Janssen-Cilag International NV — China drug registrations and re-registration deadlines
52 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HJ20171086 | Velcade 注射用硼替佐米 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20171087 | Velcade 注射用硼替佐米 | 2027-05-05 | 2026-11-05 |
| 国药准字HJ20230041 | Esketamine Hydrochloride Nasal Spray 盐酸艾司氯胺酮鼻喷雾剂 | 2028-04-16 | 2027-10-16 |
| 国药准字HJ20180020 | Invega Trinza 棕榈帕利哌酮酯注射液(3M) | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20180021 | Invega Trinza 棕榈帕利哌酮酯注射液(3M) | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20180022 | Invega Trinza 棕榈帕利哌酮酯注射液(3M) | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20180023 | Invega Trinza 棕榈帕利哌酮酯注射液(3M) | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20245003 | Paliperidone Palmitate Injection (6M) 棕榈帕利哌酮酯注射液(6M） | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20245004 | Paliperidone Palmitate Injection (6M) 棕榈帕利哌酮酯注射液(6M） | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20180078 | UPTRAVI 司来帕格片 | 2028-07-23 | 2028-01-23 |
| 国药准字HJ20180079 | UPTRAVI 司来帕格片 | 2028-07-23 | 2028-01-23 |
| 国药准字HJ20180080 | UPTRAVI 司来帕格片 | 2028-07-23 | 2028-01-23 |
| 国药准字HJ20180081 | UPTRAVI 司来帕格片 | 2028-07-23 | 2028-01-23 |
| 国药准字HJ20180083 | UPTRAVI 司来帕格片 | 2028-07-23 | 2028-01-23 |
| 国药准字HJ20180084 | UPTRAVI 司来帕格片 | 2028-07-23 | 2028-01-23 |
| 国药准字HJ20180085 | UPTRAVI 司来帕格片 | 2028-07-23 | 2028-01-23 |
| 国药准字HJ20230117 | Rilpivirine Injection 利匹韦林注射液 | 2028-10-17 | 2028-04-17 |
| 国药准字HJ20230119 | Rilpivirine Injection 利匹韦林注射液 | 2028-10-17 | 2028-04-17 |
| 国药准字SJ20170046 | Stelara 乌司奴单抗注射液 | 2028-12-13 | 2028-06-13 |
| 国药准字SJ20170047 | Stelara 乌司奴单抗注射液 | 2028-12-13 | 2028-06-13 |
| 国药准字SJ20255001 | Stelara 乌司奴单抗注射液 | 2028-12-13 | 2028-06-13 |
| 国药准字HJ20200029 | ERLEADA 阿帕他胺片 | 2029-06-17 | 2028-12-17 |
| 国药准字SJ20240025 | TECVAYLI 特立妥单抗注射液 | 2029-06-17 | 2028-12-17 |
| 国药准字SJ20240026 | TECVAYLI 特立妥单抗注射液 | 2029-06-17 | 2028-12-17 |
| 国药准字SJ20190044 | Tremfya 古塞奇尤单抗注射液 | 2029-09-01 | 2029-03-01 |
| 国药准字SJ20202004 | Tremfya 古塞奇尤单抗注射液 | 2029-09-01 | 2029-03-01 |
| 国药准字HJ20150264 | Zytiga 醋酸阿比特龙片 | 2029-10-07 | 2029-04-07 |
| 国药准字HJ20150410 | Zytiga 醋酸阿比特龙片 | 2029-10-07 | 2029-04-07 |
| 国药准字SJ20170050 | Simponi 戈利木单抗注射液 | 2029-10-09 | 2029-04-09 |
| 国药准字SJ20202003 | Simponi 戈利木单抗注射液 | 2029-10-09 | 2029-04-09 |
| 国药准字HJ20240110 | Niraparib Tosylate and Abiraterone Acetate Tablets 尼拉帕利阿比特龙片 | 2029-10-15 | 2029-04-15 |
| 国药准字HJ20240111 | Niraparib Tosylate and Abiraterone Acetate Tablets 尼拉帕利阿比特龙片 | 2029-10-15 | 2029-04-15 |
| 国药准字HJ20170374 | INVOKANA 卡格列净片 | 2029-12-30 | 2029-06-30 |
| 国药准字HJ20170375 | INVOKANA 卡格列净片 | 2029-12-30 | 2029-06-30 |
| 国药准字HJ20250007 | BALVERSA 厄达替尼片 | 2030-01-07 | 2029-07-07 |
| 国药准字HJ20250008 | BALVERSA 厄达替尼片 | 2030-01-07 | 2029-07-07 |
| 国药准字HJ20250009 | BALVERSA 厄达替尼片 | 2030-01-07 | 2029-07-07 |
| 国药准字SJ20200005 | Stelara 乌司奴单抗注射液（静脉输注） | 2030-01-14 | 2029-07-14 |
| 国药准字SJ20250003 | TALVEY 塔奎妥单抗注射液 | 2030-02-07 | 2029-08-07 |
| 国药准字SJ20250004 | TALVEY 塔奎妥单抗注射液 | 2030-02-07 | 2029-08-07 |
| 国药准字SJ20250005 | RYBREVANT 埃万妥单抗注射液 | 2030-02-07 | 2029-08-07 |
| 国药准字SJ20250006 | Guselkumab Injection (Intravenous Infusion) 古塞奇尤单抗注射液（静脉输注） | 2030-02-19 | 2029-08-19 |
| 国药准字HJ20170376 | Opsumit 马昔腾坦片 | 2030-07-21 | 2030-01-21 |
| 国药准字HJ20250092 | LAZCLUZE 甲磺酸兰泽替尼片 | 2030-07-28 | 2030-01-28 |
| 国药准字SJ20250025 | Tremfya 古塞奇尤单抗注射液 | 2030-11-11 | 2030-05-11 |
| 国药准字SJ20250028 | RYBREVANT FASPRO 埃万妥单抗注射液（皮下注射） | 2030-12-21 | 2030-06-21 |
| 国药准字SJ20250029 | RYBREVANT FASPRO 埃万妥单抗注射液（皮下注射） | 2030-12-21 | 2030-06-21 |
| 国药准字HJ20260015 | Macitentan and Tadalafil Tablets（II） 马昔腾坦他达拉非片（II） | 2031-01-26 | 2030-07-26 |
| 国药准字HJ20260016 | Macitentan and Tadalafil Tablets（I） 马昔腾坦他达拉非片（I） | 2031-01-26 | 2030-07-26 |
| 国药准字HJ20181217 | DACOGEN 注射用地西他滨 | 2031-02-01 | 2030-08-01 |
| 国药准字SJ20260033 | IMAAVY 尼卡利单抗注射液 | 2031-05-18 | 2030-11-18 |
| 国药准字SJ20260034 | IMAAVY 尼卡利单抗注射液 | 2031-05-18 | 2030-11-18 |
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.