Boehringer Ingelheim International GmbH — China drug registrations and re-registration deadlines
45 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HJ20170354 | Ofev 乙磺酸尼达尼布软胶囊 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20170355 | Ofev 乙磺酸尼达尼布软胶囊 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20170353 | Twynsta 替米沙坦氨氯地平片 | 2027-05-22 | 2026-11-22 |
| 国药准字SJ20220020 | Spevigo 佩索利单抗注射液 | 2027-12-12 | 2027-06-12 |
| 国药准字SJ20180012 | Praxbind 依达赛珠单抗注射液 | 2027-12-21 | 2027-06-21 |
| 国药准字HJ20180037 | Spiolto 噻托溴铵奥达特罗吸入喷雾剂 | 2028-03-28 | 2027-09-28 |
| 国药准字HJ20171206 | Telmisartan and Hydrochlorothiazide Tablets 替米沙坦氢氯噻嗪片 | 2029-01-23 | 2028-07-23 |
| 国药准字HJ20171207 | Telmisartan and Hydrochlorothiazide Tablets 替米沙坦氢氯噻嗪片 | 2029-01-23 | 2028-07-23 |
| 国药准字HJ20171208 | Telmisartan and Hydrochlorothiazide Tablets 替米沙坦氢氯噻嗪片 | 2029-01-23 | 2028-07-23 |
| 国药准字SJ20240012 | Spesolimab Injection (Subcutaneous Injection) 佩索利单抗注射液（皮下注射） | 2029-03-04 | 2028-09-04 |
| 国药准字HJ20140933 | Spiriva 噻托溴铵吸入粉雾剂 | 2029-05-12 | 2028-11-12 |
| 国药准字HJ20140954 | Spiriva 噻托溴铵吸入粉雾剂 | 2029-05-12 | 2028-11-12 |
| 国药准字HJ20140579 | Sifrol 盐酸普拉克索缓释片 | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20140580 | Sifrol 盐酸普拉克索缓释片 | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20140581 | Sifrol 盐酸普拉克索缓释片 | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20140582 | Sifrol 盐酸普拉克索缓释片 | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20140583 | Sifrol 盐酸普拉克索缓释片 | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20140584 | Sifrol 盐酸普拉克索缓释片 | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20150024 | Sifrol 盐酸普拉克索缓释片 | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20160526 | Sifrol 盐酸普拉克索缓释片 | 2029-05-21 | 2028-11-21 |
| 国药准字HJ20140916 | Sifrol 盐酸普拉克索片 | 2029-08-14 | 2029-02-14 |
| 国药准字HJ20140917 | Sifrol 盐酸普拉克索片 | 2029-08-14 | 2029-02-14 |
| 国药准字HJ20140918 | Sifrol 盐酸普拉克索片 | 2029-08-14 | 2029-02-14 |
| 国药准字HJ20181121 | Sifrol 盐酸普拉克索片 | 2029-08-14 | 2029-02-14 |
| 国药准字SJ20250017 | Metalyse 注射用替奈普酶 | 2030-05-12 | 2029-11-12 |
| 国药准字HJ20250104 | Hernexeos 宗艾替尼片 | 2030-05-18 | 2029-11-18 |
| 国药准字HJ20160226 | Tiotropium Bromide Inhalation Spray 噻托溴铵吸入喷雾剂 | 2030-06-11 | 2029-12-11 |
| 国药准字HJ20160227 | Tiotropium Bromide Inhalation Spray 噻托溴铵吸入喷雾剂 | 2030-06-11 | 2029-12-11 |
| 国药准字HJ20250125 | Jascayd 那米司特片 | 2030-10-20 | 2030-04-20 |
| 国药准字HJ20250126 | Jascayd 那米司特片 | 2030-10-20 | 2030-04-20 |
| 国药准字HJ20170066 | GIOTRIF 马来酸阿法替尼片 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170067 | GIOTRIF 马来酸阿法替尼片 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170068 | GIOTRIF 马来酸阿法替尼片 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170069 | GIOTRIF 马来酸阿法替尼片 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170135 | Pradaxa 达比加群酯胶囊 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170136 | Pradaxa 达比加群酯胶囊 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170138 | Pradaxa 达比加群酯胶囊 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170148 | Pradaxa 达比加群酯胶囊 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170149 | Pradaxa 达比加群酯胶囊 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170192 | GIOTRIF 马来酸阿法替尼片 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170193 | GIOTRIF 马来酸阿法替尼片 | 2031-03-11 | 2030-09-11 |
| 国药准字HJ20170163 | Trajenta Duo 利格列汀二甲双胍片(Ⅱ) | 2031-06-10 | 2030-12-10 |
| 国药准字HJ20170164 | Trajenta Duo 利格列汀二甲双胍片(Ⅱ) | 2031-06-10 | 2030-12-10 |
| 国药准字HJ20170165 | Trajenta Duo 利格列汀二甲双胍片(Ⅱ) | 2031-06-10 | 2030-12-10 |
| 国药准字HJ20170333 | Trajenta Duo 利格列汀二甲双胍片(Ⅱ) | 2031-06-10 | 2030-12-10 |
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.