Kyowa Kirin Co., Ltd. — China drug registrations and re-registration deadlines
14 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-02-09.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20171033 | GRAN 人粒细胞刺激因子注射液 | 2027-08-09 | 2027-02-09 |
| 国药准字SJ20171035 | GRAN 人粒细胞刺激因子注射液 | 2027-08-09 | 2027-02-09 |
| 国药准字SJ20171037 | GRAN 人粒细胞刺激因子注射液 | 2027-08-09 | 2027-02-09 |
| 国药准字SJ20220018 | Poteligeo 莫格利珠单抗注射液 | 2027-10-10 | 2027-04-10 |
| 国药准字SJ20171016 | ESPO 人促红素注射液 | 2028-05-16 | 2027-11-16 |
| 国药准字SJ20171018 | ESPO 人促红素注射液 | 2028-05-16 | 2027-11-16 |
| 国药准字HJ20140508 | REGPARA 盐酸西那卡塞片 | 2029-03-17 | 2028-09-17 |
| 国药准字HJ20140509 | REGPARA 盐酸西那卡塞片 | 2029-03-17 | 2028-09-17 |
| 国药准字HJ20240034 | ORKEDIA 依伏卡塞片 | 2029-06-03 | 2028-12-03 |
| 国药准字HJ20240035 | ORKEDIA 依伏卡塞片 | 2029-06-03 | 2028-12-03 |
| 国药准字SJ20200014 | NESP 达依泊汀α注射液 | 2030-09-24 | 2030-03-24 |
| 国药准字SJ20210001 | Crysvita 布罗索尤单抗注射液 | 2030-12-21 | 2030-06-21 |
| 国药准字SJ20210002 | Crysvita 布罗索尤单抗注射液 | 2030-12-21 | 2030-06-21 |
| 国药准字SJ20210003 | Crysvita 布罗索尤单抗注射液 | 2030-12-21 | 2030-06-21 |
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.