AstraZeneca AB — China drug registrations and re-registration deadlines
57 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-11-05.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20171297 | IRESSA 吉非替尼片 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20181042 | IRESSA 吉非替尼片 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20130378 | Oxis Turbuhaler 富马酸福莫特罗吸入粉雾剂 | 2027-12-27 | 2027-06-27 |
| 国药准字HJ20130379 | Oxis Turbuhaler 富马酸福莫特罗吸入粉雾剂 | 2027-12-27 | 2027-06-27 |
| 国药准字HJ20180048 | Olaparib Tablets 奥拉帕利片 | 2028-03-19 | 2027-09-19 |
| 国药准字HJ20180049 | Olaparib Tablets 奥拉帕利片 | 2028-03-19 | 2027-09-19 |
| 国药准字HJ20233138 | CALQUENCE 阿可替尼胶囊 | 2028-03-20 | 2027-09-20 |
| 国药准字HJ20140821 | BYETTA 艾塞那肽注射液 | 2028-06-13 | 2027-12-13 |
| 国药准字HJ20140822 | BYETTA 艾塞那肽注射液 | 2028-06-13 | 2027-12-13 |
| 国药准字HJ20140108 | Bricanyl 硫酸特布他林吸入溶液 | 2028-06-15 | 2027-12-15 |
| 国药准字HJ20230076 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅱ) 达格列净二甲双胍缓释片（Ⅱ） | 2028-06-20 | 2027-12-20 |
| 国药准字HJ20230077 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) 达格列净二甲双胍缓释片（Ⅰ） | 2028-06-20 | 2027-12-20 |
| 国药准字HJ20230078 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅲ) 达格列净二甲双胍缓释片（Ⅲ） | 2028-06-20 | 2027-12-20 |
| 国药准字HJ20230079 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅳ) 达格列净二甲双胍缓释片（Ⅳ） | 2028-06-20 | 2027-12-20 |
| 国药准字HJ20230080 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) 达格列净二甲双胍缓释片（Ⅰ） | 2028-06-20 | 2027-12-20 |
| 国药准字HJ20171199 | Faslodex 氟维司群注射液 | 2028-12-10 | 2028-06-10 |
| 国药准字HJ20140776 | Betaloc ZOK 琥珀酸美托洛尔缓释片 | 2028-12-19 | 2028-06-19 |
| 国药准字HJ20140777 | Betaloc ZOK 琥珀酸美托洛尔缓释片 | 2028-12-19 | 2028-06-19 |
| 国药准字HJ20140778 | Betaloc ZOK 琥珀酸美托洛尔缓释片 | 2028-12-19 | 2028-06-19 |
| 国药准字HJ20140779 | Betaloc ZOK 琥珀酸美托洛尔缓释片 | 2028-12-19 | 2028-06-19 |
| 国药准字HJ20140780 | Betaloc ZOK 琥珀酸美托洛尔缓释片 | 2028-12-19 | 2028-06-19 |
| 国药准字HJ20140807 | Betaloc ZOK 琥珀酸美托洛尔缓释片 | 2028-12-19 | 2028-06-19 |
| 国药准字HJ20140457 | Symbicort Turbuhaler 布地奈德福莫特罗吸入粉雾剂（II） | 2029-02-22 | 2028-08-22 |
| 国药准字HJ20140458 | Symbicort Turbuhaler 布地奈德福莫特罗吸入粉雾剂（II） | 2029-02-22 | 2028-08-22 |
| 国药准字HJ20140459 | Symbicort Turbuhaler 布地奈德福莫特罗吸入粉雾剂（I） | 2029-02-22 | 2028-08-22 |
| 国药准字HJ20190072 | Lokelma 环硅酸锆钠散 | 2029-05-30 | 2028-11-30 |
| 国药准字HJ20190073 | Lokelma 环硅酸锆钠散 | 2029-05-30 | 2028-11-30 |
| 国药准字SJ20240040 | Fasenra 本瑞利珠单抗注射液 | 2029-08-12 | 2029-02-12 |
| 国药准字HJ20190063 | Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol 布地格福吸入气雾剂 | 2029-09-01 | 2029-03-01 |
| 国药准字HJ20200012 | Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol 格隆溴铵福莫特罗吸入气雾剂 | 2029-12-12 | 2029-06-12 |
| 国药准字HJ20200038 | Ticagrelor Dispersible Tablets 替格瑞洛分散片 | 2030-01-25 | 2029-07-25 |
| 国药准字SJ20250007 | Fasenra 本瑞利珠单抗注射液 | 2030-03-03 | 2029-09-03 |
| 国药准字HJ20160085 | Onglyza 沙格列汀片 | 2030-04-01 | 2029-10-01 |
| 国药准字HJ20160086 | Onglyza 沙格列汀片 | 2030-04-01 | 2029-10-01 |
| 国药准字HJ20160087 | Onglyza 沙格列汀片 | 2030-04-01 | 2029-10-01 |
| 国药准字HJ20160088 | Onglyza 沙格列汀片 | 2030-04-01 | 2029-10-01 |
| 国药准字HJ20160089 | Onglyza 沙格列汀片 | 2030-04-01 | 2029-10-01 |
| 国药准字HJ20160090 | Onglyza 沙格列汀片 | 2030-04-01 | 2029-10-01 |
| 国药准字HJ20160447 | Budesonide and Formoterol Fumarate Powder for Inhalation（II） 布地奈德福莫特罗吸入粉雾剂(II) | 2030-08-21 | 2030-02-21 |
| 国药准字HJ20250151 | WAINUA 依普隆特生钠注射液 | 2030-12-21 | 2030-06-21 |
| 国药准字HJ20170166 | TAGRISSO 甲磺酸奥希替尼片 | 2031-02-05 | 2030-08-05 |
| 国药准字HJ20170167 | TAGRISSO 甲磺酸奥希替尼片 | 2031-02-05 | 2030-08-05 |
| 国药准字HJ20181062 | TAGRISSO 甲磺酸奥希替尼片 | 2031-02-10 | 2030-08-10 |
| 国药准字HJ20181063 | TAGRISSO 甲磺酸奥希替尼片 | 2031-02-10 | 2030-08-10 |
| 国药准字SJ20260021 | TEZSPIRE 特泽利尤单抗注射液 | 2031-03-24 | 2030-09-24 |
| 国药准字SJ20260022 | TEZSPIRE 特泽利尤单抗注射液 | 2031-03-24 | 2030-09-24 |
| 国药准字SJ20260025 | IMJUDO 曲麦利尤单抗注射液 | 2031-04-06 | 2030-10-06 |
| 国药准字SJ20260026 | IMJUDO 曲麦利尤单抗注射液 | 2031-04-06 | 2030-10-06 |
| 国药准字HJ20170251 | KOMBIGLYZE XR 沙格列汀二甲双胍缓释片（Ⅰ） | 2031-05-20 | 2030-11-20 |
| 国药准字HJ20170252 | KOMBIGLYZE XR 沙格列汀二甲双胍缓释片（Ⅰ） | 2031-05-20 | 2030-11-20 |
| 国药准字HJ20170253 | KOMBIGLYZE XR 沙格列汀二甲双胍缓释片（Ⅱ） | 2031-05-20 | 2030-11-20 |
| 国药准字HJ20170254 | KOMBIGLYZE XR 沙格列汀二甲双胍缓释片（Ⅱ） | 2031-05-20 | 2030-11-20 |
| 国药准字HJ20170255 | KOMBIGLYZE XR 沙格列汀二甲双胍缓释片（Ⅲ） | 2031-05-20 | 2030-11-20 |
| 国药准字HJ20170256 | KOMBIGLYZE XR 沙格列汀二甲双胍缓释片（Ⅲ） | 2031-05-20 | 2030-11-20 |
| 国药准字HJ20171049 | KOMBIGLYZE XR 沙格列汀二甲双胍缓释片（Ⅰ） | 2031-05-20 | 2030-11-20 |
| 国药准字HJ20171050 | KOMBIGLYZE XR 沙格列汀二甲双胍缓释片（Ⅱ） | 2031-05-20 | 2030-11-20 |
| 国药准字HJ20171051 | KOMBIGLYZE XR 沙格列汀二甲双胍缓释片（Ⅲ） | 2031-05-20 | 2030-11-20 |
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.