Bristol-Myers Squibb Company — China drug registrations and re-registration deadlines
6 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2028-11-07.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20240018 | AUGTYRO 瑞普替尼胶囊 | 2029-05-07 | 2028-11-07 |
| 国药准字SJ20200001 | Orencia 阿巴西普注射液 | 2029-11-26 | 2029-05-26 |
| 国药准字HJ20250153 | Xanomeline Tartrate and Trospium Chloride Capsules (Ⅰ) 呫诺美林曲司氯铵胶囊(I) | 2030-12-21 | 2030-06-21 |
| 国药准字HJ20250154 | Xanomeline Tartrate and Trospium Chloride Capsules (Ⅱ) 呫诺美林曲司氯铵胶囊(II) | 2030-12-21 | 2030-06-21 |
| 国药准字HJ20250155 | Xanomeline Tartrate and Trospium Chloride Capsules (Ⅲ) 呫诺美林曲司氯铵胶囊(III) | 2030-12-21 | 2030-06-21 |
| 国药准字HJ20250160 | AUGTYRO 瑞普替尼胶囊 | 2030-12-29 | 2030-06-29 |
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.