028-11-06 | 2028-05-06 |
| 国药准字SJ20230018 | VABYSMO 法瑞西单抗注射液 | 2028-12-12 | 2028-06-12 |
| 国药准字SJ20240048 | Lunsumio 莫妥珠单抗注射液 | 2028-12-16 | 2028-06-16 |
| 国药准字SJ20240049 | Lunsumio 莫妥珠单抗注射液 | 2028-12-16 | 2028-06-16 |
| 国药准字HJ20230153 | Baloxavir Marboxil for Suspension 玛巴洛沙韦干混悬剂 | 2028-12-28 | 2028-06-28 |
| 国药准字SJ20240007 | Piasky 可伐利单抗注射液 | 2029-02-05 | 2028-08-05 |
| 国药准字SJ20240013 | Rituximab Injection (Subcutaneous Injection) 利妥昔单抗注射液（皮下注射） | 2029-04-01 | 2028-10-01 |
| 国药准字HJ20250026 | ITOVEBI 伊那利塞片 | 2030-03-10 | 2029-09-10 |
| 国药准字HJ20250027 | ITOVEBI 伊那利塞片 | 2030-03-10 | 2029-09-10 |
| 国药准字SJ20250013 | OCREVUS 奥瑞利珠单抗注射液 | 2030-03-24 | 2029-09-24 |
| 国药准字HJ20250103 | Risdiplam Tablets 利司扑兰片 | 2030-08-25 | 2030-02-25 |
| 国药准字SJ20250024 | Tecentriq 阿替利珠单抗注射液（皮下注射） | 2030-11-11 | 2030-05-11 |
| 国药准字HJ20210027 | Xofluza 玛巴洛沙韦片 | 2031-01-03 | 2030-07-03 |
| 国药准字HJ20210028 | Xofluza 玛巴洛沙韦片 | 2031-01-03 | 2030-07-03 |
| 国药准字SJ20210017 | Enspryng 萨特利珠单抗注射液 | 2031-02-27 | 2030-08-27 |
| 国药准字HJ20210045 | Evrysdi 利司扑兰口服溶液用散 | 2031-05-05 | 2030-11-05 |
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.